Abstract

FORMULATION DEVELOPMENT AND CHARACTERIZATION OF DIRECTLY COMPRESSIBLE TABLETS OF CILOSTAZOL LOADED SPHERICAL CRYSTAL AGGLOMERATES

Nidhi H. Upadhyay*, Shrenik K. Shah and Dhaval J. Patel

ABSTRACT

Spherical Crystal Agglomerates of Cilastazol prepared to improves the solubility of poorly soluble drugs using Crystal-co-agglomeration technique. DCM select as a good solvent, Bridging solvent and water selected as a poor solvent. Initially screening trials taken to optimize the stirrer RPM, Stirring time and amount of aqueous solution. 1000 rpm speed, 45 min stirring time and 120 ml aqueous solution. Different polymers selected for screening with different drug to polymer ratio. Ethyl Cellulose, Poloxomer -188, PVP K30 and HPMC selected and trials taken by using 1:0.25 to 1:1 ratio. The best drug release found in 1:0.75 ratios with Poloxomer -188, F7 batch. Drug satration solubility found 174 microgram/ml. also all batches having drug content value within acceptable range. FTIR, DSC and XRD study shows no drug excipients compatibility between drug and excipients. Tablets prepared by using optimized Spherical Crystal Agglomerates of Cilostazol F7.all the physical parameters of prepared tablets found within acceptable range. % drug release observed similar with the F7 formulation. Comparison with marketed product suggests better and fast drug release as compared to market formulation. Additionally stability of TF7 for 1 month performed and found stable.

Keywords: Cilostazol, Crystal-co-agglomeration, Spherical Crystal Agglomerates.