abstract |
A pharmaceutical composition, in a solid form, which allows oral administration of a unit dose ranging from 0.50 mg to 25.00 mg of levocetirizine dihydrochloride as an active ingredient, and containing active granules comprising - the active substance - a polyol fraction comprising one or more solid water soluble polyols having a molecular weight below 950 g / mol, with a molar ratio between the polyol fraction and the active ingredient greater than 50, at least one soluble polyol in solid water which is mannitol, and - a buffer system, which contributes to maintaining the pH of the total pharmaceutical composition between 4.0 and 7.0 when the pharmaceutical composition containing 5 mg of active ingredient is dissolved in 100 ml of water. |