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Impregnation of active pharmaceutical ingredients into porous carriers

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TitleInfo
Title
Impregnation of active pharmaceutical ingredients into porous carriers
Name (type = personal)
NamePart (type = family)
Omar
NamePart (type = given)
Thamer A.
NamePart (type = date)
1978-
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Thamer A. Omar
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RoleTerm (authority = RULIB)
author
Name (type = personal)
NamePart (type = family)
Muzzio
NamePart (type = given)
Fernando J
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Fernando J Muzzio
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Advisory Committee
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RoleTerm (authority = RULIB)
chair
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Michniak-Kohn
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Bozena B
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Bozena B Michniak-Kohn
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Advisory Committee
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internal member
Name (type = personal)
NamePart (type = family)
Minko
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Tamara
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Tamara Minko
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Advisory Committee
Role
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internal member
Name (type = personal)
NamePart (type = family)
Glasser
NamePart (type = given)
Benjamin J
DisplayForm
Benjamin J Glasser
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 (encoding = w3cdtf); (keyDate = yes); (qualifier = exact)
2019
DateOther (encoding = w3cdtf); (qualifier = exact); (type = degree)
2019-10
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2019
Language
LanguageTerm (authority = ISO 639-3:2007); (type = text)
English
Abstract (type = abstract)
Launching of a new drug into the market consumes significant resources and research effort and it involves a number of complex steps in drug substance and drug product development. The essential component of drug product development is often the optimization of the physical properties of the drug substance. The effect of a drug’s physical properties on pharmaceutical development can be seen from the first step to the final step of development process. For instance, choosing the preferred solid-state form of the drug can influence the early steps of drug manufacturing such as the drug-substance isolation method, and it can also alter some properties of the final dosage form such as the stability and dissolution behavior of the finished product. A simple approach to product development is desirable to shorten the required development steps, preferably by excluding some unit operations. Therefore, it is of interest to develop a pharmaceutical manufacturing method that can simplify drug product development. In this dissertation, the impregnation of drugs into porous carriers is examined as an approach to achieve this aim.
This work implemented the essential tools for successful drug impregnation into porous carriers and specified the requirements for equipment and materials, which are necessary to perform this goal. A set of analytical methods to fully characterize the impregnated products was also studied. Preliminary studies regarding the use of a fluidized bed dryer as an impregnation device were presented to illustrate the applicability of this device. Also, a case study of continuous impregnation using a continuous blender as an efficient device for continuous impregnation was carried out.
The first aim of this dissertation investigated the impregnation of an active pharmaceutical ingredient (API) into a mesoporous carrier (excipient) in a fluidized bed using different transport solvents. Impregnation and drying occurred simultaneously in the fluidized bed, and this method precluded several challenges encountered in other impregnation methods. Our results showed that the method of fluidized bed impregnation yielded a product with high uniformity and overcame several challenges presented by traditional physical blends.
The second aim expanded the use of a fluidized-bed dryer for impregnation of active pharmaceutical ingredients (APIs) to include different porous carriers. Impregnating different porous carriers with the same drug allowed us to answer fundamental questions about impregnation such as drug dissolution and blend uniformity. Since there can be large differences in the prices of porous carriers/excipients, it is also important to investigate how product properties vary with different carriers to allow one to make cost/benefit decisions in terms of the different carriers. The results demonstrated that a fluidized-bed dryer can be successfully used to impregnate Indomethacin into porous carriers with different pore sizes. The resulting impregnated products displayed a significant improvement in some essential properties such as blend uniformity and drug dissolution, which are necessary to develop and formulate APIs into various pharmaceutical dosage forms.
The third and last aim investigated the development of a new manufacturing method to continuously impregnate APIs into porous carriers using a Glatt GCG-70 blender. This work focused on the characterization of the GCG-70 blender with consideration to the process parameters (flow rate, impeller rotation), porous carrier type (Neusilin or Fujicalin), and tracer amount (low, medium, and high). The characterization of the continuous blender depended on two main strategies. The first strategy was investigation of the flow behavior of the carriers in the blender. This step was accomplished by conducting residence time distribution measurements, material hold up measurements and strain calculations. The second strategy was evaluation of the blend uniformity of the impregnated products using NIR spectroscopy. These two strategies provided a good understanding of the performance of the GCG-70 blender as a piece of equipment for impregnation.
Subject (authority = RUETD)
Topic
Pharmaceutical Science
Subject (authority = local)
Topic
Impregnation
Subject (authority = LCSH)
Topic
Drug delivery systems
RelatedItem (type = host)
TitleInfo
Title
Rutgers University Electronic Theses and Dissertations
Identifier (type = RULIB)
ETD
Identifier
ETD_10263
PhysicalDescription
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application/pdf
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text/xml
Extent
1 online resource (xx, 200 pages) : illustrations
Note (type = degree)
Ph.D.
Note (type = bibliography)
Includes bibliographical references
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/t3-h1pm-gn23
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
OMAR
GivenName
THAMER
Role
Copyright Holder
RightsEvent
Type
Permission or license
DateTime (encoding = w3cdtf); (qualifier = exact); (point = start)
2019-09-18 15:09:31
AssociatedEntity
Name
THAMER OMAR
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Copyright holder
Affiliation
Rutgers University. School of Graduate Studies
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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
Type
Embargo
DateTime (encoding = w3cdtf); (qualifier = exact); (point = start)
2019-10-31
DateTime (encoding = w3cdtf); (qualifier = exact); (point = end)
2021-10-30
Detail
Access to this PDF has been restricted at the author's request. It will be publicly available after October 30th, 2021.
Copyright
Status
Copyright protected
Availability
Status
Open
Reason
Permission or license
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2019-09-18T14:46:18
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2019-09-18T14:46:18
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