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Toward the establishment of standardized in vitro tests for lipid-based formulations, part 1: method parameterization and comparison of in vitro digestion profiles across a range of representative formulations.
- Source :
-
Journal of pharmaceutical sciences [J Pharm Sci] 2012 Sep; Vol. 101 (9), pp. 3360-80. Date of Electronic Publication: 2012 May 29. - Publication Year :
- 2012
-
Abstract
- The Lipid Formulation Classification System Consortium is an industry-academia collaboration, established to develop standardized in vitro methods for the assessment of lipid-based formulations (LBFs). In this first publication, baseline conditions for the conduct of digestion tests are suggested and a series of eight model LBFs are described to probe test performance across different formulation types. Digestion experiments were performed in vitro using a pH-stat apparatus and danazol employed as a model poorly water-soluble drug. LBF digestion (rate and extent) and drug solubilization patterns on digestion were examined. To evaluate cross-site reproducibility, experiments were conducted at two sites and highly consistent results were obtained. In a further refinement, bench-top centrifugation was explored as a higher throughput approach to separation of the products of digestion (and compared with ultracentrifugation), and conditions under which this method was acceptable were defined. Drug solubilization was highly dependent on LBF composition, but poorly correlated with simple performance indicators such as dispersion efficiency, confirming the utility of the digestion model as a means of formulation differentiation.<br /> (Copyright © 2012 Wiley Periodicals, Inc.)
- Subjects :
- Centrifugation standards
Chemistry, Pharmaceutical standards
Danazol metabolism
Danazol standards
Guidelines as Topic
Hydrogen-Ion Concentration
Kinetics
Lipid Metabolism
Lipids standards
Observer Variation
Reference Standards
Reproducibility of Results
Solubility
Technology, Pharmaceutical methods
Danazol chemistry
Digestion
Drug Carriers
High-Throughput Screening Assays standards
Lipids chemistry
Technology, Pharmaceutical standards
Subjects
Details
- Language :
- English
- ISSN :
- 1520-6017
- Volume :
- 101
- Issue :
- 9
- Database :
- MEDLINE
- Journal :
- Journal of pharmaceutical sciences
- Publication Type :
- Academic Journal
- Accession number :
- 22644939
- Full Text :
- https://doi.org/10.1002/jps.23205