Informatics Publishing Limited

Soham Shukla ¹, Vikram Pandya ², Praful Bhardia ², Nitin Jonwal ³, Shashank Mishra ³, Deepak Bhatt ³, Deependra Jain ⁴

Affiliations
1 Department of Pharmaceutical Technology, B.S. Patel Pharmacy College, Saffrony Institute of Technology, Nr. Saffrony Holiday Resort, Ahmedabad-Mehsana Highway, At. & Po. Linch, Dist-Mehsana, Gujarat-384 435, IN
2 B. S. Patel Pharmacy College, Gujarat, IN
3 Cadila Pharmaceuticals Ltd., Ahmedabad, IN
4 Sagar Institute of Research & Technology-Pharmacy, Bhopal, IN

Abstract

The main objective of this combination therapy is to develop a stable formulation of antihypertensive drugs of telmisartan and amlodipine besylate as an immediate release bilayer tablet and evaluate their precompression and post-compression parameters. The FT-IR studies were also conducted and were found to have no interaction between drug and the excipients. The formulation of the developed work was initiated with wet granulation method for both the drugs. Microcrystalline cellulose pH102 and dibasic calcium phosphate were used as diluents. Starch paste was used as the binder. The croscarmellose sodium (CCS) was used as the super disintegrant. Magnesium stearate used as lubricant. The prepared granules were compressed by a double-rotary compression machine. In vitro dissolution was carried out using USP dissolution apparatus type 2 (paddle) by using HPLC method. The optimized formulation F-7 had 98.13% of drug release for telmisartan layer and 96.38% drug release for amlodipine besylate layer. The stability studies for optimized batch were carried out at 30 and 60 days and were found to be stable. The results suggest the feasibility of developing bilayer tablets with two drugs telmisartan and amlodipine besylate for the convenience of patients with severe hypertension, especially when monotherapy fails to control the blood pressure.

Keywords

Bilayer Tablet, Telmisartan, Amlodipine Besylate, Immediate Release, In Vitro.

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Soham Shukla ¹, Vikram Pandya ¹, Praful Bhardia ¹, Nitin Jonwal ², Deepak Bhatt ²

Affiliations
1 B. S. Patel Pharmacy College, Gujarat, IN
2 Cadila Pharmaceuticals Ltd., Ahmadabad, IN

Abstract

Several pharmaceutical companies are currently developing bi-layer tablets, for a variety of reasons: patent extension, therapeutic, marketing to name a few. To reduce capital investment, quite often existing but modified tablet presses are used to develop and produce such tablets. This article explains fundamentals of bilayer tablet system which includes application, advantages, disadvantages, various techniques of bilayer tablet system, various type of bilayer tablet press currently available in the market, various approaches used in bilayer tablet system, characterization as well as evaluation of the bilayer tablet system. Bi-layer tablet is suitable for sequential release of two drugs in combination, separate two incompatible substances and also for sustained release tablet in which one Layer is immediate release as initial dose and second layer is maintenance dose. Bilayer tablet is improved beneficial technology to overcome the shortcoming of the single layered tablet.

Keywords

Bilayer Tablet, Sustained Release, Immediate Release, Oros, Push Pull Technology.

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