Abstract

FORMULATION, FABRICATION AND IN-VITRO EVALUATION OF FAST DISSOLVING ORAL FILM OF CILNIDIPINE

Nisha Kumari*, Nishi Prakash Jain and Jitendra Banweer

Abstract

Patient compliance is an integral part of pharmaceutical research for better and sustained drug delivery. This is now essential for the pharmaceutical scientist to reconsider their research focus. The oral delivery of drugs is the most ideal route of administration due to ease of administration. This research work focus on development of Oral Fast Dissolving Films (OFDF), which has the unique property of rapidly dissolving and releasing the drug as soon as they come in contact with saliva. A new calcium channel blocker (CCB), Cilnidipine has an inhibitory action on the sympathetic N-type and L-type Ca2+channels. Oral Fast Dissolving Films (OFDF) of Cilnidipine was prepared by solvent casting method with HPMC E-15 and Gum acacia (2.5%w/v) as film former, PEG-400 as plasticizer, Citric acid for producing more saliva while Sodium starch glycholate were taken as superdisintigrants. The prepared films were evaluated for Weight uniformity, Folding endurance, Tensile strength, Percent Elongation, Disintegration Test and Drug Content. All OFDFs of Cilnidipine were transparent and the thickness was varying from 185±0.167 μm to 250±0.236 μm. The weight of films (COF1 to COF9) was found to be in range of 104.8±0.216 to 116±0.141 mg and folding endurance found to be 256±2.645 to 289.6±1.154 times. The prepared films found to be 1.20±0.017 to 1.50±0.043 kg/cm2 range of tensile strength. Disintegration time of all batches varies between 143.6±1.527 Sec. to 91.60±1.527 Sec. The prepared optimized batch of OFDF of Cilnidipine may be useful in Acute Hypertensive patients and other cardiac diseases patient.

Keywords: Cilnidipine, calcium channel blocker (CCB), Oral Fast Dissolving Films (OFDF), Hypertension, Cardiac diseases.