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Characterization of pharmaceutical bilayer tablets

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TitleInfo
Title
Characterization of pharmaceutical bilayer tablets
SubTitle
a fracture mechanics approach
Name (type = personal)
NamePart (type = family)
Kottala
NamePart (type = given)
Niranjan K.
NamePart (type = date)
1979-
DisplayForm
Niranjan Kottala
Role
RoleTerm (authority = RULIB)
author
Name (type = personal)
NamePart (type = family)
Cuitino
NamePart (type = given)
Alberto
DisplayForm
Alberto Cuitino
Affiliation
Advisory Committee
Role
RoleTerm (authority = RULIB)
chair
Name (type = personal)
NamePart (type = family)
Ramachandran
NamePart (type = given)
Rohit
DisplayForm
Rohit Ramachandran
Affiliation
Advisory Committee
Role
RoleTerm (authority = RULIB)
internal member
Name (type = personal)
NamePart (type = family)
Glasser
NamePart (type = given)
Benjamin
DisplayForm
Benjamin Glasser
Affiliation
Advisory Committee
Role
RoleTerm (authority = RULIB)
internal member
Name (type = personal)
NamePart (type = family)
Pelegri
NamePart (type = given)
ASSIMINA
DisplayForm
ASSIMINA Pelegri
Affiliation
Advisory Committee
Role
RoleTerm (authority = RULIB)
outside member
Name (type = corporate)
NamePart
Rutgers University
Role
RoleTerm (authority = RULIB)
degree grantor
Name (type = corporate)
NamePart
Graduate School - New Brunswick
Role
RoleTerm (authority = RULIB)
school
TypeOfResource
Text
Genre (authority = marcgt)
theses
OriginInfo
DateCreated (qualifier = exact)
2012
DateOther (qualifier = exact); (type = degree)
2012-10
CopyrightDate (qualifier = exact)
2012
Place
PlaceTerm (type = code)
xx
Language
LanguageTerm (authority = ISO639-2b); (type = code)
eng
Abstract (type = abstract)
Bilayer tablets are generating great interest recently in the pharmaceutical industry as they offer several advantages over conventional single layer tablets. However, the production of bilayer tablets has been facing great difficulties as the layered tablets are prone to delaminate at the interface and fracture in the individual layers due to insufficient bonding strength. Poor product performance is a cause of great concern as it will incur financial loses and regulatory liabilities. In the pharmaceutical industry the process of bilayer design has been heavily dependent on the trial-and-error approach during the formulation and process development stages. To overcome this hurdle it is critical to understand the mechanical properties of the materials and to develop a methodology for the characterization of bilayer tablets. The work presented in this dissertation will focus on gaining the mechanistic understanding on the factors that impact the performance of the bilayer tablets. A methodology has been developed based on the principles of fracture mechanics for the characterization of bilayer tablets. As part of this endeavor, interfacial stress intensity was estimated. To understand the impact of manufacturing process parameters and environmental conditions on the bonding strength of bilayer tablets a comprehensive DOE has been executed to obtain statistical trends. Results indicated that material properties, compaction forces of the layers and interfacial topography have a strong influence on the strength of bilayer tablets. Strength of bilayer tablets increased with the increase of interfacial roughness and curvature. Physico-mechanical properties of the powders, deformation histories of the layers, and compression process parameters greatly influenced the interfacial stress intensity factor of the bilayer tablets. For the bilayer tablets made with plastic material in the first layer, the stress intensity factor is more dependent on interfacial radius of curvature than on interfacial roughness and vice versa in the case of bilayer tablets made with brittle material in the first layer. The mechanistic understanding and the methodology developed for the characterization of the bilayer tablets in this dissertation will enable to move away from the existing “trial-and-error” approach during the design and development of bilayer tablets. The new paradigm of bilayer tablet development will incorporate the principles of the quality by design by leveraging the prior knowledge.
Subject (authority = RUETD)
Topic
Chemical and Biochemical Engineering
RelatedItem (type = host)
TitleInfo
Title
Rutgers University Electronic Theses and Dissertations
Identifier (type = RULIB)
ETD
Identifier
ETD_4138
PhysicalDescription
Form (authority = gmd)
electronic resource
InternetMediaType
application/pdf
InternetMediaType
text/xml
Extent
xii, 143 p. : ill.
Note (type = degree)
Ph.D.
Note (type = bibliography)
Includes bibliographical references
Note (type = vita)
Includes vita
Note (type = statement of responsibility)
by Niranjan K. Kottala
Subject (authority = ETD-LCSH)
Topic
Tablets (Medicine)--Design
Identifier (type = hdl)
http://hdl.rutgers.edu/1782.1/rucore10001600001.ETD.000066849
RelatedItem (type = host)
TitleInfo
Title
Graduate School - New Brunswick Electronic Theses and Dissertations
Identifier (type = local)
rucore19991600001
Location
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NjNbRU
Identifier (type = doi)
doi:10.7282/T3XK8DBT
Genre (authority = ExL-Esploro)
ETD doctoral
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Rights

RightsDeclaration (ID = rulibRdec0006)
The author owns the copyright to this work.
RightsHolder (type = personal)
Name
FamilyName
Kottala
GivenName
Niranjan
Role
Copyright Holder
RightsEvent
Type
Permission or license
DateTime (encoding = w3cdtf); (qualifier = exact); (point = start)
2012-06-02 22:31:43
AssociatedEntity
Name
Niranjan Kottala
Role
Copyright holder
Affiliation
Rutgers University. Graduate School - New Brunswick
AssociatedObject
Type
License
Name
Author Agreement License
Detail
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.
RightsEvent
DateTime (encoding = w3cdtf); (qualifier = exact); (point = start)
2012-10-31
DateTime (encoding = w3cdtf); (qualifier = exact); (point = end)
2014-10-31
Type
Embargo
Detail
Access to this PDF has been restricted at the author's request. It will be publicly available after October 31st, 2014.
Copyright
Status
Copyright protected
Availability
Status
Open
Reason
Permission or license
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