Formulation and evaluation of fast dissolving films containing Rizatriptan benzoate
Journal Title: Indian Journal of Research in Pharmacy and Biotechnology - Year 2015, Vol 3, Issue 1
Abstract
The aim of the present investigation was to develop fast dissolving films of Rizatriptan benzoate using Eudragit EPO, HPMC and PVA. Films of HPMC E5, HPMC E15, PVA and combination of Eudragit EPO and HPMC E5 were prepared by solvent casting method. Various low viscous, hydrophilic polymers HPMCE15, HPMCE5, PVA were used as film forming agents. Mouth dissolving films were dissolved/ disintegrated in the mouth with in a matter of few seconds without need of water. Propylene glycol, menthol, citric acid, sodium saccharine and sorbitol were incorporated in to the drug containing fast dissolving film as plasticizer, cooling agent, saliva stimulating agent and sweetening agents respectively. The prepared films were evaluated for thickness, content uniformity, folding endurance, in vitro, in vivo disintegration time, in vitro release studies and taste masking ability by human gustatory sensation test. Propylene glycol plays a crucial role in imparting the flexibility to the oral films. The films were found to be more flexible at 20% of plasticizer concentration. The taste masking was carried out by using the sweetening agents such as sodium saccharine and sorbitol, accompanying by the synergistic effect of citric acid and propylene glycol. Drug was uniformly distributed throughout the film and adequate thickness for handling. The clarity was observed to be clear for all the formulations. In vitro and in vivo disintegrated studies of all films revealed that disintegrates within 35-90 seconds. The formulation containing HPMC E5 showed better performance in terms of disintegration time and percent drug release profile. Although the combination of Eudragit EPO and HPMC E5 improves the taste masking of the dosage form, it has effected the in vitro drug release profile This finding suggests that the mouth dissolving films were likely to become one of the choices of Rizatriptan benzoate preparations for migraine therapy.
Authors and Affiliations
Veerababu Katragadda, Harish Gopinath, Debjit Bhowmik, Praveen Khirwadkar
Keywords
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