Sublingual pharmaceutical composition containing an antihistamine agent and method for the preparation thereof

A process for the preparation of a sublingual dosage form containing an ethanolamine-class antihistamine drug, such as Dimenhydrinate or a pharmaceutical acceptable salt, derivative or polymorph thereof, as the active ingredient, and an effective amount of a pH dependent excipient as a taste masking agent, to reduce the numbness of the mucosa, wherein said excipient is insoluble in acidic environment and soluble in neutral or alkaline conditions, wherein it comprises:

• Blending the active ingredient with the effective amount of a pH dependent excipient as a taste masking agent, to reduce the numbness of the mucosa and at least one pharmaceutically acceptable excipient selected from diluents, disintegrants, glidants, and flavour enhancers until complete homogeneity;
• Kneading the above mixture with a solvent such as ethanol and mixing until uniformity;
• Drying the wetted mass;
• Sieving the dried mass and adding to the sieved mixture, a disintegrant and mixing until uniform;
• Adding to the obtained mixture, at least one pharmaceutically acceptable excipient selected from glidants and lubricants and mixing until uniformity is achieved;
• formulating the resulting mixture in a sublingual solid dosage form by compressing it into a desired tablet form;
• Optionally, applying a coating.