Last Updated on December 30, 2023 by The Health Master
DT for Soft Gelatin Capsules
The Indian Drug Manufacturers’ Association (IDMA) has urged the Indian Pharmacopoeia Commission (IPC) to revise the disintegration time (DT) for soft gelatin capsules.
This request is to avoid serious market disruption due to climatic conditions in India, which differ from those in the United States.
The gelatin capsule undergoes several changes during transportation, making it difficult to open up in the human stomach in a DT of 30 minutes.
Recommended Disintegration Time
The IDMA recommends not more than (NMT) 60 minutes from NMT 30 minutes for soft gelatin capsules.
Most of the products in the market will change if this is not implemented timely, impacting the market of all multi-vitamins and ethical products, including the nutraceutical products.
The recommendation is, therefore, not to implement 30 minutes, considering that manufacturers might make some changes in the formula.
NMT 30 minutes need to be implemented after one year.
Phased Implementation of DT Revision
The industry has recommended implementing the revision in a phased manner, initially covering only the single ingredient drugs by incorporating them in specific monographs.
This will not make it a mandatory limit for all soft gelatin capsules by incorporating in the general test limits.
Concerns Shared by IDMA and Other Stakeholders
IDMA and other concerned stakeholders have shared their views and reservations pertaining to the IPC’s intention to revise the DT for soft gelatin capsules from NMT 60 minutes to NMT 30 minutes.
According to an official associated with the development, “Our concern specifically is the across-the-board revision of the DT, which may not be feasible or even desired for all the products, specifically for the multimineral and multivitamin products.”
“This change is very difficult to implement and will lead to serious market disruption.”
Feasibility Issues
Industry experts reiterate that it may not be feasible for the stakeholders to revise the DT for vitamin-mineral-nutraceutical extract products from NMT 60 minutes at present to NMT 30 minutes as proposed.
There are several technical issues with this, for example, the limitations of temperature or humidity in the storage condition in the supply chain within India coupled by the technical feasibility due to multiple ingredients in the case of multi-mineral/multi-vitamin formulations, among others.
Request for a Meeting
IDMA has requested another meeting with IPC to discuss the outcome of the testing of samples of vitamin-mineral-nutraceutical extract products proposed by them.
This request is also following receipt of confirmation that the vitamin-mineral-nutraceutical extract products specified by the stakeholders are checked by the IPC with respect to the DT.
Prior to seeking IPC’s appointment for the meeting, IDMA would submit a written proposal from the stakeholder’s perspective with respect to the revising of DT for the soft gelatin capsule products.
Conclusion
The revision of the disintegration time for soft gelatin capsules is a critical issue for the Indian pharmaceutical industry.
It is essential to ensure that the revision of the DT does not lead to market disruption and impact patient health.
Therefore, it is imperative that all concerned stakeholders work together to find a feasible solution.
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