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Analysis and standardization of Metiferon, Benzituron and their pharmaceutical forms


Author: Tihon Iurie
Degree:doctor of pharmacy
Speciality: 15.00.01 - Pharmacy
Year:2012
Scientific adviser: Vladimir Valica
doctor habilitat, professor, State University of Medicine and Pharmacy "Nicolae Testemitanu"
Scientific consultant: Victor Ghicavîi
doctor habilitat, professor, State University of Medicine and Pharmacy "Nicolae Testemitanu"
Institution: State University of Medicine and Pharmacy "Nicolae Testemitanu"
Scientific council: DH 50-15.00.01-27.03.08
State University of Medicine and Pharmacy "Nicolae Testemitanu"

Status

The thesis was presented on the 16 March, 2012
Approved by NCAA on the 23 May, 2012

Abstract

Adobe PDF document – 0.90 Mb / in romanian

Keywords

isothiourea derivatives, optical spectral analysis, HPLC, injectable solutions, technological flow process, stability and validity periods, NTDs

Summary

The thesis is presented on 125 typed pages and consists of: introduction, 5 chapters, general conclusions and recommendations, bibliography, containing 201 references, 36 figures, 46 tables, 33 appendices The findings results of research are published in the 13 scientific work papers.

Research Field: 15.00.01-Pharmacy.

Aim of study: The setting of physical and chemical properties, analysis and standardization of Metiferon, Benzituron and their developed pharmaceutical forms.

Objectives of research:
1) the research of the physical and chemical properties of Metiferon and Benzituron; 2) the development of methods of analysis and standardization for Metiferon and Benzituron in their own pure substance; 3) the research of preformulation and formulation of pharmaceutical forms containing Metiferon and Benzituron. 4) the development of technology for preparation of injectable Metiferon and Benzituron solutions.5) the development of analytical methods and standardization for the developed pharmaceutical forms; 6) the stability study of Metiferon and Benzituron and establishing validity term, 7) the development of Normative Technical Documents for substances and pharmaceutical forms.

Scientific novelty and originality: For the first time, are researched Metiferon and Benzituron the original pharmaceutical substances that increase the arsenal of cardiac indigenous drugs There have been optimized the conditions of synthesis and purification of Metiferon and Benzituron. Manufacture, standardization, and the methods of quality control at the stage of pharmaceutical synthesis, of pharmaceutical forms as the final product is original and allow to produce these derivatives in the large- industrial scale.

Scientific problem is consisting of complex pharmaceutical research of Metiferon and Benzituron in order to develop the Analytical Normative Documentations of quality for pure substance and their pharmaceutical forms as a prerequisite for the registration and their use as cardiovascular action

Theoretical significance of the work is consisting to approach systemically pharmaceutical research methodology by emphasizing the physicochemical properties of all studied compounds by aid of modern instrumental analytical methods and the determination of specific structural parameters responsible for the pharmacological and conceptual argumentation of a complex study in order to obtain new medications. The practical value of the work: Current research results can serve as the initial support in the development of methods of analysis, standardization and control of unstudied compounds of the isothioureical structure in the manufacturer drug laboratories.

Practical application of research results:
Based on experimental results obtained as result of analysis and standardization of researched substances and injectable pharmaceutical forms were issued the temporary pharmacopoeia monographs on "Metiferon" and "injectable solution Metiferon 10%", which were reviewed and registered by the Commission on medicines at Medicines Agency (MFT MD-08/1129-12.09 and MFT MD-08/1131-12.09. Production technological regulation for "injection, 10% Metiferon" was put into implementation in a pilot project at LLC Balkan Pharmaceuticals (executive act 427)