Methodological aspects of the development of an anthelmintic drug in the form of tablets
DOI:
https://doi.org/10.24959/sphhcj.20.187Keywords:
methodology, development, medicines, anthelmintic drugsAbstract
Aim. To substantiate the methodology for developing a domestic original highly effective medicinal product in the form of tablets for the treatment of helminthiasis of the digestive system in accordance with the existing standards.
Materials and methods. The scientific publications, electronic databases of the Ministry of Health of Ukraine and the own research, as well as methods of generalization, systematization of theoretical and practical material, bibliosemantic and system analysis, were used.
Results. The main approaches to the pharmaceutical development of original domestic medicines have been analyzed, in particular drugs for the treatment of helminthiasis of the digestive system in accordance with the requirements of the Manual ST-N MH 42-3.0:2011 “Medicines. Pharmaceutical Development (ICH Q8)”. The general scheme for the pharmaceutical development of tablets has been described taking into account the requirements of the current norms and standards of Ukraine and foreign experience. A decision tree has been proposed for choosing an active pharmaceutical ingredient for the development of anthelmintic drugs. The main stages of the development of an anthelmintic drug in the form of tablets have been described.
Conclusions. The feasibility of developing a domestic original drug in the form of tablets for the etiotropic treatment of helminthiasis of the digestive system in order to provide the needs of the population in high-quality, affordable and safe anthelmintic drugs, which is especially important in the context of import substitution policies, has been substantiated.References
Aulton, M. E. (2002). Pharmaceutics: The science of dosage form design. (2nd ed.). London: Churchill Livingstone, 682.
Ministerstvo okhorony zdorovʺia Ukrainy. (2004). Nastanova 42–3.1:2004. Nastanovy z yakosti. Likarsʹki zasoby: Farmatsevtychna rozrobka. Kyiv: Morion.
Yershova, I. B., Osychniuk, L. M., Mochalova, H. O. (2013). Perynatolohyia y pedyatryia, 2 (54), 125–131.
Horlenko, O. M., Poliak-Tovt, V. M., Poliak, M. A. (2013). Problemy klinichnoi pediatrii, 2 (20), 10– 14.
Tolochko, K. V., Vyshnevska, L. I. (2017). Analysis of the domestic pharmaceutical market of anthelmintic medicines. Visnyk farmatsii, 1 (89), 56-60.
Nastanova 00019. Hostryky (enterobioz). (2020). Available at: http://guidelines.moz.gov.ua/documents/2918?id=ebm00019&format=pdf (Date of Access: 13 Feb. 2020).
Nastanova 00020. Askarydoz. (2020). Available at: http://guidelines.moz.gov.ua/documents/2918?id=ebm00020&format=pdf (Date of Access: 13 Feb. 2020).
Nastanova 00021. Kyshkovi tsestodozy. (2020). Available at: http://guidelines.moz.gov.ua/documents/2918?id=ebm00021&format=pdf (Date of Access: 13 Feb. 2020).
Nastanova 01038. Stronhiloidoz. (2020). Available at: http://guidelines.moz.gov.ua/documents/2918?id=ebm01038&format=pdf (Date of Access: 13 Feb. 2020).
Nastanova 01039. Nematodozy. (2020). Available at: http://guidelines.moz.gov.ua/documents/2918?id=ebm01039&format=pdf (Date of Access: 13 Feb. 2020).
Nastanova 01043. Trykhotsefaloz. (2020). Available at: http://guidelines.moz.gov.ua/documents/2918?id=ebm01043&format=pdf (Date of Access: 13 Feb. 2020).
Derzhavnyi reiestr likarskykh zasobiv. (2020). Available at: http://www.drlz.com.ua/ibp/ddsite.nsf/all/shlist?opendocument (Date of Access: 13 Feb. 2020).
Chueshov, V. I., Gladukh, E. V., Saiko, I. V. et al. (2014). Tekhnologiya lekarstv promyshlennogo proizvodstva. Vinnytsia: Nova Knyha.
Downloads
Published
Issue
Section
License
Copyright (c) 2020 National University of Pharmacy
This work is licensed under a Creative Commons Attribution 4.0 International License.
Authors who publish with this journal agree to the following terms:- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).
