A pilot stability study on four-drug fixed-dose combination anti-tuberculosis products.
A pilot stability study was carried out on four fixed-dose combination anti-tuberculosis products at 40 degrees C and 75% RH. The strip-packed products were stable, while the blister-packed products showed both physical and chemical changes. The products in unpacked conditions showed severe (approximately 60%) decomposition of rifampicin and extensive physical changes. The main decomposition product in the solid state was isonicotinyl hydrazone of 3-formylrifamycin and isoniazid. It is suggested that attention should be paid to the detection and quantitation of this product in the marketed formulations. The packing material used in the manufacture of FDC products should also be of the highest quality.
Singh
S
S
Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research, SAS Nagar, Punjab, India. ssingh@niper.ac.in
Mohan
B
B
D000904:Antibiotics, Antitubercular / Q000008:administration & dosage / Q000737:chemistry* / Q000493:pharmacokinetics*; D000995:Antitubercular Agents / Q000008:administration & dosage / Q000737:chemistry* / Q000493:pharmacokinetics*; D001682:Biological Availability; D004338:Drug Combinations; D004348:Drug Labeling; D004349:Drug Packaging; D004355:Drug Stability; D004356:Drug Storage; D004977:Ethambutol / Q000008:administration & dosage / Q000737:chemistry* / Q000493:pharmacokinetics*; D006801:Humans; D007538:Isoniazid / Q000008:administration & dosage / Q000737:chemistry* / Q000493:pharmacokinetics*; D010865:Pilot Projects; D011718:Pyrazinamide / Q000008:administration & dosage / Q000737:chemistry* / Q000493:pharmacokinetics*; D012293:Rifampin / Q000008:administration & dosage / Q000737:chemistry* / Q000493:pharmacokinetics*; D013607:Tablets; D013997:Time Factors; D014376:Tuberculosis / Q000188:drug therapy*
D000904:Antibiotics, Antitubercular; D000995:Antitubercular Agents; D004338:Drug Combinations; D013607:Tablets; D011718:Pyrazinamide; D004977:Ethambutol; D007538:Isoniazid; D012293:Rifampin