Formulation for oral administration comprising melatonin in stable way and method of producing the same

摘要

A Pharmaceutical composition in the form of a Bilayer Tablet comprising melatonin as pharmaceutical Active Principle (API)Said Tablet comprising: a First Layer consisting of a First Granules which comprises 10 to 30% of APIA glyceride Derivative of saturated fatty acids is C20 C24 Chains and other excipients that allow an immediate release of API; a second layer is a Second GranulesIncludes a 70 - 90% of APIA glyceride Derivative of saturated fatty acids is C20 C24 Chains and other excipients that allow extended release API; each Granules obtained by granulating a hotTemperature from 77 to 83 Degrees for 8 - 12 minutes; in the% weight% with respect to the total weight of the API in the Bilayer tablet; in which the Derivative of saturated fatty acid glycerideC20 C24 Chains which are selected from the group consisting of arachidic acid,Lignoceric acid and behenic acid, in which the immediate release Layer comprises the glyceride Derivative of saturated fatty acids with C20 C24 Chains, used as a Stabilizer.At a rate of 0,5% to 4% by Weight with respect to the total weight of the layer in which the extended release Layer comprises the glyceride Derivative of saturated fatty acids with C20 C24 Chains,Used as a Stabilizer which is responsible for the extended release, at a rate of 4% to 30% by Weight with respect to the total weight of the layer.