Abstract

A REVIEW ON MOUTH DISSOLVING FILM OF AMLODIPINE

Prateek Kumar*, Rajneesh Kumar Gupta, Swarnakshi Upadhyay and Sonam Shukla

ABSTRACT

The present investigation was undertaken with an objective of formulating mouth dissolving films (MDFs) of Amlodipine (AMLO) to enhance convenience and compliance of the elderly and pediatric patients for better therapeutic efficacy. Film formers like hydroxy propyl methyl cellulose (HPMC) and methyl cellulose (MC) along with film modifiers like poly vinyl pyrrolidone K30 (PVP K30), and sodium lauryl sulphate (SLS) as solubilizing agents were evaluated. The prepared MDFs were evaluated for in vitro dissolution characteristics, in vitro disintegration time, and their physic mechanical properties. All the prepared MDFs showed good mechanical properties like tensile strength, folding endurance, and % elongation. MDFs were evaluated by means of FTIR, SEM, and X-RD studies. MDFs with 7.5% (w/w) of HPMC E3 gave better dissolution properties when compared to HPMC E5, HPMC E15, and MC. MDFs with PVP K30 and SLS gave superior dissolution properties when compared to MDFs without PVP K30 and SLS. The dissolution properties of MDFs with PVP K30 were superior when compared to MDFs with SLS. In the case of F3 containing 7.5% of HPMC E3 and 0.04% of PVP K30, complete and faster release was observed within 60 sec when compared to other formulations. Release kinetics data reveals diffusion is the release mechanism. Mouth dissolving films, a novel drug delivery system, especially designed for pediatric and geriatric patient population where the difficulty of swallowing larger oral dosage forms is eliminated. This study was carried out to formulate mouth dissolving films of Amlodipine Drug by solvent casting method using HPMC (15cps) as hydrophilic film polymer, PG as plasticizer and SSG as super disintegrant along with other excipients. The films were prepared in such a way that each 2×2 cm2 of the film contains 5 mg of Amlodipine Drug drug. The preliminary 15 batches were carried out to find out the effect of HPMC, SSG and PG on the films and to determine their optimum concentration ranges. Then, the final 15 optimized batches were carried out by hit and trial which revealed the effect of the concentration of polymer (HPMC, SSG, PEG) on response variable i.e. disintegration time and drug release. The films were evaluated for weight variation, thickness, surface pH, assay %, in vitro disintegration time and % drug released. The formulation F10 was found to be the optimum one considering the percentage drug release of 100.67% at the end of 10 minutes with HPMC concentration of 30% and SSG concentration of 6%. Further, the overall result suggested that the intermediate concentration of HPMC and of SSG and PEG favors less disintegration time and higher % of drug release.

Keywords: Amlodipine, mouth dissolving films, HPMC, SSG, PEG.