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Qualitative and Quantitative Evaluation of Multi-source Piroxicam Capsules Available in Nigeria

PO Osadebe, CO Esimone

Abstract


The qualitative and quantitative evaluation of eleven brands of piroxicam capsules marketed in Nigeria is presented. The disintegration time, dissolution rate and absolute drug content were determined in simulated intestinal fluid (SIF) and simulated gastric fluid (SGF) without enzymes. Weight uniformity test was also performed according to official methods. Data obtained from the dissolution profiles in both media (SIF and SGF) were mathematically treated according to the model proposed by Khan (with slight modification) and the resulting predicted availability equivalent (PAE) was used to quantitatively assess/ predict bioavailability of piroxicam from the various brands. Our results indicate variable PAE with pH. In SGF, four out of the eleven (11) brands could be adjudged to be bioequivalent with the innovator drug, Feldene (Neimeth, Nigeria); In SIF, only three out of the eleven (11) were equivalent with the innovator drug. All the capsules (except one brand) generally disintegrated within 15 min. in both SIF and SGF. The weights were also very uniform with insignificant variations. However, the variation in absolute drug contents were generally wide, with all the capsules having drug contents that are above the label claim

Key Words: Piroxicam, Qualitative, Quantitative Evaluation

Bio-Research Vol.1(2) 2003: 101-110



http://dx.doi.org/10.4314/br.v1i2.28533
AJOL African Journals Online