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Design and Development of Fast Dissolving Oral Film of Telmisartan
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| Author:
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SHAH DHIREN P, SHAH HIRVA, MAHLA PRIYANKA
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| Abstract:
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Telmisartan (TLM) is an antihypertensive agent which is a non-peptide angiotensin receptor II antagonist. The present research work was aimed to prepare Fast dissolving film of the telmisartan with the purpose of developing a dosage form for a quick onset of action which is beneficial in the management of Hypertension to the patients with swallowing difficulties or travelling patients not having the access of water. The preformulation work was first carried out. FTIR studies were carried out for checking the interaction between drug and polymer. Film forming polymers, super disintegrant and plasticizers were screened and selected. The films were prepared by solvent casting method using HPMC K4M as a polymer, PEG-400 as plasticizer, kyron as a super disintegrant, sodium lauryl sulfate solubilising agent, citric acid as saliva stimulating agent, KOH solution as a solubility enhancer, sodium sachharin as sweetener and vanillin as flavoring agent. 32 central composite design was applied using concentration of HPMC K4M and concentration of super disintegrant as independent variables. The formulations so prepared were evaluated for their content uniformity, uniformity of weight, surface pH, folding endurance, disintegration time, tensile strength, and % elongation. The optimized formulation was subjected to in-vitro studies as well as stability analysis. The FTIR studies showed no interaction between drug and polymer or with other additives. From the result, it was concluded that formulation T4 containing 40 mg HPMCK4M and 50 mg kyron was the best formulation among all other formulation as observed from the evaluation tests, statistical analysis and stability studies. It was concluded that Fast dissolving Oral film of Telmisartan can be considered suitable for treatment of Hypertension for quick onset of action which is beneficial in the management of Hypertension to the patients with swallowing difficulties and in emergency.
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| Keyword:
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Telmisartan, Anti –hypertensive drug, fast dissolving oral films
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