%0 Journal Article
%T Development and Evaluation of Mouth Dissolving Films of Amlodipine Besylate for Enhanced Therapeutic Efficacy
%A K. M. Maheswari
%A Pavan Kumar Devineni
%A Sravanthi Deekonda
%A Salma Shaik
%A Naga Pravallika Uppala
%A Buchi N. Nalluri
%J Journal of Pharmaceutics
%D 2014
%I Hindawi Publishing Corporation
%R 10.1155/2014/520949
%X The present investigation was undertaken with an objective of formulating mouth dissolving films (MDFs) of Amlodipine Besylate (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 physicomechanical 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. 1. Introduction The oral cavity has been the most prominent site of drug delivery for a long period of time. In 1847, Sobrero found that nitroglycerine was absorbed from the oral cavity [1]. Since then various active substances have been investigated for local or systemic use. Recent developments in the formulation technology have presented viable dosage alternatives from the oral route for pediatrics, geriatric, bedridden, nauseous, or noncompliant patients. Novel bioadhesive mucosal dosage forms including adhesive tablets, gels, patches, and more recently the use of polymeric films for oral cavity delivery, also known as MDFs, gained attention in formulation research. MDFs, a new and novel drug delivery system for per oral delivery of the drugs, were developed based on the technology of the transdermal patch [2]. The delivery system consists of a very thin oral strip, which is simply placed on the patient¡¯s tongue or any oral mucosal tissue; instantly wet by saliva the film rapidly hydrates and adheres onto the site of application. It then rapidly disintegrates and dissolves to release the medication for oromucosal absorption. Various film formers like polyvinyl alcohol, PVP, maltodextrin, HPMC, hydroxy propyl cellulose (HPC), MC, sodium carboxy
%U http://www.hindawi.com/journals/jphar/2014/520949/