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- Title
Formulation and Evaluation of Pharmaceutically Equivalent Parenteral Depot Suspension of Methyl Prednisolone Acetate.
- Authors
ALAM, MD. A.; AHUJA, ALKA; BABOOTA, SANJULA; GIDWANI, S. K.; ALI, J.
- Abstract
The aim of the present study was to formulate and evaluate pharmaceutically equivalent injectable aqueous suspension for parenteral depot of methyl prednisolone acetate. Various aqueous suspensions were prepared by rapid stirring and colloid milling method. The prepared aqueous suspensions were subjected to particle size determination, sedimentation study, in vitro release studies (pH dependent dissolution study), and stability studies. The optimized formulation consisted of 4% w/w of methyl prednisolone acetate, 2.91% w/w of PEG-3350, 0.19% w/v of injection grade Tween-80, 0.68% w/w of monobasic sodium phosphate, 0.15% w/w of di-basic sodium phosphate, 0.91% w/v of benzyl alcohol, 0.32% w/w sodium meta bisulphate. The f2 value was calculated for innovator (DepoMedrol®, Batch No. MPH-0254) and optimized formulation at pH 6.8 and pH 7.4 phosphate buffers. The f2 values of 62.94 and 54.37 were obtained at pH 6.8 and pH 7.4 phosphate buffers respectively. The particle size ranged 23-27 µm at D value of 0.9 for both test and innovator product.
- Subjects
SUSPENSIONS (Chemistry); PARENTERAL therapy; ACETATES; PHOSPHATES; PARTICLE size determination; SEDIMENTATION analysis; DRUG stability
- Publication
Indian Journal of Pharmaceutical Sciences, 2009, Vol 71, Issue 1, p30
- ISSN
0250-474X
- Publication type
Article