Abstract
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.
Highlights
The oral cavity has been the most prominent site of drug delivery for a long period of time
Various film formers like polyvinyl alcohol, PVP, maltodextrin, hydroxy propyl methyl cellulose (HPMC), hydroxy propyl cellulose (HPC), MC, sodium carboxy methyl cellulose (Na CMC), chitosan, and some natural gums have been used in the production of films [3]
Placebo mouth dissolving films (MDFs) were prepared with different polymers like HPMC (E3, E5, E15, E50, and K4 M), HPC, MC, NaCMC, PVP, gelatin, Polyox, and sodium alginate
Summary
The oral cavity has been the most prominent site of drug delivery for a long period of time. 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, known as MDFs, gained attention in formulation research. The usual initial dose is 5 mg daily, increased if necessary to 10 mg once daily It is well absorbed following oral administration with peak blood concentration occurring after 6–12 hours. Few reports were published on the mouth disintegrating tablets of AMLO [6,7,8,9,10]. Keeping in view with patient compliance and need of better therapeutic efficacy and since no research work has been done on AMLO MDFs, the present investigation was aimed at preparation and evaluation of AMLO MDFs to ensure quick onset of action
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