Microbiological Estimation of Nasal Spray Containing Naltrexone Hydrochloride

Abstract

Introduction. In order to standardize the quality indicators during the expected shelf life of the developed drug naltrexone hydrochloride in the form of a nasal spray containing a high concentration of poloxamer and benzalkonium chloride as a preservative, a microbiological study was carried out. The possibility of using the membrane filtration method for testing prototypes recommended by the State Pharmacopoeia XIV.Aim. Study and selection of test conditions for the «microbiological purity» indicator of nasal spray samples containing naltrexone hydrochloride.Materials and methods. As an object of research, a naltrexone hydrochloride nasal spray was used. When analyzing the microbiological purity, the membrane filtration method recommended in the State Pharmacopoeia XIV.Results and discussion. As part of the study, it was found that the samples of the drug meet the requirements for a microbiological indicator for drugs of category 2. Testing the suitability of the method for samples of the dosage form showed that the antimicrobial effect of the drug was completely removed by washing the filter, which was proved by inoculation of indicator test microorganisms, the quantitative and qualitative nature of growth, which did not differ from the control without the drug.Conclusion. As a result of the studies carried out, the optimal test conditions for the «Microbiological purity» indicator for the nasal spray containing naltrexone hydrochloride were selected and substantiated.

Keywords

• nasal spray
• naltrexone
• microbiological purity
• membrane filtration