Research Journal of Pharmaceutical Dosage Form and Technology

Hamid Khan ¹, Javed Ali ²

Affiliations
1 JK College of Pharmacy, Bilaspur, CG-495001, IN
2 Department of Pharmaceutics, Hamdard University, New Delhi-110062, IN

Abstract

A fixed dose combination (FDC) is a formulation of two or more active ingredients combined in a single dosage form available in certain fixed doses. Combination therapy with two or more agents having complementary mechanisms of action represents a type of incremental innovation that has extended the range of therapeutic options in the treatment of almost every human disease. Combining two or more active pharmaceutical ingredients in a single-dosage form can increase a drug's efficacy and improve patient compliance. Several difficulties arise during formulation development, manufacturing and regulations of FDC products. Two or more active ingredients in the FDCs must be physically and chemically compatible along with their excipients. In this review article authors provided the brief information regarding advantages, formulation development and regulations of FDC products.

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Hamid Khan ¹, Mushir Ali ², Alka Ahuja ², Javed Ali ²

Affiliations
1 JK College of Pharmacy, Bilaspur, CG, 495001, IN
2 Department of Pharmaceutics, Jamia Hamdard, New Delhi 110062, IN

Abstract

The aim of the presented work was formulation and in-vitro evaluation of in-lay tablets containing telmisartan as sustained release outer core and hydrochlorothiazide as immediate release inner core using HPMC and co-polymer carbopol 71G. Tablets were evaluated via various quality control tests and in-vitro drug release studies. Drug release study was carried out hydrochloric acid buffer of pH 1.2 (0.1N) using USP paddle apparatus. The validated HPLC-UV method was applied to determine the amount of drugs released at different time intervals. The mechanism of drug release through polymeric network was established. Prepared tablets showed extended sustain release of telmisartan over a period of 20 h and hydrochlorothiazide as immediate release within 30 min.

Keywords

In-Lay Tablet, Telmisartan, Hydrochlorothiazide, Sustained Release, Immediate Release.

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Hamid Khan ¹, Javed Ali ²

Affiliations
1 JK College of Pharmacy, Bilaspur, CG, 495001, IN
2 Department of Pharmaceutics, Hamdard University, New Delhi, 110062, IN

Abstract

The sustained release matrix tablets were formulated and evaluated by wet granulation method. Tablets were formulated using hydrophilic polymer and binder, HPMC K100 and PVP respectively. In-vitro drug release studies were carried out in hydrochloric acid buffer of pH 1.2 (0.1N) with 1% w/v SLS using USP paddle apparatus. The amount of drugs released at different time intervals were determined by validated UPLC-PDA method. In-vitro drug release from prepared tablets showed better sustained release effect when compared with marketed combination tablets. Tablets thus formulated provided extended release of aceclofenac and paracetamol over the period of 6 h.

Keywords

Aceclofenac, Paracetamol, Sustained Release, Matrix Tablets, HPMC.

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Hamid Khan ¹, Javed Ali ²

Affiliations
1 JK College of Pharmacy, Bilaspur, CG, 495001, IN
2 Department of Pharmaceutics, Hamdard University, New Delhi, 10062, IN

Abstract

The formulation and in-vitro evaluation of matrix tablets containing telmisartan as sustained release using low viscosity grade HPMC as the matrix forming hydrophilic polymer by wet granulation method. The tablets were subjected to in-vitro drug release study in hydrochloric acid buffer of pH 1.2 (0.1N) with 1% w/v SLS using USP paddle apparatus. The drug released at various time intervals were determined by validated UPLC-PDA method. The prepared tablets showed better sustained release effect when compared with marketed tablets. The drug release mechanism from hydrophilic polymer was proposed. The formulated tablets provided sustained release of telmisartan over a period of 24 h.

Keywords

Matrix Tablet, Telmisartan, HPMC, Hydrophilic Polymer, Sustained Release.

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