Methods to Assess in Vitro Drug Release from Injectable Polymeric Particulate Systems
- Susan S. D'Souza,
- Patrick P. DeLuca
- … show all 2 hide
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Abstract
This review provides a compilation of the methods used to study real-time (37°C) drug release from parenteral microparticulate drug delivery systems administered via the subcutaneous or intramuscular route. Current methods fall into three broad categories, viz., sample and separate, flow-through cell, and dialysis techniques. The principle of the specific method employed along with the advantages and disadvantages are described. With the “sample and separate” technique, drug-loaded microparticles are introduced into a vessel, and release is monitored over time by analysis of supernatant or drug remaining in the microspheres. In the “flow-through cell” technique, media is continuously circulated through a column containing drug-loaded microparticles followed by analysis of the eluent. The “dialysis” method achieves a physical separation of the drug-loaded microparticles from the release media by use of a membrane, which allows for sampling without interference of the microspheres. With all these methods, the setup and sampling techniques seem to influence in vitro release; the results are discussed in detail, and criteria to aid in selection of a method are stated. Attempts to establish in vitro–in vivo correlation for these injectable dosage forms are also discussed. It would be prudent to have an in vitro test method for microparticles that satisfies compendial and regulatory requirements, is user friendly, robust, and reproducible, and can be used for quality-control purposes at real-time and elevated temperatures.
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- Background
- Considerations in Method Development
- Additional Considerations
- Description of in Vitro Release Methods
- Ivivc with Parenteral Microspheres
- Conclusions
- References
- References
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References (126)
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About this Article
- Title
- Methods to Assess in Vitro Drug Release from Injectable Polymeric Particulate Systems
- Journal
-
Pharmaceutical Research
Volume 23, Issue 3 , pp 460-474 - Cover Date
- 2006-03-01
- DOI
- 10.1007/s11095-005-9397-8
- Print ISSN
- 0724-8741
- Online ISSN
- 1573-904X
- Publisher
- Springer-Verlag
- Additional Links
- Topics
- Keywords
-
- continuous flow
- dialysis
- in vitro release methods
- IVIVC
- microspheres
- sample and separate
- subcutaneous and intramuscular administration
- Industry Sectors
- Authors
-
- Susan S. D'Souza (1)
-
Patrick P. DeLuca
(2)
- Author Affiliations
-
- 1. University of Kentucky College of Pharmacy, Lexington, Kentucky, 40536, USA
- 2. Faculty of Pharmaceutical Sciences, University of Kentucky College of Pharmacy, Lexington, Kentucky, 40536, USA