EXPERIMENTAL DESIGN IN RESEARCH AT THE CREATION OF TABLET MEDICINES
DOI:
https://doi.org/10.11603/2312-0967.2020.2.11204Keywords:
experimental design, quality design, mathematical experiment planning, tablet medicines, quality factors, dispersion analysisAbstract
The aim of the work. Analysis and systematization of literature data on research design using mathematical experiment planning when creating and improving the technology of tablet preparations.
Materials and Methods. The methods of information retrieval, analysis of literature data on the design of the experiment at the stage of studying qualitative factors during research on the creation of tablet medicines were used in the work.
Results and Discussion. The literature data and our own research on the use of mathematical experiment planning in the study of qualitative factors at the stage of development of the composition and technology of tablet medicines are presented in the work. Examples of using plans of Latin, Greek-Latin and hyper-Greek-Latin squares for the study of qualitative factors with the same number of levels are given. Examples of using plans of Latin cubes and parallelepipeds to study qualitative factors with a different number of levels are considered.
Conclusions. Quality design is an important and widely used technique in pharmaceutical development. Experimenters use its methods at different stages of the study – from setting goals to characterizing the finished product. This is especially important in the process of creating and researching tablet medicines, which is multi-stage. The use of mathematical experiment planning at the research planning stage allows you introduce the principle of “quality design” in both scientific and industrial conditions when creating tablet medicines. The examples of conducting research on the study of qualitative factors with the same and different number of levels, methods for constructing plan of dispersion analysis, their statistical analysis and interpretation of the results of experimental studies were presented.
References
Guidance. Pharmaceutical development (ICH Q8). [Настанова СТ-Н 42-3.0:2011. Лікарські засоби. Фармацевтична розробка (ICH Q8)] Кyiv; 2011. Ukrainian.
Guidance. Quality risk management (ICH Q9). [Настанова СТ-Н 42-4.2:2011. Лікарські засоби. Управління ризиками для якості (ICH Q9)] Кyiv; 2011. Ukrainian.
Guidance. Pharmaceutical quality system (ICH Q10). [Настанова СТ-Н 42-4.3:2011. Лікарські засоби. Фармацевтична система якості (ICH Q10)] Кyiv; 2011. Ukrainian.
Fisher R. Statistical methods for researchers. [Статистические методы для исследователей] Moscow: Gosstatizdat; 1958. Russian
Hroshovyi TA, Martsenyuk VP, Kucherenko LI, Vronska LV, Huryeyeva CM. Mathematical planning of experiment in pharmacy. [Математичне планування експерименту при проведенні наукових досліджень в фармації] Ternopil: Ternopil State Medical University; 2008. Ukrainian.
Hroshovyi TA, Beley NM, Kucherenko LI, Vasenda MM, Markiv NV, Tryhubchak OV, et al. [Optimization of technological processes of drugs creation by means of mathematical planning of experiment]. Farmatsevt chasop. 2007;1: 21-8. Ukrainian.
Huryeyeva CM, Hroshovyi TA, Lukashiv OI. [Research of the assortment of excipients used in medicines products, which are registered in Ukraine]. Farmatsevt chasop. 2012;4(24): 178-83. Ukrainian.
Ravliv YuA. Development of the technology and research of drugs which are based on the cryolyophilized xenoderm. Extended abstract of Candidate’s thesis. Lviv: Danylo Halytsky Lviv National Medical University; 2015. Ukrainian.
Gureyeva SM. The theoretical and experimental substantiationof technology of solid dosage forms based on Biopharmaceutics Classification System of Active Pharmaceutical Ingredients. Extended abstract of Doctor’s thesis. Lviv: Danylo Halytsky Lviv National Medical University; 2016. Ukrainian.
Ruban OA, Kolisnyk TYe, Slipchenko GD. [Application of experimental design method in optimization of composition and technology for matrix tablets containing Vaccinium Myrtillus leaf dry extract]. Farmatsevt chasop. 2018;2: 41-7. DOI: 10.11603/2312-0967.2018.2.9003. Ukrainian. DOI: https://doi.org/10.11603/2312-0967.2018.2.9003
Tryhubchak OV, Hroshovy TA, Huryeyeva CM. [Investigation of excipients’ nature influence on the quality indices of effervescent tablets of acetylsalicylic acid, paracetamol and ascorbic acid]. Aktualni pytannia farmatsevtychnoi i medychnoi nauky ta praktyky. 2018;1(26): 64-8. DOI: 10.14739/2409-2932.2018.1.123712. Ukrainian. DOI: https://doi.org/10.14739/2409-2932.2018.1.123712
Sunil Kumar Shah, Neeraj Kumar, Neelesh Choubey et al. Formulation and optimization of expandable gastro retentive floating matrix tablet of Mosapridecitrate using factorial design. International Journal of Pharmacy and Pharmaceutical Research. 2018;12(1): 77-96.
Basakina II. Development of composition and technology of effervescent tablets of complex action for the treatment of respiratory diseases. Extended abstract of Candidate’s thesis. Kharkiv: National University of Pharmacy; 2011. Ukrainian.
Beley SYa. Development of the composition, technology and investigation of the tablets based on malva sylvestris and plantago lanceolata extracts. Extended abstract of Candidate’s thesis. Lviv: Danylo Halytsky Lviv National Medical University; 2019. Ukrainian.
Shalata VYa. Development of the technology and investigation of the tablets with plant extracts of venotonic and sedative actions. Extended abstract of Candidate’s thesis. Lviv: Danylo Halytsky Lviv National Medical University; 2013. Ukrainian.
Bidnenko OS. Development and standardization of Angiolin tablets. Extended abstract of Candidate’s thesis. Kharkiv: National Pharmaceutical University; 2013. Ukrainian.
Borsuk SO. Technology development and standardization of the new tryptophan and thiotriazoline combined drug. Extended abstract of Candidate’s thesis. Lviv: Danylo Halytsky Lviv National Medical University; 2013. Ukrainian.
Nymenko GR. Development and standardization of carbamazepine-based tablets with thiotriazolin. Extended abstract of Candidate’s thesis. Kharkiv: National Pharmaceutical University; 2018. Ukrainian.
Кoval VМ. Development of the composition, technology and standardization of the tablets with zinc aspartate, ascorbic acid and Echinacea extract. Extended abstract of Candidate’s thesis. Lviv: Danylo Halytsky Lviv National Medical University; 2012. Ukrainian.
Yezerska OI. Development of the composition, technology and research of tablets with chicory and corn extract. Extended abstract of Candidate’s thesis. Lviv: Danylo Halytsky Lviv National Medical University; 2014. Ukrainian.
Onyshkiv ОІ. Development of the composition and technology of tablets based on the phytoextract of aspen bark. Extended abstract of Candidate’s thesis. Lviv: Danylo Halytsky Lviv National Medical University; 2013. Ukrainian.
Yuryeva O.O. Development of the composition and technology of the combined tablet medication antihypertensive action. Extended abstract of Candidate’s thesis. Lviv: Danylo Halytsky Lviv National Medical University; 2019. Ukrainian.
Butkevych TA, Syatynya МL, Popovych VP. [Study of the excipients influence on pharmaco-technological properties of flammulina velutipes biomass dry powder tablets]. Farmatsevt chasop. 2017;3: 47-51. DOI: 10.11603/2312-0967.2017.3.8121. Ukrainian. DOI: https://doi.org/10.11603/2312-0967.2017.3.8121
Khromylova OV. [The study of the excipients influence on pharmaco-technological characteristics of l-arginine with thiotriazolin tablets]. Farmatsevt chasop. 2018;4: 35-41. DOI: 10.11603/2312-0967.2018.4.9704. Ukrainian. DOI: https://doi.org/10.11603/2312-0967.2018.4.9704
Kukhtenko OS. Methodological, technological and biopharmaceutical aspects of complex extracts and medicines on their basis development. Extended abstract of Candidate’s thesis. Zaporizhzhia: Zaporizhzhia State Medical University; 2019. Ukrainian.
Beley NM. Development of composition, technology and research of tabulated drugs containing calcium and lecithin. Extended abstract of Candidate’s thesis. Lviv: Danylo Halytsky Lviv National Medical University; 2009. Ukrainian.
Vasenda MM. Development of composition, technology and research of tablets based on a magnesium asparaginate. Extended abstract of Candidate’s thesis. Lviv: Danylo Halytsky Lviv National Medical University; 2010. Ukrainian.
Demchuk MB. Development of composition, technology and research of tablets famotidine with thiotriazoline. Extended abstract of Candidate’s thesis. Lviv: Danylo Halytsky Lviv National Medical University; 2011. Ukrainian.
Denys AI. Development of composition, technology and research of tablets based on the extract of chinese poplar leaf. Extended abstract of Candidate’s thesis. Lviv: Danylo Halytsky Lviv National Medical University; 2012. Ukrainian.
Kucherenko LІ. Development of technology and standardization of tableted drugs on the basis of 1,2,4-triazole derivatives. Extended abstract of Candidate’s thesis. Kharkiv: National Pharmaceutical University; 2010. Ukrainian.
Tryhubchak OV. Development of composition and technology of tablets which contain acid асеtylsalicylic in combination with thiotriazoline. Extended abstract of Candidate’s thesis. Lviv: Danylo Halytsky Lviv National Medical University; 2010. Ukrainian.
Barchuk OZ. Development of the composition, technology and methods of standardization of tablets on the basis of phytoextracts of bilberry leaves and goat’s rue herb. Extended abstract of Candidate’s thesis. Lviv: Danylo Halytsky Lviv National Medical University; 2018. Ukrainian.
Logoyda LS. Development and standardization of sedative pharmacological agent with extracts of valerian, lemon balm and glycine in tablets. Extended abstract of Candidate’s thesis. Kharkov: National University of Pharmacy; 2013. Ukrainian.
Parnyuk NV. Development of technology and standardization of tablets “Hypertril”. Extended abstract of Candidate’s thesis. Kharkiv: National University of Pharmacy; 2016. Ukrainian.
Darzuli NP. Development of composition, technology and research of tablet formulations of Pyrola rotundifolia extract. Extended abstract of Candidate’s thesis. Lviv: Danylo Halytsky Lviv National Medical University; 2019. Ukrainian.
Shoshmina OV, Gureyeva SN, Vronska LV. [Study on the influence of excipients on pharmacotechnological properties of tablet cores of dexketoprofen]. Farmatsev zhurnal. 2019;1: 53-63. DOI: 10.32352/0367-3057.1.19.05. Ukrainian. DOI: https://doi.org/10.32352/0367-3057.1.19.05
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