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A pilot stability study on four-drug fixed-dose combination anti-tuberculosis products.
Int J Tuberc Lung Dis. 2003 Mar; 7(3):298-303.IJ

Abstract

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.

Authors+Show Affiliations

Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research, SAS Nagar, Punjab, India. ssingh@niper.ac.inNo affiliation info available

Pub Type(s)

Evaluation Study
Journal Article

Language

eng

PubMed ID

12661847

Citation

Singh, S, and B Mohan. "A Pilot Stability Study On Four-drug Fixed-dose Combination Anti-tuberculosis Products." The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease, vol. 7, no. 3, 2003, pp. 298-303.
Singh S, Mohan B. A pilot stability study on four-drug fixed-dose combination anti-tuberculosis products. Int J Tuberc Lung Dis. 2003;7(3):298-303.
Singh, S., & Mohan, B. (2003). A pilot stability study on four-drug fixed-dose combination anti-tuberculosis products. The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease, 7(3), 298-303.
Singh S, Mohan B. A Pilot Stability Study On Four-drug Fixed-dose Combination Anti-tuberculosis Products. Int J Tuberc Lung Dis. 2003;7(3):298-303. PubMed PMID: 12661847.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A pilot stability study on four-drug fixed-dose combination anti-tuberculosis products. AU - Singh,S, AU - Mohan,B, PY - 2003/3/29/pubmed PY - 2003/6/19/medline PY - 2003/3/29/entrez SP - 298 EP - 303 JF - The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease JO - Int. J. Tuberc. Lung Dis. VL - 7 IS - 3 N2 - 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. SN - 1027-3719 UR - https://www.unboundmedicine.com/medline/citation/12661847/A_pilot_stability_study_on_four_drug_fixed_dose_combination_anti_tuberculosis_products_ L2 - https://www.ingentaconnect.com/openurl?genre=article&issn=1027-3719&volume=7&issue=3&spage=298&aulast=Singh DB - PRIME DP - Unbound Medicine ER -