Last Updated on October 10, 2024 by The Health Master
The Indian Pharmacopoeia Commission (IPC) has included dissolution tests in prolonged release formulations in the Indian Pharmacopoeia (IP) to address the issue of different dissolution profiles of different brands currently being marketed in India.
Dissolution profiles of prolonged-release formulations vary from manufacturer to manufacturer and may significantly affect the pharmacokinetic efficacy and safety of the product.
A flexible monograph approach will be adopted in the IP, with multiple dissolution specifications in one monograph, to assess the quality of all approved products.
Accordingly, the labeling requirements of such products would specify the dissolution method number on the label of the product for effective implementation of the flexible monographs.
IPC had discussions with the stakeholders on the proposal to include dissolution tests in prolonged release formulations in the IP.
It has been agreed that IPC would start including the dissolution tests in prolonged release monographs which are under development.
Simultaneously, IPC will revise official monographs in order to include dissolution specifications based on three point criteria:
The dissolution profile of the first product approved by the Drugs Controller General of India (DCGI), the dissolution profile recommended by OGD / USP, and the dissolution profile proposed by the stakeholders (to be accompanied with clinical data or IVIVC data of their equivalence with the first product approved by the DCGI).
If there is a proposal from stakeholders to include a different dissolution profile in the IP monograph, bioequivalence data with the international reference product or the first product approved by the CDSCO will be required before including alternative dissolution specifications in the IP.
“Monographs on the widely used drugs, such as metformin, sodium valproate, domeperidone, and rabeprazole, have to be prioritized for setting dissolution specifications in the IP,” according to an IPC official.
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