Formulation and Evaluation of Cilnidipine Mucoadhesive Buccal Film by Solvent Casting Technique for the Treatment of Hypertension

Abstract

Objective: Buccal drug delivery is the most suited route for local as well as systemic delivery of drugs. Cilnidipine is an L/N type dihydropyridine 4th generation calcium channel blocker (CCB), which decreases hypertension by blocking the N-type calcium channel to attenuate vascular sympathetic neurotransmission. It has high first-pass metabolism leading to low bioavailability. Hence the present research work was undertaken to formulate mucoadhesive buccal film of Cilnidipine with an objective to enhance therapeutic efficacy, bioavailability and was developed to administer into the unconscious and less-co-operative patients. Methods: Cilnidipine buccal films were prepared by a solvent-casting technique using various concentrations of mucoadhesive-polymers such as Hydroxyl propyl methylcellulose (HPMC) E15 and K4M and ethyl-cellulose as backing-layer, which acts like a patch providing unidirectional drug release. Prepared films were evaluated for their weight variation, thickness, surface-pH, swelling-index, drug content uniformity, in vitro residence time, folding endurance, tensile strength, in vitro release and permeability studies. Results: The infra-red (IR) spectra showed no interaction, and Physico-chemical characteristics were found within the limit. Swelling of the film increases with increasing concentration of polymers and %drug content of all formulations found to be in the range of 92.13%±0.94% to 97.92%±0.35%. The formulation F5, showed a promising tensile strength, folding endurance and in vitro drug release of about 95.18±0.03%, thus can be selected as an optimized formulation of mucoadhesive buccal film. Conclusion: The formulation of Cilnidipine mucoadhesive buccal film was found to be satisfactory and reasonable.

An Overview on Oral Thin Films–methodology, Characterization and Current Approach

“…By evaluating the API content in each strip, content consistency is ascertained. 85-115% is the limit of content uniformity [69,70].…”

Design, Development and Evaluation of Novel Mouth Dissolving Film of Tofacitinib Citrate

“…The optimized amount of HPMC was dissolved in 5 ml of water and stirrer continuously for 1hour, optimized amount of Plasticizer and drug were dissolved in 95% ethanol and then added to the polymeric solution, the optimized amount of drug was dissolved in 2 ml of water and kept on sonication for proper dispersion [13,14]. Polymeric solution was stirred for 30 min using magnetic stirrer and was kept in undisturbed condition till the entrapped air bubbles were removed [15,16]. The aqueous solution was cast in a glass mould having 2.5 x 2.5 cm 12 film areas and was dried at controlled room temperature (25 °-30 °C, 45%RH) as well as with increased temperature (microwave oven).…”

QUALITY BY DESIGN APPROACH FOR DEVELOPMENT AND OPTIMIZATION OF CHITOSAN-BASED FLOATING MICROSPHERES FOR TOPOTECAN HCl

“…Whereas, in the case of CS-XG microspheres, the increase in CS concentration (and so a lesser XG concentration) could result in decreased gel matrix complexity. A higher molecular weight of the polymer, and hence the resultant strong gel matrix, could prolong the drug release [31]. Upon increasing the level of Factor C, the response R3 was observed to decline.…”