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Elaboration, analysis and standardization of combined pharmaceutical forms containing isohydrafural


Author: Donici Elena
Degree:doctor of pharmacy
Speciality: 15.00.01 - Pharmacy
Year:2020
Scientific adviser: Livia Uncu
doctor, associate professor (docent)
Scientific consultant: Viorel Prisăcari
doctor habilitat, professor, Nicolae Testemitanu State University of Medicine and Pharmacy of the Republic of Moldova
Institution: Nicolae Testemitanu State University of Medicine and Pharmacy of the Republic of Moldova

Status

The thesis was presented on the 20 February, 2020
Approved by NCAA on the 31 July, 2020

Abstract

Adobe PDF document – 1.35 Mb / in romanian

Thesis

CZU 615.281:615.454.1.07

Adobe PDF document 8.79 Mb / in romanian
279 pages

Keywords

isohydrafural, methyluracil, benzocaine, fluocinolone acetonide, combined ointment, antibacterial activity, optimization, technology, quality, standardization

Summary

Thesis structure: introduction, four chapters, general conclusions and recommendations, references (155 titles), 33 annexes, 129 basic text pages (up to references), 41 figures, 39 tables. The obtained results were published in 23 scientific papers and presented in 15 scientific forums.

Aim of the study:elaboration, analysis, standardization, determination of antibacterial activity, local-irritant and dermato-resorbtive actions of the combined ointments of isohydrafural with regenerative, local anesthetics and dermatocorticosteroids drug substances.

Study objectives: evaluation of combined dermatological drugs on the pharmaceutical market of the Republic of Moldova in the period 2012-2017; studies of pre-formulation, formulation-optimization and elaboration of technology of production of combined ointments; development and validation of analysis methods; standardization and study of the stability of combined ointments; evaluation of antibacterial activity and dermato-resorbtive and local-irritant actions of combined ointments; elaboration of the projects of Pharmacopoeial Monographs and the projects of Technological Regulations of the combined ointments.

Scientific novelty and originality: for the first time, new combined ointments were developed for the treatment of different dermatological diseases infected with bacterial germs; the methods of analysis and standardization of combined ointments were developed and validated; the research of antibacterial activity and dermato-resorbtive and local-irritant actions were performed.

The scientific solved problem: the development of new combined ointments, containing drug substances with different therapeutic actions: antibacterial, anti-inflammatory, local anesthetic and regenerative. Although these drugs do not contain antibiotics, they have a higher antibacterial activity due to isohydrafural, which is a novel derivative of nitrofuran from local production with a lower toxicity.

Theoretical significance: the generalization of stages and methods used in preformulation, formulation-optimization, quality control, standardization and real-time stability of combined ointments. Applicative value: the obtained results contribute to the increase of compliance of the treatment of dermatological diseases infected with bacterial germs by using combined ointments.

Implementation of the scientific results: the projects of Pharmacopoeial Monographs and the projects of Technological Regulations of production of three dosage forms were elaborated: isohydrafural and methyluracil combined ointment, isohydrafural, methyluracil and benzocaine combined ointment and isohydrafural and fluocinolone acetonide combined ointment. The results were implemented at the Department of Dosage Forms of the University Pharmaceutical Center “Vasile Procopisin” of State University of Medicine and Pharmacy “Nicolae Testemitanu” and at the Department of Quality Management of JSC Pharmaco.