Pelekh-Bodnaruk I. Development of the composition, technology and study of emulsion products with excipients of microbial origin for use in dermatology.

Українська версія

Thesis for the degree of Doctor of Philosophy (PhD)

State registration number

0823U100399

Applicant for

Specialization

  • 226 - Фармація, промислова фармація

19-06-2023

Specialized Academic Board

ДФ 35.600.067

Danylo Halytsky Lviv National Medical University

Essay

The dissertation is devoted to the study of the possibility of using surface-active substances of microbial origin as promising auxiliary substances in the composition of emulsion medicinal and cosmetic products. To date, there is a steady trend towards the creation of medicinal products for skin application and cosmetic products with a high content of the aqueous phase. Such means require the inclusion of a significant number of auxiliary substances, the nomenclature of which is currently quite wide in medicine and cosmetology. Most of the auxiliary components are surface-active substances by structure, which can cause side reactions. Almost all surface-active substances are able to remove fatty substances from the surface of the body, namely the thin protective film formed by the sebaceous and sweat glands. In addition, they change the permeability of skin cell membranes for certain substances. The analysis of the composition of excipients of these products showed that polysorbates are mainly used as emulsifiers of the 1st kind to create emulsion medicines, and cetostearyl is most often used as emulsifiers of the 2nd kind alcohol and lanolin. Parabens or their mixtures, as well as benzyl alcohol, are often included as preservatives in emulsion medicines for skin application. A general research plan has been developed to study the preservative and emulsifying activity of surfactants of microbial origin based on rhamnolipids of Pseudomonas sp. PS-17 under the conventional name PS biocomplex and the sequence of research stages is substantiated. For the study of surface-active substances of microbial origin, emulsion bases of the type "oil in water" and "water in oil" were chosen, since emulsion forms make up about 90% of all cosmetics and a significant part of medicines for dermal use. Such studies are the most revealing. During quality control of the studied samples of emulsion products, the methods and recommendations given in DFU 2.0 were followed, in particular the requirements of the general article "Soft medicinal products for dermal application". Organoleptic, physico-chemical, technological, microbiological and pharmacological research methods were used in the process of work, allowing to objectively evaluate samples of emulsion products. The information on the peculiarities of the stability study and establishing the shelf life of soft medicinal and cosmetic products is summarized, the list of necessary researched characteristics, conditions and test frequency is determined, and the stability study algorithm is developed, which will be expediently applied at the stage of development of emulsion products with the PS biocomplex. The study of the stability of emulsion products includes the determination of organoleptic and physicochemical indicators, the activity of antimicrobial preservatives and microbiological purity. The allergenic properties of the PS biocomplex were investigated by the method of intradermal sensitization of guinea pigs. It has been established that the biocomplex PS does not cause reliable changes in the peripheral blood of animals and changes in allergy tests, which indicates the absence of sensitization of the body. The irritant effect of the PS biocomplex was investigated by introducing the biological preparation in a 1:10 dilution into the conjunctival sac of the rabbit eye. It was established that when applied to the mucous membranes, the PS biocomplex has a weak irritating effect. Restoration of the ophthalmic status was observed on the 2nd day without treatment. The technology of m/v type emulsion products stabilized by PS biocomplex has been tested in the conditions of industrial production of natural care cosmetics of the brand ED Cosmetics, Lviv, Ukraine. The results were implemented in the educational process of higher education institutions of the pharmaceutical profile of Ukraine.

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