NDLI: Development of a Statistical Tolerance-Based Fluid Bed Drying Design Space

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Best Practices for Drug Substance Stress and Stability Studies During Early-Stage Development Part I—Conducting Drug Substance Solid Stress to Support Phase Ia Clinical Trials

Journal of Pharmaceutical Innovation : Volume 7, Issue 2, June 2012

Journal of Pharmaceutical Innovation : Volume 7, Issue 1, March 2012

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Journal of Pharmaceutical Innovation : Volume 5

Journal of Pharmaceutical Innovation : Volume 4

Journal of Pharmaceutical Innovation : Volume 3

Journal of Pharmaceutical Innovation : Volume 2

Journal of Pharmaceutical Innovation : Volume 1

Development of a Statistical Tolerance-Based Fluid Bed Drying Design Space

Content Provider	Springer Nature Link
Author	Zacour, Brian M. Drennen, James K. Anderson, Carl A.
Copyright Year	2012
Abstract	The pharmaceutical industry has invested a substantial amount of resources in recent years to develop manufacturing systems that offer improved product quality while limiting costs. The US Food and Drug Administration (FDA) has encouraged the use of the guidelines put forth by the International Conference on Harmonization [ICH-Q8(R2)] that allow for operational flexibility within a validated design space to allow automated systems that incorporate real-time data management. Use of these systems requires substantial process understanding that is typically gained through appropriately developed design of experiments. Appropriate analyses of the data are required to optimize the understanding gained from experiments. Furthermore, these analyses must be combined with existing product specifications to set justifiable operating limits for the process.Granules containing gabapentin, and hydroxypropyl cellulose were prepared in a high-shear granulator and dried in a fluid bed processing system. The fluid bed dryer was outfitted with near infrared, pressure, temperature, and flow sensors, which were connected to a distributed control system that was used to exercise control of the system. The dried granules were blended with extragranular excipients and then compressed on a rotary tablet press. Designed experimental variations to processing were utilized at each of the manufacturing steps to produce a design space. The outputs of the design (quality attributes) that were considered in this work were the quantity of gabapentin lactam formed during processing, tablet crushing strength, final blend flow properties, and median particle size of dried granules.A tolerance-based design space was constructed for each of the quality attributes considered, and an overall design space was calculated based on the individual unit operations. The overall design space was a combination of process models and was calculated to include the uncertainty (variance) from each of the unit operations and measurements. A tolerance design space was calculated that reflects the probability that a given combination of processing parameters will produce critical quality attributes within specifications.
Starting Page	151
Ending Page	162
Page Count	12
File Format	PDF
ISSN	18725120
Journal	Journal of Pharmaceutical Innovation
Volume Number	7
Issue Number	3-4
e-ISSN	19398042
Language	English
Publisher	Springer US
Publisher Date	2012-10-14
Publisher Place	Boston
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Fluid bed processing Process analytical technology Multivariate modeling Feedback control Design space Quality by design Industrial and Production Engineering Biotechnology Biochemical Engineering Pharmacology/Toxicology
Content Type	Text
Resource Type	Article
Subject	Drug Discovery Pharmaceutical Science

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
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