Title:
METHOD FOR PRODUCING A DRUG FOR PARENTERAL ADMINISTRATION
Document Type and Number:
WIPO Patent Application WO/2022/055397
Kind Code:
A1
Abstract:
The invention relates to the chemical and pharmaceutical industry and to medicine and concerns a method for producing a drug for parenteral administration containing 1-deoxy-1-N-[-methyl-(2-acridone-9-one-10-yl-acetate)]-ammonium-D-glucitol and having an antiviral, antimicrobial, antifungal, antiparasitic, radioprotective and immunomodulatory effect. The drug is used to treat a broad spectrum of diseases of infectious origin. The aim of the present invention is to develop an optimal method for producing a drug for parenteral administration containing as active ingredient 1-deoxy-1-N-[-methyl-(2-acridone-9-one-10-yl-acetate)]-ammonium-D-glucitol, which makes it possible to reduce the amount of impurities in the final drug product and to increase the shelf life thereof. This aim is achieved in that in a method for producing a drug for parenteral administration containing as active ingredient 1-deoxy-1-N-[-methyl-(2-acridone-9-one-10-yl-acetate)]-ammonium-D-glucitol by dissolving said active ingredient in water for injection, mixing, filtering the solution through a sterilizing filter, and pouring the solution into sterile containers, N-methylglucamine is added to the solution as an excipient in an amount of not more than 0.05 wt%, mixing is carried out at a temperature of 55-60°С until the ingredients have fully dissolved, then the resulting solution is cooled to a temperature of 22-25°С, and after the step of filtering and pouring, the solution is subjected to thermal sterilization at a temperature of 121°С for a period of 8-15 minutes. In a specific embodiment, the problem of interest is solved in that N-ethylglucamine is added to the solution as an excipient in an amount of not more than 0.2 wt%.
Inventors:
KOVALENKO ALEXEY LEONIDOVICH (RU)
PETROV ANDREY YURIEVICH (RU)
PETROV ANDREY YURIEVICH (RU)
Application Number:
PCT/RU2021/050278
Publication Date:
March 17, 2022
Filing Date:
August 27, 2021
Export Citation:
Assignee:
SCIENTIFIC TECH PHARMACEUTICAL FIRM POLYSAN LTD (RU)
International Classes:
A61K9/08; A61J3/00; A61K31/435; A61K31/473; A61K47/18
Foreign References:
| RU2182004C1 | 2002-05-10 | |||
| RU2135474C1 | 1999-08-27 | |||
| RU2173155C1 | 2001-09-10 | |||
| US5925630A | 1999-07-20 |
Other References:
KOVALENKO A.L. ET AL., FIZIKO-KHIMICHESKIE I FARMATSEVTICHESKIE SVOISTVA N-METILGLIUKAMINA I EGO PRIMENENIE
Attorney, Agent or Firm:
MEDVEDEV, Valery Nikolaevich (RU)
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