Problems of scientific substantiation of extemporaneous formulations technologies and ways of its solution. P a r t І. Retrospective view on the unification aspects of extemporaneous formulations
Extemporaneous formulations largely depend on practical experience and require constant analysis, the results of which should be reported to all the medical and pharmaceutical workers.
The aim of the work is a retrospective analysis of unification of extemporaneous formulations; study the current state of the regulatory framework of extemporaneous preparations technology. Studies were performed using archival information materials, literature data and materials from our studies using conventional empirical methods.
In order to unify the extemporaneous formulations in many countries, including Ukraine, are published official collections of medicinal prescriptions, the range of which is periodically reviewed and updated.
The first guide of extemporaneous formulations «List of medicinal formulas» containing 241 formulations was published in 1930. The first Soviet «Pharmaceutical Manual» was published in 1949; it contained the widely used medicines, known under certain conventional names.
In 1993, was organized a work to prepare the «Compendium of the dosage prescriptions», which contained 728 standardized prescriptions and was recommended by the Ministry of Health to the practical work (order No. 223 from 08. 12. 91).
Similar manuals were issued in other countries: «Pharmaceutical Formulas» (England, 1944), «Formulaire de Magistrale du Syndicat» (France, 1992), «Formules Magistrales» (APIC, 1994), «Formularium Nederlandse Apothekers» (Netherlands, 1967), etc.
Among modern informal publications in Ukraine refers published in 1999 «Handbook of extemporaneous formulations. Allopathy and homeopathy» edited by acad. A. I. Tikhonov. It was first compiled and systematized over 2,000 prescriptions of extemporaneous medicines.
In view of the introduction into the work of pharmacies requirements of Good Pharmaceutical Practice (GPP) in 2000 was published already 2-nd edition of this handbook «Extemporaneous formulations (technology, use)» in 4 parts. GPP requirements to the technology of non-sterile, sterile and aseptic medicines are described in the two methodical recommendations edited by acad. A. I. Tikhonov and prof. T. G. Yarnykh and approved by the Order of the Ministry of Public Health of Ukraine No. 391 from 03. 08. 2005.
In the aspect of improving the quality of extemporaneous drugs in Ukraine is conducted a work on the development of compositions and technologies of new extemporaneous formulations. It creates a series of newsletters, regulating their production process, and approved by the Ministry of Public Health of Ukraine.
Besides, technology of extemporaneous preparations is also contained in articles published by scientists in scientific and popular journals as well as in dissertations.
Thus, on the basis of this analysis it can be argued that the establishment of the regulatory framework of extemporaneous drugs technology enhances their quality, improving production activities of pharmacies, as well as improve the drug supply of the population in terms of individualized treatment of the patient.
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