Author: Farya Zafar, Muhammad Harris Shoaib, Huma Ali, Rabia Ismail Yousuf, Ghazala Raza Naqvi, Zeb un Nisa and Yusra Shafiq
Publishing Date: 2017
E-ISSN: 1011-601X
Volume 30 Issue 1
ABSTRACT:
The objective of this study was to assess the quality of six different brands of enteric coated Ketoprofen 100 mg tablets, KPB2 to KPB6 are available in commercial market of Karachi, Pakistan, while KPB1 was obtained from international source. We performed different physico-chemical assessments i.e. weight variation, diameter, hardness, friability, thickness, disintegration, content uniformity, assay and dissolution test. Results of all the investigations were found to be in adequate limits. Also pharmaceutical equivalence was determined by selecting different tests and assay assessment. Furthermore, in vitro therapeutic equivalence was also estimated at phosphate buffer pH 6.8 and 7.5. Results were evaluated by one way ANOVA, model independent and model dependent methods. ANOVA results showed that release behaviour were found to be similar as p values >0.05, also KPB1 – KPB6 followed Weibull model at different dissolution media. Results indicated that innovator and brands not only passes the pharmaceutical equivalence assessment but also comply with the in vitro therapeutic equivalence.
KEYWORDS: Ketoprofen, Biorelevent media, model-dependent, one way ANOVA, model-independent method and Weibull model.