DEVELOPMENT OF HEMOSTATIC GELATIN SPONGE WITH MIRAMISTIN USING THE "QUALITY BY DESIGN" METHOD (QbD)

Authors

DOI:

https://doi.org/10.11603/2312-0967.2023.3.14168

Keywords:

hemostatic sponge, gelatin, miramistin, technology, mathematical planning of the experiment

Abstract

The aim of the work. Development of the composition of a medical/hemostatic sponge based on gelatin, study of the influence of miramistin and auxiliary substances on critical quality attributes.

Materials and Methods. During the experimental study, the active pharmaceutical ingredient Miramistin was used, as well as auxiliary substances medical gelatin, propylene glycol, and formaldehyde. Hemostatic sponges were obtained using the lyophilization method and examined according to six reviews: thickness, cm; pH; appearance, points; in vitro degradation, %; percentage of water absorption, %; time of complete dissolution, hours.

Results and Discussion. Using the assessment of the quality target product profile the quality and efficiency of the developed hemostatic sponges were determined. At the first stage of research, a quality target product profile was developed. Critical quality attributes are time of complete dissolution and percentage of water absorption. On the basis of previous studies, the influence of independent variables, that is, the amount of medical gelatin (x1) and the amount of aldehyde (x2), on the dependent variables was studied. The results clearly indicate that all dependent variables are strongly related to the selected independent variables.

Optimization of the composition of hemostatic sponges with miramistin was carried out using the quadratic model of the response surface. As a result of a number of conducted experiments and based on the limitations set by independent variables using the Design-Expert 10.0.0 program, the composition of the developed form with miramistin for external use was proposed and scientifically substantiated.

Conclusions. An experimental study was conducted on the development of a hemostatic sponge with miramistin for external use. The effect of the amount of auxiliary substances on the technological and physico-chemical indicators was studied, and their optimal amount was selected, which ensures the compliance of the hemostatic sponge with the quality target product profile. As a result of a number of conducted experiments and based on the limitations set by independent variables using the Design-Expert 10.0.0 program, the composition of the developed form with miramistin for external use was proposed and scientifically substantiated.

Author Biographies

B. V. Pavliuk, I. Horbachevsky Ternopil National Medical University

PhD (Pharmacy), Assistant of the Department of Pharmacy Management, Economics and Technology

M. B. Chubka, I. Horbachevsky Ternopil National Medical University

PhD (Pharmacy), Associate Professor, Department of Pharmacy, Faculty of Postgraduate Education

T. A. Hroshovyi, I. Horbachevsky Ternopil National Medical University

DSс (Pharmacy), Professor, Head of the Department of Pharmacy Management, Economics and Technology

H. B. Spetsialna, Ternopil Scientific Research Forensis Center, MIA of Ukraine

Head of the research of Narcotic Drugs, Psychotropic Substances, their Analogues and Precursors Sector, Materials, Substances and Products Research Department

V. V. Debrivskyj, I. Horbachevsky Ternopil National Medical University

student of the Department of Pharmacy Management, Economics and Technology

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Published

2023-09-30

How to Cite

Pavliuk, B. V., Chubka, M. B., Hroshovyi, T. A., Spetsialna, H. B., & Debrivskyj, V. V. (2023). DEVELOPMENT OF HEMOSTATIC GELATIN SPONGE WITH MIRAMISTIN USING THE "QUALITY BY DESIGN" METHOD (QbD). Pharmaceutical Review Farmacevtičnij časopis, (3), 4–15. https://doi.org/10.11603/2312-0967.2023.3.14168

Issue

Section

Pharmaceutical technology, biopharmacy, homeopathy, biotechnology