Разработка и регистрация лекарственных средств (Jan 2019)
RATIONALE FOR THE SELECTION OF AUXILIARY COMPONENTS FOR THE NALTREXONE HYDROCHLORIDE NASAL SPRAY
Abstract
The work is devoted to the development of nasal spray containing naltrexone hydrochloride. Naltrexone in doses of 3-5 mg/day acts on the opioid growth factor receptor (OGFr) and toll-like receptor 4 that makes it promising for use in the complex therapy of autoimmune diseases and conditions caused by impaired immunity. To prevent leakage of the drug from the nasal cavity, the thermosensitive poloxamer (Kolliphor® P 407) was introduced into its composition. The dynamic viscosity was studied of model samples in the temperature range of 7-37 °C. The rate of dialysis and the degree of release was investigated of naltrexone. Selected the optimal composition to create a comfortable to use drug «Naltrexone hydrochloride, nasal spray», 25 mg/ml.