Journal article
In-Vitro Evaluation of Brand and Generic of Meloxicam Tablets Available in Saudi Arabia

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Publication Details
Author list: Yasir Alshehry, Hassan Ghonaim, Ashfaq A. Mohsin
Publication year: 2021
Journal acronym: IJPPR
Volume number: 20
Issue number: 3
Start page: 360
End page: 371
Number of pages: 12
ISSN: 2349-7203
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Generic substitution
has become a common concern among health care providers, patients and the
government. The interchangeability idea raised several concerns related to the
safety and efficacy of generics since the late 1970s in the US. In Saudi
Arabia, the number of local drug products were increased significantly
therefore the need for comparative studies is mandatory. This study aimed to
evaluate three meloxicam drug products (15 mg tablets) that are marketed in
Saudi Arabia in comparison to the innovator brand (Mobic®, Boehringer,
Germany). The physicochemical parameters of meloxicam tablets were assessed
according to the united states pharmacopoeia methods including hardness,
thickness, uniformity of weight, friability and disintegration tests. Further,
the in vivo behavior was predicted and compared by measuring the dissolution
rate for all four products. Similarity factor (f2) was used as a quantitative
parameter to compare the dissolution curves of the generics with the
dissolution curve of the brand. The results of physical evaluations revealed
that the four meloxicam products complied with United States Pharmacopeia specifications.
The in-vitro dissolution performance of the brand and generic products of
meloxicam tablets fulfilled the official dissolution rate test limit of NLT 70%
in 30 min. Further, based on the calculated similarity factor, no significant
differences were observed which indicate possible bioequivalence. In
conclusion, the meloxicam generics could be considered equivalent or comparable
to the innovator product. However, as meloxicam belongs to class II BCS drug,
the interchangeability between these products must be recommended with in-vivo
bioequivalence studies.

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Last updated on 2021-17-10 at 23:21