MANUFACTURE OF INDIVIDUALIZED DOSING: DEVELOPMENT AND CONTROL OF A DROPWISE ADDITIVE MANUFACTURING PROCESS FOR MELT BASED PHARMACEUTICAL PRODUCTS

The improvements in healthcare systems and the advent of precision medicine initiative have created the need to develop more innovative manufacturing methods for the delivery of individualized dosing and personalized treatments. In recent years, the US Food and Drug Administration (FDA) introduced the Quality by Design (QbD) and Process Analytical Technology (PAT) guidelines to encourage innovation and efficiency in pharmaceutical development, manufacturing and quality assurance. As a result of emerging technologies and encouragement from the regulatory authorities, the pharmaceutical industry has begun to develop more efficient production systems with more intensive use of on-line measurement and sensing, real time quality control and process control tools, which offer the potential for reduced variability, increased flexibility and efficiency, and improved product quality.

Name thesis:degree_name

Doctor of Philosophy (PhD)

Level thesis:degree_level

Dissertation

Discipline thesis:degree_discipline

Chemical Engineering

Year

2016

Author dc:creator

• Icten, Elcin

Contributors dc:contributor

• Gintaras V Reklaitis
• Zoltan K Nagy
• Lynne Taylor
• Michael Harris

• additive manufacturing
• drop on demand
• drug printing
• individualized dosing
• personalized medicine
• pharmaceuticals

Repository record dc:identifier

https://docs.lib.purdue.edu/open_access_dissertations/1289

OAI identifier oai:identifier

oai:docs.lib.purdue.edu:open_access_dissertations-2505