2010 Issues

February 2010 Volume 17 Issue 1


Influence of the Changed USP Specifications on Disintegration Test Performance

Katja Schmid1 and Raimar Löbenberg2
1Department of Pharmacy - Pharmaceutical Technology and Biopharmaceutics, Ludwig-Maximilians-University Munich, Munich, Germany
2Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, Edmonton, AB, Canada

Low-Level Drug Release-Rate Testing of Ocular Implants Using USP Apparatus 4 Dissolution and HPLC End Analysis

David C. Browne and Shawn Kieselmann
Intertek QTI, Whitehouse, NJ, USA

Effect of Solvent on Crystal Habit and Dissolution Behavior of Tolbutamide by Initial Solvent Screening

Rajesh A. Keraliya, Tejal G. Soni, Vaishali T. Thakkar, and Tejal R. Gandhi
Department of Pharmaceutics, Anand Pharmacy College, Anand, jarat, India

Effect of Accelerated-Aging Conditions on the Dissolution Stability of Ciprofloxacin Tablets

Noelia L. Gonzalez Vidal1,2, Marta I. V. Brevedan1, María A. Varillas1, Laura D. Simionato2, and Maria T. Pizzorno1,2
1Cátedra Control de Calidad de Medicamentos, Departamento de Biología, Bioquímica y Farmacia, Universidad Nacional del Sur, San Juan 670, B8000ICN Bahía Blanca, Argentina
2Cátedra Control de Calidad de Medicamentos, Facultad de Farmacia y Bioquímica, Universidad de Buenos Aires, Junín 956, C1113AAD Ciudad de Buenos Aires, Argentina

Effect of Beverages on the In Vitro Disintegration of Immediate-Release Pain Medications

Monica C. Chuong1, Catherine A. Taglieri1, Steven J. Crosby1, Joe W. Ferullo1,and Pitwei Ng2
1School of Pharmacy, Boston, Massachusetts College of Pharmacy and Health Sciences, 179 Longwood Ave, Boston, MA, USA
2School of Pharmacy, National University of Singapore

Technical Note: Impact of Using Plastic Vessels in Dissolution Testing

Sanjay S. Shetgar Dr. Reddy’s Laboratories Limited, Hyderabad, India

Dissolution Highlights from the 2009 AAPS Annual Meeting in Los Angeles

Gregory P. Martin Complectors Consulting, Pottstown, PA, USA

Question & Answer Section

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

May 2010 Volume 17 Issue 2


Optimization of an In Vitro Dissolution Test Method for Inhalation Formulations

Yoen-Ju Son1, Michelle Horng1, Mark Copley2, and Jason T. McConville1
1College of Pharmacy, The University of Texas at Austin, Austin, TX, USA
2Copley Scientific Limited, Nottingham, UK

InSituFiber-OpticDissolutionAssistedbyaMathematicalSeparation Model of Dynamic Three-Wavelength K-Ratio Spectrophotometry

Kun Nie1,2, Li Li1, Xinxia Li1, Dongsheng Geng3, Qizhou Zhang4, Mingfu Tuo1, Pingping Xu1, and Jian Chen1
1School of Pharmacy, Xinjiang Medical University, Urumqi, Xinjiang, China
2Jinan Cinit Science and Technology Co., Ltd, Jinan, Shandong, China
3Institute for Drug and Instrument Control, United Logistics Department of Xinjiang Command, PLA, Urumqi, Xinjiang, China
4Xinjiang FOCS Bio-tech Development Co., Ltd., Urumqi, Xinjiang, China

Comparative Assessment of the Quality Control Measurements of Multisource Ofloxacin Tablets Marketed in Nigeria

Sunday O. Awofisayo1, Oladoja A. Awofisayo2, Nse Eyen3, and Imo E. Udoh1
1Department of Clinical Pharmacy and Biopharmacy, Faculty of Pharmacy, University of Uyo, Nigeria
2Department of Pharmaceutical and Medicinal Chemistry, Faculty of Pharmacy, University of Uyo, Nigeria
3Department of Laboratory Science, Akwa —Ibom State Polytechnic, Akwa Ibom, Nigeria

Dissolution Improvement of Simvastatin by Surface Solid Dispersion Technology

Monica Rao1, Yogesh Mandage2, Kaushik Thanki1, Sucheta Bhise1
1Department of Pharmaceutics, AISSMS College of Pharmacy, Maharashtra, India
2Department of Quality Assurance, AISSMS College of Pharmacy, Pune, India

Effects of Paddle-Shaft Position and Inclination of Dissolution Apparatus on the Dissolution Rate of Carbamazepine Tablets and the Equivalence Assessment of Generic Drugs

Mari Fujimoto1,2, Kiyoshi Mihara2,3, James A. Jorgenson4, Kuniko Otsuka5, Masaki Aburada2,3, Tomie Kawada3, Junko Ishizaki1, Ken-ichi Miyamoto1, and Makoto Otsuka3
11Graduate School of Natural Science and Technology, Kanazawa University, Kanazawa, Japan
2Research Center for Clinical Pharmacy, Faculty of Pharmacy, Musashino University, Tokyo, Japan
3Research Institute of Pharmaceutical Sciences, Faculty of Pharmacy, Musashino University, Tokyo, Japan
4Department of Hospital Pharmacy, University of Utah, Salt Lake City, Utah, USA
5Yokohama College of Pharmacy, Yokohama, Japan

Technical Note: Using Biorelevant Media with Different Types of Orally Administered Formulations

Bastian Kloefer and Peter van Hoogevest Phares AG, Muttenz, Switzerland

Question & Answer Section

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

August 2010 Volume 17 Issue 3


Study of a Standardized Taurocholate-Lecithin Powder for Preparing the Biorelevant Media FeSSIF and FaSSIF

Bastian Kloefer1,2, Peter van Hoogevest1, Ruth Moloney1, Martin Kuentz2, Mathew L.S. Leigh1, and Jennifer Dressman3
1Phares AG, Muttenz, Switzerland
2University of Applied Sciences Northwestern Switzerland, Institute of Pharma Technology, Muttenz, Switzerland
3Institute of Pharmaceutical Technology, Johann Wolfgang Goethe University, Frankfurt am Main, Germany

Product Performance Test for Medicated Chewing Gums

Jayachandar Gajendran1,3, Johannes Kraemer1,4, Stig Randers Knudsen2, 4
1PHAST GmbH, Homburg/Saar, Germany
2Fertin Pharma, Vejle, Denmark
3Department of Biopharmaceutics and Pharmaceutical Technology, Johannes Gutenberg University, Mainz, Germany
4The USP Mucosal Drug Delivery Advisory Committee

In Vitro Dissolution Kinetics of Amlodipine Tablets Marketed in Russia Under Biowaiver Conditions

I. E. Shohin1,2, G. V. Ramenskaya1,2, G. F. Vasilenko2, E. A. Malashenko1
1Sechenov's Moscow Medical Academy, Moscow, Russia
2Scientific Center for Expertise of Medical Products, Moscow, Russia

Dissolution Testing for Poorly Soluble Drugs: A Continuing Perspective

K. Gowthamarajan
1 and Sachin Kumar Singh
1Department of Pharmaceutics, J. S. S. College of Pharmacy, Tamilnadu, India
2Department of Pharmaceutical Analysis, Bharathi College of Pharmacy, Karnataka, India

Formulation and Characterization of Floating Gelucire Matrices of Metoprolol Succinate

Praneeth Kumar Siripuram, Suresh Bandari, Raju Jukanti, and Prabhakar Reddy Veerareddy
Department of Pharmaceutics and Industrial Pharmacy, St. Peter's Institute of Pharmaceutical Sciences, Hanamkonda, Andhra Pradesh, India

Workshop Report-Challenges in Dissolution Testing: Equivalence and Surrogates

Professor Izzy Kanfer Rhodes University, Grahamstown, South Africa

USP Update: Beal Award and New Expert Committee

William Brown USP, Rockville, MD, USA

Question & Answer Section

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

November 2010 Volume 17 Issue 4

Special Edition on Semisolid Dosage Forms


Development of an In Vitro Release Test (IVRT) for a Vaginal Microbicide Gel

Ryan R. Klein1, Jason Q. Tao2, Susan Wilder2, Kris Burchett1, Quyen Bui1, and Kailas D. Thakker1
1Analytical Solutions, Inc., Durham, NC USA
2International Partnership for Microbicides, Silver Spring, MD USA

Topical and Transdermal Drug Products

The Topical/Transdermal Ad Hoc Advisory Panel for the USP Performance Tests of Topical and Transdermal Dosage Forms
USP, Rockville, MD USA

In Vitro Release of Indian Penny Wort, Walnut, and Turmeric from Topical Preparations Using Two Different Types of Membranes

Sonia Khiljee1,2, Nisar-Ur-Rehman2, Muhammad Khan Sarfraz1, Hamid Montazeri1, Tanzila Khiljee2, and Raimar Löbenberg1
1Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, AB, Canada
2Faculty of Pharmacy and Alternative Medicine, The Islamia University of Bahawalpur, Pakistan

A Primer on Release-Rate Testing of Semisolids

Royal Hanson, CEO
Hanson Research Corporation, 9810 Variel Ave., Chatsworth, CA USA

Technical Note: Hydrocortisone as a Performance Verification Test Reference Standard for In Vitro Release Testing

Ryan R. Klein, Jenna L. Bechtel, Kris Burchett, and Kailas D. Thakker
Analytical Solutions, Inc., Durham, NC USA

USP Update: USP Revises the New General Chapter <3> Topical and Transdermal Drug Products: Quality Tests

Margareth Marques
USP, Rockville, MD USA

AAPS Workshop on the Role of Dissolution in QbD and Drug Product Life Cycle: A Commentary

Susan S. D'Souza1,Ruben Lozano2, Stephen Mayock3, and Vivian Gray4
1Chemistry and Pharmaceutical Sciences, Sunovion Pharmaceuticals Inc., Marlborough, MA USA
2Analytical Research & Development, Bristol-Myers Squibb, New Brunswick, NJ USA
3Vertex Pharmaceuticals, Inc., Cambridge, MA USA
4V. A. Gray Consulting, Inc., Hockessin, DE USA

Workshop Summary: AAPS Workshop on Special Dosage Forms—What's New with In Vitro Drug Release?

Vivian Gray
Dissolution Technologies, Hockessin, DE USA

Question & Answer Section

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