Problems of scientific substantiation of extemporaneous formulations technologies and ways of its solution. P a r t IІ. Comparative analysis of modern pharmacopoeial requirements to technology and quality control of extemporaneous medicines
Abstract
For today almost all countries of the world have State Pharmacopoeias, which are collections of standards for medicines and provide the basic principles of preparing dosage forms. They have legislative character, are mandatory for all medical institutions and companies in the country that are engaged in the preparation, storage, control and use of medicines.
The aim of the work is a comparative analysis of modern pharmacopoeial requirements to technology and quality control of extemporaneous medicines. Studies were performed using information materials, in particular, pharmacopoeias, literature data and own research materials using conventional empirical methods.
Modern interstate pharmacopoeial standard that defines the requirements to technology and quality control of medicines is European Pharmacopoeia (EP). But in the current editions it does not contain the individual monographs on extemporaneous medicines. Unlike EP British Pharmacopoeia includes monographs on about 120 extemporaneous medicines namely pastes, drops, solutions, lotions, inhalants, suppositories, etc.
Necessary information regarding extemporaneous medicines also include Swedish and Belgian Pharmacopoeias. But the most significant information material for the preparation and quality control of medicines in pharmacies has USP.
The legal framework for technology and quality control of extemporaneous medicines in Ukraine until 2001 was only reflected in corresponding orders of Ministry of Public Health of Ukraine.
Since October 2001, in general articles of the State Pharmacopoeia of Ukraine (SPU) began to appear instructions for extemporaneous preparation of individual dosage forms.
In 2008, in SPU 1.2 in «General texts» was included national section 5.N.1. «Extemporaneous medicines» with a block of general articles and information materials for the preparation and quality control of non-sterile medicines in pharmacies.
In a comparative analysis of requirements to technology and quality control of extemporaneous medicines according to articles SPU 5.N.1.1 «Extemporaneous non-sterile medicines» and USP 1161 «Pharmacy compound practices» was found that, despite some difference in the structure and title, many sections of these articles are similar in meaning and content, but there are some differences.
Thus, article 5.N.1.1 unlike the article 1161 contains no requirements concerning common rules of technology for certain dosage forms in terms of pharmacies. In this regard, the development of additions to general articles of SPU in the aspect of preparation extemporaneous medicines is carried out by scientists of NUPh.
Expansion and improvement of basic legal and technical documentation relevant legislative character, in particular general articles of SPU will improve the quality of medicines manufactured in pharmacies as well as to make the materials of SPU more demand for productive pharmacies.
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