Date of Award

5-2013

Document Type

Thesis

Degree Name

Master of Science (MS)

Program

Pharmaceutical Sciences

Research Advisor

Hassan Almoazen, Ph.D.

Committee

James R. Johnson, Ph.D. Duane D. Miller, Ph. D. Gerald Rajan, Ph. D. George C. Wood, Ph. D.

Keywords

Film; Formulation; Microemulsion; Nanocrystal; Pediatric; Tablet

Abstract

Pediatric formulations have received great attention from regulatory agencies in the United States and Europe. Since solid dosage forms such as tablets and capsules will not be able to improve pediatric patients’ compliance, customized pediatric formulations are needed. In response, formulators in the pharmaceutical industry have made significant effort into developing various pediatric formulations. However, developing satisfactory pediatric formulations is a process that is guided by case by case basis. The objective of this current study was to apply the scientific pharmaceutical technology concepts into developing modern pediatric formulations. We have shown that the drug delivery design will be affected by the route of administration and by the type of dosage form utilized. We are hopeful that our approach will serve as a tool to assist formulations development. Three drug molecules and an anion were utilized in this work (Chlorpheniramine Maleate, Prednisone, Sulfamerazine, and Iodide ion). Each drug molecule was utilized according to its physicochemical properties along with the pediatric patients’ needs. As a result, several pediatric formulations were developed. Here is the list: taste masked orally disintegrating tablet, taste masked orally disintegrating film, taste masked mini-tablet, reconstituted nanocrystals and a transdermal microemulsion. We are hopeful that these dosage forms will serve as good examples for specialized pediatric formulations and will attract pharmaceutical industry to adapt some these delivery systems into their development strategy.

DOI

10.21007/etd.cghs.2013.0190

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