2015 Issues

February 2015 Volume 22 Issue 1


Effect of YoYo Bitters on the Dissolution of Lisinopril Tablets

A. Ayandokun Olubunmi1, O. Oyetunde Olubukola1, and O. Akinleye Moshood2
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-fang2
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 Stuart1,2, Y. Clement1, P. Sealy1, R. Löbenberg2, L. Montane-Jaime1, R. G. Maharaj1, and A. Maxwell1
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. Foresti1,2, N. Becker1,2, A. S. Silva1,2, W. R. R. Almeida1, M. D. Malesuik1,2, S. E. Hass2, and F. E. B. Silva1,2
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 Liu1,2, Xili Zhang2, Sheng Huang3, Rongdong Li2, Ping Zhang1, Fuyuan He2, and Zuohong Chen1
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 Alkhatem4
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

May 2015 Volume 22 Issue 2



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

August 2015 Volume 22 Issue 3


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 Hahn3
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 Ujhelyi1
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 Khammash1
1Department of Pharmacy, An-Najah National University, Nablus, Palestine
2Pharmacare Ltd. Beitunia, Ramallah, Palestine

Miniature In Vitro Dissolution Testing of Powders for Inhalation

Sabine May1,2, Saskia Kind2, Birte Jensen2, Markus Wolkenhauer2, Marc Schneider1,3,4, and Claus-Michael Lehr1,4,5
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 Gray3
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

November 2015 Volume 22 Issue 4


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

Jian-Hwa Han1, Anagha Vaidya2, Daniel Bonilla1, and Stephen Anderson1
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. Gohel1
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 Koya2
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 Ozturk1,2, Mustafa Sinan Kaynak1, and Selma Sahin2
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-Ba2
1Dissolution Technologies, Hockessin, DE, USA
2Pharmalytik, Newark, DE, USA

Question & Answer Section

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