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In-vitro testing of the influence of ethanol on the release rate of oral extended-release solid dosage forms
Descriptive
TitleInfo
Title
In-vitro testing of the influence of ethanol on the release rate of oral extended-release solid dosage forms
Name
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NamePart
(type = family)
Cook
NamePart
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Rebecca Ann
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Rebecca Cook
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author
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(type = family)
Michniak-Kohn
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Bozena
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Advisory Committee
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Bozena Michniak-Kohn
Role
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(authority = RULIB)
chair
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Minko
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Tamara
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Advisory Committee
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Tamara Minko
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(authority = RULIB)
internal member
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Sinko
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Patrick
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Advisory Committee
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Patrick Sinko
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internal member
Name
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NamePart
(type = family)
Cook
NamePart
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Rebecca Ann
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Rebecca Cook
Name
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NamePart
Rutgers University
Role
RoleTerm
(authority = RULIB)
degree grantor
Name
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NamePart
Graduate School-New Brunswick
Role
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school
TypeOfResource
Text
Genre
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theses
OriginInfo
DateCreated
(qualifier = exact)
2007
DateOther
(qualifier = exact);
(type = degree)
2006
Language
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(authority = ISO 639-3:2007);
(type = text)
English
PhysicalDescription
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electronic
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application/pdf
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text/xml
Extent
ix, 93 pages
Abstract
(type = abstract)
There are many factors that can affect the rate of drug release from an extended-release formulation, such pH of the gastrointestinal tract and dietary intake [1]. However, there is on going concern that alcohol could also greatly affect the release rate of extended-release products. It has recently come to the FDA's attention that some extended-release oral dosage forms are comprised of drugs and/or excipients that exhibit higher solubility in ethanolic solutions than compared to water. Because of this, it can be expected that more rapid drug dissolution may occur when a patient simultaneously consumes alcohol with an extended-release product that is highly soluble in ethanol. This could potentially cause a large dose of the drug to be released at once instead of the slow steady release that was intended, posing a potential health risk to the patient [2].
Currently, there is a strong need to look at the potential of alcohol altering the drug release profile of controlled-release products. A large concern of the FDA is if there are alcohol sensitive extended-release products currently on the market. The goal of this research was to study the affect ethanol has on the release profile of four different types of extended-release formulations. Dissolution testing was conducted on the different dosage forms without ethanol to serve as the control and with various levels of ethanol to determine if the ethanol had an effect on drug release. Dissolution testing was used for the testing because of its ability to provide insight into an oral drug product's characterization and its in vivo performance [3]. High performance liquid chromatography was used as the means of analysis to determine such release rates.
The affect of ethanol on the drug release profiles of Palladone® XL Capsules, Detrol® LA Capsules, Cystrin® CR Tablets and Concerta® Tablets has been studied. The drug release profiles for all the formulations were altered by the presence of ethanol in the dissolution media, especially for the Palladone® XL Capsule formulation. The extended-release function of these melt-extrusion pellets was diminished with the smallest amount of ethanol present.
Currently, there is a strong need to look at the potential of alcohol altering the drug release profile of controlled-release products. A large concern of the FDA is if there are alcohol sensitive extended-release products currently on the market. The goal of this research was to study the affect ethanol has on the release profile of four different types of extended-release formulations. Dissolution testing was conducted on the different dosage forms without ethanol to serve as the control and with various levels of ethanol to determine if the ethanol had an effect on drug release. Dissolution testing was used for the testing because of its ability to provide insight into an oral drug product's characterization and its in vivo performance [3]. High performance liquid chromatography was used as the means of analysis to determine such release rates.
The affect of ethanol on the drug release profiles of Palladone® XL Capsules, Detrol® LA Capsules, Cystrin® CR Tablets and Concerta® Tablets has been studied. The drug release profiles for all the formulations were altered by the presence of ethanol in the dissolution media, especially for the Palladone® XL Capsule formulation. The extended-release function of these melt-extrusion pellets was diminished with the smallest amount of ethanol present.
Note
(type = degree)
M.S.
Note
(type = bibliography)
Includes bibliographical references (p. 89-93).
Subject
(authority = RUETD)
Topic
Pharmaceutical Science
Subject
(authority = ETD-LCSH)
Topic
Drugs
Subject
(authority = ETD-LCSH)
Topic
Enteric-coated tablets
Subject
(authority = ETD-LCSH)
Topic
Tablets (Medicine)
RelatedItem
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TitleInfo
Title
Graduate School - New Brunswick Electronic Theses and Dissertations
Identifier
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rucore19991600001
Identifier
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http://hdl.rutgers.edu/1782.2/rucore10001600001.ETD.13454
Identifier
ETD_125
Identifier
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doi:10.7282/T3CJ8DZK
Location
PhysicalLocation
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(displayLabel = Rutgers, The State University of New Jersey)
NjNbRU
Genre
(authority = ExL-Esploro)
ETD graduate
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Rights
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The author owns the copyright to this work.
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Copyright protected
Availability
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Open
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Rebecca Cook
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Copyright holder
Affiliation
Rutgers University. Graduate School-New Brunswick
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Non-exclusive ETD license
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Author Agreement License
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I hereby grant to the Rutgers University Libraries and to my school the non-exclusive right to archive, reproduce and distribute my thesis or dissertation, in whole or in part, and/or my abstract, in whole or in part, in and from an electronic format, subject to the release date subsequently stipulated in this submittal form and approved by my school. I represent and stipulate that the thesis or dissertation and its abstract are my original work, that they do not infringe or violate any rights of others, and that I make these grants as the sole owner of the rights to my thesis or dissertation and its abstract. I represent that I have obtained written permissions, when necessary, from the owner(s) of each third party copyrighted matter to be included in my thesis or dissertation and will supply copies of such upon request by my school. I acknowledge that RU ETD and my school will not distribute my thesis or dissertation or its abstract if, in their reasonable judgment, they believe all such rights have not been secured. I acknowledge that I retain ownership rights to the copyright of my work. I also retain the right to use all or part of this thesis or dissertation in future works, such as articles or books.
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