Liquid pharmaceutical composition containing flecainide and process for the preparation thereof
AssigneeColonis Pharma Ltd
InventorsAngelos KARATZAS, Argyro STAPPA, Konstantinos APOSTOLOU, Akis LOUKAS
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Abstract
The present invention relates to a liquid pharmaceutical composition comprising a therapeutically effective quantity of flecainide or a pharmaceutically acceptable salt thereof, as an active ingredient, for administration in the pediatric population and adults who are unable to swallow a solid dosage form and a process for the preparation of said liquid pharmaceutical composition.
Claims15
A storage-stable liquid pharmaceutical composition for oral administration comprising a therapeutically effective amount of flecainide or a pharmaceutically acceptable salt thereof, as an active ingredient, wherein said active ingredient is from about 0.1 to about 3.0% w/v, wherein the weight/volume percentages are expressed as g/100 mL units, wherein said composition has a pH value below 4.0.
A storage-stable liquid composition comprising 0.5% Flecainide acetate, sucralose, a citrate buffering system which comprises citric acid, acetic acid or mixtures thereof, sodium benzoate in the range from 0.6 to 1.2 mg/mL and said composition is having pH value in the range from 2.8 to 3.2.
A process for the preparation of a storage-stable liquid composition for oral administration comprising a therapeutically effective amount of flecainide or a pharmaceutically acceptable salt thereof, as an active ingredient, wherein said active ingredient is from about 0.1 to about 3.0% w/v wherein the weight/volume percentages are expressed as g/100 mL units, wherein said process comprises the following steps:
- (a) dissolving in purified water at least one of the excipients selected from citrate buffering system, and/or preservatives;
- (b) adding the total amount of flecainide or salt thereof, to the resulting solution of step (a) and stirring for appropriate time until complete dissolution;
- (c) optionally adding to the solution of step (b) at least one of the excipients selected from sweeteners and/or flavouring agents;
- and
- (d) adjusting the pH of the final solution to a value below 4.0 with suitable citric acid solution, or hydrochloric acid or sodium hydroxide solution.
Dependencies are inferred from the claim text.