FORMULATION AND EVALUATION OF INSTANT DISSOLVING FILM OF A POORLY SOLUBLE DRUG CILNIDIPINE

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Hauptverfasser: Manoj Singh Khanayat, Meenakshi Kandwal, Shivanand Patil
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Veröffentlicht: Zenodo 2025
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author Manoj Singh Khanayat
Meenakshi Kandwal
Shivanand Patil
author_facet Manoj Singh Khanayat
Meenakshi Kandwal
Shivanand Patil
contents <p>This study developed an instant dissolving film (IDF) of the poorly soluble antihypertensive drug Cilnidipine to overcome its bioavailability limitations. The films were prepared using solvent casting technique with hydroxypropyl methylcellulose (HPMC E5) and polyvinylpyrrolidone (PVP K30) as film-forming polymers, optimized through a 3² factorial design. Key parameters evaluated included film thickness (50-90 μm), disintegration time (22±3 seconds), folding endurance (>300 folds), and drug content uniformity (98.2±1.8%). Incorporation of Tween 80 as surfactant significantly enhanced drug dissolution, with 89.4±2.1% release within 5 minutes compared to 28.7±1.9% from conventional tablets. Ex vivo permeation studies using porcine buccal mucosa demonstrated 3.2-fold higher permeability than oral suspension. Accelerated stability studies (40°C/75% RH for 3 months) confirmed formulation stability with no significant changes in physicochemical properties. Sensory evaluation by human volunteers indicated excellent palatability (4.5/5 score) and mouthfeel. The optimized IDF showed rapid disintegration, improved drug dissolution, and enhanced buccal absorption, making it a promising alternative for geriatric and dysphagic patients. These results demonstrate the potential of IDF technology to improve the therapeutic performance of poorly soluble drugs like Cilnidipine while offering better patient compliance compared to traditional dosage forms.</p>
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spellingShingle FORMULATION AND EVALUATION OF INSTANT DISSOLVING FILM OF A POORLY SOLUBLE DRUG CILNIDIPINE
Manoj Singh Khanayat
Meenakshi Kandwal
Shivanand Patil
<p>This study developed an instant dissolving film (IDF) of the poorly soluble antihypertensive drug Cilnidipine to overcome its bioavailability limitations. The films were prepared using solvent casting technique with hydroxypropyl methylcellulose (HPMC E5) and polyvinylpyrrolidone (PVP K30) as film-forming polymers, optimized through a 3² factorial design. Key parameters evaluated included film thickness (50-90 μm), disintegration time (22±3 seconds), folding endurance (>300 folds), and drug content uniformity (98.2±1.8%). Incorporation of Tween 80 as surfactant significantly enhanced drug dissolution, with 89.4±2.1% release within 5 minutes compared to 28.7±1.9% from conventional tablets. Ex vivo permeation studies using porcine buccal mucosa demonstrated 3.2-fold higher permeability than oral suspension. Accelerated stability studies (40°C/75% RH for 3 months) confirmed formulation stability with no significant changes in physicochemical properties. Sensory evaluation by human volunteers indicated excellent palatability (4.5/5 score) and mouthfeel. The optimized IDF showed rapid disintegration, improved drug dissolution, and enhanced buccal absorption, making it a promising alternative for geriatric and dysphagic patients. These results demonstrate the potential of IDF technology to improve the therapeutic performance of poorly soluble drugs like Cilnidipine while offering better patient compliance compared to traditional dosage forms.</p>
title FORMULATION AND EVALUATION OF INSTANT DISSOLVING FILM OF A POORLY SOLUBLE DRUG CILNIDIPINE
url https://doi.org/10.5281/zenodo.15609896