2015 Issues

Effect of YoYo Bitters on the Dissolution of Lisinopril Tablets

A. Ayandokun Olubunmi¹, O. Oyetunde Olubukola¹, and O. Akinleye Moshood^2
1 Department of Clinical Pharmacy and Biopharmacy, Faculty of Pharmacy, University of Lagos, Nigeria
² Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Lagos, Nigeria

New Innovations in Testing Sustained-Release Tablets Using an Automated Dissolution System with Online Dilution

Huang Hai-wei¹, Yuan Song¹, Yu Li-ju¹, He Lan¹, Zhang Qi-ming¹, Ning Bao-ming¹, Keith Wilkinson², Wei Shi², and ShiI Li-fang^2
1 National Institutes for Food and Drug control, Beijing, China
² Automated Lab Systems, Berkshire, UK

Comparing the Dissolution Profiles of Seven Metformin Formulations in Simulated Intestinal Fluid

A. Villarroel Stuart^1,2, Y. Clement¹, P. Sealy¹, R. Löbenberg², L. Montane-Jaime¹, R. G. Maharaj¹, and A. Maxwell^1
1 University of the West Indies, St. Augustine, Trinidad
² University of Alberta, Alberta, Canada

An Alternative Method for the Dissolution of Enrofloxacin Tablets

G. R. Foresti^1,2, N. Becker^1,2, A. S. Silva^1,2, W. R. R. Almeida¹, M. D. Malesuik^1,2, S. E. Hass², and F. E. B. Silva^1,2
1 Núcleo de Pesquisa em Fármacos e Medicamentos, UNIPAMPA, Campus Uruguaiana, RS, Brasil
² Programa de Pós-graduação em Ciências Farmacêuticas (PPGCF)-UNIPAMPA, Campus Uruguaiana, RS, Brasil

Quality Control Studies on ZuoJin Sustained-Release Tablets

Wenlong Liu^1,2, Xili Zhang², Sheng Huang³, Rongdong Li², Ping Zhang¹, Fuyuan He², and Zuohong Chen^1
1 School of Life and Science, Hunan Normal University, Changsha, Hunan, P. R. China
² School of Pharmacy, Hunan University of Chinese Medicine, Changsha, Hunan, P. R. China
³ Hunan Jiuzhitang Co., Ltd., Changsha, Hunan, P. R. China

Establishment of a Bioequivalence-Indicating Dissolution Specification for Candesartan Cilexetil Tablets Using a Convolution Model

Hassan Ali Hassan¹, Naseem Ahmad Charoo², Areeg Anwer Ali³, and Sumaiya Ser Alkhatem^4
1 Department of Pharmaceutics, Faculty of Pharmacy, Khartoum University, Khartoum, Sudan
² AlFalah Life Sciences Pvt. Ltd., Wathora, Budgam, India
³ RAK Medical & Health Sciences University, Ras Al Khaima, UAE
⁴ College of Pharmacy and Health Sciences, Ajman University of Science and Technology, Fujairah Campus, United Arab Emirates

Workshop Report: In Quest of More Affordable and More Accessible Medicines

Isadore Kanfer
Rhodes University, Grahamstown, South Africa

Question & Answer Section

Margareth Marques and William Brown
U.S. Pharmacopeia, Rockville, MD, USA

Impact of Discordance Among Regulations for Biopharmaceutics Classification System-Based Waivers of Clinical Bioequivalence Studies

Jack Cook

How-To: Empirical IVIVR Without Intravenous Data

Aleksander Mendyk, Paweł Konrad Tuszyński, Mohammad Hassan Khalid, Renata Jachowicz, and Sebastian Polak

In Vitro-In Vivo Correlation: Shades on Some Non-Conventional Dosage Form

Abdulwahab Barakat, Johannes Krämer, Cristiane de Souza Carvalho, and Claus-Michael Lehr

Development of a Dissolution Test for Extended-Release Bromopride Pellets with In Vivo-In Vitro Correlation

Marcos Giovani R. da Silva, Nadia Maria Volpato, Eduardo C. Pinto, Lúcio M. Cabral, and Valéria P. de Sousa

Use of IVIVC in the Development of Oral Extended-Release Formulations: A Personal Perspective

Mario A. Gonzalez and Douglas F. Smith

Use of IVIVC to Optimize Generic Development

J.-M. Cardot, G. Garrait, and E. Beyssac

Role of In Vitro-In Vivo Correlations in Drug Development

Patrick Marroum

AAPS Open Forum Report: Proposals for Regulatory Harmonization of a Global BCS Framework: Challenges and Opportunities

Isadore Kanfer

Meeting Report: In Vivo Predictive Dissolution Conference

Johannes Krämer and Erika Stippler

Meeting Report: International Workshop on Implementation of Biowaivers Based on the Biopharmaceutics Classification System (BCS)

Rodrigo Cristofoletti, Vinod P. Shah, Peter Langguth, James E. Polli, Mehul Mehta, Bertil Abrahamsson, Jennifer B. Dressman, and Pablo Quiroga

Question & Answer Section

Margareth Marques and William Brown
U.S. Pharmacopeia, Rockville, MD, USA

European versus United States Pharmacopeia Disintegration Testing Methods for Enteric-Coated Soft Gelatin Capsules

J. Al-Gousous and P. Langguth
Institute of Pharmacy and Biochemistry, Johannes Gutenberg University, Mainz, Germany

A Strategy for Quality Control Dissolution Method Development for Immediate-Release Solid Oral Dosage Forms

Gerard M. Bredael¹, Steve Liang², and David Hahn^3
1Pharmaceutical Sciences and Clinical Supply, Preformulation, Merck, Summit, NJ USA
²Analytical Chemistry in Development and Supply, Merck, Summit, NJ USA
³Formerly from Pharmaceutical Sciences and Clinical Supply, Analytical Sciences, Merck, Summit, NJ USA

Development of a Glass-Bead Device for Dissolution Testing

Marija Bogataj, Greta Cof, and Aleš Mrhar
Faculty of Pharmacy, University of Ljubljana, Ljubljana, Slovenia

Flow-Through Dissolution: A Useful Tool from Discovery Phase to Preclinical Development

Márta Venczel¹, Tamás Sovány², Klára Pintye-Hódi², and Gabriella Ujhelyi^1
1Sanofi, Budapest, Hungary
²Department of Pharmaceutical Technology, University of Szeged, Szeged, Hungary

Development of a Dissolution Method to Compare Tablet Formulations Containing Valsartan/Amlodipine

Abdel Naser Zaid¹, Aiman Qaddomi², Mashhour Ghanem², Lina Shehadeh², Murad Abualhasan¹, Salam Natur², and Saed Khammash^1
1Department of Pharmacy, An-Najah National University, Nablus, Palestine
²Pharmacare Ltd. Beitunia, Ramallah, Palestine

Miniature In Vitro Dissolution Testing of Powders for Inhalation

Sabine May^1,2, Saskia Kind², Birte Jensen², Markus Wolkenhauer², Marc Schneider^1,3,4, and Claus-Michael Lehr^1,4,5
1PharmBioTec GmbH, Saarbrücken, Germany
²Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany
³Pharmaceutics and Biopharmacy, Philipps-Universität Marburg, Marburg, Germany
⁴Biopharmaceutics and Pharmaceutical Technology, Saarland University, Saarbrücken, Germany
⁵Helmholtz Institute for Pharmaceutical Sciences Saarland, Helmholtz Center for Infection Research, Saarbrücken, Germany

Meeting Report: AAPS Workshop on Inhalation Product Biopharmaceutical Classification System Development: Challenges and Opportunities

Vivian A. Gray
Dissolution Technologies, Hockessin, DE, USA

Dissolution Highlights from the 2014 AAPS Annual Meeting in San Diego

Nikoletta Fotaki¹, Gregory P. Martin², and Vivian Gray^3
1Department of Pharmac and Pharmacology, University of Bath, Claverton Down, Bath, UK
²Complectors Consulting, Pottstown, PA, USA
³Dissolution Technologies, Hockessin, DE, USA

Question & Answer Section

Margareth Marques and William Brown
U.S. Pharmacopeia, Rockville, MD, USA

Assessing the Impact of Vessel Centering on Dissolution Results-A Case Study

Jian-Hwa Han¹, Anagha Vaidya², Daniel Bonilla¹, and Stephen Anderson^1
1NCE Analytical R&D, AbbVie Inc, North Chicago, IL USA
²Formulation R&D, Teva Pharmaceuticals, North Wales, PA USA

Performance Test for Parenteral Dosage Forms

Vinod P. Shah, James DeMuth, and Desmond G. Hunt
United States Pharmacopeia, Rockville, MD, USA

Design and Evaluation of a Novel Bio-Mimicking In Vitro Dissolution Test Apparatus for Floating Drug Delivery Systems

L. Baldaniya¹, S. Saisivam², and M. Gohel^1
1Department of Pharmaceutical Technology, Anand Pharmacy College, Gujarat, India
²Department of Pharmaceutical Technology, N. R. Vekaria Institute of Pharmacy, Gujarat, India

Effect of Polymorphism and Application of Kinetic Models for the Evaluation of In Vitro Dissolution Profiles of an Eletriptan Hydrobromide Formulation

Pavan Kommavarapu¹, Arthanareeswari Maruthapillai¹, Kamaraj Palanisamy¹, and Ravi Teja Koya^2
1Department of Chemistry, SRM University, Tamilnadu, India
²Department of Pharmaceutical Analysis, Acharya Nagarjuna University, Guntur, India

Comparison of Dissolution Profiles of Commercially Available Lamivudine Tablets

Naile Ozturk^1,2, Mustafa Sinan Kaynak¹, and Selma Sahin^2
1Faculty of Pharmacy, Department of Pharmaceutical Technology, Inonu University, Malatya, Turkey
²Faculty of Pharmacy, Department of Pharmaceutical Technology, Hacettepe University, Ankara, Turkey

Meeting Report: Profiling of Drug Dissolution, Pharmacokinetics and Pharmacodynamics

Vivian A. Gray¹ and Kim Huynh-Ba^2
1Dissolution Technologies, Hockessin, DE, USA
²Pharmalytik, Newark, DE, USA

Question & Answer Section

Margareth Marques and William Brown
U.S. Pharmacopeia, Rockville, MD, USA