STUDY OF THE INFLUENCE OF EXCIPIENTS ON THE PHARMACO-TECHNOLOGICAL INDICATORS OF THE TABLETS OF BISOPROLOL FUMARATE AND INDAPAMIDE
DOI:
https://doi.org/10.11603/2312-0967.2023.4.14368Keywords:
antihypertensive drugs, tablets, direct compression, bisoprolol fumarate, indapamide, excipients, pharmaco-technological indicatorsAbstract
The aim of the work. Study of the influence of excipients on the pharmaco-technological parameters of powder masses and tablets of bisoprolol fumarate with indapamide.
Materials and Methods. Bisoprolol fumarate and indapamide powders; 27 excipients from the groups of disintegrants, sliding agents, lubricants, diluents based on microcrystalline cellulose (MCC) and multifunctional fillers were chosen for the pharmaceutical development of tablets. A five-factors experiment based on the Graeco-Latin cube of the second order was used to study the influence of excipients.
Tablets were obtained by direct compression. The study of the properties of the powder mixtures and the quality indicators of the tablets was carried out in accordance with the requirements of the State Pharmacopoeia of Ukraine. The process of pressing tablets and their appearance were also evaluated. Conclusions regarding the selection of optimal excipients were made using the desirability function.
Results and Discussion. The results of the study show that the flowability, bulk and tapped density, the angle of repose of the powder mixtures and the evaluation of the pressing process were most affected by sliding agents, namely Neusilin US 2, as well as samples of multifunctional fillers (MagGran or Cellactose 80) and fillers based on MCC (Vivapur 200 or 302). Better indicators of hardness testing and friability of tablets were provided by sliding substances, namely Syloid 244 FP. Disintegrants, namely sodium croscarmellose, had a decisive effect on the time of disintegration of tablets. To make a decision on the selection of optimal excipients used a generalized indicator - the desirability function.
Conclusions
The influence of the 27th excipients on the pharmaco-technological indicators of powder masses and tablets of bisoprolol fumarate with indapamide was studied. It was established that the optimal quality indicators of tablets with bisoprolol fumarate and indapamide were obtained when using sodium starch glycolate type VivaStar, Neusilin US 2, PEG-6000, Prosolv EASY tab SP and SacheLac 80. The results of this study are the basis for determining the optimal quantitative ratio of excipients in composition of tablets using regression analysis.
References
Sirenko YuM, Rekovets OL, Radchenko HD. Arterialna hipertenziia ta stres: S-typ arterialnoii hipertenziii ta rezystentnist do antyhipertenzyvnoii terapiii. Klinichni doslidzhennia. Arterialna hipertenziia. 2022;15(3-4):8-29. https://doi.org/10.22141/2224-1485.15.3-4.2022.342] DOI: https://doi.org/10.22141/2224-1485.15.3-4.2022.342
Bayhush YuV, Slobodyanyuk MM. Doslidzhennia asortymentu ta dostupnosti blokatoriv beta-adrenoretseptoriv u rozdribnomu sehmenti vitchyznianoho farmatsevtychnoho rynku. Sotsialna farmatsiia v okhoroni zdorovia. 2016;2(1):13-21.
Tolochko VM, Mishchenko OYa, Adonkina VYu. Beta-adrenoblokatory: doslidzhennia asortymentu, sotsialno-ekonomichnoii dostupnosti ta obsiahiv spozhyvannia v Ukraiini. Scientific Journal «Science rise». 2015;12/4(17):20-26.
Malanchuk NV, Demchuk MB. The study of doctors’ attitude to the use of fixed combinations in the therapy of arterial hypertension. Sotsialna farmatsiia. 2023;9(2):26-34. https://doi.org/10.24959/sphhcj.23.289 DOI: https://doi.org/10.24959/sphhcj.23.289
Lazaryev PO. Kombinovana terapiia arterialnoii hipertenziii z zastosuvannyam beta-blokatoriv z hidno z suchasnymy rekomendatsiiamy. Arterialna hipertenziia. 2022; 15(3-4):3-7. https://doi.org/10.22141/2224-1485.15.3-4.2022.340 DOI: https://doi.org/10.22141/2224-1485.15.3-4.2022.340
Sait Kompendium [Elektronni resurs]. – Rezhym dostupu: https://compendium.com.ua
Wenting Song , Dongmei Cun , Peng Quan , Nannan Liu , Yang Chen, Hongxia Cui, Rongwu Xiang, Liang Fang. Dual-directional regulation of drug permeating amount by combining the technique of ion-pair complexation with chemical enhancers for the synchronous permeation of indapamide and bisoprolol in their compound patch through rabbit skin. European Journal of Pharmaceutics and Biopharmaceutics . 2015;91:59–65. http://dx.doi.org/10.1016/j.ejpb.2015.01.025 DOI: https://doi.org/10.1016/j.ejpb.2015.01.025
Hroshovyi TA, Martseniuk VP, Kucherenko LI, Vronska LV, Hureeva SM. Matematychne planuvannia eksperymentu pry provedenni naukovykh doslidzhen v farmatsiii. Ternopil: Ukrmedknyha, 2008. 368 s.
Derzhavna Farmakopeia Ukraiiny: v 3 t. / Derzhavne pidpryiemstvo «Ukrayinskyi naukovyi farmakopeinyi tsentr iakosti likarskykh zasobiv». – 2-he vyd. – Kharkiv : Derzhavne pidpryiemstvo «Ukrayinskyy naukovyi farmakopeynyi tsentr yakosti likarskykh zasobiv», 2015. T. 1. 1128 s.
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2024 Pharmaceutical Review / Farmacevtičnij časopis
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International 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).
