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Gujarat FDCA attributes 45% of drug samples failing quality tests due to dissolution testing failure

Shardul Nautiyal, Mumbai
Monday, September 25, 2023, 08:00 Hrs  [IST]

The Gujarat Food and Drug Control Administration (FDCA) has attributed 45% of drug samples failing quality tests due to dissolution testing failure.

The state drug regulator collects 15, 000 drug samples annually of which 2% samples fail quality tests related to content, disintegration, dissolution, description, variation in weight and sterility. Out of the failed samples, 45% alone are due to failure in dissolution testing.  

Dissolution testing determines the drug absorption rate in the human body and hence helps determine its efficacy.  Dissolution testing is a requirement for all solid oral dosage forms and some other category products. It is an important parameter to be complied throughout the development life-cycle, product release testing and ongoing stability testing.

Gujarat FDCA Commissioner Dr H G Koshia has revealed that majority of the quality test failure is due to dissolution testing failure, which has been a predominant trend observed recently. This could safely be addressed if the manufacturers equip themselves with knowledge of dissolution science and implement the same during the product development.

During the life cycle of the product, a number of changes take place like API/excipient source, formulation, pharmacopoeial dissolution method, Invitro-Invivo correlation, adverse drug effects etc. In the post approval inspection, if any problem is noticed related to data integrity of dissolution, Bio-availability or Bio-equivalence (BA/BE) data, it is going to be disastrous for the patient and the manufacturing company. So there is a need to monitor dissolution profile throughout the life cycle (product development/launch till its discontinuation).

Each medicine has its own delivery system and therefore dissolution testing is required to be done on a regular basis to determine the time and efficacy of medicine in the human body. Experts have advocated developing a Centre of Excellence for Dissolution Science with the help of industry partners as it is the key to any product development.

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