Thesis (Ph.D.) - Cairo University - Faculty of Pharmacy - Department of Analytical Chemistry

This thesis consists of four parts. Part (I): which includes an introduction to near infrared spectroscopy, raman spectroscopy, chemometrics, analytical method validation, process analytical technology and quality by design. Part (II): This part provides a general introduction about topical gel, chemical structure and physical properties of the ketoprofen, and the literature review of the applications of NIR spectroscopy and raman spectroscopy in pharmaceutical gel analysis. Three spectroscopic techniques; NIR transflection, NIR transmission and raman spectroscopy were developed and validated for determination of ketoprofen; the active ingredient in pharmaceutical topical gel.. The performance of the proposed methods was compared to determine the one with better performance. Part (III): This part provides a general introduction about granulation, fluid bed granulation (FBG), variables in FBG, plackett-burman design as an experimental design for screening purpose and the literature review of the applications of NIR spectroscopy in FBG end-point detection. Plackett-Burman design was used for screening the process variables in FBG and studies their influence on the pharmaceutical properties of the acetaminophen granules. Besides, both in-line (real-time) and at-line NIR reflectance methodologies were developed and validated for predictions of granule moisture content and granule size during the entire granulation process. Part (IV): Applications of NIR spectroscopy as a process analytical technology in tablet process development - blending uniformity of ibuprofen powder, and content uniformity, tablet hardness of ibuprofen tablet and dissolution profile of acetaminophen tablets

Issued also as CD