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Investigation of continuous wet granulation processes via implementation of pharmaceutical quality by design principles

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TitleInfo
Title
Investigation of continuous wet granulation processes via implementation of pharmaceutical quality by design principles
Name (type = personal)
NamePart (type = family)
Meng
NamePart (type = given)
Wei
NamePart (type = date)
1988-
DisplayForm
Wei Meng
Role
RoleTerm (authority = RULIB)
author
Name (type = personal)
NamePart (type = family)
Muzzio
NamePart (type = given)
Fernando J.
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Fernando J. Muzzio
Affiliation
Advisory Committee
Role
RoleTerm (authority = RULIB)
chair
Name (type = personal)
NamePart (type = family)
Michniak-Kohn
NamePart (type = given)
Bozena B.
DisplayForm
Bozena B. Michniak-Kohn
Affiliation
Advisory Committee
Role
RoleTerm (authority = RULIB)
internal member
Name (type = personal)
NamePart (type = family)
Minko
NamePart (type = given)
Tamara
DisplayForm
Tamara Minko
Affiliation
Advisory Committee
Role
RoleTerm (authority = RULIB)
internal member
Name (type = personal)
NamePart (type = family)
Igne
NamePart (type = given)
Benoit
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Benoit Igne
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
School of Graduate Studies
Role
RoleTerm (authority = RULIB)
school
TypeOfResource
Text
Genre (authority = marcgt)
theses
OriginInfo
DateCreated (qualifier = exact)
2018
DateOther (qualifier = exact); (type = degree)
2018-05
CopyrightDate (encoding = w3cdtf); (qualifier = exact)
2018
Place
PlaceTerm (type = code)
xx
Language
LanguageTerm (authority = ISO639-2b); (type = code)
eng
Abstract (type = abstract)
Wet granulation is a widely used downstream unit operation for size enlargement in the manufacturing of solid oral dosage forms. It has also been considered as a particle design technique to improve powder flow properties, reduce ingredient segregation and modulate compatibility of particulates as well as drug release kinetics. In recent years, continuous manufacturing has been drawing considerable attention due to its intrinsic advantages over conventional batch processing such as improved manufacturing efficiency and enhanced product quality. The main focus of this dissertation is to understand diverse continuous wet granulation systems by employing pharmaceutical quality by design principles. The performance of different commercial twin-screw and high-shear granulators were compared and their design space was explored by leveraging statistical design of experiments. Critical process parameters (e.g., rotation speed, liquid to solid ratio, throughput and barrel temperature), design elements (e.g., screw configuration and injection location of liquid constituents) and formulation variables (e.g., drug hydrophobicity, primary particle size, binder delivery methods and granulation liquid viscosity and surface tension) were comprehensively studied to examine the influence on critical attributes of granules (e.g., size distribution, porosity, bulk density, tapped density, flowability, strength, drug segregation and particle shape) and tablets (tensile strength, porosity, friability, disintegration time, drug agglomerate size distribution and release kinetics). Furthermore, process understanding was enhanced by unraveling the granulation mechanisms with fundamental regime maps regarding wetting and nucleation as well as consolidation and coalescence. Dissolution mechanisms of tablets produced at different processing conditions were elucidated by delving into the discrepancy in their physical and chemical microstructures. In addition, several complementary process analytical technologies such as EyeconTM, near-infrared and Raman spectroscopy were implemented in a twin-screw granulation process to enable real-time release testing of granule physical properties and drug content uniformity.
Subject (authority = RUETD)
Topic
Pharmaceutical Science
RelatedItem (type = host)
TitleInfo
Title
Rutgers University Electronic Theses and Dissertations
Identifier (type = RULIB)
ETD
Identifier
ETD_8788
PhysicalDescription
Form (authority = gmd)
electronic resource
InternetMediaType
application/pdf
InternetMediaType
text/xml
Extent
1 online resource (xxvii, 255 p. : ill.)
Note (type = degree)
Ph.D.
Note (type = bibliography)
Includes bibliographical references
Subject (authority = ETD-LCSH)
Topic
Granulation
Subject (authority = ETD-LCSH)
Topic
Pharmaceutical industry
Note (type = statement of responsibility)
by Wei Meng
RelatedItem (type = host)
TitleInfo
Title
School of Graduate Studies Electronic Theses and Dissertations
Identifier (type = local)
rucore10001600001
Location
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NjNbRU
Identifier (type = doi)
doi:10.7282/T39G5R89
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
Meng
GivenName
Wei
Role
Copyright Holder
RightsEvent
Type
Permission or license
DateTime (encoding = w3cdtf); (qualifier = exact); (point = start)
2018-04-09 14:43:31
AssociatedEntity
Name
Wei Meng
Role
Copyright holder
Affiliation
Rutgers University. School of Graduate Studies
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.
Copyright
Status
Copyright protected
Availability
Status
Open
Reason
Permission or license
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