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