โดย zartingtong » 23 ส.ค. 2007, 13:11
แถม US Pharmacopeial Forum ให้อีก 1 ชุดใหญ่ๆเป็นน้ำจิ้มด้วยนะครับเพราะมีเจตนารมณ์ที่ให้การทดสอบนี้ใช้ต่อ ผลิตภัณฑ์ที่หุ้มด้วยชั้นเจลาตินทุกตัว
"Announcement is the basis for a proposal elsewhere in this PF to accommodate additional gelatin encapsulated products."
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US Pharmacopeial Forum
Vol. 24, No. 5 Sept.-Oct. 1998
PROPOSED REVISION TO ALLOW A SECOND TIER OF DISSOLUTION TESTING FOR HARD AND SOFT GELATIN CAPSULES AND GELATIN- COATED TABLETS
The revision to the general test chapter Dissolution <711> implemented via the Twentieth Interim Revision Announcement is the basis for a proposal elsewhere in this PF to accommodate additional gelatin encapsulated products. New levels of enzyme that may be added at the second tier of testing have been determined to overcome the problem of pellicle formation in the dissolution test while promoting continued discrimination. The proposed change will no longer allow a choice of Dissolution Medium when water is used in the first-tier testing.
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Pharmacopeial Forum
Vol. 24, No. 5 Sept.-Oct. 1998
Collaborative Development of Two-Tier Dissolution Testing for Gelatin Capsules and Gelatin-Coated Tablets using Enzyme-Containing Media
Members of the Gelatin Capsule Working Group Mark Aikman National Pharmaceutical Alliance, Schwarz Pharma
Larry Augsburger University of Maryland at Baltimore
Ira Berry National Association of Pharmaceutical Manufacturers, Wockhardt Americas Inc.
John Bodenmiller Hoechst Marion Roussel
Stan Brandon Shinoqi Qualicaps, Inc.
Carey Bottom Banner Pharmacaps/Chase Pharmaceutical Co.
Nicholas Buhay Center for Drug Evaluation and Research, FDA
Michael Dunn Gelatin Manufacturers Institute of America, Kind & Knox Gelatine, Inc.
Florence Fang Center for Drug Evaluation and Research, FDA
Dean Cirotta Pfizer Pharmaceutical Group
Ewart Cole Capsugel
Michael Ganey Pfizer Pharmaceutical Group
Greg Guyer Merck & Co.
Hal Goff Capsugel USA, Morris Plains, NJ 07950
Vivian A. Gray DuPont-Merck Pharmaceutical Company
Deborah Grelle Center for Drug Evaluation and Research, FDA
Paul L. Hepp Center for Drug Evaluation and Research, FDA
Charles Hoiberg Center for Drug Evaluation and Research, FDA
Charles S. Kumkumian Retired, Center for Drug Evaluation and Research, FDA
Larry Lesko Center for Drug Evaluation and Research, FDA
Todd Light Hoechst Marion Roussel
Henry J. Malinowski Center for Drug Evaluation and Research, FDA
Ramakant M Mhatre Retired, Center for Drug Evaluation and Research, FDA
Justina Molzon Center for Drug Evaluation and Research, FDA
Hoianhon Nguyen Center for Drug Evaluation and Research, FDA
Carol Noory Center for Drug Evaluation and Research, FDA
Clyde Ofner Philadelphia College of Pharmacy and Sciences
Robert A. Rippere Center for Drug Evaluation and Research, FDA
David Scarpetti Center for Drug Evaluation and Research, FDA
Roger Schwede Generic Pharmaceutical Industry Association, Apothecon, Inc.
Norman Schmuff Center for Drug Evaluation and Research, FDA
John Schwier Eli Lilly
Vinod P. Shah Center for Drug Evaluation and Research, FDA
Norman Stroud R.P.Scherer, North America
Gerald K. Shiu Center for Drug Evaluation and Research, FDA
Lloyd L. Tilman ISIS
Jin Tsai Wang Center for Drug Evaluation and Research, FDA
Thomas White Pharmaceutical Research and Manufacturers of America
Bradford Williams Center for Drug Evaluation and Research, FDA
Roger L. Williams Center for Drug Evaluation and Research, FDA
Rebecca Wood Center for Drug Evaluation and Research, FDA
Abstract
A Gelatin Capsule Working Group was formed to assess the noncompliance of certain gelatin capsule products with the required dissolution specifications and the potential relationship to changes in bioavailability. Available information indicated that satisfactory dissolution might be obtained for bioavailable products upon the addition of pepsin or pancreatin enzymes to the dissolution medium. In vitro studies were conducted using pepsin in simulated gastric fluid and in water, or using Pancreatin USP (1X) in simulated intestinal fluid. The Working Group developed a protocol using differentially stressed gelatin capsules to determine the relationship of in vitro to in vivo performance. Stressed capsules were also compared to unstressed capsules in two bioequivalence studies. The research showed that moderately stressed capsules
