SUSTAINABLE AMORPHIC PREMIX BASED ON POTASSIUM RALTEGRAVIR AND THE METHOD OF ITS PRODUCTION

摘要

1. A stable amorphous premix based on potassium raltegravir, containing potassium raltegravir and at least one pharmaceutically acceptable adjuvant. A stable amorphous premix based on potassium raltegravir according to claim 1, characterized in that the pharmaceutically acceptable auxiliary agent may be a diluent, lubricant, disintegrant, stabilizer, flowability regulator or surfactant, or mixtures thereof. 3. The stable amorphous premix based on potassium raltegravir according to claim 2, characterized in that the pharmaceutically acceptable auxiliary agent is selected from the group consisting of polyvinylpyrrolidone (also called povidone), polyvinyl alcohol, polyethylene glycol, polyol (mannitol), sodium starch glycolate, colloidal silicon dioxide ( aerosil), hydroxypropyl methyl cellulose, methyl cellulose, carboxymethyl cellulose, sodium carboxymethyl cellulose, hydroxyethyl cellulose, polyvinyl acetate, cyclodextrins, gelatins, hypromellose phthalate, sugar and their mixtures. 4. A method for producing a stable amorphous premix based on potassium raltegravir, comprising the steps of: (i) preparing a solution of crystalline potassium raltegravir in a solvent, (ii) adding suitable pre-mixing agent (s) and (iii) removing substantially the solvents from the solution to obtain a stable amorphous premix based on raltegravir potassium. 5. The method according to claim 4, characterized in that the solvent in step i) is selected from the group consisting of dichloromethane, 1,2-dichloroethane, chloroform, carbon tetrachloride, methanol, ethanol, isopropyl alcohol, 1-propanol, 2-propanol, 1- butanol, 2-butanol and tert-butyl alcohol