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Model development and analysis of solid oral dosage manufacturing processes involving particle size change
Descriptive
TitleInfo
Title
Model development and analysis of solid oral dosage manufacturing processes involving particle size change
Name
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NamePart
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Metta
NamePart
(type = given)
Nirupaplava
NamePart
(type = date)
1986-
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Nirupaplava Metta
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(authority = RULIB)
author
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Ierapetritou
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Marianthi G
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Marianthi G Ierapetritou
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Advisory Committee
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chair
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NamePart
(type = family)
Ramachandran
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Rohit
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Rohit Ramachandran
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Advisory Committee
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(authority = RULIB)
internal member
Name
(type = personal)
NamePart
(type = family)
Singh
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(type = given)
Ravendra
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Ravendra Singh
Affiliation
Advisory Committee
Role
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(authority = RULIB)
internal member
Name
(type = personal)
NamePart
(type = family)
Barrasso
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(type = given)
Dana
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Dana Barrasso
Affiliation
Advisory Committee
Role
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(authority = RULIB)
outside member
Name
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NamePart
Rutgers University
Role
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(authority = RULIB)
degree grantor
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School of Graduate Studies
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school
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theses
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2020
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2020-01
Language
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English
Abstract
Continuous pharmaceutical manufacturing offers advantages in cost, efficiency and acceleration in process development, particularly in the time of increasing research and development, and production costs. A science-based approach to process development promoted by the Quality by design paradigm requires incorporating the effect of variability in material properties and process conditions on product properties. This has increased focus on development of detailed and complex models capturing phenomenon from several scales, which led to an increase in computational expense. The limitations are exacerbated when several such models are integrated to simulate a continuous manufacturing process. This dissertation explores several modeling methods for the development of hybrid models of particulate processes. Milling operation is used as a case study for hybrid model development that supports the Quality by design approach and also addresses computational limitations. Several unit operation models are integrated to simulate a wet granulation continuous manufacturing process leading to a computationally expensive model with several variables. This dissertation also establishes efficient methodologies to utilize the high dimensional and computationally expensive integrated process models for obtaining the space in which process needs to operate, thus supporting continuous pharmaceutical process development.
Subject
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Topic
Chemical and Biochemical Engineering
Subject
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Topic
Design space
Subject
(authority = LCSH)
Topic
Pharmaceutical technology
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Title
Rutgers University Electronic Theses and Dissertations
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ETD_10534
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application/pdf
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Extent
1 online resource (xviii, 266 pages) : illustrations
Note
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Ph.D.
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Includes bibliographical references
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School of Graduate Studies Electronic Theses and Dissertations
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rucore10001600001
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NjNbRU
Identifier
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doi:10.7282/t3-7n9q-a703
Genre
(authority = ExL-Esploro)
ETD doctoral
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Rights
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The author owns the copyright to this work.
RightsHolder
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Name
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Metta
GivenName
Nirupaplava
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Copyright Holder
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Permission or license
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2020-01-11 16:05:29
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Name
Nirupaplava Metta
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Affiliation
Rutgers University. School of Graduate Studies
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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.
Copyright
Status
Copyright protected
Availability
Status
Open
Reason
Permission or license
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2020-01-11T16:00:58
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