THE THE METHOD OF RANDOM BALANCE FOR STUDYING THE INFLUENCE OF EXCIPIENTSʼ QUANTITIES ON TECHNOLOGICAL PARAMETERS OF METFORMIN ORODISPERSIBLE TABLETS

  • MARIANA DEMCHUK Department of Pharmacy Management, Economics and Technology, I. Horbachevsky Ternopil State Medical University, Ternopil city, Ukraine
  • MARIANA CHUBKA Pharmacy Department of Educational Scientific Institute of Postgraduate Education, I. Horbachevsky Ternopil State Medical University, Ternopil city, Ukraine
  • TARAS HROSHOVYI Department of Pharmacy Management, Economics and Technology, I. Horbachevsky Ternopil State Medical University, Ternopil city, Ukraine

Abstract

Objective: The present investigation was undertaken with an objective of analyzing the influence of excipientsʼ amount on the technological parameters of metformin orodispersible tablets using the method of random balance.


Methods: The tablets were prepared by using direct compression method. The formulations were designed according to the method of random balance. The technological parameters of metformin orodispersible tablets have been studied as a function of quantitative factors: crospovidone (Polyplasdone XL-10®), magnesium aluminometasilicate (Neusilin US2®), microcrystalline cellulose (MCC Sanaq® burst), lactose monohydrate, magnesium stearate (Tablube® MgSt micronized vegetable) and talc.  


 Results: The flowability results were ranging from excellent to good according to the quantities of Neusilin US2® and Polyplasdone XL-10® crospovidone, which used. Results of bulk density and tapped density of the powder mixtures for pressing depended from the quantities of Neusilin US2® and talc. The obtained tablets had uniform weight from 0.93 to 2.30 %. The increase in the amount of Polyplasdone XL-10® crospovidone and the decrease in the amount of talk improved the uniformity of tablets’ weights. All of the prepared tablets showed acceptable hardness and friability which were improved with decrease in the amount of MCC Sanaq®burst and increase in the amount of Neusilin US2®. The rapid disintegration and wetting time for all formulations of tablets were obtained by using the Polyplasdone XL-10® crospovidone and MCC Sanaq®burst.


 Conclusion: Oral disintegrating tablets of metformin were successfully prepared by direct compression method. The random balance method enabled us to identify the most significant quantitative factors and stabilize them at optimal values.

Keywords: Method of random balance, Oral disintegrating tablets, Metfomin

References

1. Krynytska ?, Marushchak M. The indices of nitric oxide system in rats with carrageenan-induced enterocolitis combined with diabetes mellitus. Rom J Diabetes Nutr Metab Dis 2018;25:283-8.
2. Demchuk M, Pokotylo O, Denys A, Hroshovyi T, Ravliv Y. Nationwide trends in antidiabetic drugs (Type-2) utilization, Ukraine, 2014-2016. Int J Green Pharm 2018;12:181-7.
3. International Diabetes Federation. IDF Diabetes Atlas. 8th ed. Available from: http://reports.instantatlas.com/report/view/ 846e76122b5f476fa6ef09471965aedd/UKR [Last accessed on 18 Feb 2019].
4. International Diabetes Federation. Clinical Practice Recommendations for managing Type 2 Diabetes in Primary Care; 2017. Available from: https://www.idf.org/our-activities/ advocacy-awareness/resources-and-tools/128:idf-clinical-practice-recommendations-for-managing-type-2-diabetes-in-primary-care.html [Last accessed on 18 Feb 2019]
5. Meneilly GS, Knip A, Tessier D. Canadian diabetes association 2013 clinical practice guidelines for the prevention and management of diabetes in Canada: diabetes in the elderly. Can J Diabetes 2013;37 Suppl 1:184-90.
6. Sinclair AJ, Paolisso G, Castro M, Bourdel-Marchasson I, Gadsby R, Mañas LR. European diabetes working party for older people. European diabetes working party for older people 2011 clinical guidelines for Type 2 diabetes mellitus. Executive summary. Diabetes Metab 2011;37 Suppl 3:27-38.
7. Sehgal P, Gupta RG, Singh UK, Chaturvedi A, Gulati A, Sharma M. Fast dissolving tablets: a new venture in drug delivery. Am J PharmTech Res 2012;2:252-79.
8. European Directorate for the Quality of Medicines (EDQM). Strasbourg Cedex 9th ed. France: Council of Europe; 2016. p. 885-7.
9. Demchuk M, Grochovuy T, Chubka M, Stechyshyn I. Greco-latin square design for selection of excipients in the development of metformin orodispersible tablets. Asian J Pharm 2018;12:211-20.
10. Zivorad R Lazic. Design of experiments in chemical engineering. A practical guide. Weinheim: Wiley-VCH; 2004.
11. Hroshovyi TA, Martsenyuk VP, Kucherenko LI, Vronska LV, Huryeyeva SM. Matematychne planuvannya eksperymentu v farmatsiyi [Mathematical planning of experiment in pharmacy]. Ternopil, Ukrainian: Ternopil State Medical University; 2008. p. 49-74.
12. Mohanachandran PS, Sindhumol PG, Kiran TS. Superdisintegrants: an overview. Int J Pharm Sci Rev Res 2011;6:105-9.
13. Polyplasdone crospovidone superdisintegrants. Product overview. Ashland. Available from: https://www.ashland.com/ file_source/Ashland/Industries/Pharmaceutical/links/PTR-097_Polyplasdone_crospovidone_as_a_Superdisintegrant.pdf [Last accessed on 10 Jan 2019].
14. Pinakin P, Pandey NK, Singh SKr, Garg V. MCC SANAQ® burst: a unique carrier for the formulation of sublingual tablets. Int J Pharm Tech Res 2016;9:15-22.
15. Khade S, Pore Y. Formulation and evaluation of Neusilin®US2 adsorbed amorphous solid self-microemulsifying delivery system of atorvastatin calcium. Asian J Pharm Clin Res 2016;9:93-100.
16. Helmis M, Mohamad B, Kumpugdee Vollrath M. Influence of several excipients on drug release of tablets containing resveratrol. Med J Pharm 2016;1:007. Available from: http://mathewsopenaccess.com/PDF/pharmaceutical-science/M_J_Phar_1_2_007.pdf [Last accessed on 10 Jan 2019]
17. Arijit G. Mouth dissolving tablets: a new venture in modern formulation technology. Pharma Innovation 2012;1:14-31.
18. Kumar S, Gupta SK, Sharma PK. A review on recent trends in oral drug delivery-fast dissolving formulation technology. Adv Biol Res 2012;6:6-13.
19. Derzhavna Farmakopeya Ukrayini [State Pharmacopoeia of Ukraine]: v 3 t. Kharkiv: Derzhavne pidpriemstvo. Ukrayinskiy naukoviy farmakopeyniy tsentr yakosti likarskih zasobiv; 2015;2:1121-5.
20. Jaya S, Amala V. Formulation and in vitro evaluation of oral disintegrating tablets of amlodipine besylate. Int J Appl Pharm 2019;11:49-54.
21. Maraie NK, Salman ZD, Yousif NZ. Design and characterization of or slippery buoyant tablets for ranitidine hydrochloride. Asian J Pharm Clin Res 2018;11:143-9.
22. Adeoye O, Alebiowu G. Evaluation of coprocessed disintegrants produced from tapioca starch and mannitol in orally disintegrating paracetamol tablet. Acta Pol Pharm 2014;71:803-11.
Statistics
66 Views | 110 Downloads
Citatons
How to Cite
DEMCHUK, M., CHUBKA, M., & HROSHOVYI, T. (2019). THE THE METHOD OF RANDOM BALANCE FOR STUDYING THE INFLUENCE OF EXCIPIENTSʼ QUANTITIES ON TECHNOLOGICAL PARAMETERS OF METFORMIN ORODISPERSIBLE TABLETS. International Journal of Applied Pharmaceutics, 11(3), 168-175. https://doi.org/10.22159/ijap.2019v11i3.32792
Section
Original Article(s)