Preparation and in vivo evaluation of oral dissolving films containing sumatriptan succinate

نویسندگان

  • Samineni Kishore Kumar
  • Maddi Venkata Nagabhushanam
  • K. R. S. Sambasiva Rao
  • D. V. R. N. Bhikshapathi
چکیده

The present investigation deals with the formulation of oral dissolving films (ODFs) of sumatriptan succinate which is used for the treatment of migraine. Rapidly dissolving films have acquired great importance in present scenario because of exclusive properties. The films of sumatriptan succinate were carried out using different grades of HPMC E3, E6, and E15, maltodextrin DE6, xanthan gum and other polymers by solvent casting method. The prepared films were evaluated for film thickness, folding Endurance, Surface pH, morphological properties, %drug content and content uniformity, tensile strength, percent elongation, in vitro disintegration time and in vitro dissolution studies. The optimized formulation F24 prepared using HPMC E15 showed minimum disintegration time (9 sec), highest dissolution rate i.e. 99.6% of drug within 8 min and satisfactory physicochemical properties. The optimized film was evaluated for its bioavailability compared with pure drug as reference standard. Statistical analysis declare that no significant difference between the bioavailability parameters Cmax, Tmax, AUC0–∞ and AUC0–t of the test film (F24) and the reference product (Pure drug) indicated that they exhibited comparable plasma level-time profiles. These results revealed that the oral dissolving film containing sumatriptan succinate is considered to be effectively useful for the treatment of migraine where quick onset of action is expected.

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تاریخ انتشار 2013