World experience of the monograph development for compounding preparations

Journal Title: Фармацевтичний журнал - Year 2014, Vol 1, Issue 1

Abstract

The practice of compounding and quality control of compounding preparations are different all over the world. There is no common approach of quality assurance system creating for compounding preparations that leads to the existence of a number of risks and problems associated with their quality and safety. Based on the world experience, modern approaches of compounding preparation quality assurance are the implementation of good practices, pharmacopoeia concept formation, national formulary creation and development of monographs for extemporaneous preparations. The aim of this article was a comparative analysis conduction of compounding preparation monographs which are given in pharmacopoeias and national formularies in different countries of the world. The more detailed comparison was made for monographs structure of compounding preparation which are given in the British Pharmacopoeia, the US Pharmacopoeia, National formularies of France, Germany and Malaysia. In the result of the analysis the most specific parts of compounding preparation monographs were identified, such as: composition, technology, common pharmacopoeial requirements, range of ingredients content, properties, tests, assay, expiration date, labeling, storage, and indications. Today in Ukraine questions of compounding preparation monographs creating remain under discussion. It is necessary to consider establishing a National formulary in Ukraine, which would include all the features of technology and quality control of compounding preparations.

Authors and Affiliations

O. A. Zdoryk, V. А. Georgiyants

Keywords

Related Articles

Comparative analysis of antimicrobial drugs recommended by medical and technological documents for the treatment of patients with community-acquired pneumonia

Today community-acquired pneumonia remains one of the leading causes of death as a result of infectious diseases. For effective treatment must be guided by such guidelines which would take into account not only recent wo...

The development of standard of good pharmacy practice regarding the participation of pharmacists in public health

The change in the focus of healthcare in Ukraine from treatment to preventive medicine is necessary for improvement of medical and demographic situation in the country and the formation of a responsible attitude of citiz...

Сhronic toxicity testing complex phytopoliextraction of sedative action

Development and introduction in medical practice sedative meals on the base of complex phytopoliextracts from the domestic medical plants permitted for medical application is highly actual because of incrised incidence o...

Effect of different diluent’s type on trimetazidine dihydrochloride release from matrix tablets

Oral matrix tablets are the modern dosage forms using which could be achieved desirable in vitro release kinetics of active pharmaceutical ingredient (API) and correspondent in vivo concentration level. That’s why the st...

Study the appropriateness of extemporaneous production of homeopathic drugs in pharmacies

Homeopathic treatment provides an individualized approach to each patient, which can be achieved through extemporaneous production of homeopathic medicines (drugs). Therefore, the goal of this study is to prove the appro...

Download PDF file
  • EP ID EP587395
  • DOI -
  • Views 62
  • Downloads 0

How To Cite

O. A. Zdoryk, V. А. Georgiyants (2014). World experience of the monograph development for compounding preparations. Фармацевтичний журнал, 1(1), 22-27. https://europub.co.uk/articles/-A-587395