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Design and development of fast mouth dissolving tablet of telmisartan for enhanced bioavailability

Author: 
Bijitha Das, K. and Vimal Mathew
Subject Area: 
Health Sciences
Abstract: 

An ideal dosage regimen in the drug therapy of any disease is the one, which immediately attains the desire therapeutic concentration of drug in plasma (or at the site of action) and maintain constant for the entire duration of treatment. To fulfill these medical needs, Formulator have devoted considerable efforts for developing a novel type of dosage form for oral administration known as mouth dissolving tablets (MDT). It is define as “a tablet that disintegrates and dissolves rapidly in the saliva within a few seconds without the need of drinking water or chewing.” A mouth dissolving tablet usually dissolves in the oral cavity within 15sec to 30sec Most of the MDTs include certain superdisintegrantsand taste masking agents. Telmisartan (TLM) is a non-peptide Angiotensin receptor II (Type- ATI) antagonist, that cause inhibition of action of Angiotensin II on vascular smooth muscle in the treatment of hypertension. The bioavailability of telmisartan is poor about 45% which is due to extensive first pass hepatic metabolism. The bioavailability can be increased by fast dissolving formulation. Conventional telmisartan tablets available in markets are not suitable were quick onset of action is required. In order for better patient compliance its better to develop a dosage form that can rapidly disintegrate and dissolve in saliva without need of water. The aim of present investigation was to prepare mouth dissolving tablet of an anti hypertensive drug telmisartan. The solubility of poorly soluble drug was enhanced by preparing inclusion complexes (solvent evaporation and kneading method) with β cyclodextrin and PEG 4000 in various concentrations. The optimized complexes (drug:βcyclodextrin, 1:2 ratio) were further kneaded with suitable proportion of superdisintegrant such as crosscarmellose, sodium starch glycolate and crosspovidone. Mouth dissolving tablets of Telmisartan was prepared by Direct compression method. The pre-compressive parameters for the blends and post compressive parameter for the prepared tablet were evaluated. All formulation showed desired pre and post-compressive characteristics. FTIR study showed no evidence of drug excipient interaction. The optimized formulation was found to be F6. It can be concluded that Mouth dissolving tablet of Telmisartan can be prepared by inclusion complexes with cyclodextrin and combination of superdisintegrants provide complete and better dissolution within in shorter period of time. Hypertensive treatment anywhere, and anytime particularly for ageriatric, pediatric, metally ill, bedridden and patients who do not easy access to water.

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