Study on Preparation and Optimization of Fast Dissolving HPMC/PVA Blended films of Loperamide Hydrochloride

Abstract

Since discovering new chemical entities is a complex, expensive, and time-consuming process, current trends have shifted toward designing and developing improved drug delivery methods for existing drugs. Recent times, fast dissolving oral films were introduced to the market, attracting the attention of a large number of pharmaceutical companies due to their numerous advantages over other oral dosage forms, including ease of administration, better patient compliance, rapid drug absorption, and rapid onset of action with instant bioavailability. Aside from these advantages, quick dissolving oral films can be employed in children, the geriatric, and bedridden patients who have difficulties swallowing tablets or capsules. Initially, fast-dissolving oral films of breath strips, confectionary, and oral care treatments were developed, but it has now evolved into an innovative and widely accepted technique for delivering both OTC and prescription drugs.  Fast dissolving films are gaining interest as an alternative to fast dissolving tablets. The films are designed to disintegrate in a matter of seconds when they come into touch with a wet surface, such as the tongue, allowing the user to eat the food without the need for extra liquid. This ease of use gives a marketing benefit as well as greater patient compliance. Since the medicine is absorbed straight into the systemic circulation, it avoids gastrointestinal degradation and the first-pass impact.Solvent casting is used to make the Loperamide hydrochloride mouth dissolving film. The ingredient used for formulation Loperamide hydrochloride as a Anti-Diarrheal, HPMC-E50, HPMC-E15-LV and PVA as film forming polymer, propylene glycol as a plasticizer, Sodium starch glycolate (2-8%) as super disintegrant, lemon oil (2-5%) as a flavoring agent, citric acid (2-6%) as a Saliva Stimulating Agent, methylparaben (0.015%) as a preservative. Tensile strength, disintegration time, and percentage drug dissolution were chosen as independent variables, whereas tensile strength, disintegration time, and percentage drug dissolution were chosen as response variables. Mass uniformity, thickness, percent drug content, folding endurance, surface pH, moisture uptake, % swelling, percentage elongation, tensile strength, in vitro disintegration time, and in vitro percentage drug dissolution were all considered when evaluating the formulations. Loperamide was discovered to be a viable candidate for development of Fast Mouth Dissolving Films. The solvent casting procedure used to create Loperamide oral films is simple and cost-effective. It was deemed acceptable by the super disintegrants who were used in this study. FT-IR tests of drug-excipient compatibility indicated no physicochemical interaction. The obtained oral films were clear, had sufficient physical strength, and had a suitable disintegration time. In vitro dissolution experiments of all formulations revealed a superior release profile than pure medicines.Based on the test results, it was determined that film formulation F7, which contains a blend of HPMC E15 and PVA film formers, is the best formulation among the others..