Bioequivalence evaluation of two different controlled release matrix formulations of ketoprofen tablets in healthy malaysian volunteers
The aim of this study was to evaluate the in vivo behavior of matrix tablets formulated with ketoprofen as a model drug after oral administrations in healthy Malaysian male volunteers and to compare its rate and extent of absorption with the commercially available tablet Apo-Keto SR® as a reference...
Guardado en:
| Autores principales: | , , , , , , , , , , |
|---|---|
| Formato: | Articulo |
| Lenguaje: | Inglés |
| Publicado: |
2011
|
| Materias: | |
| Acceso en línea: | http://sedici.unlp.edu.ar/handle/10915/8406 http://www.latamjpharm.org/resumenes/30/10/LAJOP_30_10_1_18.pdf |
| Aporte de: |
| id |
I19-R120-10915-8406 |
|---|---|
| record_format |
dspace |
| institution |
Universidad Nacional de La Plata |
| institution_str |
I-19 |
| repository_str |
R-120 |
| collection |
SEDICI (UNLP) |
| language |
Inglés |
| topic |
Farmacia Cetoprofeno Medicamentos Bioequivalentes |
| spellingShingle |
Farmacia Cetoprofeno Medicamentos Bioequivalentes Mohammed, Kaleemullah Fadli, Mohd Yusuf, Eddy Hamid, Junainah Abd Chitneni, Mallikarjun Elhassan, Gamal O. Al-Dhalli, Samer Wong, Jia W. NG, Bee H. Yuen, Kah H. Khan, Jiyauddin Bioequivalence evaluation of two different controlled release matrix formulations of ketoprofen tablets in healthy malaysian volunteers |
| topic_facet |
Farmacia Cetoprofeno Medicamentos Bioequivalentes |
| description |
The aim of this study was to evaluate the in vivo behavior of matrix tablets formulated with ketoprofen as a model drug after oral administrations in healthy Malaysian male volunteers and to compare its rate and extent of absorption with the commercially available tablet Apo-Keto SR® as a reference product. The test formulation containing 20 % HPC (GXF) as release retardant was selected in this regards. The bioequivalence study was conducted according to a single dose, randomized, 2-treatment, 2-sequence, 2-period crossover study design on six healthy non-smoking Malaysian adult male volunteers. Plasma concentrations of ketoprofen were determined by a high-performance liquid chromatographic method with UV detection. The pharmacokinetic parameters, T<sub>max</sub> , C<sub>max</sub> , AUC<sub>0–∞</sub>, K<sub>e</sub> , and T<sub>1/2</sub> were determined. The 90 % confidence intervals of the mean values for the test/reference ratios were 96.89-107.03 % for AUC<sub>0–∞</sub> and 99.64-104.62 % for C<sub>max</sub> , respectively. The results of this study suggest that the two preparations, the test formulation of ketoprofen 200 mg tablets were bioequivalent to the marketed reference tablet of Apo-Keto SR® 200 mg in these healthy Malaysian male volunteers. However, this study results are to be further confirmed by carrying out a pivotal biostudy using more number of subjects. |
| format |
Articulo Articulo |
| author |
Mohammed, Kaleemullah Fadli, Mohd Yusuf, Eddy Hamid, Junainah Abd Chitneni, Mallikarjun Elhassan, Gamal O. Al-Dhalli, Samer Wong, Jia W. NG, Bee H. Yuen, Kah H. Khan, Jiyauddin |
| author_facet |
Mohammed, Kaleemullah Fadli, Mohd Yusuf, Eddy Hamid, Junainah Abd Chitneni, Mallikarjun Elhassan, Gamal O. Al-Dhalli, Samer Wong, Jia W. NG, Bee H. Yuen, Kah H. Khan, Jiyauddin |
| author_sort |
Mohammed, Kaleemullah |
| title |
Bioequivalence evaluation of two different controlled release matrix formulations of ketoprofen tablets in healthy malaysian volunteers |
| title_short |
Bioequivalence evaluation of two different controlled release matrix formulations of ketoprofen tablets in healthy malaysian volunteers |
| title_full |
Bioequivalence evaluation of two different controlled release matrix formulations of ketoprofen tablets in healthy malaysian volunteers |
| title_fullStr |
Bioequivalence evaluation of two different controlled release matrix formulations of ketoprofen tablets in healthy malaysian volunteers |
| title_full_unstemmed |
Bioequivalence evaluation of two different controlled release matrix formulations of ketoprofen tablets in healthy malaysian volunteers |
| title_sort |
bioequivalence evaluation of two different controlled release matrix formulations of ketoprofen tablets in healthy malaysian volunteers |
| publishDate |
2011 |
| url |
http://sedici.unlp.edu.ar/handle/10915/8406 http://www.latamjpharm.org/resumenes/30/10/LAJOP_30_10_1_18.pdf |
| work_keys_str_mv |
AT mohammedkaleemullah bioequivalenceevaluationoftwodifferentcontrolledreleasematrixformulationsofketoprofentabletsinhealthymalaysianvolunteers AT fadlimohd bioequivalenceevaluationoftwodifferentcontrolledreleasematrixformulationsofketoprofentabletsinhealthymalaysianvolunteers AT yusufeddy bioequivalenceevaluationoftwodifferentcontrolledreleasematrixformulationsofketoprofentabletsinhealthymalaysianvolunteers AT hamidjunainahabd bioequivalenceevaluationoftwodifferentcontrolledreleasematrixformulationsofketoprofentabletsinhealthymalaysianvolunteers AT chitnenimallikarjun bioequivalenceevaluationoftwodifferentcontrolledreleasematrixformulationsofketoprofentabletsinhealthymalaysianvolunteers AT elhassangamalo bioequivalenceevaluationoftwodifferentcontrolledreleasematrixformulationsofketoprofentabletsinhealthymalaysianvolunteers AT aldhallisamer bioequivalenceevaluationoftwodifferentcontrolledreleasematrixformulationsofketoprofentabletsinhealthymalaysianvolunteers AT wongjiaw bioequivalenceevaluationoftwodifferentcontrolledreleasematrixformulationsofketoprofentabletsinhealthymalaysianvolunteers AT ngbeeh bioequivalenceevaluationoftwodifferentcontrolledreleasematrixformulationsofketoprofentabletsinhealthymalaysianvolunteers AT yuenkahh bioequivalenceevaluationoftwodifferentcontrolledreleasematrixformulationsofketoprofentabletsinhealthymalaysianvolunteers AT khanjiyauddin bioequivalenceevaluationoftwodifferentcontrolledreleasematrixformulationsofketoprofentabletsinhealthymalaysianvolunteers |
| bdutipo_str |
Repositorios |
| _version_ |
1764820488336441347 |