Abstract

FORMULATION AND EVALUATION OF MOUTH DISSOLVING FILM OF VENLAFAXINE HYDROCHLORIDE

Sheenal Soni*, Mihir Patel and Dr. Shreeraj Shah

Abstract

Objective: Venlafaxine hydrochloride is serotonin norepinephrinereuptake inhibitors, antidepressants. Main symptoms associated with this disease are anger, loss of energy, sleep changes and weight changes etc. which results in major depressive disorder, generalized anxiety disorder etc requires fast relief. So, dosage form which gives quick onset of action is needed. MDF was suitable dosage form. The objective was to formulate MDF having least disintegration time with a better mechanical strength which ultimately gives faster onset of action. Experimental work: The films were formulated by various film forming polymers (PVA, HPMC E15, PVP K30, Guar Gum and Xanthan Gum), Plasticizers (PEG 400, PG and Glycerin), saliva stimulating agent (citric acid), sweetening agent (mannitol) and surfactant (tween 80). MDF were prepared by solvent casting technique. Trial batches were formulated to optimize plasticizer, polymer and polymer combination. The optimized plasticizer and polymer combination was selected, 32 factorial designs was applied and from factorial batches the batch with least DT and good mechanical properties was optimized and kept for stability study for 1 month. Result: Trail batches, PG was optimized as plasticizer. While single polymer was not able to produce the film with desired quality, polymer combination was used. The polymer combination of HPMC E15 and PVA was optimized. Further factorial design was applied, the batch with 14mg of HPMC E15 and 4mg of PVA was optimized and found stable after 1 month. The optimized batch of venlafaxine hydrochloride film having desired DT and mechanical properties that is potentially useful for the treatment of depression were fast onset of action is required.

Keywords: Venlafaxine hydrochloride, Mouth dissolving film, PG, HPMC E15, PVA.