Wonder Drug
- Posted by CERC India
- Posted in Pharmaceuticals
We tested two national brands of soluble aspirin tablets and four plain generic aspirin tablets against the Indian Pharmacopoeia (IP) and the US Pharmacopoeia (USP). The key findings are :
September-October 1998
KEY FINDINGS
Aspirin Tested
We tested two national brands of soluble aspirin tablets and four plain generic aspirin tablets against the Indian Pharmacopoeia (IP) and the US Pharmacopoeia (USP). The key findings are :
- Aspirin of Indigenous Drug Pharmaceuticals, CPM Enterprise, Debonair PHarmaceuticals and Manish Pharma Lab failed to meet the IP standards.
- The national brands of soluble aspirin, Disprin and Colsprin, met the IP standards.
- The plain aspirin of CPM Enterprise met the standards for assay with an aspirin content of 97.89 per cent. (Assay gives the amount of aspirin in the tablet and as per the IP it should be within 95-105 per cent of the amount claimed on the label.)
- The aspirin content was found to be less in Manish Pharma Lab (94.08 per cent) and Indigenous Pharmaceuticals (93.03 per cent). In case of Debonair PHarmaceuticals it was 90.98 per cent, 4 per cent less than the minimum permitted by IP.
- The aspirin of CPM Enterprise took 2 hours and 41 minutes to disintegrate against the IP standard of 15 minutes. The aspirin of Indigenous Drug Pharmaceuticals took only 8 seconds to disintegrate. (Disintegration is an important test to check how fast the tablet breaks. The faster it breaks, the sooner it will be available to the system.)
- Dissolution is a test specified by the USP which gives information on the actual release of the drug content from the tablet. There is a direct relationship between the bioavailability of the drugs and its dissolution rate. Only aspirin of Indigenous Drug Pharmaceuticals could meet the standard where 85.48 per cent of the labelled aspirin dissolved against the standard of 80 per cent. The rest failed to meet the USP standards. The aspirin of CPM Enterprise could dissolve only 12.80 per cent of labelled aspirin. This is not surprising because it took 2 hours and 41 minutes to disintegrate. The tablet formulation may be faulty. Manish Pharma Lab dissolved 21.02 per cent and Debonair 26.65 per cent.
- The salicylic acid test is conducted to check the amount of salicylic acid in the tablet as more of it can be harmful beyond a certain limit. While the IP stipulates only the colour comparison test, the USP has more stringent stipulations. It states that salicylic acid should not be more than 0.3 per cent. The aspirin of Debonair Pharmaceuticals had 1.3 per cent of salicylic acid and, therefore, failed the USP test.
- The aspirin of Indigenous Drug Pharmaceuticals did not exhibit any manufacturing licence number, which is required by the law.
- The aspirin of Debonair PHarmaceuticals had no dosage information while aspirin of Manish Pharma Lab did not give any storage information.
- Disprin gave storage and labelling information only on the carton and not on the strip.
- Colsprin gave labelling information only on the carton and not on the strip.
