Formulation of Rapid Dissolving Films Containing Granisetron Hydrochloride and Ondansetron Hydrochloride

Abstract

The oral mucosa is conveniently and easily accessible and therefore allows uncomplicated application of dosage forms. A rapid-dissolving drug delivery system, in most cases, is a tablet that dissolves or disintegrates in the oral cavity without the need for water or chewing. More recently, fast-dissolving films are gaining interest as an alternative to fast-dissolving tablets to definitely eliminate patients’ fear of chocking and overcome patent impediments. In the present study, calculations for amount of drugs were determined, Rapid dissolving films containing GSH were prepared using solvent casting method. An aqueous solution of polymer was prepared in distilled water. For preparing the solution, polymer was soaked in water for some time (wherever required). This was followed by addition of GSH in the aqueous solution of the polymer. Now, plasticizer (PEG 400 and/or Glycerol), sweetening agent (Aspartame and/or Sucralose), citric acid and flavor were also added to this solution. In-vitro disintegration time (DT) of the prepared rapid dissolving films was determined visually in a glass beaker containing 50ml water and swirling every 10 seconds. Average of 3 films was taken for this purpose. In-vivo DT of the prepared rapid dissolving film was determined by mouth in three human volunteers. Evaluation of taste was done by a taste panel with 2mg drug and subsequently one film held in the mouth for 10-15 seconds. For preparing rapid dissolving films, varying amount of Pullulan, METHO K3P, METHO E3P were taken. Solvent evaporation method was used for preparation of the film. Various polymers used in the study were: Pullulan, Metho K3P, Metho E3P, Metho E15P and Poly N10. PEG-400 and glycerol were used as plasticizer. Aspartame and sucralose were used as sweetening agent while citric acid was used as saliva stimulating agent Keywords: Rapid dissolving film, Ondansetron hydrochloride (OND), Granisetron Hydrochloride (GSH).