2014 Issues

Revision of the Dissolution Procedure: Development and Validation <1092>

R Skwierczynski, P Curry, V Gray, J Krämer, E Stippler, J Suggett, T Mirza, and W Brown
USP Subcommittee, USP, Rockville, MD, USA

Effect of Alcohol on Drug Release Kinetics from HPMC-Based Matrix Tablets Using Model Drugs

Amelia M. Avachat and Dinesh S. Nandare
Department of Pharmaceutics, Sinhgad College of Pharmacy, Vadgaon(Bk.), Maharashtra, India

Development, Physical-Chemical Stability, and Release Studies of Four Alcohol-Free Spironolactone Suspensions for Use in Pediatrics

Nora Provenza Bernal¹, Ana C. Calpena¹, Mireia Mallandrich¹, Adolfina Ruiz², and Beatriz Clares^2
1Department of Pharmacy and Pharmaceutical Technology, Faculty of Pharmacy, University of Barcelona, Barcelona, Spain
²Department of Pharmacy and Pharmaceutical Technology, Faculty of Pharmacy, University of Granada, Granada, Spain

Biopharmaceutical Relevance of Dissolution Profile Comparison: Proposal of a Combined Approach

María Esperanza Ruiz and María Guillermina Volonté
Quality Control of Medications, Department of Biological Sciences, Faculty of Exact Sciences, University of La Plata (UNLP), La Plata, Buenos Aires, Argentina

A Simple, Safe, and Environmentally Friendly Method of FaSSIF and FeSSIF Preparation Without Methylene Chloride

Hitesh Jogia, Surya Prakash Sola, Lovleen Kumar Garg, Srinivas Arutla, Annarapu Malleswara Reddy, and Vobalaboina Venkateswarlu
Integrated Product Development, Dr. Reddy’s Laboratories Ltd, Bachupally, Hyderabad, India

Question & Answer Section

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

Evolution of Dissolution Media Over the Last Twenty Years

Jennifer Dressman
Institute of Pharmaceutical Technology, Goethe University, Frankfurt am Main, Germany

History and Evolution of the Dissolution Test

Patrick Marroum
Marroum Pharmaceutical Consulting, Springield, VA, USA

Einstein’s Tea Leaf Paradox and Its Relevance to Dissolution Testing

David F. Long¹, Satish V. Perivilli², and John W. Mauger ^3
1 Eli Lilly and Company, Indianapolis, IN, USA
² Dosage Form Performance Laboratory, U.S. Pharmacopeial Convention, Rockville, MD, USA
³ University of Utah, College of Pharmacy, Department of Pharmaceutics and Pharmaceutical Chemistry, Salt Lake City, UT, USA

An Early Look at Dissolution Testing, Including Equipment, Calibration, and Acceptance Criteria

Lee Timothy Grady
Vice President and Director Emeritus, United States Pharmacopeia

USP and Dissolution—20 Years of Progress

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

Celebration of Twenty Years from Dissolution Tester Equipment Manufacturers and Other Providers of Dissolution Related Services

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

Dissolution Technologies Twentieth Anniversary

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

Historical Narrative on Dissolution Technologies, the Journal

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

Book Review: Specification of Drug Substances and Products Development and Validation of Analytical Methods Edited by Christopher M. Riley, Thomas W. Rosanske, and Shelley R. Rabel Riley

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

Dissolution Highlights from the 2013 AAPS Annual Meeting in San Antonio

Nikoletta Fotaki¹, Gregory P. Martin², and Alger Salt^3
1Department of Pharmacy and Pharmacology, University of Bath, Claverton Down, Bath, UK
²Complectors Consulting LLC, Pottstown, PA, USA
³GlaxoSmithKline, Product Development, Research Triangle Park, NC, USA

Question & Answer Section

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

Use of Enzymes in the Dissolution Testing of Gelatin Capsules and Gelatin-Coated Tablets— Revisions to Dissolution <711> and Disintegration and Dissolution of Dietary Supplements <2040>

USP Expert Panel
U.S. Pharmacopeial Convention, Rockville, MD, USA

Formulating Buffered Dissolution Media for Sparingly Soluble Weak Acid and Weak Base Drug Compounds Based on Microenvironmental pH_o Considerations

Erika S. Stippler¹, Naiffer E. Romero¹, and John W. Mauger^2
1 U.S. Pharmacopeial Convention, Rockville, MD, USA
² University of Utah, College of Pharmacy, Skaggs Pharmacy Institute, Department of Pharmaceutics and Pharmaceutical Chemistry, Salt Lake City, UT, USA

UV Imaging for In Vitro Dissolution and Release Studies: Initial Experiences

Jesper Østergaard¹, Jim Lenke², Sabrine S. Jensen¹, Yu Sun¹, and Fengbin Ye^1
1 Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark
² DissoFX, Maine, USA

Analysis of Drug Release from Different Agglomerates Using a Mathematical Model

Jiri Petru and Petr Zamostny
Department of Organic Technology, Faculty of Chemical Technology, Institute of Chemical Technology Prague, Czech Republic

Improvement of Dissolution Rate of Gliclazide Through Sodium Salt Formation

Dina El-Sabawi and Imad I. Hamdan
Faculty of Pharmacy, The University of Jordan, Amman, Jordan

UV Spectrophotometric Method for Determination of the Dissolution Profile of Rivaroxaban

Mustafa Çelebier¹, Mustafa Sinan Kaynak², Sacide Altinöz¹, and Selma Sahin^3
1Hacettepe University, Faculty of Pharmacy, Department of Analytical Chemistry, Ankara, Turkey
²Inonü University, Faculty of Pharmacy, Department of Pharmaceutical Technology, Malatya, Turkey
³Hacettepe University, Faculty of Pharmacy, Department of Pharmaceutical Technology, Ankara, Turkey

Assessment of the Physicochemical Properties and In Vitro Dissolution of Glibenclamide Tablets Marketed in Saudi Arabia

Gamal A. Shazly^1,2 and Gama^l M. Mahrous^1
1Department of Pharmaceutics, King Saud University, Riyadh, Saudi Arabia
²Department of Industrial Pharmacy, Faculty of Pharmacy, Assiut University, Assiut, Egypt

Summary Report from the USP Workshop on Dissolution Testing of Capsules

Summarized on behalf of the FIP Dissolution-In Vitro Performance Focus Group by Amy R. Barker and Johannes Krämer

Meeting Report: Controlled and Modified Drug Release

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

Question & Answer Section

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