Approach formation for the development of compounding preparation monographs
Journal Title: Фармацевтичний журнал - Year 2015, Vol 3, Issue 3
Abstract
Questions of standardization of compounding preparations are quite relevant both in Ukraine and abroad. Today the general monograph «5.N.1. Extemporaneous preparations» of the State Pharmacopoeia of Ukraine is revised by the staff of the Ukrainian scientific pharmacopoeial center for quality of medicines and the National University of Pharmacy, also the additional articles for compounding preparations are developed. The aim of this work is substantiation of the structure and format of the compounding preparation monographs for introduction to the national part of the State Pharmacopoeia of Ukraine. The researches were performed using data of the world pharmacopoeias and national formularies, as well as the experience of standardization of compounding preparations in Ukraine and the USSR. In the study, general statements for the development of compounding preparations monographs were formed and its structure was discussed. The requirements and examples are described for each item of the monograph. For monographs of the State Pharmacopoeia of Ukraine such structure were offered: name, composition, lists the acceptable range of labeled amount of main ingredient, technology of preparation, reference for the general monographs, properties, identification, tests, assay, expiration date, labeling, storage, references to the regulatory documents, and indications. For systematization of the monographs’ development procedure the work order was composed. The procedure of monographs development includes selection of the object, study of literature data, and study of the basic stages of the compounding process, evaluation of quality control methods, experimental researches, and conclusion about conformity with the requirements, quality control method validation protocols, stability studies, and development of the monograph’s draft. As the result of research the structure, format, stages and order of the development of compounding preparations’ monographs for introduction to the State Pharmacopoeia of Ukraine were proposed.
Authors and Affiliations
O. A. Zdoryk, V. А. Georgiyants, O. I. Gryzodub
Keywords
Related Articles
- EP ID EP586444
- DOI -
- Views 84
- Downloads 0
Determination of the glucose residues on pharmaceutical equipment surfaces by both methods: polarimetry and HPLC
Cleaning of equipment in the production of medicines is an important requirement of good manufacturing practice (GMP). As a rule, the same process equipment is used for the production of a number of different drugs that...
Conceptual foundations of pharmacoeconomic analysis of prevention technologies of chronic viral infections
The introduction of various technologies for the prevention of chronic viral infections into practice requires well-founded evidence of their effectiveness, which can be obtained using pharmacoeconomic methods and models...
Study of influence of surface-active substances сoncentration on diltiazem releasing from rectal suppositories
Diltiazem is one of the most widely used calcium antagonist in clinical practice. The results of its action are the lowering of myocardium oxygen need, improvement of the coronary blood flow and reducing of arterial pres...
The rationale for the method of administration of decamethoxinum and lidocaine hydrochloride in the basis of drug films
It is known that the efficiency of the medicine depends on pharmaceutical factors, in particular on the technology of preparation. The choice of optimal technology preparation of a drug depends on such factors as the met...
Study of influence of the surface-active substances concentration on releasing of praziquantel from the rectal suppository
Acne dermatosis (rosacea, perioral dermatitis, seborrheic dermatitis etc.) are one of the most actual problem in dermatology. Praziquantel is an antiparasitic medication effective towards trematodes, cestodes. Investigat...