The study of the stability of silver proteinate solutions prepared in pharmacies

Abstract

Today, medicines made in pharmacies are increasingly attracting consumers' attention and are in growing demand in Ukraine. Pharmacy production faces a number of problems, including the study of the stability of extemporaneous dosage forms and the determination of an optimal shelf life. 1 % and 2 % water silver proteinate solutions used in ophthalmology, otolaryngology and nephrology are produced in Ukrainian pharmacies both extemporaneously and as a reserve.
 The aim. The aim of the work is to develop methods for quality support and study the chemical stability of 1 % and 2 % water solutions of silver proteinate, and to study the microbiological purity to extend the storage time of nasal drops.
 Materials and methods. A study of the chemical stability of 1 % and 2 % water silver proteinate solutions of pharmaceutical production is carried out using chemical identification reactions (to silver and protein), quantitative determination by thiocyanatometric titrimetric method and determination of microbiological purity.
 Results. The validation characteristics of the method for the quantitative thiocyanatometric determination of silver proteinate were studied (the correlation coefficient r = 0.9995 and 0.9996; the systematic error – 0.26 % and 0.03 %, the relative confidence interval – 0.88 % and 0.74 % for 1 % and 2 % solutions, respectively), as well as its suitability for this purpose was proven. “Silver proteinate solution, 1.0 %” and “Silver proteinate solution, 2.0 %” prepared in the pharmacy were studied for 150 days by the “Microbiological purity” indicator and were biologically stable.
 Conclusions. The chemical identification reactions and methods for the quantitative determination of silver proteinate in an extemporaneous dosage form used to study the chemical stability of the drug have been proposed. The study results of the chemical stability and microbiological purity allow us to recommend pharmacies to extend the shelf life of nasal drops containing silver proteinate as an active pharmaceutical ingredient for 150 days

Determination of chromatographic conditions for quantitative assessment of active components in complex nasal spray after manufacturing and expiry date

“…The results of tests of the stability of the samples for 6 months under long-term storage conditions are shown in Table 5. 1.60 1.77 NF 3 1.11 1.04 PVP 4 1.04 0.87 LD 5 1.21…”

“…Despite the wide range of industrially produced medicinal products, manufacturing in pharmacy conditions remains a popular practice throughout the world [2]. Among the extemporaneous medicinal products presented on the pharmaceutical market of Ukraine, the largest part consists of liquid dosage forms, of which otorhinolaryngological preparations are the priority link [3,4].…”