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Understanding the effect of granulation and mill process parameters on granule critical quality attributes

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TitleInfo
Title
Understanding the effect of granulation and mill process parameters on granule critical quality attributes
Name (type = personal)
NamePart (type = family)
Kotamarthy
NamePart (type = given)
Lalith Venkat Gopal
NamePart (type = date)
1993-
DisplayForm
Lalith Venkat Gopal Kotamarthy
Role
RoleTerm (authority = RULIB)
author
Name (type = personal)
NamePart (type = family)
Ramachandran
NamePart (type = given)
Rohit
DisplayForm
Rohit Ramachandran
Affiliation
Advisory Committee
Role
RoleTerm (authority = RULIB)
chair
Name (type = personal)
NamePart (type = family)
Shapley
NamePart (type = given)
Nina
DisplayForm
Nina Shapley
Affiliation
Advisory Committee
Role
RoleTerm (authority = RULIB)
internal member
Name (type = personal)
NamePart (type = family)
Singh
NamePart (type = given)
Ravendra
DisplayForm
Ravendra Singh
Affiliation
Advisory Committee
Role
RoleTerm (authority = RULIB)
internal 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)
2018-01
CopyrightDate (encoding = w3cdtf); (qualifier = exact)
2018
Place
PlaceTerm (type = code)
xx
Language
LanguageTerm (authority = ISO639-2b); (type = code)
eng
Abstract (type = abstract)
Milling is an essential unit operation used for particle size reduction in solid oral dosage manufacturing. Milling generally follows the granulation or crystallization during API manufacturing. Granulation process is primarily required in processing of drug product in order to alleviate issues related to powder handling, flowability of the material and segregation. However, granulation may produce particles with undesirable size distributions which might lead to problems during further downstream processing. Particle size distribution needs to be controlled, as it affects the drug bioavailability and also tablet compaction. To avoid uneven granule size distribution, milling is done post granulation. There are different kinds of mills such as hammer mills, ball mills, conical screen mills etc. which can be classified on the basis of type of force applied to break the particles. This study mainly focuses on conical screen mill. Breakage of particles in comil is due to the intense shear applied on the particles between impeller and the screen and also due to the impact from a rotating impeller. Particles exit the mill based on their size relative to the aperture size of the screen bores. In the current work, the effect of mill screen type and mill operating parameters such as amount of material fed to the mill and impeller speed are studied. Milled particle size distribution and other critical quality attributes such as bulk density, friability, and porosity are also studied. In addition, the effect of granulation variables such as liquid to solid ratio, granulator impeller speed and the amount of binder in the formulation are analyzed. For the current work, Caffeine is chosen as the Active Pharmaceutical Ingredient. The formulation used has 8% caffeine, 46% Lactose monohydrate and 46% MCC Avicel PH101. Polyvinylpyrrolidone (PVP K-30) is selected as the binder. Predictive regression models are developed for throughput of the mill, milled product bulk density and milled product tapped density, to enable their use in downstream process modeling.
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_8616
PhysicalDescription
Form (authority = gmd)
electronic resource
InternetMediaType
application/pdf
InternetMediaType
text/xml
Extent
1 online resource (xii, 72 p. : ill.)
Note (type = degree)
M.S.
Note (type = bibliography)
Includes bibliographical references
Subject (authority = ETD-LCSH)
Topic
Granulation
Note (type = statement of responsibility)
by Lalith Venkat Gopal Kotamarthy
RelatedItem (type = host)
TitleInfo
Title
School of Graduate Studies Electronic Theses and Dissertations
Identifier (type = local)
rucore10001600001
Location
PhysicalLocation (authority = marcorg); (displayLabel = Rutgers, The State University of New Jersey)
NjNbRU
Identifier (type = doi)
doi:10.7282/T33B63CX
Genre (authority = ExL-Esploro)
ETD graduate
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Rights

RightsDeclaration (ID = rulibRdec0006)
The author owns the copyright to this work.
RightsHolder (type = personal)
Name
FamilyName
Kotamarthy
GivenName
Lalith Venkat Gopal
Role
Copyright Holder
RightsEvent
Type
Permission or license
DateTime (encoding = w3cdtf); (qualifier = exact); (point = start)
2018-01-04 16:14:57
AssociatedEntity
Name
Lalith Venkat Gopal Kotamarthy
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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