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Determining the polymer threshold amount for achieving robust drug release from HPMC and HPC matrix tablets containing a high-dose BCS class I model drug [Elektronski vir] : in vitro and in vivo studiesKlančar, Uroš ...It is challenging to achieve mechanically robust drug-release profiles from hydrophilic matrices containing a high dose of a drug with good solubility. However, a mechanically robust drug release ... over prolonged period of time can be achieved, especially if the viscosity and amount of the polymer is sufficiently high, above the Žthreshold values.Ž The goal of this research was to determine the hydroxypropyl cellulose (HPC) and hydroxypropyl methylcellulose (HPMC) polymer threshold amount that would enable robust drug release from matrix tablets containing a high dose of levetiracetam as a class I model drug according to the Biopharmaceutical Classification System (BCS). For this purpose, formulations containing HPC or HPMC of similar viscosity range, but in different amounts, were prepared. Based on the dissolution results, two final formulations were selected for additional in vitro and in vivo evaluation to confirm the robustness and to show bioequivalence. Tablets were exposed to various stress conditions in vitro with the use of different mechanically stress-inducing dissolution methods. The in vitro results were compared with in vivo results obtained from fasted and fed bioequivalence studies.Under both conditions, the formulations were bioequivalent and food had a negligible influence on the pharmacokinetic parameters Cmax and area under the curve (AUC). It was concluded that the drug release from both selected formulations is mechanically robust and that HPC and HPMC polymers with intrinsic viscosities above 9 dL/g and in quantities above 30% enable good mechanical resistance, which ensures bioequivalence. In addition, HPC matrices were found to be more mechanically robust compared to HPMC.Source: AAPS PharmSciTech [Elektronski vir]. - ISSN 1530-9932 (Vol. 16, issue 2, 2015, str. 398-406)Type of material - e-articlePublish date - 2015Language - englishCOBISS.SI-ID - 3750001
Author
Klančar, Uroš |
Baumgartner, Saša, 1969-2015 |
Legen, Igor |
Novak, Polona, 19.8.1978- |
Jeraj, Nataša |
Krajcar, Dejan |
Markun, Boštjan |
Kočevar, Klemen
Topics
matrix tablets |
mechanically robust dissolution |
threshold amount |
hydroxypropyl cellulose |
hydroxypropyl methylcellulose |
matrične tablete |
farmacevtska industrija |
hidroksipropil celuloza |
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Database name | Field | Year |
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Links to authors' personal bibliographies | Links to information on researchers in the SICRIS system |
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Klančar, Uroš | 33368 |
Baumgartner, Saša, 1969-2015 | 15104 |
Legen, Igor | 20369 |
Novak, Polona, 19.8.1978- | 23833 |
Jeraj, Nataša | 21494 |
Krajcar, Dejan | ![]() |
Markun, Boštjan | 23397 |
Kočevar, Klemen | 16408 |
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