Porous Core/Dense Shell PLA Microspheres Embedded with High Drug Loading of Bupivacaine Crystals for Injectable Prolonged Release - Jinghua Xu; Yanjie Bai; Xuehui Li; Zhenping Wei; Lu Sun; Hongdan Yu; Hui Xu (AAPS PharmSciTech, 2021)

Development of an RTD-Based Flowsheet Modeling Framework for the Assessment of In-Process Control Strategies - Geng Tian; Abdollah Koolivand; Zongyu Gu; Michael Orella; Ryan Shaw; Thomas F. O’Connor (AAPS PharmSciTech, 2021)

pH-Independent Dissolution and Enhanced Oral Bioavailability of Aripiprazole-Loaded Solid Self-microemulsifying Drug Delivery System - Sundar Mahajan; Dilpreet Singh; Rashi Sharma; Gurdeep Singh; Neena Bedi (AAPS PharmSciTech, 2021)

Preparation and Biological Property Evaluation of Novel Cationic Lipid-Based Liposomes for Efficient Gene Delivery - Yunchun Zhao; Haili Zheng; Xiaorong Wang; Xiaoling Zheng; Yongquan Zheng; Yue Chen; Weidong Fei; Jiahuan Zhu; Wenxi Wang; Caihong Zheng (AAPS PharmSciTech, 2021)

Development, In Vitro and In Vivo Evaluation of Racecadotril Orodispersible Films for Pediatric Use - Bing Wang; Liuliu Yang; Bing Wang; Chunlin Luo; Yuhan Wang; Hao Wang; Fang Chen; Xiaoqiang Xiang (AAPS PharmSciTech, 2021)

Optimization of Critical Quality Attributes in Tablet Film Coating and Design Space Determination Using Pilot-Scale Experimental Data - Huolong Liu; Robert Meyer; Matthew Flamm; Laura Wareham; Matthew Metzger; Anthony Tantuccio; Seongkyu Yoon (AAPS PharmSciTech, 2021)

Evaluation of Drug Dissolution Rate in Co-amorphous and Co-crystal Binary Drug Delivery Systems by Thermodynamic and Kinetic Methods - Chunhui Hu; Fabin Zhang; Haining Fan (AAPS PharmSciTech, 2021)

Comparative Evaluation of Pellet Cushioning Agents by Various Imaging Techniques and Dissolution Studies - Konrád Sántha; Nikolett Kállai-Szabó; Viktor Fülöp; Géza Jakab; Péter Gordon; Barnabás Kállai-Szabó; Emese Balogh; István Antal (AAPS PharmSciTech, 2021)
Most of the commercially available pharmaceutical products for oral administration route are marketed in the tablet dosage forms. However, compression of multiparticulate systems is a challenge for the pharmaceutical research and industry, especially if the individual unit is a coated particle, as the release of the active ingredient depends on the integrity of the coating. In the present study, polymer-coated pellets tableted with different types of excipients (powder, granules, pellets) then were investigated by various tablet-destructive (microscopic) and tablet non-destructive (microfocus X-ray; microCT) imaging methods. The information obtained from the independent evaluation of the in vitro drug release profiles model is confirmed by the results obtained by image analysis, regardless of whether X-ray or stereomicroscopic images of the coated, tableted pellets were used for image analysis. The results of this study show that the novel easy-to-use, fast, and non-destructive MFX method is a good alternative to the already used microscopic image analysis methods regarding the characterization of particulates, compressed into tablets.

Correction to: A Novel Eutectic-Based Transdermal Delivery System for Risperidone - Faisal Al-Akayleh; Samer Adwan; Mai Khanfar; Nasir Idkaidek; Mayyas Al-Remawi (AAPS PharmSciTech, 2021)

Correction to: Treatment of Brucellosis in Guinea Pigs via a Combination of Engineered Novel pH-Responsive Curcumin Niosome Hydrogel and Doxycycline-Loaded Chitosan–Sodium Alginate Nanoparticles: an In Vitro and In Vivo Study - Fatma I. Abo El-Ela; Khaled H. Hussein; Hossny A. El-Banna; Amr Gamal; Sherin Rouby; Ahmed M. S. Menshawy; El-Shaymaa El-Nahass; Shehata Anwar; Mohamed M. A. Zeinhom; Heba F. Salem; Marawa Ahmed Yahia Al-Sayed; Hala A. El-Newery; et al. (AAPS PharmSciTech, 2021)

Quantitative Chemical Profiling of Commercial Glyceride Excipients via 1H NMR Spectroscopy - Isha Saraf; Varun Kushwah; Hansjoerg Weber; Dattatray Modhave; Thean Yeoh; Amrit Paudel (AAPS PharmSciTech, 2021)
Glycerides are the main components of oils, and fats, used in formulated products in the food and cosmetic industry as well as in the pharmaceutical product industry. However, there is limited literature available on the analysis of the chemical composition of glycerides. The lack of a suitable analytical method for complete chemical profiling of glycerides is one of the bottlenecks in understanding and controlling the change in chemical composition during processing, formulation, and storage. Thus, the aim of the present study is to develop a calibration-free quantitative proton nuclear magnetic resonance (qHNMR) method for the simultaneous quantification of different components of glycerides. The qHNMR method was developed for the quantification of mono-, di-, and triglycerides; their positional isomers; free fatty acids; and glycerol content. The accuracy, precision, and robustness of the developed method were evaluated and were found suitable for the quantitative analysis of five batches of marketed excipient. The study demonstrates the potential of qHNMR method for the quantification of different components of glycerides in various marketed products. The method has the ability to identify the variability of glycerides among different batches and suppliers in terms of chemical composition and also to discern the changes during storage.

Validating a Numerical Simulation of the ConsiGma(R) Coater - Peter Boehling; Dalibor Jacevic; Frederik Detobel; James Holman; Laura Wareham; Matthew Metzger; Johannes G. Khinast (AAPS PharmSciTech, 2021)
Continuous manufacturing is increasingly used in the pharmaceutical industry, as it promises to deliver better product quality while simultaneously increasing production flexibility. GEA developed a semi-continuous tablet coater which can be integrated into a continuous tableting line, accelerating the switch from traditional batch production to the continuous mode of operation. The latter offers certain advantages over batch production, e.g. , operational flexibility, increased process/product quality, and decreased cost. However, process understanding is the key element for process control. In this regard, computational tools can improve the fundamental understanding and process performance, especially those related to new processes, such as continuous tablet coating where process mechanics remain unclear. The discrete element method (DEM) and computational fluid dynamics (CFD) are two methods that allow transition from empirical process design to a mechanistic understanding of the individual process units. The developed coupling model allows to track the heat, mass, and momentum exchange between the tablet and fluid phase. The goal of this work was to develop and validate a high-fidelity CFD-DEM simulation model of the tablet coating process in the GEA ConsiGma® coater. After the model development, simulation results for the tablet movement, coating quality, and heat and mass transfer during the coating process were validated and compared to the experimental outcomes. The experimental and simulation results agreed well on all accounts measured, indicating that the model can be used in further studies to investigate the operating space of the continuous tablet coating process.

Overdose and Alcohol Sensitive Immediate Release System (OASIS) for Deterring Accidental Overdose or Abuse of Drugs - Manali Patki; Siddhant Palekar; Pavan Kumar Nukala; Richa Vartak; Ketankumar Patel (AAPS PharmSciTech, 2021)

Shear-Thinning Viscous Materials for Subconjunctival Injection of Microparticles - Shiyu Xia; Zheng Ding; Lixia Luo; Baiwei Chen; Joanna Schneider; Jin Yang; Charles G. Eberhart; Walter J. Stark; Qingguo Xu (AAPS PharmSciTech, 2021)

Novel Coating Uniformity Models for Tablet Pan Coaters - Michael Choi; Stuart C. Porter; Betsy Macht; Axel Meisen (AAPS PharmSciTech, 2021)

Patient-Friendly, Olfactory-Targeted, Stimuli-Responsive Hydrogels for Cerebral Degenerative Disorders Ensured > 400% Brain Targeting Efficiency in Rats - Noha Nafee; Abd El Rahman Ameen; Osama Y. Abdallah (AAPS PharmSciTech, 2021)

Development of a Highly Water-Soluble Lycopene Cyclodextrin Ternary Formulation by the Integrated Experimental and Modeling Techniques - Yan Ma; Liuting Zhong; Zhuo Peng; Xinyang Liu; Defang Ouyang; Shixia Guan (AAPS PharmSciTech, 2021)

A Novel Eutectic-Based Transdermal Delivery System for Risperidone - Faisal Al-Akayleh; Samer Adwan; Mai Khanfar; Nasir Idkaidek; Mayyas Al-Remawi (AAPS PharmSciTech, 2021)

Mechanistic Modeling of Wet Stirred Media Milling for Production of Drug Nanosuspensions - E. Bilgili; G. Guner (AAPS PharmSciTech, 2021)

Transdermal Delivery of Salmon Calcitonin Using a Dissolving Microneedle Array: Characterization, Stability, and In vivo Pharmacodynamics - Lu Zhang; Yingying Li; Fang Wei; Hang Liu; Yushuai Wang; Weiman Zhao; Zhiyong Dong; Tao Ma; Qingqing Wang (AAPS PharmSciTech, 2021)

Mechanistic Approaches of Internalization, Subcellular Trafficking, and Cytotoxicity of Nanoparticles for Targeting the Small Intestine - Asadullah Madni; Sadia Rehman; Humaira Sultan; Muhammad Muzamil Khan; Faiz Ahmad; M. Rafi Raza; Nadia Rai; Farzana Parveen (AAPS PharmSciTech, 2020)

Contrastive Studies of Cytarabine/Daunorubicin Dual-Loaded Liposomes Prepared by pH Gradient and Cu2+ Gradient Method - Jiaoyang Zhang; Lingli Zhou; Yu Zhang; Haibing He; Tian Yin; Jingxin Gou; Yanjiao Wang; Xing Tang (AAPS PharmSciTech, 2020)

Treatment of Brucellosis in Guinea Pigs via a Combination of Engineered Novel pH-Responsive Curcumin Niosome Hydrogel and Doxycycline-Loaded Chitosan–Sodium Alginate Nanoparticles: an In Vitro and In Vivo Study - Fatma I. Abo El-Ela; Khaled H. Hussein; Hossny A. El-Banna; Amr Gamal; Sherin Rouby; Ahmed M. S. Menshawy; EL-Shimaa EL-Nahass; Shehata Anwar; Mohamed M. A. Zeinhom; Heba F. Salem; Marawa Ahmed Yahia Al-Sayed; Hala A. El-Newery; et al. (AAPS PharmSciTech, 2020)

Acid-Liable Cleavage of Doxorubicin@Plunoric-Carbon Dots in Multiplexed Bioimaging and Drug Delivery - Eepsita Priyadarshini; Paulraj Rajamani (AAPS PharmSciTech, 2020)

Fabrication, Physical Characterizations, and In Vitro, In Vivo Evaluation of Ginger Extract-Loaded Gelatin/Poly(Vinyl Alcohol) Hydrogel Films Against Burn Wound Healing in Animal Model - Barkat Ali Khan; Shahid Ullah; Muhammad Khalid Khan; Bushra Uzair; Farid Menaa; Valdir A. Braga (AAPS PharmSciTech, 2020)

Enhanced Stability of the Pharmacologically Active Lactone Form of 10-Hydroxycamptothecin by Self-Microemulsifying Drug Delivery Systems - Ruiming Li; Yong Wang; Qiang Yang; Baolong Lai; Xie Zhou; Min Feng (AAPS PharmSciTech, 2020)

Nanostructure of DiR-Loaded Solid Lipid Nanoparticles with Potential Bioimaging Functions - Lei Shu; Fangqin Fu; Zhengwei Huang; Ying Huang; Ping Hu; Xin Pan (AAPS PharmSciTech, 2020)

Preparation of Gastro-retentive Tablets Employing Controlled Superporous Networks for Improved Drug Bioavailability - Thi Ngoc Le; Jaewon Her; Taehoon Sim; Chan Eun Jung; Jin Kook Kang; Kyung Taek Oh (AAPS PharmSciTech, 2020)

Thermally Conductive Excipient Expands KinetiSol® Processing Capabilities - Daniel A. Davis; Dave A. Miller; Yongchao Su; Robert O. Williams (AAPS PharmSciTech, 2020)

Molecular Mobility and Crystal Growth in Amorphous Binary Drug Delivery Systems: Effects of Low-Concentration Poly(Ethylene Oxide) - Qin Shi; Jin Cheng; Fang Li; Jia Xu; Chen Zhang (AAPS PharmSciTech, 2020)

Development and Evaluation of Astaxanthin as Nanostructure Lipid Carriers in Topical Delivery - Qiang Geng; Yuming Zhao; Lu Wang; Lulu Xu; Xiong Chen; Jing Han (AAPS PharmSciTech, 2020)

Effects of Borneol on the Release of Compound Danshen Colon-Specific Osmotic Pump Capsule In Vitro and Pharmacokinetics Study in Beagle Dogs - Liangyu Shao; Chaojie Sun; Wenjie Lu; Jiayi Chen; Dan Su; Song Gao; Shengqi Chen; Wenyou Fang; Yu Liu; Bin Wang; Rongfeng Hu (AAPS PharmSciTech, 2020)

Paclitaxel-Loaded Colloidal Silica and TPGS-Based Solid Self-Emulsifying System Interferes Akt/mTOR Pathway in MDA-MB-231 and Demonstrates Anti-tumor Effect in Syngeneic Mammary Tumors - Jaya Gopal Meher; Shivani Dixit; Yuvraj Singh; Vivek K. Pawar; Rituraj Konwar; Ravi Saklani; Manish K. Chourasia (AAPS PharmSciTech, 2020)

Modeling Drying Behavior of an Aqueous Chitosan Single Droplet Using the Reaction Engineering Approach - Belal Al Zaitone; Abdulrahim Al-Zahrani (AAPS PharmSciTech, 2020)

Fabrication, Optimization, and In Vitro and In Vivo Characterization of Intra-vitreal Implant of Budesonide Generally Made of PHBV - Zahra Mohtashami; Hamid Akbari Javar; Morteza Rafiee Tehrani; Mohammad Riazi Esfahani; Ramak Roohipour; Leila Aghajanpour; Fahimeh Asadi Amoli; Molood Alsadat Vakilinezhad; Farid A. Dorkoosh (AAPS PharmSciTech, 2020)

Oleosomes Encapsulating Sildenafil Citrate as Potential Topical Nanotherapy for Palmar Plantar Erythrodysesthesia with High Ex vivo Permeation and Deposition - Lamiaa R. Abdelalim; Yosra S. R. Elnaggar; Ossama Y. Abdallah (AAPS PharmSciTech, 2020)

Development of Photoprotective Formulations Containing Nanostructured Lipid Carriers: Sun Protection Factor, Physical-Mechanical and Sensorial Properties - Elisa C. Felippim; Priscyla D. Marcato; Patrícia Maria Berardo Gonçalves Maia Campos (AAPS PharmSciTech, 2020)

Innovations in Thermal Processing: Hot-Melt Extrusion and KinetiSol® Dispersing - Deck Khong Tan; Daniel A. Davis; Dave A. Miller; Robert O. Williams; Ali Nokhodchi (AAPS PharmSciTech, 2020)
Thermal processing has gained much interest in the pharmaceutical industry, particularly for the enhancement of solubility, bioavailability, and dissolution of active pharmaceutical ingredients (APIs) with poor aqueous solubility. Formulation scientists have developed various techniques which may include physical and chemical modifications to achieve solubility enhancement. One of the most commonly used methods for solubility enhancement is through the use of amorphous solid dispersions (ASDs). Examples of commercialized ASDs include Kaletra®, Kalydeco®, and Onmel®. Various technologies produce ASDs; some of the approaches, such as spray-drying, solvent evaporation, and lyophilization, involve the use of solvents, whereas thermal approaches often do not require solvents. Processes that do not require solvents are usually preferred, as some solvents may induce toxicity due to residual solvents and are often considered to be damaging to the environment. The purpose of this review is to provide an update on recent innovations reported for using hot-melt extrusion and KinetiSol® Dispersing technologies to formulate poorly water-soluble APIs in amorphous solid dispersions. We will address development challenges for poorly water-soluble APIs and how these two processes meet these challenges.

Overview of Extensively Employed Polymeric Carriers in Solid Dispersion Technology - Athira R. Nair; Yarlagadda Dani Lakshman; Vullendula Sai Krishna Anand; K. S. Navya Sree; Krishnamurthy Bhat; Swapnil J. Dengale (AAPS PharmSciTech, 2020)
Solid dispersion is the preferred technology to prepare efficacious forms of BCS class-II/IV APIs. To prepare solid dispersions, there exist a wide variety of polymeric carriers with interesting physicochemical and thermochemical characteristics available at the disposal of a formulation scientist. Since the advent of the solid dispersion technology in the early 1960s, there have been more than 5000 scientific papers published in the subject area. This review discusses the polymeric carrier properties of most extensively used polymers PVP, Copovidone, PEG, HPMC, HPMCAS, and Soluplus® in the solid dispersion technology. The literature trends about preparation techniques, dissolution, and stability improvement are analyzed from the Scopus® database to enable a formulator to make an informed choice of polymeric carrier. The stability and extent of dissolution improvement are largely dependent upon the type of polymeric carrier employed to formulate solid dispersions. With the increasing acceptance of transfer dissolution setup in the research community, it is required to evaluate the crystallization/precipitation inhibition potential of polymers under dynamic pH shift conditions. Further, there is a need to develop a regulatory framework which provides definition and complete classification along with necessarily recommended studies to characterize and evaluate solid dispersions.

Polymeric Nanoparticle Versus Liposome Formulations: Comparative Physicochemical and Metabolomic Studies as l-Carnitine Delivery Systems - Merve Yaşacan; Açelya Erikçi; Cemil Can Eylem; Samiye Yabanoğlu Çiftçi; Emirhan Nemutlu; Kezban Ulubayram; İpek Eroğlu (AAPS PharmSciTech, 2020)

Latanoprost Loaded in Polymeric Nanocapsules for Effective Topical Treatment of Alopecia - Ana Christina S. Oliveira; Paula M. Oliveira; Marcilio Cunha-Filho; Tais Gratieri; Guilherme M. Gelfuso (AAPS PharmSciTech, 2020)

In Vitro Cytotoxicity and Cellular Uptake of Tamoxifen Citrate-Loaded Polymeric Micelles - Mohamed Nasr; Fahima Hashem; Raghda Abdelmoniem; Norhan Tantawy; Mohamed Teiama (AAPS PharmSciTech, 2020)

Design of Pegylated-Nanocapsules to Diphenyl Diselenide Administration: In Vitro Evidence of Hemocompatible and Selective Antiglioma Formulation - Luana Mota Ferreira; Marcel Henrique Marcondes Sari; Verônica Ferrari Cervi; Vinícius Costa Prado; Jessica Mendes Nadal; Juliana Hofstatter Azambuja; Elita Ferreira da Silveira; Cristina Wayne Nogueira; Paulo Vitor Farago; Elizandra Braganhol; Letícia Cruz (AAPS PharmSciTech, 2020)

Co-Delivery of Hispolon and Doxorubicin Liposomes Improves Efficacy Against Melanoma Cells - Ahmed Al Saqr; Mohammed F. Aldawsari; Hamad Alrbyawi; Ishwor Poudel; Manjusha Annaji; Vanisree Mulabagal; Modukuri V. Ramani; Subbaraju Gottumukkala; Amit K. Tiwari; Muralikrishnan Dhanasekaran; Peter R. Panizzi; Robert D. Arnold; et al. (AAPS PharmSciTech, 2020)

Development of Chlorhexidine Digluconate and Lippia sidoides Essential Oil Loaded in Microemulsion for Disinfection of Dental Root Canals: Substantivity Profile and Antimicrobial Activity - Marcondes Cavalcante Santana Neto; Marina Lua Vieira de Abreu Costa; Paulo Henrique da Silva Fialho; Glaucia Lais Nunes Lopes; Kayo Alves Figueiredo; Iluska Martins Pinheiro; Sidney Gonçalo de Lima; Rogéria de Souza Nunes; Patrick Veras Quelemes; André Luis Menezes Carvalho (AAPS PharmSciTech, 2020)

Correction to: Preparation and Evaluation of Cubic Nanoparticles for Improved Transdermal Delivery of Propranolol Hydrochloride - Lingjun Zeng; Chun Tao; Zhihong Liu; Jing Zhang; Minxin Zhang; Jialiang Zhang; Shengnan Fang; Xiaoyu Ma; Hongtao Song; Xin Zhou (AAPS PharmSciTech, 2020)

Performance Evaluation of a High-Precision Low-Dose Powder Feeder - Sara Fathollahi; Stephan Sacher; M. Sebastian Escotet-Espinoza; James DiNunzio; Johannes G. Khinast (AAPS PharmSciTech, 2020)
Highly potent active pharmaceutical ingredients (APIs) and low-dose excipients, or excipients with very low density, are notoriously hard to feed with currently available commercial technology. The micro-feeder system presented in this work is capable of feeding low-dose rates of powders with different particle sizes and flow properties. Two different grades of lactose, di-calcium phosphate, croscarmellose sodium, silicon dioxide, a spray-dried intermediate, and an active ingredient were studied to vary material properties to test performance of the system. The current micro-feeder system is a volumetric feeder combined with a weighing balance at the outlet that measures feeder output rates. Feeding results are shown as a so-called “displacement-feed factor” curve for each material. Since the powder mass and volume are known in the micro-feeder system, in this work, we characterized an observed density variation during processing via a “displacement-feed factor” profile for each of the fed powders. This curve can be later used for calibrating the system to ensure an accurate, constant feed rate and in addition predicting feeding performance for that material at any feed rate. There is a relation between powder properties and feeding performance. Powders with finer particles and higher compressibility show densification during their feeding process. However, powders with larger particles and lower compressibility show both “densification” and “powder bed expansion,” which is the manifestation of dilation and elastic recovery of particles during the micro-feeding process. Through the application of the displacement-feed factor, it is possible to provide precise feeding accuracy of low-dose materials. Graphical abstract

The Contribution of PEG Molecular Weights in PEGylated Emulsions to the Various Phases in the Accelerated Blood Clearance (ABC) Phenomenon in Rats - Jiao Jiao; Xiaoqin Jiao; Chunling Wang; Liting Wei; Gaofeng Wang; Yihui Deng; Yanzhi Song (AAPS PharmSciTech, 2020)

Targeted and Combined TPCA-1-Gold Nanocage Therapy for In Vivo Treatment of Inflammatory Arthritis - Ziyi Wang; Jing Yang; Yang Yang; Xiaorong Pu; Jingnan Zhao; Nan Zhang (AAPS PharmSciTech, 2020)

Lipid Nanoparticles Improve the Uptake of α-Asarone Into the Brain Parenchyma: Formulation, Characterization, In Vivo Pharmacokinetics, and Brain Delivery - Prakash Ramalingam; Palanivel Ganesan; D. S. Prabakaran; Pardeep K. Gupta; Sriramakamal Jonnalagadda; Karthivashan Govindarajan; Revuri Vishnu; Kalaiselvi Sivalingam; Srushti Sodha; Dong-Kug Choi; Young Tag Ko (AAPS PharmSciTech, 2020)

Docetaxel Loaded Pomegranate Seed Oil Based Nanostructured Lipid Carriers: A Potential Alternative to Current Formulation - Swapnil S. Talkar; Prachi B. Kharkar; Vandana B. Patravale (AAPS PharmSciTech, 2020)

Formulation and Pharmacokinetic Evaluation of a Drug-in-Adhesive Patch for Transdermal Delivery of Koumine - Yanping Su; Wenxiang Lu; Xiaoling Fu; Ying Xu; Lixiang Ye; Jian Yang; Huihui Huang; Changxi Yu (AAPS PharmSciTech, 2020)

Development of Aggregation-Caused Quenching Probe-Loaded Pressurized Metered-Dose Inhalers with Fluorescence Tracking Potentials - Wenhua Wang; Zhengwei Huang; Ke Xue; Jiaye Li; Wenhao Wang; Jingyi Ma; Cheng Ma; Xuequn Bai; Ying Huang; Xin Pan; Chuanbin Wu (AAPS PharmSciTech, 2020)

Bigger or Smaller? Size and Loading Effects on Nanoparticle Uptake Efficiency in the Nasal Mucosa - Mohammed A. Albarki; Maureen D. Donovan (AAPS PharmSciTech, 2020)

The Impact of Science-Unbased Measures Against COVID-19 in Clinical Decision-Making Process - João Vitor Cândido Pimentel; Thaíse Duarte Onofre Sabiá e Silva; Ana Beatriz Tavares Filgueiras; Modesto Leite Rolim Neto (AAPS PharmSciTech, 2020)

Coarse-Grained Molecular Dynamics (CG-MD) Simulation of the Encapsulation of Dexamethasone in PSS/PDDA Layer-by-Layer Assembled Polyelectrolyte Nanocapsules - Daniel P. Otto; Melgardt M. de Villiers (AAPS PharmSciTech, 2020)

Nanodelivery of Resveratrol-Loaded PLGA Nanoparticles for Age-Related Macular Degeneration - Priyanka Bhatt; Gulimirerouzi Fnu; Deepak Bhatia; Amna Shahid; Vijaykumar Sutariya (AAPS PharmSciTech, 2020)

Transbuccal Delivery of Isoniazid: Ex Vivo Permeability and Drug-Surfactant Interaction Studies - Roselene Kroth; Débora Fretes Argenta; Julia Conte; Beatriz Ribeiro Amaral; Thiago Caon (AAPS PharmSciTech, 2020)

Estimating Shelf Life Through Tolerance Intervals - James Schwenke; Michelle Quinlan; Walter Stroup; Patrick Forenzo (AAPS PharmSciTech, 2020)

Bemotrizinol-Loaded Carnauba Wax-Based Nanostructured Lipid Carriers for Sunscreen: Optimization, Characterization, and In vitro Evaluation - Thayse S. Medeiros; Lívia M. C. C. Moreira; Tiago M. T. Oliveira; Demis F. Melo; Eduardo P. Azevedo; Amanda E. G. Gadelha; Marcus V. L. Fook; João A. Oshiro-Júnior; Bolívar P. G. L. Damasceno (AAPS PharmSciTech, 2020)

PEGylated Lipid Polymeric Nanoparticle–Encapsulated Acyclovir for In Vitro Controlled Release and Ex Vivo Gut Sac Permeation - Syed Mahmood; Kong Chak Kiong; Chun Shern Tham; Tan Choo Chien; Ayah Rebhi Hilles; Jayarama Reddy Venugopal (AAPS PharmSciTech, 2020)

Analysis of Commercial Hand Sanitisers amid CoViD-19: Are We Getting the Products that We Need? - Alberto Berardi; Beniamino Cenci-Goga; Luca Grispoldi; Lina Cossignani; Diego Romano Perinelli (AAPS PharmSciTech, 2020)

Impact of Food and Drink Administration Vehicles on Paediatric Formulation Performance Part 2: Dissolution of Montelukast Sodium and Mesalazine Formulations - J. Martir; T. Flanagan; J. Mann; Nikoletta Fotaki (AAPS PharmSciTech, 2020)
Paediatric medicines are not always age-appropriate, causing problems with dosing, acceptability and adherence. The use of food and drinks as vehicles for medicine co-administration is common practice, yet the impact on drug bioavailability, safety and efficacy remains unaddressed. The aim of this study was to use in vitro dissolution testing, under infant simulating conditions, to evaluate the effect of co-administration with vehicles on the dissolution performance of two poorly soluble paediatric drugs. Dissolution studies of mesalazine and montelukast formulations were conducted with mini-paddle apparatus on a two-stage approach: simulated gastric fluid followed by addition of simulated intestinal fluid. The testing scenarios were designed to reflect daily administration practices: direct administration of formulation; formulation co-administered with food and drinks, both immediately after mixing and 4 h after mixing. Drug dissolution was significantly affected by medicine co-administration with vehicles, compared to the direct administration of formulation. Furthermore, differences were observed on drug dissolution when the formulations were mixed with different vehicles of the same subtype. The time between preparation and testing of the drug-vehicle mixture also impacted dissolution behaviour. Drug dissolution was shown to be significantly affected by the physicochemical properties and composition of the vehicles, drug solubility in each vehicle and drug/formulation characteristics. Ultimately, in this study, we show the potential of age-appropriate in vitro dissolution testing as a useful biopharmaceutical tool for estimating drug dissolution in conditions relevant to the paediatric population. The setup developed has potential to evaluate the impact of medicine co-administration with vehicles on paediatric formulation performance.

Emerging Trends in Topical Delivery of Curcumin Through Lipid Nanocarriers: Effectiveness in Skin Disorders - Tejashree Waghule; Srividya Gorantla; Vamshi Krishna Rapalli; Pranav Shah; Sunil Kumar Dubey; Ranendra Narayan Saha; Gautam Singhvi (AAPS PharmSciTech, 2020)

Formulation and Evaluation of Novel Hybridized Nanovesicles for Enhancing Buccal Delivery of Ciclopirox Olamine - Mona M. AbouSamra; Alaa H. Salama; Ghada E. A. Awad; Soheir S. Mansy (AAPS PharmSciTech, 2020)

In Vivo Predictive Dissolution Testing of Montelukast Sodium Formulations Administered with Drinks and Soft Foods to Infants - J. Martir; T. Flanagan; J. Mann; N. Fotaki (AAPS PharmSciTech, 2020)
In vitro dissolution testing conditions that reflect and predict in vivo drug product performance are advantageous, especially for the development of paediatric medicines, as clinical testing in this population is hindered by ethical and technical considerations. The aim of this study was to develop an in vivo predictive dissolution test in order to investigate the impact of medicine co-administration with soft food and drinks on the dissolution performance of a poorly soluble compound. Relevant in vitro dissolution conditions simulating the in vivo gastrointestinal environment of infants were used to establish in vitro - in vivo relationships with corresponding in vivo data. Dissolution studies of montelukast formulations were conducted with mini-paddle apparatus on a two-stage approach: infant fasted-state simulated gastric fluid (Pi-FaSSGF; for 1 h) followed by either infant fasted-state or infant fed-state simulated intestinal fluid (FaSSIF-V2 or Pi-FeSSIF, respectively; for 3 h). The dosing scenarios tested reflected in vivo paediatric administration practices: (i.) direct administration of formulation; (ii.) formulation co-administered with vehicles (formula, milk or applesauce). Drug dissolution was significantly affected by co-administration of the formulation with vehicles compared with after direct administration of the formulation. Montelukast dissolution from the granules was significantly higher under fed-state simulated intestinal conditions in comparison with the fasted state and was predictive of the in vivo performance when the granules are co-administered with milk. This study supports the potential utility of the in vitro biorelevant dissolution approach proposed to predict in vivo formulation performance after co-administration with vehicles, in the paediatric population.

Structure-Property Relationship of Amorphous Maltitol as Tableting Excipient - Franck Bourduche; Noelia M. Sanchez-Ballester; Bernard Bataille; Philippe Lefèvre; Tahmer Sharkawi (AAPS PharmSciTech, 2020)

Folate-Targeted Cholesterol-Grafted Lipo-Polymeric Nanoparticles for Chemotherapeutic Agent Delivery - Saurabh Sharma; Sudeep Sudesh Pukale; Deepak K. Sahel; Devesh S. Agarwal; Manu Dalela; Sujata Mohanty; Rajeev Sakhuja; Anupama Mittal; Deepak Chitkara (AAPS PharmSciTech, 2020)

Investigation of 1,2-Dimyristoyl-sn-Glycero-3-Phosphoglycerol-Sodium (DMPG-Na) Lipid with Various Metal Cations in Nanocochleate Preformulation: Application for Andrographolide Oral Delivery in Cancer Therapy - Raj J. Ahiwale; Bothiraja Chellampillai; Atmaram P. Pawar (AAPS PharmSciTech, 2020)

In Vitro and In Vivo Evaluation of SP94 Modified Liposomes Loaded with N-14NCTDA, a Norcantharimide Derivative for Hepatocellular Carcinoma-Targeting - Ying Jiang; Xiaolin Liu; Xinyi Tan; Ye Hou; Wanxiao Sun; Jingxin Gou; Tian Yin; Haibing He; Yu Zhang; Xing Tang (AAPS PharmSciTech, 2020)

Nanoparticulated Systems Based on Natural Polymers Loaded with Miconazole Nitrate and Lidocaine for the Treatment of Topical Candidiasis - G. Tejada; M. G. Barrera; P. García; M. Sortino; M. C. Lamas; V. Lassalle; V. Alvarez; D. Leonardi (AAPS PharmSciTech, 2020)

Correction to: Preparation and Characterization of Nanostructured Lipid Carriers for Improved Topical Drug Delivery: Evaluation in Cutaneous Leishmaniasis and Vaginal Candidiasis Animal Models - Amina Riaz; Sarah Hendrickx; Kimberley Elbrink; Guy Caljon; Louis Maes; Naveed Ahmed; Filip Kiekens; Gul Majid Khan (AAPS PharmSciTech, 2020)

Drug–Smectite Clay Amorphous Solid Dispersions Processed by Hot Melt Extrusion - Uttom Nandi; Md. S.H. Mithu; Andrew P. Hurt; Vivek Trivedi; Dennis Douroumis (AAPS PharmSciTech, 2020)

Production of Lysozyme-PLGA-Loaded Microparticles for Controlled Release Using Hot-Melt Extrusion - Susana Farinha; Cláudia Moura; Maria Diná Afonso; João Henriques (AAPS PharmSciTech, 2020)

An Overview of Drug Substance Manufacturing Processes - Noah J. Wichrowski; Adam C. Fisher; Nilou S. Arden; Xiaochuan Yang (AAPS PharmSciTech, 2020)

A Rapid Tool to Optimize Process Variables for Continuous Manufacturing of Metronidazole Ointment Using Melt Extrusion Technique - Srinivas Ajjarapu; Srinath Rangappa; Vijay Kumar Shankar; Abhishek Shettar; H.N. Shiva Kumar; Vijay I. Kulkarni; Micheal A Repka; S. Narasimha Murthy (AAPS PharmSciTech, 2020)

Use of Drug Release Testing to Evaluate the Retention of Abuse-Deterrent Properties of Polyethylene Oxide Matrix Tablets - Saikishore Meruva; Leyla Rezaei; Prajwal Thool; Maureen D. Donovan (AAPS PharmSciTech, 2020)

A Novel Nanoemulsion Intermediate Gel as a Promising Approach for Delivery of Itraconazole: Design, In Vitro and Ex Vivo Appraisal - Sara R. Botros; Amal K. Hussein; Heba F. Mansour (AAPS PharmSciTech, 2020)

Towards a Continuous Manufacturing Process of Protein-Loaded Polymeric Nanoparticle Powders - Stefan Schiller; Andrea Hanefeld; Marc Schneider; Claus-Michael Lehr (AAPS PharmSciTech, 2020)
To develop a scalable and efficient process suitable for the continuous manufacturing of poly(lactic-co-glycolic acid) (PLGA) nanoparticles containing ovalbumin as the model protein. PLGA nanoparticles were prepared using a double emulsification spray-drying method. Emulsions were prepared using a focused ultrasound transducer equipped with a flow cell. Either poly(vinyl alcohol) (PVA) or poloxamer 407 (P-407) was used as a stabilizer. Aliquots of the emulsions were blended with different matrix excipients and spray dried, and the yield and size of the resuspended nanoparticles was determined and compared against solvent displacement. Nanoparticle sizes of spray-dried PLGA/PVA emulsions were independent of the matrix excipient and comparable with sizes from the solvent displacement method. The yield of the resuspended nanoparticles was highest for emulsions containing trehalose and leucine (79%). Spray drying of PLGA/P-407 emulsions led to agglomerated nanoparticles independent of the matrix excipient. PLGA/P-407 nanoparticles pre-formed by solvent displacement could be spray dried with limited agglomeration when PVA was added as an additional stabilizer. A comparably high and economically interesting nanoparticle yield could be achieved with a process suitable for continuous manufacturing. Further studies are needed to understand the robustness of a continuous process at commercial scale.

Correction to: Bioavailability Enhancement of Olmesartan Medoxomil Using Hot-Melt Extrusion: In-Silico, In-Vitro, and In-Vivo Evaluation - Pankaj Jadhav; Vinod Gokarna; Vineeta Deshpande; Pradeep Vavia (AAPS PharmSciTech, 2020)

Influence of Polyvinyl Alcohol (PVA) on PVA-Poly-N-hydroxyethyl-aspartamide (PVA-PHEA) Microcrystalline Solid Dispersion Films - Zahra Al-Sahaf; Bahijja Raimi-Abraham; Mariano Licciardi; Laura Modica de Mohac (AAPS PharmSciTech, 2020)
This study was conducted to formulate buccal films consisting of polyvinyl alcohol (PVA) and poly- N -hydroxyethyl-aspartamide (PHEA), to improve the dissolution of the drug through the oral mucosa. Ibuprofen sodium salt was used as a model drug, and the buccal film was expected to enhance its dissolution rate. Two different concentrations of PVA (5% w/v and 7.5% w/v) were used. Solvent casting was used to prepare films, where a solution consisting of drug and polymer was cast and allowed to dry. Attenuated total reflection Fourier transform infrared spectroscopy (ATR-FTIR), differential scanning calorimetry (DSC), and scanning electron microscopy (SEM) were used to investigate the properties of films. In vitro dissolution studies were also conducted to investigate drug release. SEM studies showed that films containing a higher concentration of PVA had larger particles in microrange. FTIR studies confirmed the presence of the drug in films and indicated that ibuprofen sodium did not react with polymers. DSC studies confirmed the crystalline form of ibuprofen sodium when incorporated within films. In vitro dissolution studies found that the dissolution percentage of ibuprofen sodium alone was increased when incorporated within the film from 59 to 74%. This study led to the development of solid microcrystalline dispersion as a buccal film with a faster dissolution rate than the drug alone overcoming problem of poor solubility.

Preparation and Evaluation of Cubic Nanoparticles for Improved Transdermal Delivery of Propranolol Hydrochloride - Lingjun Zeng; Chun Tao; Zhihong Liu; Jing Zhang; Minxin Zhang; Jialiang Zhang; Shengnan Fang; Xiaoyu Ma; Hongtao Song; Xin Zhou (AAPS PharmSciTech, 2020)

Dual Asymmetric Centrifugation Efficiently Produces a Poloxamer-Based Nanoemulsion Gel for Topical Delivery of Pirfenidone - Eugene P. Chung; Adrienne R. Wells; Mia Mae Kiamco; Kai P. Leung (AAPS PharmSciTech, 2020)
This study used dual asymmetric centrifugation (DAC) to produce a topical vehicle for Pirfenidone (Pf; 5-methyl-1-phenyl-2[1H]-pyridone)—a Food and Drug Administration-approved antifibrotic drug indicated for idiopathic fibrosis treatment. Pf was loaded (8 wt%) in a poloxamer nanoemulsion gel (PNG) formulation consisting of water (47.8 wt%), triacetin (27.6 wt%), poloxamer 407 (P407, 13.8 wt%), polysorbate 80 (1.8 wt%), and benzyl alcohol (0.9 wt%). To our knowledge, poloxamer gels are typically processed with either high-shear methods or temperature regulation and have not been emulsified using DAC. Using a single-step emulsification process, 2 min mixed at 2500 RPM resulted in the lowest Pf loading variability with a relative standard deviation (RSD) of 0.96% for a 1.5 g batch size. Batch sizes of 15 g and 100 g yield higher RSD of 4.18% and 3.05%, respectively, but still in compliance with USP guidelines. Ex vivo permeation in full thickness porcine skin after 24 h showed total Pf permeation of 404.90 ± 67.07 μg/cm 2 . Tested in vitro on human dermal fibroblasts stimulated with transforming growth factor-beta 1 (TGF-β1), Pf-PNG resulted in a > 2 fold decrease in α-SMA expression over vehicle control demonstrating that formulated Pf retained its biological activity. One-month stability testing at 25°C/60% relative humidity (RH) and 40°C/75% RH showed that % drug content, release kinetics, and biological activity were largely unchanged for both conditions; however, pH decreased from 6.7 to 5.5 (25°C/60% RH) and 4.5 (40°C/75% RH) after 1 month. Overall, these data demonstrate the utility of DAC to rapidly and reproducibly prepare lab-scale batches of emulsified gels for pharmaceutical formulation development.

Preparation and Evaluation of Mebendazole Microemulsion for Intranasal Delivery: an Alternative Approach for Glioblastoma Treatment - Julio Mena-Hernández; Helgi Jung-Cook; Monserrat Llaguno-Munive; Patricia García-López; Adriana Ganem-Rondero; Simón López-Ramírez; Fernando Barragán-Aroche; Marisol Rivera-Huerta; Lourdes Mayet-Cruz (AAPS PharmSciTech, 2020)

Atorvastatin Solid Lipid Nanoparticles as a Promising Approach for Dermal Delivery and an Anti-inflammatory Agent - Seyed Sadegh Shahraeini; Jafar Akbari; Majid Saeedi; Katayoun Morteza-Semnani; Shidrokh Abootorabi; Milad Dehghanpoor; Seyyed Sohrab Rostamkalaei; Ali Nokhodchi (AAPS PharmSciTech, 2020)
In the current research, the main focus was to overcome dermal delivery problems of atorvastatin. To this end, atorvastatin solid lipid nanoparticles (ATR-SLNs) were prepared by ultra-sonication technique. The prepared SLNs had a PDI value of ≤ 0.5, and the particle size of nanoparticles was in the range 71.07 ± 1.72 to 202.07 ± 8.40 nm. It was noticed that, when the concentration of lipid in ATR-SLNs increased, the size of nanoparticles and drug entrapment efficiency were also increased. Results showed that a reduction in the HLB of surfactants used in the preparation of SLN caused an increase in the particle size, zeta potential (better stability), and drug entrapment efficiency. Despite Tween and Span are non-ionic surfactants, SLNs containing these surfactants showed a negative zeta potential, and the absolute zeta potential increased when the concentration of Span 80 was at maximum. DSC thermograms, FTIR spectra, and x-ray diffraction (PXRD) pattern showed good incorporation of ATR in the nanoparticles without any chemical interaction . In vitro skin permeation results showed that SLN containing atorvastatin was capable of enhancing the dermal delivery of atorvastatin where a higher concentration of atorvastatin can be detected in skin layers. This is a hopeful promise which could be developed for clinical studies of the dermal delivery of atorvastatin nanoparticles as an anti-inflammatory agent.

Characterizing and Exploring the Differences in Dissolution and Stability Between Crystalline Solid Dispersion and Amorphous Solid Dispersion - Xiaolin Wang; Lu Zhang; Danyang Ma; Xing Tang; Yu Zhang; Tian Yin; Jingxin Gou; Yanjiao Wang; Haibing He (AAPS PharmSciTech, 2020)

Quality by Design Adapted Chemically Engineered Lipid Architectonics for HIV Therapeutics and Intervention: Contriving of Formulation, Appraising the In vitro Parameters and In vivo Solubilization Potential - Bushra Nabi; Saleha Rehman; Sumit Aggarwal; Sanjula Baboota; Javed Ali (AAPS PharmSciTech, 2020)

Autophagy-Inducing Inhalable Co-crystal Formulation of Niclosamide-Nicotinamide for Lung Cancer Therapy - Eupa Ray; Kalpesh Vaghasiya; Ankur Sharma; Rahul Shukla; Rehan Khan; Anil Kumar; Rahul Kumar Verma (AAPS PharmSciTech, 2020)

Efficiency of Different Treatment Regimens Combining Anti-tumor and Anti-inflammatory Liposomes for Metastatic Breast Cancer - Jingxuan Liu; Yuqing Sun; Xiao Liu; Yueying Yang; Andy Samuel Widjaya; Zhiguo Long; Yanyan Jiang (AAPS PharmSciTech, 2020)

A New Approach to Ex Vivo Permeation Studies in In-Situ Film-Forming Systems - Amanda F. Silva-Alvarez; Maíra P. Ferreira; Fabiana T. M. C. Vicentini; Vinicius Pedrazzi; Osvaldo de Freitas (AAPS PharmSciTech, 2020)

Development and Evaluation of Cucurbitacin B Microemulsion: the Effect of Oil Phase and Aqueous Phase on Drug Percutaneous Absorption Based on ATR-FTIR Spectroscopy and Molecular Modeling - Qi Tian; Jianbo Guo; Qi Zhang; Liang Fang; Chao Liu; Hui Xu (AAPS PharmSciTech, 2020)

Enhancing the Furosemide Permeability by Papain Minitablets Through a Triple Co-culture In Vitro Intestinal Cell Model - Fúlvio G. Corazza; Julia V. Ernesto; Felipe A. N. Nambu; Leandro A. Calixto; Gustavo H. C. Varca; Daniel P. Vieira; Vânia R. Leite-Silva; Newton Andréo-Filho; Patricia S. Lopes (AAPS PharmSciTech, 2020)

Design, Characterization, and Application of a pH-Triggered In Situ Gel for Ocular Delivery of Vinpocetine - Qun Ma; Rui Luo; Huimin Zhang; Manman Dai; Luyu Bai; Qingsong Fei; Fang Lei; Ning He (AAPS PharmSciTech, 2020)

Development of 3D-Printed Layered PLGA Films for Drug Delivery and Evaluation of Drug Release Behaviors - Ioannis Serris; Panagiotis Serris; Kathleen M. Frey; Hyunah Cho (AAPS PharmSciTech, 2020)

Bioavailability Enhancement of Olmesartan Medoxomil Using Hot-Melt Extrusion: In-Silico, In-Vitro, and In-Vivo Evaluation - Pankaj Jadhav; Vinod Gokarna; Vineeta Deshpande; Pradeep Vavia (AAPS PharmSciTech, 2020)

Lyophilization of Small-Molecule Injectables: an Industry Perspective on Formulation Development, Process Optimization, Scale-Up Challenges, and Drug Product Quality Attributes - Arun Butreddy; Narendar Dudhipala; Karthik Yadav Janga; Rajendra Prasad Gaddam (AAPS PharmSciTech, 2020)

Interfacial Stress and Container Failure During Freezing of Bulk Protein Solutions Can Be Prevented by Local Heating - Andreia Duarte; Pedro Rego; Aida Ferreira; Paulo Dias; Vítor Geraldes; Miguel A. Rodrigues (AAPS PharmSciTech, 2020)

Fabrication of Nanosuspensions to Improve the Oral Bioavailability of Total Flavones from Hippophae rhamnoides L. and their Comparison with an Inclusion Complex - Rui Tian; Hui Wang; Yi Xiao; Pengyue Hu; Ruofei Du; Xiufeng Shi; Zhengtao Wang; Yan Xie (AAPS PharmSciTech, 2020)

Development and Application of a Modified Method to Determine the Encapsulation Efficiency of Proteins in Polymer Matrices - Abdulkareem A. Alanezi; Steven H. Neau; Anil P. D’mello (AAPS PharmSciTech, 2020)

Correction to: the Effect of Cross-Linking Efficiency of Drug-Loaded Novel Freeze Gelated Chitosan Templates for Periodontal Tissue Regeneration - Syed Saad B. Qasim; Liebert Parreiras Nogueira; Amr S. Fawzy; Umer Daood (AAPS PharmSciTech, 2020)

Prefilled Cyclic Olefin Sterilized Syringes of Norepinephrine Injection Solution Do Not Need to Be Stabilized by Antioxidants - Karin H. M. Larmené- Beld; Stefan van Berkel; Rommert Wijnsma; Katja Taxis; Henderik W. Frijlink (AAPS PharmSciTech, 2020)
Norepinephrine is a potent α-sympathomimetic drug which plays an important role in the acute treatment of hypotension and shock. Commercially available norepinephrine solutions contain sodium metabisulfite (Na2S2O5) as an antioxidant. However, prefilled cyclic olefin polymer syringes are not compatible with sodium metabisulfite. The aim of this study was to develop a new formulation of 0.1-mg/mL norepinephrine solution without sodium metabisulfite which is chemically stable and sterile and can be stored in prefilled polymer syringes. Formulation studies were performed with 0.1-mg/mL norepinephrine solution with 0, 0.05, or 0.1% ascorbic acid added as antioxidant. The syringes were filled under nitrogen gassing, stored at 20 ± 5°C, and protected from daylight. Based on the formulation test results, the final formulation was defined and stability testing at 20 ± 5°C was performed measuring norepinephrine concentration, pH, clarity, color of the solution, subvisible particles, and sterility at time intervals up to 12 months. The norepinephrine concentrations at t = 22 weeks were 100.4%, 95.4%, and 92.2% for the formulations with no ascorbic acid and with 0.05% and 0.10% ascorbic acid, respectively. Three batches for the stability study were produced containing norepinephrine, sodium edetate, sodium chloride, and water for injections filled under nitrogen gassing and stored at 20 ± 5°C. Norepinephrine concentrations were respectively 98.8%, 98.6%, and 99.3% for batches 1, 2, and 3 at t = 12 months. It can be concluded that norepinephrine (0.1 mg/mL) solution without metabisulfite is stable for at least 12 months at room temperature when protected from daylight.

Fabrication of Taste-Masked Donut-Shaped Tablets Via Fused Filament Fabrication 3D Printing Paired with Hot-Melt Extrusion Techniques - Honghe Wang; Nagireddy Dumpa; Suresh Bandari; Thomas Durig; Michael A. Repka (AAPS PharmSciTech, 2020)

Core in Cup Ethylmorphine Hydrochloride Tablet for Dual Fast and Sustained Pain Relief: Formulation, Characterization, and Pharmacokinetic Study - Aliaa Nabil ElMeshad; Khaled M. Abdel-Haleem; Nabaweya A. Abdel Gawad; Mohamed Ahmed El-Nabarawi; Nermin M. Sheta (AAPS PharmSciTech, 2020)

Antimicrobial Activity of Schinopsis brasiliensis Engler Extract-Loaded Chitosan Microparticles in Oral Infectious Disease - Pedro Henrique Sette-de-Souza; Cleildo Pereira de Santana; Lucas Amaral-Machado; Marta Cristina Teixeira Duarte; Francinalva Dantas de Medeiros; Germano Veras; Ana Cláudia Dantas de Medeiros (AAPS PharmSciTech, 2020)

Evaluation of the Impacts of Formulation Parameters on the Pharmacokinetics and Bioequivalence of Risperidone Orodispersible Film: a Physiologically Based Pharmacokinetic Modeling Approach - Fang Chen; Hongrui Liu; Bing Wang; Zhou Yang; Yusheng Chen; Liuliu Yang; Bing Wang; Zheng Jiao; Hai-Shu Lin; Yingjun Quan; Hao Wang; Xiaoqiang Xiang (AAPS PharmSciTech, 2020)

Effect of Hydroxypropyl Cellulose Level on Twin-Screw Melt Granulation of Acetaminophen - Tongzhou Liu; Shubhajit Paul; Brian T Beeson; Johnny Alexander; Fengyuan Yang; Vivian Bi; Thomas Durig; Changquan Calvin Sun; Feng Zhang (AAPS PharmSciTech, 2020)

An Investigation into the Influence of Process Parameters and Formulation Variables on Compaction Properties of Liquisolid Systems - Ivana Aleksić; Ilija German Ilić; Sandra Cvijić; Jelena Parojčić (AAPS PharmSciTech, 2020)

Characterization and Evaluation of the Solubility and Oral Bioavailability of Rutin–Ethanolate Solvate - Yanjie Liu; Xiuhua Zhao; Qian Zhang; Lingling Wang; Yuanyuan Li; Yuanzuo Li (AAPS PharmSciTech, 2020)

Addressing the Need for Controls on Particle Bounce and Re-entrainment in the Cascade Impactor and for the Mitigation of Electrostatic Charge for Aerodynamic Particle Size Assessment of Orally Inhaled Products: an Assessment by the International Consortium on Regulation and Science (IPAC-RS) - William Doub; Stephen Stein; Jolyon Mitchell; Adrian P. Goodey (AAPS PharmSciTech, 2020)

Respiratory Tract: Structure and Attractions for Drug Delivery Using Dry Powder Inhalers - Nermeen A. ElKasabgy; Islam M. Adel; Mohamed F. Elmeligy (AAPS PharmSciTech, 2020)

Nanocrystals of Novel Valerolactam-Fenbendazole Hybrid with Improved in vitro Dissolution Performance - Maria Elisa Melian; Alejandro Paredes; Beatriz Munguía; Maximiliano Colobbio; Juan Carlos Ramos; Ramiro Teixeira; Eduardo Manta; Santiago Palma; Ricardo Faccio; Laura Domínguez (AAPS PharmSciTech, 2020)

Intractable Ocular Diseases and Treatment Progress - Xinru Zhang; Shuhan Li; Yue Tang; Yuzun Guo; Shuai Gao (AAPS PharmSciTech, 2020)

Lipid/Hyaluronic Acid–Coated Doxorubicin-Fe3O4 as a Dual-Targeting Nanoparticle for Enhanced Cancer Therapy - Jinying Liang; Xue Yang; Danmeng Liu; Mei Cong; Yu Song; Suping Bai (AAPS PharmSciTech, 2020)

Formulation Optimization of Selective Laser Sintering 3D-Printed Tablets of Clindamycin Palmitate Hydrochloride by Response Surface Methodology - Eman M. Mohamed; Sogra F. Barakh Ali; Ziyaur Rahman; Sathish Dharani; Tanil Ozkan; Mathew A. Kuttolamadom; Mansoor A. Khan (AAPS PharmSciTech, 2020)

Comparative Pharmacokinetics of Nimodipine in Rat Plasma and Tissues Following Intraocular, Intragastric, and Intravenous Administration - Fang Li; Qingsong Fei; Dan Mao; Qiaoyun Si; Manman Dai; Qun Ma; Huimin Zhang; Luyu Bai; Ning He (AAPS PharmSciTech, 2020)

Exploring Endolysin-Loaded Alginate-Chitosan Nanoparticles as Future Remedy for Staphylococcal Infections - Jasjeet Kaur; Avneet Kour; Jiban Jyoti Panda; Kusum Harjai; Sanjay Chhibber (AAPS PharmSciTech, 2020)

Matrix Vaginal Rings for Female Dogs—Effect of Altering Dimensions on Mechanical Properties and Dissolution Characteristics, and In vivo Safety Study - Veronika Nováková Tkadlečková; Veronika Pitronová; Kateřina Kubová; Sylvie Pavloková; Jan Elbl; Robert Novotný; David Vetchý; Jakub Vysloužil (AAPS PharmSciTech, 2020)

Development and In Vitro Evaluation of Long Circulating Liposomes for Targeted Delivery of Gemcitabine and Irinotecan in Pancreatic Ductal Adenocarcinoma - S. Deodhar; A. K. Dash; E. J. North; M. Hulce (AAPS PharmSciTech, 2020)

Erlotinib-Loaded Poly(ε-Caprolactone) Nanocapsules Improve In Vitro Cytotoxicity and Anticlonogenic Effects on Human A549 Lung Cancer Cells - Franciele Aline Bruinsmann; Julieti Huch Buss; Gabriele Dadalt Souto; Eduarda Schultze; Aline de Cristo Soares Alves; Fabiana Kömmling Seixas; Tiago Veiras Collares; Adriana Raffin Pohlmann; Silvia Stanisçuaski Guterres (AAPS PharmSciTech, 2020)

Assessment of Dose Proportionality of Rivaroxaban Nanocrystals - Huriye Demir; Tugba Gulsun; Melike Hacer Ozkan; Emirhan Nemutlu; Selma Sahin; Levent Öner (AAPS PharmSciTech, 2020)

In Vitro Evaluation of the Antibacterial Properties of Tea Tree Oil on Planktonic and Biofilm-Forming Streptococcus mutans - Yu-Meng Song; Hong-Yan Zhou; Ye Wu; Jue Wang; Qian Liu; Yu-Feng Mei (AAPS PharmSciTech, 2020)

Nobiletin as a Molecule for Formulation Development: An Overview of Advanced Formulation and Nanotechnology-Based Strategies of Nobiletin - Siddharth S. Kesharwani; Pooja Mallya; Vadikari Arun Kumar; Vikas Jain; Swagat Sharma; Surajit Dey (AAPS PharmSciTech, 2020)

The COVID-19 Vaccine Race: Challenges and Opportunities in Vaccine Formulation - Jieliang Wang; Ying Peng; Haiyue Xu; Zhengrong Cui; Robert O. Williams (AAPS PharmSciTech, 2020)

The Evaluations of Menthol and Propylene Glycol on the Transdermal Delivery System of Dual Drug–Loaded Lyotropic Liquid Crystalline Gels - Chunling Tian; Liu Liu; Mengqiu Xia; Xiao-qin Chu (AAPS PharmSciTech, 2020)

Enhancing the Hypolipidemic Effect of Simvastatin in Poloxamer-Induced Hyperlipidemic Rats via Liquisolid Approach: Pharmacokinetic and Pharmacodynamic Evaluation - Khalid M El-Say; Tarek A Ahmed; Osama A A Ahmed; Hanan Elimam (AAPS PharmSciTech, 2020)

3D Printing Technologies: Recent Development and Emerging Applications in Various Drug Delivery Systems - Shery Jacob; Anroop B. Nair; Vimal Patel; Jigar Shah (AAPS PharmSciTech, 2020)

Orphan Formulations for Pediatric Use: Development and Stability Control of Two Sildenafil Citrate Solutions for the Treatment of Pulmonary Hypertension - Mauro Morri; Cecilia Casabonne; Darío Leonardi; Silvana Vignaduzzo (AAPS PharmSciTech, 2020)

Diagnostic and Treatment Strategies for COVID-19 - Humzah Jamshaid; Fatima Zahid; Intisar ud Din; Alam Zeb; Han Gon Choi; Gul Majid Khan; Fakhar ud Din (AAPS PharmSciTech, 2020)

Development, Characterization and Evaluation of Parenteral Formulation of Diclofenac Sodium - Neha Panchal; Manjot Kaur; Abhay Tharmatt; Shubham Thakur; Subheet Kumar Jain (AAPS PharmSciTech, 2020)

Determining the Impact of Roller Compaction Processing Conditions on Granule and API Properties - James Clarke; John F. Gamble; John W. Jones; Mike Tobyn; Neil Dawson; Conrad Davies; Andrew Ingram; Richard Greenwood (AAPS PharmSciTech, 2020)

Augmented Therapeutic Efficacy of Naringenin Through Microemulsion-Loaded Sericin Gel Against UVB-Induced Photoaging - Poonam Parashar; Surabhi Pal; Monika Dwivedi; Shubhini A. Saraf (AAPS PharmSciTech, 2020)

Correction to: Employing Multivariate Statistics and Latent Variable Models to Identify and Quantify Complex Relationships in Typical Compression Studies - William C. Stagner; Abhay Jain; Antoine Al-Achi; Rahul V. Haware (AAPS PharmSciTech, 2020)

Construction of Inflammatory Directed Polymer Micelles and Its Application in Acute Lung Injury - Jisen Zhang; Meiling Su; Zongning Yin (AAPS PharmSciTech, 2020)

Electrospun Solid Formulation of Anaerobic Gut Microbiome Bacteria - Panna Vass; Eszter Pantea; András Domokos; Edit Hirsch; Júlia Domján; Áron Németh; Mónika Molnár; Csaba Fehér; Sune K. Andersen; Tamás Vigh; Geert Verreck; István Csontos; et al. (AAPS PharmSciTech, 2020)
A model anaerobic bacterium strain from the gut microbiome ( Clostridium butyricum ) producing anti-inflammatory molecules was incorporated into polymer-free fibers of a water-soluble cyclodextrin matrix (HP-β-CD) using a promising scaled-up nanotechnology, high-speed electrospinning. A long-term stability study was also carried out on the bacteria in the fibers. Effect of storage conditions (temperature, presence of oxygen) and growth conditions on the bacterial viability in the fibers was investigated. The viability of the sporulated anaerobic bacteria in the fibers was maintained during 12 months of room temperature storage in the presence of oxygen. Direct compression was used to prepare tablets from the produced bacteria-containing fibers after milling (using an oscillating mill) and mixing with tableting excipients, making easy oral administration of the bacteria possible. No significant decrease was observed in bacterial viability following the processing of the fibers (milling and tableting).

Comparison of Different Liquid and Semisolid Vehicles Selected for Oral Administration of Pellets and Minitablets with Diazepam: In Vitro Investigation - Hanna Kotlowska; Marta Szymanska; Malgorzata Sznitowska (AAPS PharmSciTech, 2020)
The acceptability and palatability of a dosage form are extremely important to improve patient compliance. Mixing oral solid dosage forms with food carriers is often necessary to ease swallowing and provide the taste-masking effect. The present research investigated how a liquid or semisolid carrier influences the disintegration time and drug dissolution rate of pellets and minitablets with diazepam. The disintegration of pellets and minitablets in liquid carriers (water, milk and apple juice) was determined using a texture analyser. Dissolution tests were performed for the dosage forms dispersed in gel vehicles (2% carmellose and 0.5% carbomer gels) or applesauce. The disintegration of minitablets in water and apple juice was fast (1 min), but it slowed to 3 and 5 min in milk and gel vehicles, respectively. The pellets disintegrated in liquid carriers within 3 min. The drug dissolution rate in 0.1 M HCl depended on the gel viscosity in this medium. The preserved high viscosity of a carmellose gel inhibited the dissolution of diazepam. On the other hand, the viscosity of the carbomer gel decreased rapidly, and in effect, the dissolution rate of diazepam from the incorporated pellets or minitablets was comparable to the dissolution from loose pellets or minitablets.

Catechol-Functionalized Alginate Nanoparticles as Mucoadhesive Carriers for Intravesical Chemotherapy - Nitjawan Sahatsapan; Tanasait Ngawhirunpat; Theerasak Rojanarata; Praneet Opanasopit; Prasopchai Patrojanasophon (AAPS PharmSciTech, 2020)

Formulation Development, Characterization, and Evaluation of a Novel Dexibuprofen-Capsaicin Skin Emulgel with Improved In Vivo Anti-inflammatory and Analgesic Effects - Imran Khan Burki; Muhammad Khalid Khan; Barkat Ali Khan; Bushra Uzair; Valdir A. Braga; Qazi Adnan Jamil (AAPS PharmSciTech, 2020)

Development and Stability Control of Pediatric Oral Tizanidine Hydrochloride Formulations for Hospital Use - Caren Gobetti; Maria Eduarda Balsan; Márcio Vinícius Ayres; Sílvia Helena Oliveira de Almeida; Elisa de Saldanha Simon; Nathalie Ribeiro Wingert; Tércio Paschke Oppe; Cássia Virginia Garcia (AAPS PharmSciTech, 2020)

Emulgels Containing Carbopol 934P and Different Vegetable Oils for Topical Propolis Delivery: Bioadhesion, Drug Release Profile, and Ex Vivo Skin Permeation Studies - Rafaela Said dos Santos; Camila Félix Vecchi; Hélen Cássia Rosseto; Jéssica Bassi da Silva; Maria Eduarda Lima Dano; Lidiane Vizioli de Castro-Hoshino; Mauro Luciano Baesso; Marcos Luciano Bruschi (AAPS PharmSciTech, 2020)

Self-Nanoemulsifying Drug Delivery Systems (SNEDDS) Containing Rice Bran Oil for Enhanced Fenofibrate Oral Delivery: In Vitro Digestion, Ex Vivo Permeability, and In Vivo Bioavailability Studies - Christina Karavasili; Ioannis I. Andreadis; Maria P. Tsantarliotou; Ioannis A. Taitzoglou; Paschalina Chatzopoulou; Dimitrios Katsantonis; Constantinos K. Zacharis; Catherine Markopoulou; Dimitrios G. Fatouros (AAPS PharmSciTech, 2020)

Spray-Dried Rosuvastatin Nanoparticles for Promoting Hair Growth - Amr Maged; Azza A. Mahmoud; Salwa Salah; Nehad M. Abd-elmonsif; Mahmoud M. Ghorab (AAPS PharmSciTech, 2020)

High-Molecular-Weight Hypromellose from Three Different Suppliers: Effects of Compression Speed, Tableting Equipment, and Moisture on the Compaction - Peter Grdešič; Amrit Paudel; Ilija German Ilić (AAPS PharmSciTech, 2020)

Targeted Delivery of Doxorubicin Liposomes for Her-2+ Breast Cancer Treatment - Nusrat Chowdhury; Shanzay Chaudhry; Nicholas Hall; George Olverson; Qian-Jin Zhang; Tarun Mandal; Srikanta Dash; Anup Kundu (AAPS PharmSciTech, 2020)

Correction to: EGFR Targeted Paclitaxel and Piperine Co-loaded Liposomes for the Treatment of Triple Negative Breast Cancer - Ankita Sanjay Burande; Matte Kasi Viswanadh; Abhishek Jha; Abhishesh Kumar Mehata; Azad Shaik; Nishi Agrawal; Suruchi Poddar; Sanjeev Kumar Mahto; Madaswamy S. Muthu (AAPS PharmSciTech, 2020)

Digital Pharmaceutical Sciences - Safa A. Damiati (AAPS PharmSciTech, 2020)

Correction to: Optimization of Thymoquinone-Loaded Coconut Oil Nanostructured Lipid Carriers for the Management of Ethanol-Induced Ulcer - Usama A. Fahmy; Ahmed L. Alaofi; Zuhier A. Awan; Hani M. Alqarni; Nabil A. Alhakamy (AAPS PharmSciTech, 2020)

The Fundamental and Functional Property Differences Between HPMC and PVP Co-Processed Herbal Particles Prepared by Fluid Bed Coating - Zhe Li; Fei Wu; YanLong Hong; Lan Shen; Xiao Lin; Yi Feng (AAPS PharmSciTech, 2020)

A Comparison Between Lab-Scale and Hot-Melt-Extruder-Based Anti-inflammatory Ointment Manufacturing - Rishi Thakkar; Eman A. Ashour; Ashay Shukla; Rui Wang; Walter G. Chambliss; Suresh Bandari; Narasimha Murthy; Michael A. Repka (AAPS PharmSciTech, 2020)

Preparation and Characterization of PVA-Co-PE Drug-Loaded Nanofiber Membrane by Electrospinning Technology - Si Sheng; Xiaoying Yin; Fangmei Chen; Yixin Lv; Lin Zhang; Menghui Cao; Yun Sun (AAPS PharmSciTech, 2020)

An Analytic Investigation of the Drug Formulation-Based Recalls in the USA: See More Beyond the Literal - Mian Yang; Stephen R. Byrn; Kari L. Clase (AAPS PharmSciTech, 2020)

In Vitro–In Vivo Correlation for Desvenlafaxine Succinate Monohydrate Extended Release Tablets - Jéssica Domingos da Silva; Valéria Pereira de Sousa; Lucio Mendes Cabral; Marcelo Gomes Davanço; Jessica Meulman; Patrícia de Oliveira Carvalho; Daniel Rossi Campos (AAPS PharmSciTech, 2020)

Role of Taurine Transporter in the Retinal Uptake of Vigabatrin - Anitha Police; Vijay Kumar Shankar; S. Narasimha Murthy (AAPS PharmSciTech, 2020)

Characterization of Controlled Release Microspheres Using FIB-SEM and Image-Based Release Prediction - Shawn Zhang; Dan Wu; Liping Zhou (AAPS PharmSciTech, 2020)

Correction to: Once-daily sustained-release matrix tablets of nicorandil: Formulation and in vitro evaluation - Raghu Rami Reddy Kasu; Srinivas Mutalik; Srinivas Reddy (AAPS PharmSciTech, 2020)

Preparation and Evaluation of Stearylamine-Bearing Pemetrexed Disodium-Loaded Cationic Liposomes In Vitro and In Vivo - Kongfang He; Jingjing Liu; Yan Gao; Yanyun Hao; Xuehua Yang; Guihua Huang (AAPS PharmSciTech, 2020)

Development and Characterization of Biocompatible Mannose Functionalized Mesospheres: an Effective Chemotherapeutic Approach for Lung Cancer Targeting - Laxmikant Gautam; Rajeev Sharma; Priya Shrivastava; Sonal Vyas; S. P. Vyas (AAPS PharmSciTech, 2020)

Using Self-Nanoemulsifying System to Improve Oral Bioavailability of a Pediatric Antiepileptic Agent Stiripentol: Formulation and Pharmacokinetics Studies - Qiuyang Dai; Peiyan Zhang; Yilan Jin; Mi Tang; Mengling Shen; Shujun Xu; Susu Huang; Yong Chen (AAPS PharmSciTech, 2020)

Development, In Vitro Characterization, and In Vivo Toxicity Evaluation of Chitosan-Alginate Nanoporous Carriers Loaded with Cisplatin for Lung Cancer Treatment - Mo’tasem M. Alsmadi; Rana M. Obaidat; Mohammad Alnaief; Borhan Aldeen Albiss; Nabil Hailat (AAPS PharmSciTech, 2020)

Impact of Drug-Polymer Interaction in Amorphous Solid Dispersion Aiming for the Supersaturation of Poorly Soluble Drug in Biorelevant Medium - Cassiana Mendes; Rafael G. Andrzejewski; Juliana M. O. Pinto; Leice M. R. de Novais; Andersson Barison; Marcos A. S. Silva; Alexandre L. Parize (AAPS PharmSciTech, 2020)

Lipospheres for Simultaneous Controlled Release and Improved Pharmacokinetic Profiles of Saxagliptin-Enalapril: Formulation, Optimization, and Comparative In Vitro-In Vivo Evaluation - Safirah Maheen; Akhtar Rasul; Muhammad Hanif; Hafeez Ullah Khan (AAPS PharmSciTech, 2020)

Enhanced Oral Delivery of Curcumin via Vitamin E TPGS Modified Nanodiamonds: a Comparative Study on the Efficacy of Non-covalent and Covalent Conjugated Strategies - Dandan Liu; Sen Qiao; Bingchao Cheng; Dongyang Li; Jisuan Chen; Qingyin Wu; Hao Pan; Weisan Pan (AAPS PharmSciTech, 2020)

Employing Multivariate Statistics and Latent Variable Models to Identify and Quantify Complex Relationships in Typical Compression Studies - William C. Stagner; Abhay Jain; Antoine Al-Achi; Rahul V. Haware (AAPS PharmSciTech, 2020)

Cyclodextrin Complexation for Enhanced Stability and Non-invasive Pulmonary Delivery of Resveratrol—Applications in Non-small Cell Lung Cancer Treatment - Xuechun Wang; Vineela Parvathaneni; Snehal K. Shukla; Dipti D. Kanabar; Aaron Muth; Vivek Gupta (AAPS PharmSciTech, 2020)

(−)-linalool-Loaded Polymeric Nanocapsules Are a Potential Candidate to Fibromyalgia Treatment - Tatianny de Araujo Andrade; Paula dos Passos Menezes; Yasmim Maria Barbosa Gomes de Carvalho; Bruno dos Santos Lima; Eloísa Portugal Barros Silva Soares de Souza; Adriano Antunes de Souza Araujo; Marlange Almeida Oliveira Melo; Lucindo José Quintans-Júnior; Jullyana de Souza Siqueira Quintans; Sílvia Stanisçuaski Guterres; Adriana Raffin Pohlmann; Saravanan Shanmugam; et al. (AAPS PharmSciTech, 2020)

Preparation and Characterization of Nanostructured Lipid Carriers for Improved Topical Drug Delivery: Evaluation in Cutaneous Leishmaniasis and Vaginal Candidiasis Animal Models - Amina Riaz; Sarah Hendricks; Kimberley Elbrink; Caljon Guy; Louis Maes; Naveed Ahmed; Filip Kiekens; Gul Majid Khan (AAPS PharmSciTech, 2020)

Development of Solid Self-Microemulsifying System of Tizanidine Hydrochloride for Oral Bioavailability Enhancement: In Vitro and In Vivo Evaluation - Sugata Pramanik; Hetal Thakkar (AAPS PharmSciTech, 2020)

Effect of Spray Drying on Amorphization of Indomethacin Nicotinamide Cocrystals; Optimization, Characterization, and Stability Study - Hesham M. Tawfeek; Tejashri Chavan; Nitesh K. Kunda (AAPS PharmSciTech, 2020)

Potential of Sonophoresis as a Skin Penetration Technique in the Treatment of Rheumatoid Arthritis with Transdermal Patch - Jai Vaidya; Pravin Shende (AAPS PharmSciTech, 2020)

Application of Process Analytical Technology for Pharmaceutical Coating: Challenges, Pitfalls, and Trends - Hanzhou Feng; Shikhar Mohan (AAPS PharmSciTech, 2020)

Nanoparticles in Colorectal Cancer Therapy: Latest In Vivo Assays, Clinical Trials, and Patents - Laura Cabeza; Gloria Perazzoli; Cristina Mesas; Cristina Jiménez-Luna; José Prados; Ana Rosa Rama; Consolación Melguizo (AAPS PharmSciTech, 2020)

Impact of Food and Drink Administration Vehicles on Paediatric Formulation Performance: Part 1—Effects on Solubility of Poorly Soluble Drugs - J. Martir; T. Flanagan; J. Mann; N. Fotaki (AAPS PharmSciTech, 2020)
Food and drinks are commonly used to facilitate administration of paediatric medicines to improve palatability and enhance patient compliance. However, the impact of this practice on drug solubility and on oral drug bioavailability is not usually studied. Based on recommended strategies for oral administration of paediatric medicines with food and drink vehicles, the aims of this study were (i) to measure the physicochemical properties of (soft) food and drink vehicles, commonly mixed with paediatric medicines prior to administration, and (ii) to assess the impact of the co-administered vehicles on the solubility of two poorly soluble paediatric drugs. Montelukast (sodium) and mesalazine were selected as the model compounds. Distinct differences were observed between the physicochemical properties ( i.e. pH, surface tension, osmolality, viscosity and buffer capacity) and macronutrient composition ( i.e. fat, sugar and protein content) of the different soft foods and drinks, not only among vehicle type but also within vehicles of the same subtype. Solubility studies of the two model compounds in selected drinks and soft foods resulted in considerably different drug solubility values in each vehicle. The solubility of the drugs was significantly affected by the vehicle physicochemical properties and macronutrient composition, with the solubility of montelukast being driven by the pH, fat and protein content of the vehicles and the solubility of mesalazine by vehicle osmolality, viscosity and sugar content. This vehicle-dependent impact on drug solubility could compromise its bioavailability, and ultimately affect the safety and/or efficacy of the drug and should be taken into consideration during paediatric product development.

Developing HME-Based Drug Products Using Emerging Science: a Fast-Track Roadmap from Concept to Clinical Batch - Josip Matić; Amrit Paudel; Hannes Bauer; Raymar Andreina Lara Garcia; Kinga Biedrzycka; Johannes G. Khinast (AAPS PharmSciTech, 2020)
This paper presents a rational workflow for developing enabling formulations, such as amorphous solid dispersions, via hot-melt extrusion in less than a year. First, our approach to an integrated product and process development framework is described, including state-of-the-art theoretical concepts, modeling, and experimental characterization described in the literature and developed by us. Next, lab-scale extruder setups are designed (processing conditions and screw design) based on a rational, model-based framework that takes into account the thermal load required, the mixing capabilities, and the thermo-mechanical degradation. The predicted optimal process setup can be validated quickly in the pilot plant. Lastly, a transfer of the process to any GMP-certified manufacturing site can be performed in silico for any extruder based on our validated computational framework. In summary, the proposed workflow massively reduces the risk in product and process development and shortens the drug-to-market time for enabling formulations.

Biosynthesis, Characterization, and Wound-Healing Activity of Phenytoin-Loaded Copper Nanoparticles - Mohammed S. Saddik; Fahd M. Alsharif; Mohamed A. El-Mokhtar; Mostafa F. Al-Hakkani; Mona M. El-Mahdy; Hatem S. Farghaly; Heba A. Abou-Taleb (AAPS PharmSciTech, 2020)

Galactosylated TPGS Micelles for Docetaxel Targeting to Hepatic Carcinoma: Development, Characterization, and Biodistribution Study - Pawan Tekchandani; Balak Das Kurmi; Rishi Paliwal; Shivani Rai Paliwal (AAPS PharmSciTech, 2020)

The Effect of Cross-linking Efficiency of Drug-Loaded Novel Freeze Gelated Chitosan Templates for Periodontal Tissue Regeneration - Syed Saad B. Qasim; Liebert Parreiras Nogueria; Amr S. Fawzy; Umer Daood (AAPS PharmSciTech, 2020)
Innovative strategies for periodontal regeneration have been the focus of research clusters across the globe for decades. In order to overcome the drawbacks of currently available options, investigators have suggested a novel concept of functionally graded membrane (FGM) templates with different structural and morphological gradients. Chitosan (CH) has been used in the past for similar purpose. However, the composite formulation of composite and tetracycline when cross-linked with glutaraldehyde have received little attention. Therefore, the purpose of the study was to investigate the drug loading and release characteristics of novel freeze gelated chitosan templates at different percentages of glutaraldehyde. These were cross-linked with 0.1 and 1% glutaraldehyde and loaded with doxycycline hyclate. The electron micrographs depicted porous morphology of neat templates. After cross-linking, these templates showed compressed ultrastructures. Computerized tomography analysis showed that the templates had 88 to 92% porosity with average pore diameter decreased from 78 to 44.9 μm with increasing concentration. Fourier transform infrared spectroscopy showed alterations in the glycosidic segment of chitosan fingerprint region which after drug loading showed a dominant doxycycline spectral composite profile. Interestingly, swelling profile was not affected by cross-linking either at 0.1 and 1% glutaraldehyde and template showed a swelling ratio of 80%, which gained equilibrium after 15 min. The drug release pattern also showed a 40 μg/mL of release after 24 h. These doxycycline-loaded templates show their tendency to be used in a functionally graded membrane facing the defect site.

Development and Validation of Sample Preparation and an HPLC Analytical Method for Dissolution Testing in Fed-State Simulated Gastric Fluid—Illustrating Its Application for Ibuprofen and Ketoconazole Immediate Release Tablets - Harsh S. Shah; Rusha Sardhara; Kajal Nahar; Ting Xu; Poonam Delvadia; Akhtar Siddiqui; Zongming Gao; Arzu Selen; Kenneth Morris (AAPS PharmSciTech, 2020)

Enhanced Oral Bioavailability of Felodipine from Solid Lipid Nanoparticles Prepared Through Effervescent Dispersion Technique - Yingmeng He; Chenglin Zhan; Chao Pi; Ying Zuo; Siyun Yang; Mei Hu; Yuntian Bai; Ling Zhao; Yumeng Wei (AAPS PharmSciTech, 2020)

Enhanced Antitumor Efficacy of Curcumin-Loaded PLGA Nanoparticles Coated with Unique Fungal Hydrophobin - Lu Sun; Hui Xu; Jing-hua Xu; Shao-ning Wang; Jun-wei Wang; Hong-feng Zhang; Wei-ru Jia; Lin-sen Li (AAPS PharmSciTech, 2020)

Bacteriosomes as a Promising Tool in Biomedical Applications: Immunotherapy and Drug Delivery - Gamaleldin I. Harisa; Abdelrahman Y. Sherif; Abdullah M.E. Youssof; Fars K. Alanazi; Mounir M. Salem-Bekhit (AAPS PharmSciTech, 2020)

Pharmacokinetic Study of Ferulic Acid Following Transdermal or Intragastric Administration in Rats - Na Yan; Zhan Tang; Yuqi Xu; Xiumin Li; Qiao Wang (AAPS PharmSciTech, 2020)

A Combinational Approach Towards Treatment of Breast Cancer: an Analysis of Noscapine-Loaded Polymeric Nanoparticles and Doxorubicin - Seyedeh Sara Esnaashari; Samad Muhammadnejad; Saeid Amanpour; Amir Amani (AAPS PharmSciTech, 2020)

Formulation of Chitosan Polymeric Vesicles of Ciprofloxacin for Ocular Delivery: Box-Behnken Optimization, In Vitro Characterization, HET-CAM Irritation, and Antimicrobial Assessment - Ameeduzzafar; Nabil K Alruwaili; Syed Sarim Imam; Nasser Hadal Alotaibi; Nabil A. Alhakamy; Khalid Saad Alharbi; Sultan Alshehri; Muhammad Afzal; Sattam Khulaif Alenezi; Syed Nasir Abbas Bukhari (AAPS PharmSciTech, 2020)

Complex Drug Delivery Systems: Controlling Transdermal Permeation Rates with Multiple Active Pharmaceutical Ingredients - Daniel A. Davis; Patricia P. Martins; Michael S. Zamloot; Shawn A. Kucera; Robert O. Williams; Hugh D. C. Smyth; Zachary N. Warnken (AAPS PharmSciTech, 2020)

Improved Activity of Rifampicin Against Biofilms of Staphylococcus aureus by Multicomponent Complexation - Antonella V. Dan Córdoba; Virginia Aiassa; Marcela R. Longhi; Mario A. Quevedo; Ariana Zoppi (AAPS PharmSciTech, 2020)

Physiologically Based Dissolution Testing in a Drug Development Process—a Case Study of a Successful Application in a Bioequivalence Study of Trazodone ER Formulations Under Fed Conditions - Dorota Danielak; Bartłomiej Milanowski; Krzysztof Wentowski; Maria Nogowska; Michał Kątny; Piotr Rogowski; Łukasz Konwicki; Ewa Puk; Jarosław Pieczuro; Marek Bawiec; Grzegorz Garbacz; Janina Lulek (AAPS PharmSciTech, 2020)
Development of generic extended-release (ER) formulations is challenging. Especially under fed conditions, the risk of failure in bioequivalence trials is high because of long gastric residence times and susceptibility to food effects. We describe the development of a generic trazodone ER formulation that was aided with a biorelevant dissolution evaluation. Trazodone hydrochloride 300-mg monolithic matrix tablets were dissolved both in USP and EMA compliant conditions and in the StressTest device that simulated both physicochemical and mechanical conditions of the gastrointestinal passage. The final formulation was tested against the originator, Trittico XR 300 mg, in a randomized cross-over bioequivalence trial with 44 healthy volunteers, in agreement with EMA guidelines. Initially developed formulations dissolved trazodone similarly to the originator under standard conditions (f 2 factor above 50), but their dissolution kinetics differed significantly in the biorelevant tests. The formulation was optimized by the addition of low-viscosity hypromellose and mannitol. The final formulation was approved for the bioequivalence trial. Calculated C max were 1.92 ± 0.77 and 1.92 ± 0.63 [μg/mL], AUC 0-t were 27.46 ± 8.39 and 29.96 ± 9.09 [μg∙h/mL], and AUC 0-∞ were 28.22 ± 8.91 and 30.82 ± 9.41 [μg∙h/mL] for the originator and test formulations, respectively. The 90% confidence intervals of all primary pharmacokinetic parameters fell within the 80–125% range. In summary, biorelevant dissolution tests supported successful development of a generic trazodone ER formulation pharmaceutically equivalent with the originator under fed conditions. Employment of biorelevant dissolution tests may decrease the risk of failure in bioequivalence trials of ER formulations.

Formulation, Optimization, and Evaluation of Allopurinol-Loaded Bovine Serum Albumin Nanoparticles for Targeting Kidney in Management of Hyperuricemic Nephrolithiasis - Gurpreet Kandav; D. C. Bhatt; Deepak Kumar Jindal; Shailendra Kumar Singh (AAPS PharmSciTech, 2020)

Formulation and Characterization of a 3D-Printed Cryptotanshinone-Loaded Niosomal Hydrogel for Topical Therapy of Acne - Zhuxian Wang; Li Liu; Shijian Xiang; Cuiping Jiang; Wenfeng Wu; Shifa Ruan; Qunqun Du; Tingting Chen; Yaqi Xue; Huoji Chen; Lidong Weng; Hongxia Zhu; et al. (AAPS PharmSciTech, 2020)

In Vitro-In Vivo Correlation for Solid Dispersion of a Poorly Water-Soluble Drug Efonidipine Hydrochloride - Xu Cheng; Jianlong Gao; Jiaqi Li; Gang Cheng; Meijuan Zou; Hongyu Piao (AAPS PharmSciTech, 2020)

Relationship Between Geometric and Aerodynamic Particle Size Distributions in the Formulation of Solution and Suspension Metered-Dose Inhalers - Hiroyuki Yoshida; Akiko Usui; Yasuhiro Abe; Yukihiro Goda; Ken-ichi Izutsu (AAPS PharmSciTech, 2020)

Development of Dry Powder Inhaler Patient Interfaces for Improved Aerosol Delivery to Children - Karl Bass; Worth Longest (AAPS PharmSciTech, 2020)

In and Beyond COVID-19: US Academic Pharmaceutical Science and Engineering Community Must Engage to Meet Critical National Needs - Vadim J. Gurvich; Ajaz S. Hussain (AAPS PharmSciTech, 2020)

Proniosomal Microcarriers: Impact of Constituents on the Physicochemical Properties of Proniosomes as a New Approach to Enhance Inhalation Efficiency of Dry Powder Inhalers - Amr Gamal; Haitham Saeed; Ossama M. Sayed; Rasha M. Kharshoum; Heba F. Salem (AAPS PharmSciTech, 2020)

Continuous Manufacturing of a Polymer Stabilized Emulsion Monitored with Process Analytical Technology - Pernille Kjærgaard Qwist; Camilla Sander; Nils Bostijn; Vibeke Jessen; Jukka Rantanen; Thomas De Beer (AAPS PharmSciTech, 2020)

Meloxicam Carrier Systems Having Enhanced Release and Aqueous Wettability Prepared Using Micro-suspensions in Different Liquid Media - Nikita Marinko; Petr Zámostný (AAPS PharmSciTech, 2020)

Understanding Concomitant Physical and Chemical Transformations of Simvastatin During Dry Ball Milling - Dattatray Modhave; Isha Saraf; Anjali Karn; Amrit Paudel (AAPS PharmSciTech, 2020)
The present study investigates concomitant processes of solid-state disordering and oxidation of simvastatin during milling. The separate dry ball milling of crystalline and amorphous powders of simvastatin were conducted at ambient temperature for 10 and 60 min each. The relative crystallinity was determined using X-ray scattering and oxidative degradation was analyzed using liquid chromatography. The physical and chemical transformations in the milled powder were evaluated using modulated differential scanning calorimetry (DSC) and Fourier transform infrared spectroscopy. The disordering during milling of the crystalline powder was found to progressively decrease the crystallinity. For the amorphous starting material, milling for 10 min induced a large extent of recrystallization, while milling for 60 min largely re-amorphized the powder. This solid-state disordering and/or ordering were accompanied by progressive air oxidation during milling. The infrared spectroscopic analysis revealed the molecular manifestations associated with the physicochemical transformations in the disordered solid states. The melting point of simvastatin depressed systematically with the increase in the degree of disorder as well as the degradation. The in situ cooling in DSC of milled samples from their molten state led to the formation of the co-amorphous phase between the drug and degradation products, which showed a consistent increase in glass transition temperature with the increase in the content of degradation products. The study overall demonstrates the solid-state re-ordering and disordering of crystalline and amorphous simvastatin accompanied by chemical degradation as the consequence of the mechano-activation.

Effect of Genotype and Sex of the Host on the Bioavailability of Novel Albendazole Microcrystals Based on Chitosan and Cellulose Derivatives - Ana V. Codina; Josefina Priotti; Darío Leonardi; María D. Vasconi; Lucila I. Hinrichsen; María C. Lamas (AAPS PharmSciTech, 2020)

The Effect of Enzymes and Sodium Lauryl Sulfate on the Surface Tension of Dissolution Media: Toward Understanding the Solubility and Dissolution of Carvedilol - Rania Hamed; Sabreen Hasan Alnadi; Areeg Awadallah (AAPS PharmSciTech, 2020)

Robustness of Controlled Release Tablets Based on a Cross-linked Pregelatinized Potato Starch Matrix - D. Elgaied-Lamouchi; N. Descamps; P. Lefèvre; A. R. Mackin-Mohamour; C. Neut; F. Siepmann; Juergen Siepmann; S. Muschert (AAPS PharmSciTech, 2020)

Development of Morin-Loaded Nanoemulsions Containing Various Polymers; Role of Polymers in Formulation Properties and Bioavailability - Yuri Ikeuchi-Takahashi; Shingo Murata; Wataru Murata; Ayaka Kobayashi; Chizuko Ishihara; Hiraku Onishi (AAPS PharmSciTech, 2020)

Evaluation of the Sensitivity and Robustness of Modified Chi-Square Ratio Statistic for Cascade Impactor Equivalence Testing Through Monte Carlo Simulations - Abhinav Kurumaddali; David Christopher; Helen Strickland; Beth Morgan; Christopher Wiggenhorn; Stephen Stein; Svetlana Lyapustina; Günther Hochhaus (AAPS PharmSciTech, 2020)