23, June 2025

Development characterisation and optimization of fast dissolving oral films of vardenafil using 32 full factorial design

VOLUME-9; ISSUE-6; JUNE-2025

Author(s): 1. T GAYATHRI, 2. DR B RAJA NARENDER

Authors Affiliations:

1 Assistant Professor, CVM College of Pharmacy, Velichala, Karimnagar, Telangana.

2 Associate Professor, CVM College of Pharmacy, Velichala, Karimnagar, Telangana.

DOIs:10.2017/IJRCS/202506014     |     Paper ID: IJRCS202506014


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The current research in the field of drug delivery by which fast release can be achieved has been intensified. The Aim of the Present Study was to Develop, Characterize and Optimize Fast Dissolving Oral Films of Vardenafil by Solvent Casting Method. Based on Preliminary trials, HPMCE52V was selected as polymer, PEG 400 was selected as Plasticizer, Citric acid as Saliva Stimulating Agent, and Sucrose as sweetener respectively. A 32  Full  Factorial design was employed for the Optimization to study the Effect of concentration of HPMCE52V (X1)& Concentration of film former PEG 400(X2) as Independent variables and to study the effect of  Tensile strength(Y1), Disintegration time(Y2), In-vitro drug release in phosphate buffer PH 6.8at Q5 min  Y3) as Dependent variables. Oral Fast Dissolving film of Batch F1(HPMC E52V 100 mg; PEG 400  0.2ml ) was identified as an Optimized Batch showing in –vitro Disintegration time 21.6 s,96.3% Drug Release at Q5 min, Satisfactory thickness, Strength % elongation ,Ease of Handling, Smooth Mouth Feel, Excellent Over taste ,Even distribution of all Ingredients and stable film at specified conditions. It had a positive impact on disintegration time and drug release. Concluding that HPMCE52v, PEG 400 are used in combination to make palatable ,stable Oral Fast Dissolving Film of Vardenafil.

Oro-dispersible, Optimize, Solvent Casting, Palatable, Stable

T. Gayathri, Dr B Raja Narender(2025);  Development characterisation and optimization of fast dissolving oral films of vardenafil using 32  full factorial design, International Journal of Research Culture Society,    ISSN(O): 2456-6683,  Volume – 9,   Issue –  6,  Pp.101-125.       Available on – https://ijrcs.org/

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