Development and Evaluation of Chlorpheniramine Maleate Orally Disintegrating Tablets

Abstract

Introduction: Orally Disintegrating Tablets (ODTs) have garnered significant attention in the pharmaceutical industry, particularly for medications with delayed dissolution and low oral bioavailability. These tablets offer advantages, especially for patients with swallowing difficulties, both young and elderly, and those who may face dehydration during extended periods on the road. This study focuses on the use of super-disintegrants as part of a novel approach to manufacturing ODTs containing chlorpheniramine maleate (CPM), with additional consideration given to the impact of sweeteners on the formulation.

Objective: The primary objective of this work is to create CPM-ODTs using a direct compression method, emphasizing fast disintegration qualities to enhance patient compliance. The study aims to assess various parameters, including drug content, hardness, friability, disintegration time, wetting duration, water absorption ratio, and in vitro release of drugs, to evaluate the performance of the manufactured tablets.

Methods: The method employed in this study involves the use of two super-disintegrants, namely sodium starch glycolate and croscarmellose sodium, in the formulation of CPM-ODTs. The direct compression method is utilized, and the tablets are subjected to a comprehensive analysis to measure their key characteristics and performance. Stability analysis is also conducted on the final trial formulation to ensure both chemical and physical sustainability.

Results: The results of the study reveal that the formulation incorporating 10mg Croscarmellose Sodium (CCS) exhibits the quickest disintegration time and the fastest drug release among the tested formulations. Additionally, stability analysis demonstrates that formulation ODT6, which includes 10 mg CCS, sucralose, and menthol powder, is both chemically and physically sustainable.

Conclusion: In conclusion, the use of super-disintegrants, specifically CCS, in the direct compression method for CPM-ODTs proves to be effective in achieving fast disintegration and drug release. The optimized formulation (ODT6) with 10 mg CCS, sucralose, and menthol powder is identified as both chemically and physically sustainable, indicating its potential for further development as a patient-friendly oral medication.