2009 Issues

February 2009 Volume 16 Issue 1


Description of the Upcoming Change in Data Analysis for USP Dissolution Performance Verification Tests

Walter W. Hauck, Anthony J. DeStefano, William E. Brown, Erika S. Stippler, Darrell R. Abernethy, Roger L. Williams, and the Biopharmaceutics Expert Committee
US Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD, USA

Monitoring Ambroxol Hydrochloride Sustained-Release Tablets Release by Fiber-Optic Drug Dissolution In Situ Test System

Kun Nie, Li Li, Xinxia Li, Yan Zhang, Xuan Mu, and Jian Chen
School of Pharmacy, Xinjiang Medical University, Urumqi, Xinjiang China

2009 Trends in Small-Volume Dissolution Apparatus for Low-Dose Compounds

G. Bryan Crist Varian, Inc., 13000 Weston Parkway, Cary, NC USA

USP Disintegration Apparatus as a Potential Tool for Evaluating Drug Release from Controlled-Release Dosage Forms

Monica C. Chuong, Ronald G. Lee, Vaibhav Saxena, and Luca Palugan Department of Pharmaceutical Sciences, School of Pharmacy, Massachusetts College of Pharmacy and Health Sciences ó Boston, Boston, MA, USA

Goodness-of-Fit Model-Dependent Approach for Release Kinetics of Levofloxacin Hemihydrates Floating Tablet

V. T. Thakkar1, P. A. Shah1, T. G. Soni1, M. Y. Parmar1, M. C. Gohel2, and T. R. Gandhi1
1Department of Pharmaceutics, Anand Pharmacy College, Gujarat, INDIA
2Department of Pharmaceutics, L.M. College of Pharmacy, Gujarat, INDIA

Book Review: Pharmaceutical Dosage Forms: Tablets (Third Edition), Volume 3: Manufacture and Process Control Edited by Larry L. Augsburger and Stephen W. Hoag

David C. Sperry Lilly Research Laboratories, Indianapolis, IN, USA

Workshop Report: Current Performance Testing for Pharmaceutical and TCM Dosage Forms

Raimer Löebenberg1, Hai Wei2, and Jianfang Feng2
1University of Alberta, Edmonton AB, Canada
2Shanghai University of Traditional Chinese Medicine, Shanghai, China

Question & Answer Section

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

May 2009 Volume 16 Issue 2


Investigation of the Dissolution Characteristics of Nifedipine Extended-Release Formulations Using USP Apparatus 2 and a Novel Dissolution Apparatus

Grzegorz Garbacz1, Henning Blume2, and Werner Weitschies1
1Department of Biopharmaceutics and Pharmaceutical Technology, Ernst Moritz Arndt University of Greifswald, Greifswald, Germany
2SocraTec R&D GmbH, Oberursel, Germany

The Evaluation of Eudragit Microcapsules Manufactured by Solvent Evaporation Using USP Apparatus 1

Sandile M. Khamanga, Natalie Parfitt, Tsitsi Nyamuzhiwa, Hendrina Haidula, and Roderick B. Walker
Faculty of Pharmacy, Rhodes University, Grahamstown, South Africa

Investigation of the Effect of Different Flow-Through Cell Designs on the Release of Diclofenac Sodium SR Tablets

Laila H. Emara1, Nesrin F. Taha1, and Nadia M. Mursi2
1Industrial Pharmacy Laboratory, Division of Pharmaceutical Industries, National Research Centre, Egypt
2Department of Pharmaceutics, Faculty of Pharmacy, Cairo University, Egypt

Physicochemical Properties of Various Shellac Types

Y. Farag and C. S. Leopold University of Hamburg, Institute of Pharmacy, Department of Pharmaceutical Technology, Hamburg, Germany

Modeling and Comparison of Dissolution Profiles of Diltiazem Modified-Release Formulations

D. Samaha, R. Shehayeb, and S. Kyriacos
Department of Pharmaceutical Sciences, School of Pharmacy, Lebanese American University, Byblos, Lebanon

Commentary: Towards Physico-Relevant Dissolution Testing: The Importance of Solid-State Analysis in Dissolution

Jaakko Aaltonen1,2 and Thomas Rades1
1School of Pharmacy, University of Otago, Dunedin, New Zealand
2Department of Pharmaceutics, University of Kuopio, Kuopio, Finland

CRS/AAPS Joint Workshop on Critical Variables in the In Vitro and In Vivo Performance of Parenteral Sustained-Release Products

Michael J. Rathbone1, Marilyn N. Martinez2, Mai Huynh2, and Diane Burgess3
1School of Pharmacy, Gold Coast Campus, Griffith University, Queensland , Australia
2US Food and Drug Administration, Center for Veterinary Medicine, Rockville, MD, USA
3University of Connecticut, Storrs, CT, USA

Question & Answer Section

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

August 2009 Volume 16 Issue 3

Special Edition on Biorelevant Dissolution: Methodology and Applications


Biorelevant Dissolution: Methodology and Application in Drug Development

Qingxi Wang1, Nikoletta Fotaki2, and Yun Mao3
1Analytical Development and Commercialization, Merck and Co, Inc., West Point, PA USA
2Department of Pharmacy and Pharmacology, University of Bath, Bath, UK
3Pharmaceutical R&D, Merck and Co, Inc., West Point, PA USA

Evaluation of Dissolution Media Containing a Novel Synthetic Surfactant by In Vitro Testing of BCS Class II Drugs

Hitesh Jogia1,2, Tushar Mehta2, and Madhabhai Patel1
1Kalol Institute of Pharmacy, Gujarat, India
2Analytical Development Laboratory, Torrent Pharmaceutical Ltd., Gujarat, India

Biorelevant Dissolution Media Simulating the Proximal Human Gastrointestinal Tract: An Update

Ekarat Jantratid and Jennifer Dressman Institute of Pharmaceutical Technology, Johann Wolfgang Goethe University, Frankfurt am Main, Germany

Predicting Food Effects on Drug Release from Extended-Release Oral Dosage Forms Containing a Narrow Therapeutic Index Drug

Sandra Klein Institute of Pharmaceutical Technology, Goethe University, Frankfurt am Main, Germany

Instant FaSSIF and FeSSIFóBiorelevance Meets Practicality

Julia Elisabeth Boni1,2, Rolf Stefan Brickl1, Jennifer Dressman2, and Martin L. Pfefferle1
1Pharmaceutical Research & Development, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany
2Institute of Pharmaceutical Technology, Johann Wolfgang Goethe University, Frankfurt am Main, Germany

Physicochemical Characterization of Simulated Intestinal Fed-State Fluids Containing Lyso-Phosphatidylcholine and Cholesterol

D. G. Fatouros1, I. Walrand1, B. Bergenstah2, and A. Mullertz3
1Department of Pharmaceutics and Analytical Chemistry Faculty of Pharmaceutical Sciences, University of Copenhagen, Denmark
2Department of Food Technology, Center for Chemistry and Chemical Engineering, Lund University, Lund, Sweden
3Bioneer:FARMA, Faculty of Pharmaceutical Sciences, University of Copenhagen, Denmark

Meeting Report: APQ/IPA Workshop on Challenges for Dissolution Testing in the 21st Century

Kailas Thakker1 and Vivian Gray2
1President, Analytical Solutions, Inc., Durham, NC.
2Research Editor, Dissolution Technologies, Hockessin, DE

Question & Answer Section

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

November 2009 Volume 16 Issue 4


FIP Position Paper on Qualification of Paddle and Basket Dissolution Apparatus

Members of FIP Special Interest Group, Dissolution/Drug Release

A Discriminatory and Biorelevant Dissolution Test Method for Simvastatin Drug Products

N. Singla1, G. D. Gupta2, K. Kohli3, and A. K. Singla4
1Institute of Pharmacy, B.S.A.I.P, Faridabad, India
2Amar Shaheed Baba Ajit Singh Jujhar Singh Memorial College of Pharmacy, Bela (Ropar), India
3Faculty of Pharmacy, Jamia Hamdard, New Delhi, India
4Department of Pharmaceutical Research and Development, Ranbaxy Research Lab, Gurgaon, India

An Approach for Improvement of the Dissolution Rate of Gliclazide

Sudarsan Biswal, Gouri S. Pasa, Jagannath Sahoo, and Padala N. Murthy Royal College of Pharmacy and Health Sciences, Berhampur, Orissa, India

Formulation, Characterization, and Optimization of Fast-Dissolve Tablets Containing Celecoxib Solid Dispersion

Vikram M. Pandya, Dhaval J. Patel, Jayvadan K. Patel, and Rakesh P. Patel S. K. Patel College of Pharmaceutical Education and Research, Ganpat University, Gujarat, India

Effect of Paddle-Shaft Position on the Dissolution Rate of Sodium Diclofenac Tablets and the Equivalence Assessment of a Generic Product

Mari Fujimoto1,2, Kiyoshi Mihara2,3, James A. Jorgenson4, Kuniko Otsuka5, Masaki Aburada2,3, Tomie Kawada3, Junko Ishizaki1, Ken-ichi Miyamoto1, and Makoto Otsuka3
1Graduate School of Natural Science and Technology, Kanazawa University, Kakuma, Kanazawa, Japan
2Research Center for Clinical Pharmacy, Faculty of Pharmacy, Musashino University, Nishitokyo, Tokyo, Japan
3Research Institute of Pharmaceutical Sciences, Faculty of Pharmacy, Musashino University, Nishitokyo, Tokyo, Japan
4Department of Hospital Pharmacy, University of Utah, UT
5Yokohama College of Pharmacy, Totsuka, Yokohama, Japan

Meeting Report: University of Wisconsin/AAPS/FDA Workshopñ Applied Biopharmaceutics and Quality by Design for Dissolution/ Release Specification Setting: Product Quality for Patient Benefit

Vivian A. Gray Dissolution Technologies Hockessin, DE

Meeting Report: USP Workshop on Topical and Transdermal Drug Products

Margareth Marques United States Pharmacopeia, Rockville, MD

Question & Answer Section

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