Design and Development of Pravastatin Sodium Fast Dissolving Films from Natural Mucilage of Ocimum Bacilicum Seeds
The present research work, aims to prepare and evaluate the fast dissolving oral films containing Pravastatin sodium, an anti hyperlipidemic drug using different ratios of polymers, Hydroxypropyl methylcellulose E3,E5,E6, Polyvinyl alcohol and Ocimum bacilicum mucilage powder. The film was prepared by solvent casting technique using Glycerine and Propylene Glycol, PEG 400 as plasicizers, Aspartame as sweetner , Eugenol as flavouring agent and Xylitol, Mannitol,Sorbitol and as Film modifiers. The study examines the influence of polymers ratio on physicochemical properties and drug release potential of films. Pravastatin sodium, a HMGCoA- Reductase inhibitor with the absorption rate of 34% but the bioavailability is 45% due to its first pass effect, the half life of the drug was around 1.5-2 hours. The present study investigated the possibility of developing Pravastatin sodium fast dissolving films allowing fast, reproducible drug dissolution in the oral cavity, thus bypassing first pass metabolism to provide rapid onset of action of the drug. The films were thin, smooth, flexible, and uniform in drug content, weight and thickness as observed from low SD values. The film formulation, (F14) consisting of polyvinyl alcohol and ocimum bacilicum mucilage powder in the ratio of (1.5%: 0.5%) was found to be suitable in the form of fast dissolving oral film. The optimized formulation, F14 showed less disintegration time and faster drug release. All the systems were found to be stable with respect to drug content as well as physical changes at at 40 ± 2°C ; Relative Humidity (RH) Maintained at 75%±5%RH.