A controlled release Tablet comprising betahistine and a process for the preparation of the tablet

摘要

A controlled release Tablet comprising an active ingredient which is a Salt of the same betahistine or acceptable for pharmaceutical use.Incorporated in at least a Fatty compound; at least a Hydrophilic Polymer able to absorb Water and suitable excipients.Betahistine is an active Vasodilator used for oral administration in the treatment of vertigo.The preparation of a Pharmaceutical Form with a suitable Release Profile of betahistine would reduce the amount of daily Administrations only.While maintaining a constant concentration of the active ingredient within the therapeutic dose Range.A process for the preparation of Controlled Release Tablets comprising the steps of: (a) to incorporate the active ingredient of it,In at least a Fatty Compound by Melt granulation; (b) The Step to mix the Granules with at least a compound Hydrophilic excipients and appropriate; (c) subjecting the mixture of compressionL STEP (b).