Theophylline granule formulation prepared by the wet granulation method: comparison of in vitro dissolution profiles and estimation of in vivo plasma concentrations
Karasulu, E; Apaydin, S; Ince, I; Tuglular, I
HERO ID
4929378
Reference Type
Journal Article
Year
2006
Language
English
PMID
| HERO ID | 4929378 |
|---|---|
| In Press | No |
| Year | 2006 |
| Title | Theophylline granule formulation prepared by the wet granulation method: comparison of in vitro dissolution profiles and estimation of in vivo plasma concentrations |
| Authors | Karasulu, E; Apaydin, S; Ince, I; Tuglular, I |
| Journal | European Journal of Drug Metabolism and Pharmacokinetics |
| Volume | 31 |
| Issue | 4 |
| Page Numbers | 291-298 |
| Abstract | The primary and secondary objectives of this study were to develop and evaluate the predictability of in vitro-in vivo correlation models for theophylline sustained release (SR) granules. Theophylline SR granules meeting the USP Drug Release Test criteria were prepared using ethyl cellulose (EC) and/or stearyl alcohol (SA) and the wet granulation method. In vitro dissolution studies of granule formulation were performed, and a commercial dosage form was prepared using USP XXIII apparatus II at pH 4.5. Differences and similarities between in vitro dissolution curves were compared using both model-dependent (t-test) and -independent (f1, f2 test) statistical techniques, and it was shown that the three dissolution profiles i.e model-dependent, model-independent, and methods based on ANOVA were very similar. The in vivo performance of the commercial dosage form was tested by oral route using male rabbits and in vitro-in vivo correlations were established. This study indicates that the dosage forms with similar in vitro dissolution profiles may have a similar in vivo performance, and that this performance could be estimated using appropriate correlation equations. |
| Doi | 10.1007/BF03190470 |
| Pmid | 17315541 |
| Wosid | WOS:000244193500007 |
| Is Certified Translation | No |
| Dupe Override | No |
| Is Public | Yes |
| Language Text | English |
| Keyword | sustained release; granules; theophylline; similarity; in vitro-in vivo correlation; estimation |