Abstract
Purpose: To develop fast dissolving oral film to address vomiting and nausea in pediatric population.Methods: Oral films of Dimenhydrinate were prepared by solvent casting method by using hydroxypropylmethyl cellulose E5 (HPMC E5), polyethylene glycol 400 (PEG 400) and croscarmellose sodium. Solubility of dimenhydrinate was enhanced by ethanol as a co-solvent. To make dimenhydrinate palatable sodium saccharin and peppermint oil were used. All films were evaluated for mechanical parameters, surface pH, morphology, disintegration time and percent dissolution.Results: Films were smooth, acceptable and white in colour. For optimized batch, drug content (99.106%), disintegration time (25 sec), dissolution (99.10% in 210 sec), surface pH (6.81) were acceptable.Conclusion: Optimized batch, due to its potential to deliver through fast dissolving film, can be developed for clinical use.
Highlights
Fast dissolving oral film disintegrates or dissolves in oral cavity without need of water
Dimenhydrinate is a salt of diphenhydramine and 8chlorotheophylline
The concentrations of hydroxypropylmethyl cellulose E5 (HPMC E5) and polyethylene glycol 400 (PEG 400) were chosen at low (-1), middle (0) and high (+1) levels
Summary
Fast dissolving oral film disintegrates or dissolves in oral cavity without need of water. This is the best alternative to tablets.[1] Fast dissolving oral film is designed as a very thin, and instantly wetting by saliva if put on a tongue It disintegrates or dissolves once hydrated and release medicaments immediately. It gives fast absorption and thereby early bioavailability of drugs due to high surface area, high blood flow and permeability to pre-gastric mucosa.[2] Oral film facilitates drug administration to paediatric, old age and non- cooperating patients.[3] For better bioavailability, improvisation in solubility of drug is needed.[4] Pre-gastric absorption avoids first pass metabolism.[5] This results in increase in bioavailability compared to other dosage forms.[6] A large population is affected by the vomiting and nausea. The present work was aimed to develop fast dissolving oral film of poorly water soluble drug, dimenhydrinate; using water soluble polymer
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