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Published on: February 9, 2016
Review article: Oral, modified-release mesalazine formulations--proprietary versus generic
A Forbes1, A Cartwright, S Marchant
1St Mark's Academic Institute, St Mark's Hospital, Northwick Park, Harrow, UK. alastair.forbes@ic.ac.uk
Alimentary Pharmacology & Therapeutics
|May 21, 2003
Summary
Generic mesalazine products for inflammatory bowel disease require rigorous assessment. New regulatory standards are needed to ensure therapeutic equivalence for topical drug delivery, benefiting patients and physicians.
Area of Science:
- Pharmacology
- Gastroenterology
- Drug Development
Background:
- Mesalazine is a key treatment for inflammatory bowel disease (IBD).
- Many oral, modified-release mesalazine products are nearing patent expiration, leading to generic development.
- Current formulations are designed for topical action at the inflammation site, necessitating specific release profiles.
Purpose of the Study:
- To evaluate the adequacy of standard regulatory processes for generic, topically acting, oral, modified-release mesalazine products.
- To propose a more rigorous assessment framework for ensuring therapeutic equivalence of new mesalazine formulations.
- To provide confidence for physicians and patients regarding the interchangeability and efficacy of generic mesalazine.
Main Methods:
- Analysis of current regulatory assessment practices for modified-release drug products.
- Review of the topical mechanism of action for mesalazine in IBD.
- Proposal for a combined assessment approach including dissolution, bioequivalence, and clinical trials.
Main Results:
- Standard systemic bioequivalence testing is insufficient for topically acting, oral, modified-release mesalazine.
- Current guidelines recommend against interchangeability of oral, delayed-release mesalazine formulations.
- A need exists for a more robust regulatory evaluation to ensure therapeutic equivalence.
Conclusions:
- Regulatory bodies should mandate a combination of dissolution testing, bioequivalence studies, and comparative clinical trials for new oral mesalazine products.
- This comprehensive assessment is crucial for therapeutic equivalence and patient safety.
- Enhanced regulatory rigor will ensure confidence in the use of generic modified-release mesalazine products for IBD management.
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