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Formulation and In Vivo Evaluation of Granisetron HCI Mouth Dissolving Films in Healthy Human Volunteers
Fast dissolving drug delivery systems such as mouth dissolving films (MDF) are novel dosage forms that disintegrate or dissolve within the oral cavity and it is considered the most convenient, easy, safest route of administration. Present work aimed at preparing quick onset of action of Graniserton HCl which is beneficial in emesis, aiding in the enhancement of bioavailability and is very convenient for administration without the problem of swallowing and using water. Present mouth dissolving films were prepared by the solvent-casting method using a combination of different polymers, HPMC E3, HPMC E5 and HPMC E15, along with Propylene glycol as a plasticizer. Mouth dissolving films were evaluated for physical characteristics such as thickness, folding endurance, drug content, surface pH, percentage elongation and tensile strength and results were found to be satisfactory. The Fourier-transform infrared study and scanning electron microscopy for the drug-polymer interaction was carried out. The formulations were subjected to disintegration, in-vitro drug release test. The in vitro disintegration time of the optimized batch F14 was found to be 9 sec and drug release was found to be very fast i.e. 99.69±6.27% of within 7min. In vitro and in vivo evaluation of the films confirmed their potential as an innovative dosage form to improve bioavailability and quick onset of action of Graniserton HCl in the management of chemotherapy induced vomitings.
Graniserton HCI, Mouth Dissolving Films, Solvent-Casting Method, HPMC, Human Volunteers.
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