Abstract

FORMULATION AND EVALUATION OF ORODISPERSIBLE TABLETS OF CILNIDIPINE BY SPRAY DRYING TECHNIQUE

Dr. Shailesh T. Prajapati*, Priyank D. Maheshwari and Chhaganbhai N. Patel

ABSTRACT

Cilnidipine is a novel dihydropyridine calcium antagonist and its calcium antagonistic activity is lasting longer than those of Nifedipine and Nicardipine. Cilnidipine has been used for the treatment of hypertension. It is a BCS Class-II drug. Therefore, it is necessary to enhance the solubility and dissolution rate and minimize the variability in absorption of Cilnidipine. Diverse water soluble carriers viz. Polyethylene glycols (PEG 4000, 6000), Hydroxypropyl Methyl cellulose (HPMC E5 LV), Chitosan, Carrageenan, Poloxamer 188, Na.CMC and β‐cyclodextrin were used for this purpose. Phase solubility studies revealed an increase in drug solubility with PVP K30, Na.CMC. Spray drying of Cilnidipine with PVP K30 and Na.CMC in order to determine the potential effect on solubility Cilnidipine. Preformulation studies were conducted to select the appropriate carriers and drug:carrier ratio for preparing the spray dried compositions. The solid state interactions of the spray dried mixtures were evaluated by DSC. DSC studies showed that the Drug polymer complex formed by spray drying. Results show that increase in solubility was achieved for Cilnidipine by preparing spray dried dispersion using PVP K30 in ratio of (1:1) with pure drug. Optimized SDDs was further compressed into as orodispersible tablet by direct compression method. The prepared tablets were evaluated for the drug content, weight variation, wetting time, in vitro disintegration, hardness, friability, thickness and in vitro dissolution. Results revealed that Kyron T314 showed least disintegration time compare other disintegrant. Hence spray drying technique can be used for formulation of tablets of Cilnidipine by direct compression technique.

Keywords: Cilnidipine, Spray drying Technique, Orodispersible tablet, PVP K 30, Kyron T314.