Design and Characterization of a Parenteral Formulation of Meloxicam
DOI:
https://doi.org/10.37285/ijpsn.2010.3.1.7Abstract
Parenteral formulation of meloxicam was developed using pH 9.2 glycine-sodium hydroxide buffer containing 10% v/v of dimethylacetamide as the solvent. Various batches of meloxicam injection formulation were prepared in order to assess the influence of light, atmospheric oxygen and antioxidants (sodium bisulfite; sodium sulfite and thiourea) on the stability of the drug and the formulations were also subjected to accelerated stability testing (at 40o, 50o and 60o C) in order to predict the shelf-life of the product. Since light and atmospheric oxygen reduced the stability of the formulation, air in the ampoules was replaced with an inert gas (carbon dioxide) and the product was filled in amber coloured containers (ampoules). Sodium bisulfite (0.15% w/v) as an antioxidant gave a shelf-life of approximately 200 days under ambient temperature conditions.
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Keywords:
Meloxicam, parenteral formulation, dimethylacetamide, glycine-sodium hydroxide buffer, shelf-life, sodium bisulfite, sodium sulfite, thioureaDownloads
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