2013 Issues

February 2013 Volume 20 Issue 1

Establishing Acceptance Limits for Dissolution Performance Verification of USP Apparatus 1 and 2 Using USP Prednisone Tablets Reference Standard Lot Q0H398

Walter W. Hauck, Chensheng Li, Erika S. Stippler, and William E. Brown
U.S. Pharmacopeial Convention, Rockville, MD, USA

PhEq_bootstrap:Open-Source Software for the Simulation of f2Distribution in Cases of Large Variability in Dissolution Profiles

Aleksander Mendyk, Adam Pacławski, Jakub Szlęk, and Renata Jachowicz
Department of Pharmaceutical Technology and Biopharmaceutics, Faculty of Pharmacy, Jagiellonian University- Medical College, Kraków, Poland

Discriminatory Dissolution Test for Tablets Containing α- and β-Thalidomide Polymorphs

Ana Paula Cappra Silva¹, Leonardo Zanchetti Meneghini¹, Lisiane Bajerski¹, Juliana Poglia Carini¹,Silvia Ligório Fialho², Paulo Mayorga¹, and Pedro Eduardo Fröehlich¹
¹Programade Pós-Graduação em Ciências Farmacêuticas, Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil
²FUNED- Fundação Ezequiel Dias, R. Conde Pereira Carneiro, Belo Horizonte, Brazil

In Vitro Release Evaluation of Gastroretentive Amoxicillin Floating Tablets Employing a Specific Design of the Flow-Through Cell

Laila H. Emara¹, Aya R. Abdou¹, Ahmed A. El-Ashmawy¹,Rania M. Badr¹, Nesrin F. Taha¹, and Nadia M. Mursi²
¹Industrial Pharmacy Laboratory, Medical and Pharmaceutical Chemistry Department, Division of Pharmaceutical Industries, National Research Centre, Dokki, Giza, Egypt
²Department of Pharmaceutics, Faculty of Pharmacy, Cairo University, Egypt

Physicochemical Characterization and Dissolution Study of Ibuprofen Compression-Coated Tablets Using Locust Bean Gum

Negar Bashardoust^1,2, J. Josephine Leno Jenita¹, and Parvin Zakeri-Milani³
¹Department of Pharmaceutics, Dayananda Sagar College of Pharmacy, Kumaraswamy, Layout, Bangalore, Karnataka, India
²Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran
³Drug Applied Research Center and Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran

UV Analytical Method Suitability for Investigation of BCS Class 2 Biowaivers: Ibuprofen Case

Noelia L. Gonzalez Vidal¹ and M. Esther Gil Alegre²
¹Cátedra Control de Calidad de Medicamentos, Departamento de Biología, Bioquímica y Farmacia, Universidad Nacional del Sur, Bahía Blanca, Argentina
²Departamento de Tecnología Farmacéutica, Facultad de Farmacia, Universidad Complutense de Madrid, Madrid, España

Comparison of In Vitro Dissolution Tests for Commercially Available Aspirin Tablets

Fawzia Khan, Mingzhong Li, and Walkiria Schlindwein
School of Pharmacy, De Montfort University, the Gateway, Leicester, UK

Tribute to Dirk Barends

Question & Answer Section

Margareth Marques and William Brown
United States Pharmacopeia, Rockville,MD

May 2013 Volume 20 Issue 2

Dissolution Testing of a Controlled-Release Capsule Formulation: Challenges and Solutions Using a Semi-Automated Dissolution System

Lili Lo, Xujin Lu, and David Lloyd
Analytical and Bioanalytical Development, Bristol-Myers Squibb, New Brunswick, NJ, USA

In Situ Drug Release Monitoring with a Fiber-Optic System: Overcoming Matrix Interferences Using Derivative Spectrophotometry

Alexis Guillot^1,2, Markus Limberger¹, Johannes Krämer¹, and Claus-Michael Lehr²
¹PHAST GmbH, Homburg, Germany
²Helmholtz Institute for Pharmaceutical Research Saarland (HIPS), Helmholtz Center for Infection Research (HZI), Department DDEL, Saarland University, Saarbrücken, Germany

Effect of a Fiber-Optic Probe on the Dissolution of Salicylic Acid Tablets in USP Apparatus 2

Bing Wang¹, Gerard Bredael², and Piero M. Armenante¹
¹New Jersey Institute of Technology, Otto H. York Department of Chemical, Biological and Pharmaceutical Engineering, Newark, NJ, USA
²Merck & Co., Inc., Summit, NJ, USA

Evaluation of Automation to Increase Efficiency in the Dissolution Lab

Jonathan Kretz and Kirby Wong-Moon
Analytical R&D, Amgen Inc., Thousand Oaks, CA, USA

A Primer on Automating the Vertical Diffusion Cell (VDC)

Royal Hanson and John Heaney
Hanson Research Corp., Chatsworth, CA, USA

Considerations for Automating the Dissolution Test

G. Bryan Crist
Agilent Technologies, Cary, NC, USA

Survey Results for In Vitro-In Vivo Correlations (IVIVC): Critical Variables for Success

Nikoletta Fotaki¹, Vivian Gray², Filippos Kesisoglou³, Steve Mayock⁴, Tahseen Mirza⁵, Alger Salt⁶, and Arzu Selen⁷
¹Department of Pharmacy and Pharmacology, University of Bath, Bath, UK
²Dissolution Technologies, Hockessin, DE, USA
³Biopharmaceutics, Product Value Enhancement, Pharmaceutical Sciences and Clinical Supply, Merck Sharp & Dohme Corp., West Point, PA, USA
⁴Collegium Pharmaceutical, Inc., Canton, MA, USA
⁵Office of Manufacturing and Product Quality / Office of Compliance / CDER, United States Food and Drug Administration, Silver Spring, MD, USA
⁶GlaxoSmithKline, Product Development Laboratory Automation and Platforms, Research Triangle Park, NC, USA
⁷Office of New Drug Quality Assessment / CDER, United States Food and Drug Administration, Silver Spring, MD, USA

Meeting Report: AAPS Workshop on Oral Bioperformance and 21st Century Testing

Margareth Marques
United States Pharmacopeia, Rockville, MD, USA

Dissolution Highlights from the 2012 AAPS Annual Meeting in Chicago

Nikoletta Fotaki¹, Gregory P. Martin², and Johannes Krämer³
¹University of Bath, UK
²Complectors Consulting, Pottstown, PA, USA
³PHAST, Germany

Question & Answer Section

Margareth Marques and William Brown
United States Pharmacopeia, Rockville,MD

August 2013 Volume 20 Issue 3

Rationale for Selection of Dissolution Media: Three Case Studies

Nikoletta Fotaki¹, William Brown², Jianmei Kochling³, Hitesh Chokshi⁴, Hai Miao⁵, Kin Tang⁴, and Vivian Gray⁶
¹University of Bath, Bath, UK
²United States Pharmacopeial Convention, Rockville, MD, USA
³Genzyme, Waltham, MA, USA
⁴Roche, Nutley, NJ, USA
⁵Vertex Pharmaceuticals, Cambridge, MA, USA
⁶V. A. Gray Consulting, Inc., Hockessin, DE, USA

Enhancement in Dissolution Rate of Piroxicam by Two Micronization Techniques

J. Varshosaz, A. Khajavinia, M. Ghasemlu, E. Ataei, K. Golshiri, and I. Khayam
Department of Pharmaceutics, Faculty of Pharmacy and Novel Drug Delivery Systems Research Center, Isfahan University of Medical Sciences, Isfahan, Iran

A Dissolution Test for Finasteride in Immediate-Release Capsules

Olimpia Maria Martins Santos, Ana Laura Araújo Santos, Gislaine Ribeiro Pereira, Rudy Bonfilio, and Magali Benjamim de Araújo
Faculdade de Ciências Farmacêuticas, Universidade Federal de Alfenas, Rua Gabriel Monteiro da Silva, Alfenas-MG, Brazil

The Effect of Probe Path Length Calibration on Dissolution Tests Performed with a Fiber-Optic In Situ Dissolution Test System

Pingping Xu, Xinxia Li, Li Li, Yang Liu, Bin Kong, Kun Nie, and Jian Chen
School of Pharmacy, Xinjiang Medical University, Xinjiang, Urumqi, China

Comparison of the Solubility and Dissolution of Drugs in Fasted-State Biorelevant Media (FaSSIF and FaSSIF-V2)

Mathew Leigh, Bastian Kloefer, and Michael Schaich
Biorelevant.com, Capital Business Centre, Croydon, Surrey, United Kingdom

Meeting Report: AAPS Workshop on Dissolution Testing and Bioequivalence

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

Updates on USP Activities Related to Dissolution, Disintegration, and Drug Release

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

Question & Answer Section

Margareth Marques and William Brown
United States Pharmacopeia, Rockville,MD

November 2013 Volume 20 Issue 4

Investigation of the Disintegration Behavior of Dietary Supplements in Different Beverages

Jieyu Zuo, Yuan Gao, May Almukainzi, and Raimar Löbenberg
Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, Edmonton, Alberta, Canada

In Vitro Dissolution of Insulin Crystal Polymorphs at Model Conditions Relevant to In Vivo Environment

I. Dimitrov¹, F. Hodzhaoglu¹, and I. Ivanov²
¹Department of Phase Formation, Crystalline and Amorphous Materials, Rostislaw Kaischew Institute of Physical Chemistry, Bulgarian Academy of Sciences, Sofia, Bulgaria
²Department of Biomechanics, Institute of Mechanics, Bulgarian Academy of Sciences, Sofia, Bulgaria

Development and Validation of a Discriminating Dissolution Method for Darifenacin Extended-Release Tablets

Leonardo Z. Meneghini¹, Vinícius Bicca¹,², César A. Junqueira¹, Andréa I. H. Adams², Graciela Carlos¹, Pedro E. Fröehlich¹, and Ana M. Bergold¹
¹Programa de Pós-Graduação em Ciências Farmacêuticas, Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul-UFRG, Porto Alegre, RS, Brasil
²Universidade Federal de Santa Maria-UFSM, Centro de Ciências da Saúde, Depto. Farmácia Industrial-Prédio, Santa Maria, RS, Brasil

Comparative Dissolution Studies of Albendazole Oral Suspensions for Veterinary Use

Noelia L. Gonzalez Vidal1¹, Walter J. Starkloff¹, Silvia Bentancor², Silvina Castro³, Gonzalo Suarez², and Santiago D. Palma³
¹Cátedra Control de Calidad de Medicamentos, Departamento de Biología, Bioquímica y Farmacia, Universidad Nacional del Sur, San Juan, Bahía Blanca, Argentina
²Laboratorio Farmacología, Facultad Veterinaria, Universidad de la República, Montevideo, Uruguay
³UNITEFA-CONICET, Departamento de Farmacia, Facultad de Ciencias Químicas, Universidad Nacional de Córdoba, Ciudad Universitaria, Córdoba, Argentina

Remembering Jim Swon, Industry Pioneer

In Vitro Dissolution Enhancement of Ondansetron by Solid Dispersion in Superdisintegrants

Rajnikant M. Suthar¹, Narendra P. Chotai¹, Hardik K. Patel¹, Sandip R. Patel¹, Digesh D. Shah², and Mukesh B. Jadeja³
¹Department of Pharmaceutics and Pharmaceutical Technology, Sardar Patel University, A. R. College of Pharmacy, Vallabh Vidyanagar, Anand, Gujarat, India
²Sanofi Aventis Pharmadeuticals Ltd., Ankaleshwar, Gujarat, India
³Smt. S. M. Shah College of Pharmacy, Mahemdavad, Gujarat, India

Technical Note: Non-Sink Dissolution Media for Identification of Functional Formulation Excipients— The Case of a Precipitation Inhibitor

Maria T. Cruañes, Kimberly Bentz, Wei Xu, and Laura Artino
Pharmaceutical Sciences and Clinical Supply, Merck Research Laboratories, Merck and Co., West Point, PA, USA