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Tools for real time release testing (RTRt) in batch and continuous tablet manufacturing
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Pawar, Pallavi. Tools for real time release testing (RTRt) in batch and continuous tablet manufacturing. Retrieved from https://doi.org/doi:10.7282/T36975RN

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TitleTools for real time release testing (RTRt) in batch and continuous tablet manufacturing
NamePawar, Pallavi (author); Muzzio, Fernando J (chair); Callegari, Gerardo (internal member); Cuitino, Alberto (internal member); Snee, Ronald D (outside member); Rutgers University; Graduate School - New Brunswick
Date Created2016
Other Date2016-05 (degree)
SubjectChemical and Biochemical Engineering, Pharmaceutical technology, Pharmaceutical industry--Quality control
Extent1 online resource (xiii, 153 p. : ill.)
DescriptionAfter 50 years of near-stagnation, pharmaceutical manufacturing is experiencing unprecedented scientific and technological innovation. There is a paradigm shift from testing product quality using lengthy off-line (and after-the-fact) assays to quality being tested during the process using online/ at-line measurements. This ability to evaluate and ensure quality of final product based on process data, geared towards making batch release decisions, is known as real time release testing (RTRt). Application of RTRt allows increased assurance of quality, greater manufacturing flexibility, reduced inventory, lesser end product testing, and lower laboratory and manufacturing costs. In this work, RTR strategies were developed for different critical quality attributes (CQAs) such as Blend and Content uniformity (B.U. and C.U.), and tablet dissolution in real- time. The utility of different sampling methodologies was investigated with the intention of extracting maximum information and reducing redundancy in data collection. The first aim of this dissertation investigated the use of Near IR Spectroscopy (NIRS) for online monitoring of B.U. The second specific aim involved developing a RTR strategy to assess C.U. of tablets. NIRS was found to be an effective tool for expedited C.U. predictions enabling interrogation of a greater number of tablet samples. These extensive tablet C.U. studies provided a rigorous basis for assessing and verifying the various thief sampling and PAT methods and determining their relative accuracy and reliability. A key component of a meaningful RTR strategy for most products is the ability to predict dissolution utilizing the available on/at-line sensing infrastructure. Specific aim 3 focused on using NIRS to develop a RTR strategy for dissolution prediction of tablets made from blends exposed to different levels of mechanical strain in batch processing. This effect of strain was also investigated using traditional approaches such as tensile strength and porosity measurements. The fourth and final aim focused on using soft sensing combined with at-line Near IR measurements to predict dissolution of tablets manufactured in a continuous direct compaction (CDC) line. Individual dissolution profiles were predicted using this approach with a high correlation between the predicted and the observed dissolution profiles. This concluded the RTRt strategy for solid dosage manufacturing.
NotePh.D.
NoteIncludes bibliographical references
Noteby Pallavi Pawar
Genretheses, ETD doctoral
Persistent URLhttps://doi.org/doi:10.7282/T36975RN
Languageeng
CollectionGraduate School - New Brunswick Electronic Theses and Dissertations
Organization NameRutgers, The State University of New Jersey
RightsThe author owns the copyright to this work.
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