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The effects of the treatment conditions on the dissolution profile of ethylcellulose coated pellets
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SYSNO ASEP 0504450 Document Type J - Journal Article R&D Document Type Journal Article Subsidiary J Článek ve WOS Title The effects of the treatment conditions on the dissolution profile of ethylcellulose coated pellets Author(s) Pavloková, S. (CZ)
Muselík, J. (CZ)
Sabadkova, D. (CZ)
Bernatová, Silvie (UPT-D) RID, SAI
Samek, Ota (UPT-D) RID, ORCID, SAI
Neumann, D. (CZ)
Franc, A. (CZ)Number of authors 7 Source Title European Journal of Pharmaceutical Sciences. - : Elsevier - ISSN 0928-0987
Roč. 132, APR (2019), s. 86-95Number of pages 10 s. Publication form Print - P Language eng - English Country NL - Netherlands Keywords coated pellets ; wet treatment ; coating penetration ; pellet volume increase ; stability Subject RIV BH - Optics, Masers, Lasers OECD category Optics (including laser optics and quantum optics) R&D Projects LO1212 GA MŠMT - Ministry of Education, Youth and Sports (MEYS) ED0017/01/01 GA MŠMT - Ministry of Education, Youth and Sports (MEYS) GA16-12477S GA ČR - Czech Science Foundation (CSF) Method of publishing Limited access Institutional support UPT-D - RVO:68081731 UT WOS 000462467400009 EID SCOPUS 85062420209 DOI 10.1016/j.ejps.2019.02.034 Annotation Due to the additional particle coalescence in the coating, changes in the dissolution profile occur over time in the formulations coated by aqueous ethylcellulose latex. Dry thermal treatment (DT) of the coating can be used as a prevention of this process. Alternatively, it is advisable to take advantage of the synergistic effect of high humidity during wet treatment (WT), which substantially accelerates the film formation. This can be a problem for time-controlled systems, which are based on the coating rupture due to the penetration of water into the core causing the increase in the system volume. This process can begin already during the WT, which may affect the coating adversely. The submitted work was focused on the stability testing of two pellet core compositions: pellets containing swelling superdisintegrant sodium carboxymethyl starch (CMS) and pellets containing osmotically active polyethylene glycol (PEG). Another objective was to identify the treatment/storage condition effects on the pellet dissolution profiles. These pellets are intended to prevent hypoglycemia for patients with diabetes mellitus and therefore, besides the excipients, pellet cores contain 75% or 80% of glucose. The pellet coating is formed by ethylcellulose-based latex, which provides the required lag time (120-360 min). The sample stability was evaluated depending on the pellet core composition (PEG, CMS) for two types of final pellet coating treatment (DT or WT). Scanning electron microscopy and Raman microspectroscopy revealed the penetration of glucose and polyethylene glycol from the core to the PEG pellet surface after WT. For the CMS sample, significant pellet swelling after WT (under the conditions of elevated humidity) was statistically confirmed by the means of stereomicroscopic data evaluation. Therefore, the acceleration of dissolution rate during the stress tests is caused by the soluble substance penetration through the coating in the case of PEG pellets or by dosage form volume increase in the case of CMS pellets. The observed mechanisms can be generally anticipated during the stability testing of the ethylcellulose coated dosage forms. The aforementioned processes do not occur after DT and the pellets are stable in the environment without increased humidity. Workplace Institute of Scientific Instruments Contact Martina Šillerová, sillerova@ISIBrno.Cz, Tel.: 541 514 178 Year of Publishing 2020 Electronic address https://www.sciencedirect.com/science/article/pii/S0928098719300958?via%3Dihub
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