Formulation and Evaluation of Diltiazem Hydrochloride Ip 60 mg Immediate Release Tablet.

Abstract

Diltiazem Hydrochloride, a benzothiazepine calcium channel blocker, is widely used in the management of hypertension, angina pectoris, and cardiac arrhythmias due to its potent vasodilatory and cardio depressant actions.
The development of an Immediate Release (IR) tablet of Diltiazem HCl 60 mg requires a comprehensive understanding of its physicochemical properties, excipient compatibility, and formulation behaviour to ensure rapid disintegration and optimal bioavailability.
As a highly water-soluble BCS Class I drug, Diltiazem HCl lends itself well to IR formulations; however, challenges such as moisture sensitivity, poor flowability, and compression characteristics demand a carefully optimized manufacturing approach.
This review critically evaluates the formulation strategies, including the selection of suitable diluents, binders, disintegrants, and lubricants, along with the influence of granulation techniques on tablet quality.
It further discusses key pre-compression and post-compression parameters—such as flow properties, hardness, friability, drug content, and dissolution profile—that determine the overall performance of the dosage form.
Emphasis is placed on achieving rapid drug release, complying with pharmacopeial standards, and ensuring stability under ICH-recommended conditions. Overall, this article provides a detailed scientific overview of the formulation and evaluation of Diltiazem Hydrochloride IP 60 mg Immediate Release tablets, highlighting critical factors that contribute to a safe, stable, and therapeutically effective oral dosage form for cardiovascular disease management.

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