Pharmaceutical development of the anti-epileptic tablets on the basis of levetiracetam substance. the specificity of pharmaco-technological studies at standardization of the remedy
DOI:
https://doi.org/10.15587/2519-4852.2017.93393Keywords:
quality target product profile, standardization, specification, eligibility criteria, pharmaco-technological indexes, anti-epileptic tablets, development, technologyAbstract
Remedies containing Levetiracetam are widely used in medical practice for treatment of different forms of epilepsy. In result of pharmaceutical development, manufacturing formulation for the tablets on the basis of Levetiracetam substance was obtained, and the new technology for its production was developed.
The aim of research within the pharmaceutical development of the remedy was to determine the necessity of the complex of operations related to the standardization of the remedies Levetiracetam 250, film coated tablets 250 mg and Levetiracetam 500, film coated tablets 500 mg. Experimental studies should be devoted to determination of quality target product profile (QTPP), according to ICH Q8 recommendations. Concerning the specificity of the mentioned drugs production, the amount of work was determined to develop pharmaco-technological indexes for their implementation to the relevant specifications for the finished drug product, as well as for the intermediate products obtained at different stages of the technological process.
Methods. By results of tests, which were carried out in accordance to pharmacopoeia requirements, the eligibility criteria of pharmaco-technological parameters for the corresponding control objects were determined.
Results. Results of quality target product profile (QTPP) studies were used for development of specifications for the remedies Levetiracetam 250, film coated tablets 250 mg and Levetiracetam 500, film coated tablets 500 mg, which were completed in the form of quality control methods and specifications for the finished drug product series.
Experimental research of the samples of products, which were obtained at appropriate stages of the technological process, were carried out; pharmaco-technological indexes, which were implemented into the specifications for the finished drug product, as well as the specifications for the intermediate products, were developed. According to the given data estimation, it was displayed, that pharmaco-technological indexes are rather important both for the quality of drug assesment, and for evidence base formation to confirm the reproducibility of the technological process.
Conclusion. The results of research within standardization of the remedies Levetiracetam 250, film coated tablets 250 mg and Levetiracetam 500, film coated tablets 500 mg show processability of obtaining drugs, which LLC "Pharma Start" carries out, as well as guarantee of the drugs quality from batch to batch
References
- Vlasov, P. N. (2002). Klinicheskaja harakteristika i perspektivy ispol'zovanija novyh protivojepilepticheskih preparatov u vzroslyh. Farmateka, 1, 25–33.
- Gromov, S. A., Mihajlov, V. A., Begi, E. (1997). Jepidemiologija jepilepsii i risk uhudshenija kachestva bol'nyh. Nevrologicheskij zhurnal, 3 (2), 27–30.
- Pellock, J. M., Bourgeois, B. F. D., Dodson, E. W., Nordli, D. R., Sankar, R. (Eds.) (2008). Pediatric Epilepsy. Diagnosis and treatment. New York: Demos, 895.
- Holtkamp, M., Meierkord, H. (2007). Anticonvulsant, antiepileptogenic, and antiictogenic pharmacostrategies. Cellular and Molecular Life Sciences, 64 (15), 2023–2041. doi: 10.1007/s00018-007-7021-2
- Geht, A. B. (2002). Sovremennaja strategija lechenija jepilepsii. Farmateka, 1, 15–24.
- Jur'jev, K. L. (2012). Novitni – tret'ogo pokolinnja – protyepileptychni preparaty. Ukrai'ns'kyj medychnyj chasopys, 4, 107–109.
- Ljapunov, M., Bezugla, O., Pidpruzhnykov, Ju., Zhemerova, K., Solovjov, O., Tahtaulova, N. (Eds.) (2011). Nastanova 42-3.0:2011. Likars'ki zasoby. Farmacevtychna rozrobka (ICH Q8). Kyiv: MOZ Ukrai'ny, 42.
- Georgijevs'kyj, V. (Ed.) (2004). Nastanova 42-3.2:2004. Nastanovy z jakosti. Likars'ki zasoby. Specyfikacii': kontrol'ni vyprobuvannja ta kryterii' pryjnjatnosti. Kyiv: MOZ Ukrai'ny, 38.
- Derzhavna Farmakopeja Ukrai'ny. Vol. 1 (2015). Kharkiv: Derzhavne pidpryjemstvo «Ukrai'ns'kyj naukovyj farmakopejnyj centr jakosti likars'kyh zasobiv», 1130.
- European Pharmacopoeia current hot topics (2016). European Directorate for the Quality of Medicines and Health Care (EDQM). Strasbourg: Council of Europe, 21.
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2017 Євген Сергійович Шакін, Наталія Миколаївна Асмолова, Тетяна Григорівна Ярних
This work is licensed under a Creative Commons Attribution 4.0 International License.
Our journal abides by the Creative Commons Attribution 4.0 International License copyright rights and permissions for open access journals.
Authors, who are published in this journal, agree to the following conditions:
1. The authors reserve the right to authorship of the work and pass the first publication right of this work to the journal under the terms of a Creative Commons Attribution 4.0 International License, which allows others to freely distribute the published research with the obligatory reference to the authors of the original work and the first publication of the work in this journal.
2. The authors have the right to conclude separate supplement agreements that relate to non-exclusive work distribution in the form in which it has been published by the journal (for example, to upload the work to the online storage of the journal or publish it as part of a monograph), provided that the reference to the first publication of the work in this journal is included.
3. Authors have the right to store the final accepted version of the article in an institutional, thematic, or any other repository to ensure visibility and accessibility.
