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A formulation approach for development of HPMC-based sustained release tablets for tolterodine tartrate with a low release variation.
- Source :
-
Drug development and industrial pharmacy [Drug Dev Ind Pharm] 2013 Nov; Vol. 39 (11), pp. 1720-30. Date of Electronic Publication: 2012 Oct 15. - Publication Year :
- 2013
-
Abstract
- Objective: The purpose of this study was to develop hydroxypropylmethylcellulose (HPMC)-based sustained release (SR) tablets for tolterodine tartrate with a low drug release variation.<br />Methods: The SR tablets were prepared by formulating a combination of different grades of HPMC as the gelling agents. The comparative dissolution study for the HPMC-based SR tablet as a test and Detrusitol SR capsule as a reference was carried out, and the bioequivalence study of the two products was also conducted in human volunteers.<br />Results: The amount of HPMC, the grade of HPMC and the combination ratio of different grades of HPMC had remarkable effects on drug release from the SR tablets. Both the test and reference products had no significant difference in terms of comparative dissolution patterns in four different media (f₂ > 50). Furthermore, the dissolution method and rotation speed showed no effects on the drug release from the two products. The 90% confidence intervals of the AUC(0-36) and C(max) ratios for the test and reference products were within the acceptable bioequivalence intervals of log0.8-log1.25.<br />Conclusions: A HPMC-based SR tablet for tolterodine tartrate with a low release variation was successfully developed, which was bioequivalent to Detrusitol® SR capsule.
- Subjects :
- Adult
Benzhydryl Compounds blood
Benzhydryl Compounds chemistry
Benzhydryl Compounds pharmacokinetics
Capsules
Chemical Phenomena
Cresols blood
Cresols chemistry
Cresols pharmacokinetics
Cross-Over Studies
Delayed-Action Preparations administration & dosage
Delayed-Action Preparations analysis
Delayed-Action Preparations chemistry
Delayed-Action Preparations pharmacokinetics
Drug Compounding
Gels
Half-Life
Humans
Hydrogen-Ion Concentration
Hypromellose Derivatives
Male
Methylcellulose chemistry
Muscarinic Antagonists blood
Muscarinic Antagonists chemistry
Muscarinic Antagonists pharmacokinetics
Phenylpropanolamine blood
Phenylpropanolamine chemistry
Phenylpropanolamine pharmacokinetics
Solubility
Surface Properties
Tablets
Therapeutic Equivalency
Tolterodine Tartrate
Urological Agents blood
Urological Agents chemistry
Urological Agents pharmacokinetics
Viscosity
Young Adult
Benzhydryl Compounds administration & dosage
Cresols administration & dosage
Excipients chemistry
Methylcellulose analogs & derivatives
Muscarinic Antagonists administration & dosage
Phenylpropanolamine administration & dosage
Urological Agents administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1520-5762
- Volume :
- 39
- Issue :
- 11
- Database :
- MEDLINE
- Journal :
- Drug development and industrial pharmacy
- Publication Type :
- Academic Journal
- Accession number :
- 23062115
- Full Text :
- https://doi.org/10.3109/03639045.2012.730528