Proposed Revision : General Chapter <1092> The Dissolution Procedure: Development and Validation
The General Chapters—Dosage Forms Expert Committee is proposing to revise General Chapter <1092> The Dissolution Procedure:; Development and Validation. In addition to a reorganization of the existing content, the proposed revision will include additional information on:
• Preliminary assessments needed before initiating procedure development,
• Automation, and
• Acceptance criteria and interpretation of results from a dissolution test.
A companion Stimuli article explains the rationale and content of this proposed revision.
General Chapter <1092> and the associated Stimuli article have been approved for publication in Pharmacopeial Forum 40(1) [Jan.-Feb. 2014]. Both are being presented in advance of the publication of PF 40(1) to allow additional time for public review and comment. Comments will be accepted until March 31, 2014, the end of the comment period for Pharmacopeial Forum 40(1).
Article shared by: Dr. Atul Moghe
New Dissolution test to be included in BP monograph for Levothyroxin Tablets
04 Feb, 2013
Over recent years, the MHRA has received reports from prescribers and patients of difficulties with levothyroxine tablets, mostly concerning the quality or effectiveness of the product. The numbers of reports were very small in relation to the number of patients taking this medicine, nevertheless, they were persistently received. In January 2011 the MHRA decided to undertake a detailed investigation into possible underlying reasons for these reports that might be connected to the known sensitivity of the drug substance, levothyroxine. The findings were presented to the Commission of Human Medicines for their consideration.
The Commission on Human Medicines is an independent panel of experts with whom the licensing authority (MHRA) consults to obtain advice on the safety, quality and efficacy of medicines.
The CHM made several recommendations aimed at improving the quality and consistency of levothyroxine products. A key recommendation was the introduction of a new discriminatory dissolution test that all products will have to meet when tested.
Dissolution is a way of testing that the levothyroxine drug is able to adequately dissolve out of the tablet and be available in a solution for absorption from the gut. If the drug doesn’t completely dissolve, then it may not be fully absorbed by the body to give an optimal clinical effect. A dissolution test was developed by the MHRA.
The dissolution test will shortly be included in the BP monograph for Levothyroxine Tablets. This will become a legal requirement once published by BP. The timescale for this is expected to be about January 2014.