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Medicina is published by MDPI from Volume 54 Issue 1 (2018). Articles in this Issue were published by another publisher in Open Access under a CC-BY (or CC-BY-NC-ND) licence. Articles are hosted by MDPI on mdpi.com as a courtesy and upon agreement with Lithuanian Medical Association, Lithuanian University of Health Sciences, and Vilnius University.
Open AccessArticle

The Development of Eudragit® NM-Based Controlled-Release Matrix Tablets

1
Department of Pharmaceutics, Faculty of Pharmacy, University of Veterinary and Pharmaceutical Sciences Brno, Czech Republic
2
Department of Drug Technology and Social Pharmacy, Medical Academy, Lithuanian University of Health Sciences
3
Institute of Physiology and Pharmacology, Medical Academy, Lithuanian University of Health Sciences, Lithuania
*
Author to whom correspondence should be addressed.
Medicina 2012, 48(4), 28; https://doi.org/10.3390/medicina48040028
Received: 26 October 2011 / Accepted: 24 April 2012 / Published: 29 April 2012
Eudragit® NM was investigated as a matrix former in combination with microcrystalline cellulose as an insoluble filler for preparing controlled-release tablets containing model drugs with different solubility.
Material and Methods. Three sets of matrix tablets differing in the drug-to-filler ratio (1:1, 2:1, and 4:1) and polymer amount with diltiazem hydrochloride (freely soluble) or caffeine (sparingly soluble) were prepared. Samples were evaluated by the dissolution test at pH 6.8 corresponding to the upper part of the small intestine; the selected samples were tested at a changing pH level to better simulate in vivo conditions.
Results. The prepared matrix tablets fulfilled all the requirements of the European Pharmacopoeia. Tablets with Eudragit® NM showed excellent mechanical characteristics. In vitro studies showed that the set 1:1 was the most suitable for the sustained release of a freely soluble drug concerning the burst effect and the total drug amount released within 12 hours. The significant effect of the drug-to-filler ratio and polymer amount on the dissolution profile was confirmed by similarity factor analysis. A faster drug release was observed during the dissolution test within changing pH levels because of the pH-dependent solubility of diltiazem. A prolonged release of the sparingly soluble drug was not achieved, and a trend for fast disintegration was observed.
Conclusions.
The combination of Eudragit®NM with microcrystalline cellulose as an insoluble filler seems to be suitable only for freely soluble drugs, when the amount of the drug and the filler is similar.
Keywords: matrix tablets; Eudragit® NM; drug solubility; microcrystalline cellulose; dissolution profile matrix tablets; Eudragit® NM; drug solubility; microcrystalline cellulose; dissolution profile
MDPI and ACS Style

Dvočková, K.; Kalėdaitė, R.; Gajdziok, J.; Rabišková, M.; Bajerová, M.; Muselík, J.; Lažauskas, R.; Pečiūra, R.; Bernatonienė, J. The Development of Eudragit® NM-Based Controlled-Release Matrix Tablets. Medicina 2012, 48, 28.

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