Abstract

FORMULATION AND EVALUATION OF TRIPLE DRUG COMBINATION OF TELMISARTAN, AMLODIPINE BESYLATE, AND HYDROCHLOROTHIAZIDE TABLETS BY DIRECT COMPRESSION METHOD

Sagar K. C.*, Sanjeet Khadka, Prajol Paudel, Navaraj Khadka, Kedar Prasad Shah, Stuti Shrestha, Bijaya Dahal and Break Fast Neupane

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Abstract

To enhance patient compliance, this research assesses a triple-drug combination that includes Telmisartan, Amlodipine Besylate and Hydrochlorothiazide, all of which are anti- hypertensive drugs. The drug-drug and drug-excipient compatibility was verified using FTIR analysis, which was used to investigate the interaction between drugs and excipients. Using a variety of diluents and binders, nine formulations of tablets (F-1 to F-9) were formulated by using the direct compression method. Tablets were subjected to three tests: hardness, friability, and disintegration time. An in-vitro drug dissolution test was conducted on tablets using 0.1N HCl and pH 6.8 phosphate buffer solution as dissolving media. It was found that the tablet's DT, hardness, and friability were, respectively, 4.4 to 7.5 kg/cm², 0.17 to 0.91%, and 5 to 11 minutes. Around 90% of drugs are released within 30 minutes, according to in-vitro testing. Formulation F-6, with 3.5% croscarmellose, demonstrated superior performance as a disintegrant compared to 3.5% SSG and 3.5% crospovidone. It was found that croscarmellose was a better disintegrant than the other two, as disintegration time and dissolution properties were better with the croscarmellose. Hence, the study concluded that these formulations are promising for hypertension treatment. They can be considered as one of the promising fixed-drug dosage forms.

Keywords: Telmisartan, Amlodipine besylate, Hydrochlorothiazide, Fixed dose combination form, Anti-hypertensive.