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Formulation and In vitro Evaluation of Immediate Release Bilayer Tablets of Telmisartan and Amlodipine Besylate


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, India
2 B. S. Patel Pharmacy College, Gujarat, India
3 Cadila Pharmaceuticals Ltd., Ahmedabad, India
4 Sagar Institute of Research & Technology-Pharmacy, Bhopal, India
     

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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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  • Formulation and In vitro Evaluation of Immediate Release Bilayer Tablets of Telmisartan and Amlodipine Besylate

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Authors

Soham Shukla
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, India
Vikram Pandya
B. S. Patel Pharmacy College, Gujarat, India
Praful Bhardia
B. S. Patel Pharmacy College, Gujarat, India
Nitin Jonwal
Cadila Pharmaceuticals Ltd., Ahmedabad, India
Shashank Mishra
Cadila Pharmaceuticals Ltd., Ahmedabad, India
Deepak Bhatt
Cadila Pharmaceuticals Ltd., Ahmedabad, India
Deependra Jain
Sagar Institute of Research & Technology-Pharmacy, Bhopal, India

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.