FORMULATION AND CHARACTERIZATION OF ORAL THIN FILM CONTAINING DOMPERIDONE HCL
Abstract
Domperidone Hydrochloride is a psycho stimulant drug which is freely soluble in water and other organic solvents. Drug is not having any bitter taste. The estimation of drug was carried out with the help of UV-spectrophotometer using the higher concentration range of 100 g/ml to1000 g/ml.
Simplex centroid design was applied to optimize the amounts of polymers. Percentage drug release at 2minutes, disintegration time and tensile strength were taken as responses and amounts of three polymers HPMCE5, HPMCE 15 and Maltodextrin were taken as formulation variables affecting the response. The polynomial equations showing relationship between formulation variables and each response were derived. Surface plots showing relationship between in dependent variables and responses were prepared. The surface plots and polynomial equations indicated the desired properties of drug release were obtained due to presence of HPMCE5. Required disintegration time was achieved with the help of HPMCE 5 and Maltodextrin. Good tensile strength was achieved with the help of HPMCE15. FTIR study was done to detect whether any chemical interaction occurs between drug and polymer. Further stability study was carried out at 40ºC/75% RH condition. The results of the stability study indicated formulations are stable there are no significant changes.
From the whole study it was understood that Mouth dissolving film is an acceptable dosage form for Domperidone Hydrochloride. These findings suggest that mouth dissolving film containing DomperidoneHydrochloride is likely to become one of the choices of Domperidone Hydrochloride preparations for treatment in the ADHD and Narcolepsy conditions.
Key words: Domperidone Hydrochloride, HPMC
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