This study aims to develop and evaluate fast disintegrating films and tablets of Valsartan, an angiotensin II receptor blocker used in the management of hypertension and heart failure. The goal is to enhance patient compliance and therapeutic efficacy by providing a rapid and convenient dosage form that disintegrates quickly in the oral cavity.

The formulation of Valsartan was carried out using two different dosage forms: fast disintegrating films and tablets. Various excipients such as superdisintegrants, binders, and film-forming agents were selected based on their compatibility with Valsartan and their ability to promote rapid disintegration. For the films, hydroxypropyl methylcellulose (HPMC) and polyvinyl alcohol (PVA) were utilized as film-forming polymers, combined with superdisintegrants like croscarmellose sodium and sodium starch glycolate. For the tablets, similar superdisintegrants were employed alongside direct compression techniques.

Formulation Process:

Fast Disintegrating Films: The films were prepared using solvent casting methods. The polymers and superdisintegrants were dissolved in a suitable solvent to form a homogeneous solution, which was then cast onto a Petri dish and dried to obtain films of uniform thickness. Various formulations were tested to optimize the film thickness, disintegration time, and mechanical strength.

Fast Disintegrating Tablets: Tablets were formulated using direct compression techniques. The active pharmaceutical ingredient (Valsartan) was mixed with excipients and compressed into tablets. The formulations were designed to achieve rapid disintegration, utilizing superdisintegrants to enhance the tablet’s breakdown in the oral cavity.

Evaluation Parameters:

Disintegration Time: The disintegration time of both films and tablets was assessed using the disintegration test apparatus, measuring the time required for the dosage form to break down in the simulated oral environment.

Mechanical Properties: For films, parameters such as tensile strength and elongation at break were evaluated to ensure adequate handling and resistance during storage and use. For tablets, hardness and friability tests were conducted to confirm their structural integrity.

Dissolution Profile: The dissolution rate of Valsartan from both dosage forms was measured to determine the release profile and to ensure that the drug is released effectively in the oral cavity.

Stability Testing: Stability studies were performed to assess the physical and chemical stability of the films and tablets over a specified period under various environmental conditions.

The fast disintegrating films exhibited a rapid disintegration time, with optimal formulations achieving complete disintegration within 30 seconds. The mechanical properties of the films were satisfactory, with good tensile strength and flexibility. The tablets also demonstrated rapid disintegration, with times comparable to the films. The dissolution profiles indicated efficient drug release from both dosage forms, ensuring therapeutic efficacy. Stability studies confirmed that both films and tablets maintained their integrity and potency over the storage period.

Valsartan, fast disintegrating films, fast disintegrating tablets

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