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THE PHARMA REVIEW (MARCH - APRIL 2011)

Design and Evaluation of Diltiazem Hydrochloride Matrix Tablets by Using Damar Gum as Polymer

S.Vidyadhara1, S. Siva Prasad1, V. Akhila Devi1 and Y.A.Chowdary2

Abstract: The objective of present study was to develop an oral monolithic controlled release dosage form of diltiazem hydrochloride with damar gum as controlled release polymer, and to evaluate the prepared dosage forms for physical parameters like, weight uniformity, hardness, friability and drug content. Damar gum, a natural hydrophobic polymer, compatible with physiologic environment, possessing substantial matrix forming characteristics and binding properties, was used to prepare controlled release matrix tablets. In the present study, the influence of different concentrations of polymer on erosion of matrix system was studied, with a view to develop slow release formulation of diltiazem hydrochloride. The diltiazem hydrochloride matrix tablets were prepared by direct compression and wet granulation methods with solvents such as distilled water, ethanol, and propylene glycol. Microcrystalline cellulose was used as a diluent and Talc at 1% was used as lubricant. The results from the in vitro drug release studies indicated that, the formulations DTZ-5and DTZ-6 with drug: polymer concentrations, 1:1 and 1:1.5 respectively, prepared by wet granulation method using distilled water as solvent were found to release the drug at a steady state over an extended period of time up to 12 hours. The dissolution profiles followed first order kinetics. The mechanism of drug release was governed by Higuchi’s and Peppas models.
Introduction
The oral controlled release systems allow optimization of drug input rate into systemic circulation, to improve therapeutic efficacy, patient compliance, and reduced frequency of administration1. The controlled release dosage forms are most commonly manufactured as matrix systems because of their ease of manufacture2. Three classes of polymers - polymers forming insoluble or skeleton matrices, hydrophobic and water-insoluble polymers, and hydrophilic polymers respectively, have been employed as drug release retarding agents, each of which presents a different approach to the mechanism of drug release from matrix system. The hydrophobic and waxy materials are potentially erodible and control the release of drug through pore diffusion and erosion3. The objective of present study was to develop an oral Bioerodible with a Combination of diffusion and dissolution controlled release of diltiazem hydrochloride using hydrophobic polymer - damar gum as controlled release polymer. Damar gum is a whitish to yellowish natural gum of plant Shorea Wiesneri (family Dipterocarpaceae)4. The physicochemical evaluation and characterization indicated its soft and amorphous nature with good chemical stability. Damar gum has been investigated and proved to have substantial matrix forming ability that could be used for sustained drug delivery5. Diltiazem hydrochloride is a calcium channel blocker widely used in the treatment of variant angina, hypertension, and supraventricular tachyarrhythmia’s6. The treatment for hypertension is a long term therapy and hence controlled release dosage forms are useful for alleviating patient’s symptoms, thus achieving quality healthcare7. The present study has been carried out to develop matrix tablets of diltiazem hydrochloride (DTZ) with effective controlled rate.

 

 

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