Fluidized bed coating process is widely used in the pharmaceutical industry. In the case of lipid-based excipients as a coating material, the coating process requires an additional operation of melting the coating material prior to its application. Thus the process is said to be a hot melt fluid bed coating process. The objective of this study is to understand the hot-melt fluid bed coating process for coating of lipid-based excipients onto drug crystals to produce orally disintegrating granules. Orally disintegrating granules are a ‘direct to mouth’ dosage form and offers better patient compliance by making it easier to swallow the medication in the form of granules. However, for such dosage form, it is imperative to have a drug product with an immediate release profile and a good taste masking to mask the unpleasant taste of the active ingredient. In this work, a parametric study using a fractional factorial design of experiments was carried out to understand the influence of process parameters on thickness of the coating layer, dissolution rate of the API and taste masking ability of the coating material. With the help of analysis of the factorial design, an optimal design space to achieve desired quality of the drug product was found. In this work, in addition to the parametric study, an experimental study to understand polymorphism of the coating layer was also performed. Lipids tend to exhibit polymorphism. The presence of an unstable crystal form in the product may result in storage instabilities and in turn affect the dissolution rate of the drug. Therefore, the influence of fluidization air temperature and emulsifier content on polymorphism of the coating layer was studied in detail. Thermal analysis of the coated granules helped understand the melting and crystallization behavior of different polymorphs exhibited by the coating layer. The results of this work suggests that a more detailed investigation of kinetics of crystallization and phase transformation of lipids is required for its application as a coating material for pharmaceutical products.
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_6296
PhysicalDescription
Form (authority = gmd)
electronic resource
InternetMediaType
application/pdf
InternetMediaType
text/xml
Extent
1 online resource (x, 48 p. : ill.)
Note (type = degree)
M.S.T.
Note (type = bibliography)
Includes bibliographical references
Subject (authority = ETD-LCSH)
Topic
Excipients
Subject (authority = ETD-LCSH)
Topic
Fluidization
Note (type = statement of responsibility)
by Siddhi Santosh Hate
RelatedItem (type = host)
TitleInfo
Title
Graduate School - New Brunswick Electronic Theses and Dissertations
Identifier (type = local)
rucore19991600001
Location
PhysicalLocation (authority = marcorg); (displayLabel = Rutgers, The State University of New Jersey)
Rutgers University. Graduate School - New Brunswick
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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.