Date of Award
January 2016
Degree Type
Dissertation
Degree Name
Doctor of Philosophy (PhD)
Department
Industrial and Physical Pharmacy
First Advisor
Stephen R. Byrn
Committee Member 1
Lynne S. Taylor
Committee Member 2
Rodolfo Pinal
Committee Member 3
Gregory T. Knipp
Committee Member 4
Patrick J. Marsac
Abstract
Most drug substances are reported to be either weak acids or weak bases. Hence, acid-base reactions are commonly observed in pharmaceutical systems with samples including salts, amorphous solid dispersions, and in formulated products. Salt formation of active pharmaceutical ingredients (APIs) is widely recognized as one of the most commonly used approaches to modify the solubility and dissolution rate. Formulating poorly water-soluble weak acids or weak bases into salts can not only increase bioavailability, but also improve the stability and manufacturability of APIs by changing their solid-state properties. However, from a formulation perspective, acid-base reactions might occur between APIs and ionizable excipients, which would induce deleterious form conversions or chemical degradation of the APIs during storage or manufacturing. Therefore, understanding the fundamentals of acid-base reactions is critical to design a robust formulation and to avoid drug-excipients incompatibility issues in multicomponent pharmaceutical products.
Recommended Citation
Nie, Haichen, "ACID-BASE REACTIONS IN DIFFERENT SOLID-STATE FORMS" (2016). Open Access Dissertations. 1295.
https://docs.lib.purdue.edu/open_access_dissertations/1295