Formulation and Evaluation of Fast Disintegrating Tablets of Antihistamine Drug Using Natural Super Disintegrants

ABSTRACT

Background:Fast Disintegrating Tablets (FDTs) are crucial in pharmaceuticals for rapid drug onset and improved patient compliance, particularly for those who have difficulty swallowing. Chlorpheniramine Maleate (CPM), an antihistamine used for allergy relief, is the focus of this study to develop FDTs. The rapid onset of action is advantageous in treating allergic reactions, providing quick relief from symptoms like sneezing, runny nose, and itching. By exploring this innovative approach, the present study aims to enhance the convenience, effectiveness, and patient acceptance of oral drug delivery. Materials and Methods:Tablets were formulated by direct compression, incorporating three superdisintegrants: Tulasi powder, Isabgolmucilage, and Croscarmellose sodium. Various pre- and post-compression parameters were examined, including flow properties, hardness, wetting time, water absorption ratio, disintegration time, in-vitro dissolution studies, and accelerated stability studies. Results:Pre-compression parameters showed good compressibility and flow properties. Post-compression parameters met specified limits, with formulation F6, containing 14 mg Isabgolmucilage, demonstrating the lowest disintegration time (7 sec) and highest cumulative drug release (98.85%). Accelerated stability testing confirmed the stability of formulation F6 over three months under elevated temperature and humidity conditions. Conclusion:Isabgolmucilage proved to be the optimal superdisintegrant, exhibiting the fastest disintegration time, highest drug release, and favorable flow properties offering a reliable solution for patients with swallowing difficulties and ensuring rapid relief. This study highlights the potential of Isabgolmucilage in enhancing the performance of FDTs, paving the way for improved patient outcomes and compliance.

KEYWORDS

• Chlorpheniramine maleate
• Croscarmellose sodium
• Fast disintegrating tablets
• Isabgol mucilage
• Superdisintegrant
• Tulasi powder

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• DOI10.5530/jyp.2024.16.96Copy

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