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Understanding the effect of granulation and mill process parameters on granule critical quality attributes
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Kotamarthy, Lalith Venkat Gopal. Understanding the effect of granulation and mill process parameters on granule critical quality attributes. Retrieved from https://doi.org/doi:10.7282/T33B63CX

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TitleUnderstanding the effect of granulation and mill process parameters on granule critical quality attributes
NameKotamarthy, Lalith Venkat Gopal (author); Ramachandran, Rohit (chair); Shapley, Nina (internal member); Singh, Ravendra (internal member); Rutgers University; School of Graduate Studies
Date Created2018
Other Date2018-01 (degree)
SubjectChemical and Biochemical Engineering, Granulation
Extent1 online resource (xii, 72 p. : ill.)
DescriptionMilling 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.
NoteM.S.
NoteIncludes bibliographical references
Noteby Lalith Venkat Gopal Kotamarthy
Genretheses, ETD graduate
Persistent URLhttps://doi.org/doi:10.7282/T33B63CX
Languageeng
CollectionSchool of Graduate Studies Electronic Theses and Dissertations
Organization NameRutgers, The State University of New Jersey
RightsThe author owns the copyright to this work.
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