METHOD FOR PRODUCTION OF NIFEDIPINE OINTMENT (VERSIONS) Russian patent published in 2017 - IPC A61K9/06 A61K31/4422 A61K47/30 

FIELD: pharmacology.

SUBSTANCE: nifedipine and polyethylene glycol with a molecular weight of 1500±1000 (PEG) are mixed at the ratio of 1.00:2.00-4.00. The mixture of nifedipine and PEG is dissolved in 95% ethanol at a mixture/ethanol ratio of 1.00:13.00-15.00 at a temperature of 25±5°C. The resulting solution is introduced into the molten mixture of PEG with a molecular weight of 400 (70.00 parts) and PEG with a molecular weight of 1500 (30.00 parts) at a temperature of 95±5°C at a solution:base ratio of 1.00:5.00-11.00. The resulting ointment is thoroughly mixed and packed in sealed packages. Version 2 is proposed. A methods for nifedipine ointment preparation, comprising dilution of the mixture of nifedipine and polyvinylpyrrolidone with a molecular weight of 10000±2000 at a ratio of 1.00:0.50-1.50 in 95% ethanol at a mixture and ethanol ratio of 1:26.00-30.00 at a temperature of 25±5°C, the resulting solution is injected into anhydrous lanolin at the solution: anhydrous lanolin ratio of 1:2.15-4.55, petroleum jelly is added, at the lanolin mixture:petroleum jelly ratio of 1:1.05-1.25. The resulting ointment is thoroughly mixed and packed in sealed packages.

EFFECT: increased bioavailability of nifedipine slightly soluble in water, providing better release by increasing the solubility and dissolution rate of the drug substance DS, reduced dose and side effects of the drug substance DS on the body, increasing the comfort of ointments application.

2 cl, 1 dwg, 2 ex