Last Updated on December 30, 2023 by The Health Master
The Indian Pharmacopoeia Commission (IPC) has decided to include dissolution tests in prolonged-release formulations in the Indian Pharmacopeia (IP) and adopt a flexible monograph approach in the wake of different dissolution profiles of different brands currently being marketed in India.
Dissolution tests
The flexible monograph approach aims to include multiple dissolution specifications in one monograph to assess the quality of all approved products.
IPC had held discussion with the stakeholders on the proposal to include a dissolution test in prolonged-release formulations in the IP.
Dissolution profiles of prolonged-release formulations vary from manufacturer to manufacturer and may significantly affect the pharmacokinetics, efficacy and safety of the product, said a senior scientific official at IPC.
He said it had been agreed that IPC would start including the dissolution tests in prolonged release monographs, which are under development.
Simultaneously, revision of official monographs will also be taken up by IPC for inclusion of dissolution specifications based on three point criteria, which include the dissolution profile of the first product approved by the Central Drugs Standard Control Organization (CDSCO), the dissolution profile recommended by the Office of Generic Drugs (OGD)/United States Pharmacopoeia (USP) and dissolution profile proposed by the stakeholders (to be accompanied with clinical data/in vitro in vivo correlation (IVIVC) data of their equivalence with first product approved by the CDSCO), he added.
In order to address the issue of different dissolution profiles of different brands currently being marketed in India, flexible monograph approach will be adopted in the IP with multiple dissolution specifications in one monograph to assess the quality of all approved products, the official informed.
Accordingly, labelling requirements of such products would specify the dissolution method number on the label of the product for effective implementation of the flexible monographs, he stated.
The official added that if there is a proposal from stakeholders to include a different dissolution profile in the IP monograph, bioequivalence data with an international reference product or the first product approved by the CDSCO will be required before including alternative dissolution specifications in the IP.
He opined that monographs on widely used drugs, such as metformin, sodium valproate, domperidone, and rabeprazole, will be prioritized for setting dissolution specifications in the IP, he said.
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