The Farmacopeia Brasileira announced the Call for Contributions No. 10/2024, aimed at enhancing the evaluation of pharmaceutical specialties through dissolution testing. This initiative seeks input from the production sector and educational and research institutions to support the inclusion of these tests in 32 monographs of pharmaceutical specialties that currently lack them.
Importance of Dissolution Testing
Dissolution tests are crucial for assessing the efficacy and safety of medications, ensuring their quality and performance. These tests measure the rate and extent to which the active ingredient is released from its dosage form and becomes available for absorption in the body. Incorporating these tests into monographs will significantly improve the standards for pharmaceutical products, benefiting both consumers and the industry.
Details of the Call for Contributions
The new call invites stakeholders to submit data that will inform the inclusion of dissolution tests in the specified monographs. The details of the active ingredients and pharmaceutical specialties involved, as well as the criteria for submission, can be found on Anvisa‘s portal. The submission period began on July 17, 2024, and will run until September 14, 2024.
Specifics from the Call for Contributions No. 10/2024
According to the official document, the Farmacopeia Brasileira aims to select proposals that will expand the number of monographs containing dissolution tests. This process is intended to ensure comprehensive pharmaceutical monographs and expedite their publication.
Key details from the Call include:
- Submission Requirements: Proposals must include a description of the dissolution method currently approved by Anvisa, a development report, a validation report, and the approval document of the method.
- Evaluation Process: Submitted proposals will undergo a two-stage evaluation process by the Farmacopeia Brasileira Coordination (Cofar) and the Thematic Technical Committee for Pharmaceutical Specialties. Valid proposals will be analyzed for technical adequacy and compliance with established guidelines.
- Timeline:
- Call launch: July 17, 2024
- Submission deadline: September 17, 2024
- Document screening: November 17, 2024
- Disclosure of recommended methods: April 17, 2025
Targeted Pharmaceutical Specialties
The call targets various forms of pharmaceuticals, including tablets, capsules, and oral suspensions. Some of the specific drugs involved are:
- Oral Suspensions: Amoxicillin and clavulanate potassium, Cefaclor, Azithromycin, and Nitazoxanide.
- Tablets and Capsules: Artesunate, Bisacodyl, Clindamycin hydrochloride, and Lamotrigine.
- Chewable Tablets: Aluminum hydroxide.
Conclusion
The Farmacopeia Brasileira’s initiative to incorporate dissolution tests into pharmaceutical monographs is a significant step toward improving medication quality and safety in Brazil. By involving the production sector and research institutions, this effort aims to enhance regulatory practices and support the continuous advancement of the pharmaceutical industry.