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ISSN 2063-5346
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USE OF BETA-CYCLODEXTRIN COMPLEX AND NOVEL SUPERDISINTEGRANT (KYRON-T) FOR FORMULATION OF MOUTH DISSOLVING FILM OF TELMISARTAN

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Diwas Adhikari, Meenakshi Kandwal, Dr. Shivanand Patil
» doi: 10.48047/ecb/2023.12.si13.117

Abstract

Telmisartan, an antihypertensive agent which lies in BCS class II, is used for treating Hypertension. Due to the poor solubility of the API i.e. Telmisartan, Beta Cyclodextrin complexation was performed and the ratio of the Telmisartan to the Beta Cyclodextrin was 1:1.Inclusion complex was developed using Kneading Method. Further Mouth Dissolving Film was prepared by using “Solvent Casting Method” and Dose of the Telmisartan per film used was 40 mg. Various Excipients were used for the formulation such as film forming polymer (HPMC E5), Plasticizer (Povidone K 30), Surfactant (Tween 80), Superdisintegrant (Kyron –T), Saliva Stimulating agent (Trisodium Citrate), Sweetening agent (Aspartame) etc. HPMC E5 was used at various concentration i.e. 1200 mg/ film, 1600 mg/film and 2000 mg/film. Similarly Polacrilin Potassium (Kyron-T) was used at three level of concentration i.e. 2%, 5% and 8% of the amount of film forming polymer HPMC E5. Povidone K 30 (PVP K 30) was used at various amount i.e. 0.5 mg/film, 1.75 mg/film, 3 mg/film. Others materials were kept in constant quantity. Altogether Nine different formulations were prepared and one optimized formulation was also prepared. Formulated Mouth Dissolving film were analyzed for different parameters such as film’s Folding Endurance, Film Thickness, Average weight of film, Degree of swelling, Disintegration time ,Percentage Absorption of moisture, Percentage Loss of moisture, Assay %, In-vitro dissolution rate. All the parameters are found to be within the acceptable limit. Folding Endurance, Film Thickness, Degree of swelling, Disintegration Time, In-vitro dissolution rate etc were found varied with variation applied during formulation but Assay %, Percentage Moisture Absorption, Percentage Moisture Loss, Average weight etc. were found almost similar and did not show significant variation with respect to variation applied. Mouth Dissolving Film containing lower amount of film forming polymer, Intermediate amount of plasticizer and higher amount of superdisintegrant was found to provide the better result among other formulation. All the evaluation parameters were found optimized in the optimized formulation.

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