FORMULATION AND EVALUATION OF SUBLINGUAL STRIPS OF NARATRIPTAN Naresh Kshirasagar* Sriram Pavani, D Adukondalu, J.Kishan Pavani
Authors: Naresh Kshirasagar* Sriram Pavani, D Adukondalu, J.Kishan Pavani
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Naratriptan hydrochloride, a piperidine derivatives selective agonist of serotonin, binds with high affinity to 5-HT1B and1D receptor (Hydroxy Tryptamine) has oral bioavailability in men 63% and women 74% due to hepatic first metabolism. The present investigation is to development of naratriptan sublingual films, allowing easy of drug dissolution in oral cavity, thus by passing first pass metabolism and to produce rapid onset of action. Sublingual films were prepared by solvent casting method. Low viscosity grade HPMC E5, HPMC E15, HPMC E50 (Hydroxy Propyl Methyl Cellulose) were used in combination also as film forming polymer with different ratios, PEG 400 (Poly Ethylene Glycol) is used as plasticizer, mannitol and aspartame were used as sweetener, to decrease the disintegrating time of formulation sodium starch glycolate was used as disintegrating agent. Mint is used as cooling agent, all the films formulation (A1-A4, B1-B4, C1-C4, and D1-D4) was evaluated for their thickness weight variation, assay, folding endurance, surface pH, in-vitro disintegration. Disintegration time showed by the formulation was found to be in range of 21-48 sec. B1 showed 99.89% of drug dissolved within 10 sec, the film showed an excellent stability for 1 month when stored at 40ºC and 75% RH (Relative Humidity) in stability chamber.
Key words: Naratriptan, Sublingual films, solvent casting method, stability chamber