Last Updated on June 15, 2022 by The Health Master
The drug industry has urged Indian Pharmacopoeia Commission (IPC) to retain disintegration (DT) time of 60 minutes in general monograph of soft gelatin capsules and include the stringent limit of 30 minutes in individual monographs.
The Eighth Edition of Indian Pharmacopoeia (IP-2018) released by the Union ministry of health and family welfare has revised general chapters on disintegration tests of soft gelatin capsules among others.
With this disintegration time for soft gelatin capsules has been revised from 60 minutes to 30 minutes.
Majority of the stakeholders have opposed the change in DT limit and informed IPC to hold the change until a proper statistically validated protocol-based study is performed and shared with all the stakeholders.
The Indian Pharmacopoeia Laboratory is accredited for both chemical and biological testing and has tested market samples and control samples in two groups i.e of ethical therapeutic medicinal products and nutraceutical in which category of vitamins and dietary supplements are included.
The category 1 products meet the stringent standards for the limit of DT, whereas the nutraceutical products had 25 per cent failure to pass the stringent limit of DT, said Dr Viranchi Shah, national president, Indian Drug Manufacturers’ Association (IDMA).
In order to meet the stringent limit of DT for soft gelatin capsules there is need for modification in the product composition and the stakeholders have a reservation to do the changes in product composition as it would take the product out of market and there will be shortage of medicines, said Dr Shah.
The IDMA has appealed to Dr Rajeev Singh Raghuvanshi, secretary-cum-scientific director of IPC to retain the DT time of 60 minutes in general monograph of soft gel capsules, and incorporate the stringent limit of 30 minutes in individual monographs.
The semi-digested food (chyme) takes minimum 45-60 minutes to travel to the stomach and hence the drug can be available for dissolution and absorption only after 45-60 minutes. For dissolution water is required over the small intestine lining.
This water comes from three enzymes of the small intestine i.e. pancreatic juice, intestinal juices and bile. These juices are secreted only after the chyme enters the small intestine.
Thus, faster DT is not an important determinant as the timing of chyme entering the intestine decides the dissolution indirectly, said Dr Vinay G Nayak, chairman, quality management & technical committee, IDMA.
Reformation of the existing widely used products violates schedule M, where the clinical and BE (Bio Equivalency) studies which was performed prior to marketing of products will be needed to be repeated so that the reduction of DT limit does not create dose dumping or any adverse reaction in clinical patients, explained Dr Nayak.
It is recommended that dietary supplements and ethical medicinal products be set apart, and FSSAI can decide the limit for DT test rather than link it to IP, added the industry body.
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