NAISEROVÁ, M., K. KUBOVÁ, Jakub VYSLOUŽIL, S. PAVLOKOVÁ, D. VETCHÝ, M. URBANOVÁ, J. BRUS, Jan VYSLOUŽIL a P. KULICH. Investigation of Dissolution Behavior HPMC/Eudragit®/Magnesium Aluminometasilicate Oral Matrices Based on NMR Solid-State Spectroscopy and Dynamic Characteristics of Gel Layer. AAPS PHARMSCITECH. NEW YORK: SPRINGER, roč. 19, č. 2, s. 681-692. ISSN 1530-9932. doi:10.1208/s12249-017-0870-6. 2018.
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Základní údaje
Originální název Investigation of Dissolution Behavior HPMC/Eudragit®/Magnesium Aluminometasilicate Oral Matrices Based on NMR Solid-State Spectroscopy and Dynamic Characteristics of Gel Layer
Autoři NAISEROVÁ, M. (203 Česká republika), K. KUBOVÁ (203 Česká republika), Jakub VYSLOUŽIL (203 Česká republika, domácí), S. PAVLOKOVÁ (203 Česká republika), D. VETCHÝ (203 Česká republika), M. URBANOVÁ (203 Česká republika), J. BRUS (203 Česká republika), Jan VYSLOUŽIL (203 Česká republika, domácí) a P. KULICH (203 Česká republika).
Vydání AAPS PHARMSCITECH, NEW YORK, SPRINGER, 2018, 1530-9932.
Další údaje
Originální jazyk angličtina
Typ výsledku Článek v odborném periodiku
Obor 30104 Pharmacology and pharmacy
Stát vydavatele Spojené státy
Utajení není předmětem státního či obchodního tajemství
Impakt faktor Impact factor: 2.608
Kód RIV RIV/00216224:14310/18:00102251
Organizační jednotka Přírodovědecká fakulta
Doi http://dx.doi.org/10.1208/s12249-017-0870-6
UT WoS 000423720400017
Klíčová slova anglicky matrix tablets HPMC Eudragit® NE30D Neusilin® US2 gel layer Levetiracetam Burst effect thermal treatment multivariate data analysis
Změnil Změnila: Mgr. Tereza Miškechová, učo 341652. Změněno: 2. 5. 2019 13:51.
Anotace
Burst drug release is often considered a negative phenomenon resulting in unexpected toxicity or tissue irritation. Optimal release of a highly soluble active pharmaceutical ingredient (API) from hypromellose (HPMC) matrices is technologically impossible; therefore, a combination of polymers is required for burst effect reduction. Promising variant could be seen in combination of HPMC and insoluble Eudragits® as water dispersions. These can be applied only on API/insoluble filler mixture as over-wetting prevention. The main hurdle is a limited water absorption capacity (WAC) of filler. Therefore, the object of this study was to investigate the dissolution behavior of levetiracetam from HPMC/Eudragit®NE matrices using magnesium aluminometasilicate (Neusilin® US2) as filler with excellent WAC. Part of this study was also to assess influence of thermal treatment on quality parameters of matrices. The use of Neusilin® allowed the application of Eudragit® dispersion to API/Neusilin® mixture in one step during high-shear wet granulation. HPMC was added extragranularly. Obtained matrices were investigated for qualitative characteristics, NMR solid-state spectroscopy (ssNMR), gel layer dynamic parameters, SEM, and principal component analysis (PCA). Decrease in burst effect (max. of 33.6%) and dissolution rate, increase in fitting to zero-order kinetics, and paradoxical reduction in gel layer thickness were observed with rising Eudragit® NE concentration. The explanation was done by ssNMR, which clearly showed a significant reduction of the API particle size (150–500 nm) in granules as effect of surfactant present in dispersion in dependence on Eudragit®NE amount. This change in API particle size resulted in a significantly larger interface between these two entities. Based on ANOVA and PCA, thermal treatment was not revealed as a useful procedure for this system.
VytisknoutZobrazeno: 28. 3. 2024 13:37