2010 Issues

Optimization of an In Vitro Dissolution Test Method for Inhalation Formulations

Yoen-Ju Son¹, Michelle Horng¹, Mark Copley², and Jason T. McConville^1
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 Nie^1,2, Li Li¹, Xinxia Li¹, Dongsheng Geng³, Qizhou Zhang⁴, Mingfu Tuo¹, Pingping Xu¹, and Jian Chen^1
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. Udoh^1
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 Bhise^1
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 Fujimoto^1,2, Kiyoshi Mihara^2,3, James A. Jorgenson⁴, Kuniko Otsuka⁵, Masaki Aburada^2,3, Tomie Kawada³, Junko Ishizaki¹, Ken-ichi Miyamoto¹, and Makoto Otsuka^3
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

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 Dressman^3
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 Gajendran^1,3, Johannes Kraemer^1,4, Stig Randers Knudsen^{2, 4
1}PHAST 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. Shohin^1,2, G. V. Ramenskaya^1,2, G. F. Vasilenko², E. A. Malashenko^1
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
^2
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

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. Thakker^1
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 Khiljee^1,2, Nisar-Ur-Rehman2, Muhammad Khan Sarfraz¹, Hamid Montazeri¹, Tanzila Khiljee², and Raimar Löbenberg^1
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 Gray^4
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