The invention relates to a pharmaceutical formulation for oral administration, the formulation containing an effective quantity of Vardenafil hydrochloride or Vardenafil hydrochloride trihydrate, stearic acid and at least one further pharmaceutically acceptable excipient. A further solution provides a process for the preparation of said formulation.

Production of solid medicaments (A) containing vardenafil hydrochoride (I) in the form of the trihydrate involves using (I) of any water content in the production of (A) and converting (I) into the trihydrate form at an intermediate processing stage or in the final product. An independent claim is included for the medicaments (A) (specifically in coated tablet form) obtained by the process. - ACTIVITY : Vasotropic. - MECHANISM OF ACTION : None given in the source material.

FIELD: medicine pharmaceutics.SUBSTANCE: present invention refers to a method for preparing a medicinal agent containing vardenafil hydrochloride trihydrate in the solid form wherein vardenafil hydrochloride trihydrate is treated with suitable pharmaceutical additives at temperature from approximately 20°C to approximately 45°C. The ambient relative humidity of the procedure makes 30% to 90%. The treated medicinal agent is film-coated at temperature within the range from 40°C to 55°C.EFFECT: met...

PURPOSE: A rapidly disintegrating film formulation in the oral cavity is provided to show excellent physical properties of a film and to manufacture a film formulation which is rapidly disintegrated in the oral cavity. CONSTITUTION: A rapidly disintegrating film formulation in the oral cavity contains pullulan and hydroxypropyl pea starch in a weight ratio of 7:3-3:7 (w/w%). The formulation also contains a drug which is selected among PDE5 inhibitors including vardenafil, sildenafil, mirodenafil...

A pharmaceutical formulation for the transmucosal delivery of a phopshodiesterase-5 (PDE-5) inhibitor comprises a PDE-5 inhibitor and a carrier in which the PDE-5 inhibitor is soluble or forms a suspension or emulsion. The PDE-5 inhibitor may be hydrophilic, preferably selected from sildenafil mesylate or a salt of vardenafil, where the carrier may be an aqueous solution, such that the PDE5 inhibitor is solubilised in the carrier. Alternatively, the PDE-5 inhibitor may be hydrophobic, preferably...

The present invention relates to a process for preparing vardenafil salts with an acid in the ratio of both the components 1:1, of the general formula 2a, and crystalline hydrates thereof, which preparation process comprises: a) preparation of a vardenafil solution in an organic solvent that is immiscible or partially miscible with water