EXPERIMENTAL DESIGN IN RESEARCH AT THE CREATION OF TABLET MEDICINES Message 2. Design of the experiment in the study of the quantitative factors influence at the stage of tablet medicines composition and technology optimization
DOI:
https://doi.org/10.11603/2312-0967.2020.3.11428Keywords:
experimental design, quality design, mathematical experiment planning, tablet medicines, quality factors, regression analysisAbstract
The aim of the work. Analysis and systematization of literature data on the design of the experiment in the study of quantitative factors at the stage of finding the optimal composition in the development of technology of tablet drugs.
Materials and Methods. The paper uses methods of information retrieval, analysis of literature data on the design of the experiment in the study of quantitative factors, the search for optimal compositions in research on the development of the composition and technology of tablet drugs.
Results and Discussion. The paper presents data from the literature and our own research on the use of experimental design in the study of quantitative factors at the stage of development of the optimal composition and technology of tablets. Examples of using the method of random balance, regression analysis plans to study the influence of quantitative factors on the main technological indicators of tablet drugs are given.
Conclusions. Quality by design is an important and widely used technique in the development of medicines. Experimenters use the quality by design methods at different stages of the study - from the formation of the goals to establish the optimal composition of the drug. Examples of research on the study of the influence of quantitative factors, methods of constructing regression analysis, interpretation of the results of experimental studies are presented in this article.
References
Нroshovyi TA, Demchuk MB, Beley NM, Naida YV, Pavlyuk BV. [Experimental design in research at the creation of tablet medicines. Message 1. Design of the experiment in the study of the influence of qualitative factors at the stage of development at the stage of development of tablet drugs]. Farmatsevt chasop. 2020;2: 101-10. Ukrainian.
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.
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
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.
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
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
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.
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.
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.
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.
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.
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.
Revyatskyy І, Barchuk O. [Presentation optimization of research results using the accidential balance method and influence factors that have different equivalents of measurement]. Farmatsev zhurnal. 2019;1: 76-85. Ukrainian. DOI: https://doi.org/10.32352/0367-3057.1.19.07
Isa Martins Fukuda, Camila Francini Fidelis Pinto, Camila dos Santos Moreira, Alessandro Morais Saviano, Felipe Rebello Lourenço. Design of Experiments (DoE) applied to Pharmaceutical and Analytical Quality by Design (QbD). Brazilian Journal of Pharmaceutical. 2018;54: 1-16. Available from: https://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502018000700405 DOI: https://doi.org/10.1590/s2175-97902018000001006
Anilkumar J Shinde, Karan B Swami, Harinath N More. Formulation and Optimization of Expandable Gastroretentive Tablet of Diltiazem Hydrochloride using Factorial Design. Asian Journal of Pharmaceutics. 2017;11(1): 24-36.
Hesham M. Tawfeek, Jelan A. Abdel-Aleem, Mahmoud M. Ahmed. Development and optimization of Itopride Hydrochloride fast disintegrating tablets using factorial design and response surface methodology. International Journal of Pharmaceutical Sciences and Research. 2015;6(4): 1661-72.
Mohammad Ali Shahtalebi, Majid Tabbakhian, Sina Koosha. Formulation and evaluation of orally disintegrating tablet of ondansetron using natural superdisintegrant. J Herbmed Pharmacol. 2015;4(3): 102-9.
Chandan Kumar Brahma, Raghavendra Kumar Gunda, Suresh Kumar JN, V Satyanarayana, Naga Prashant K. Design Formulation and Evaluation of Ranitidine HCl gastro retentive floating tablets. International Journal of Pharma Research and Health. 2015;3(5): 862-73.
Gurunath S, Baswaraj KN, Patil PA. Optimization and formulation design with in-vitro evaluation of fast disintegrating tablets containing Candesartan Solid dispersions. Journal of Pharmaceutical Research. 2017;1(6): 1-11. Available from: https://medwinpublishers.com/OAJPR/OAJPR16000135.pdf DOI: https://doi.org/10.23880/OAJPR-16000135
Muhammad Ahsan, Nasir Abbas, Amjad Hussain, Hamid Saeed, Pervaiz Akhtar Shah, Sohail Mohammad et al. Formulation optimization and in-vitro evaluation of oral floating captopril matrix tablets using factorial design tropical. Journal of Pharmaceutical Research. 2015;14(10): 1737-48.
Samar A Afifi, Walaa M Mandour, Kadria A Elkhodairy. Optimization of a novel oral colon delivery system of Indomethacin using full factorial design. Tropical Journal of Pharmaceutical Research. 2015;14(5): 761-8 DOI: https://doi.org/10.4314/tjpr.v14i5.3
Shanu Sharma, Vivek Chauhan, Neha M. Khalid Кhan. Formulation optimization of mouth dissolving tablets of Meloxicam using mixed hydrotropic solublization technique. Journal of Scientific and Innovative Research. 2015;4(2): 76-82. DOI: https://doi.org/10.31254/jsir.2015.4206
Vaddemukkala Yohan, Muneer Syed, D. Srinivasarao. Research Article on optimization of Olmesartan tablet formulation by 23 factorial design. International Journal of Research in Pharmaceutical and Nano Sciences. 2015;4 (4): 188-95.
Girish S. Sonar, Swati Rawat. Formulation and design of multiunit particulate system (mups) tablet of Pantoprazole by QbD: Study effect of formulation variables on tablet characteristics. International Journal of PharmTech Research. 2015;8(8): 5-23.
K. P. R. Chowdary, Ravi Shankar Р., V. L. S. P. Sowjanya. Optimization of Irbesartan tablet formulation by 23 factorial design. World Journal of Pharmacy and Pharmaceutical Sciences. 2014;3(10): 1110-9.
K.P.R. Chowdary, K. Ravi Shankar P. Ravi Sankar. Optimization of Valsartan tablet formulation by 23 factorial design. Journal of Global Trends in Pharmaceutical Sciences. 2014;5(1): 1374-9.
Bala Vishnu Priya Mukkala, T. E. G. K. Murthy, Prameela Rani Avula. Multi-particulate drug delivery systems of Methylphenidate Hydrochloride: Optimization of formulation using statistical experimental design. Asian Journal of Pharmaceutics. 2017;11(3): 239-49.
Rybachuk VD, Ruban OA. [Selection of composition of excipients in creation of natural zeolite tablets (clinoptilolite)]. Farmatsevt chasop. 2018;2: 48-53. Ukrainian.
Bobrytska LO. Scientific and practical substantiation of technology of solid dosage forms of antimicrobial and antiviral action: Extended abstract of Candidate’s thesis. Kharkov: National University of Pharmacy; 2013. Ukrainian
Amira Touil, Ahlem Haj Ammar. Experimental design approach for optimization of sucrose fluid bed drying process conditions. Glob J Pharmaceu Sci. 2017;4(1): 555-628. Available from: https://juniperpublishers.com/gjpps/GJPPS.MS.ID.555628.php DOI: https://doi.org/10.19080/GJPPS.2017.04.555628
Gureyeva SM. The theoretical and experimental substantiation of 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.
Bui Thanh. Applying experimental design and optimization of studying the hydrophilic matrix sustained-release tablets of felodipine. Asian Journal of Biomedical and Pharmaceutical Sciences. 2018;8(64): 14-21.
Slipchenko HD, Ruban OA., Beley NM. [Optimization of composition and technology of tablets based on scutellaria baicalensis dry extract]. Farmatsevt chasop. 2016;1: 50-3. Ukrainian.
Harekrishna Roy, Sk. Abdul Rahaman. Box-Behnken design for optimization of formulation variables for fast dissolving tablet of urapidil. Asian Journal of Pharmaceutics. 2018;12(3): 946-54.
Yuryeva OO. 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.
Alexandru Gavan, Alina Porfire, Cristina Marina, Ioan Tomuta. Formulation and pharmaceutical development of quetiapine fumarate sustained release matrix tablets using a QbD approach. Acta Pharm. 2017;67: 53-70. DOI: https://doi.org/10.1515/acph-2017-0009
Mali RN, Desai SR, Disouza JI. Quality by Design-based formulation and evaluation of fast dissolving tablet of Aspirin. Asian Journal of Pharmaceutics. 2018;12(1): S92-S101.
Rashmi Dahima, Amit Gupta, Devashish Rathore. Quality by Design (QbD) approach for formulation development of hydralazine hydrochloride tablets. Journal of Chemical and Pharmaceutical Research. 2016;8(5): 336-41.
Sanjay Bansal, Sarwar Beg, Babita Garg, Abhay Asthana, Gyati S. Asthana, Bhupinder Singh. QbD-оriented development and characterization of effervescent floating-bioadhesive tablets of cefuroxime axetil. American Association of Pharmaceutical Scientists. 2016;17(5): 1086-99.
Virag A. Shah, Deepika N. Rathod, Tarashankar Basuri, Vishal S. Modi Ishvar. Applications of Bioinformatics in Pharmaceutical Product Designing: A Review. World journal of pharmacy and pharmaceutical sciences. 2015;4(1): 477-93.
Downloads
Published
How to Cite
Issue
Section
License
The authors who publish their materials in this journal agree with the following terms:
- Authors reserve the right to authorship of their work and assign to the journal the right to first publish this work under the terms of the Creative Commons Attribution License, which allows other persons to freely distribute the published work with a mandatory reference to the authors of original work and the first publication of work in this journal
. - Authors have the right to make independent extra-exclusive work agreements in the form they are published by this journal (for example, posting work in an electronic repository of an institution or publishing as part of a monograph), provided that the link to the first publication of the work in this journal is maintained.
Journal policy allows and encourages publication of manuscripts on the Internet (for example, in institutions repositories or on personal websites), both before the publication of this manuscript and during its editorial review, as it contributes to productive scientific discussion and positively affects the efficiency and dynamics of the citation of the published work (see The Effect of Open Access).
