title: Impact Of Excipient Variability On Drug Product Processing And Performance.
abstract: It is rare to have a pharmaceutical dosage form presented with just the pure active pharmaceutical ingredient because the drug substance does not possess adequately desirable physical attributes to be processed into the final dosage form. Consequently, additives or excipients which are inert ingredients serving a functional purpose are added to enhance the overall properties of the final formulation for ease of processability or drug product performance. Variability in excipients arises from source of raw materials and in synthesis/manufacturing process resulting in different mechanisms of action, optimum concentration for use and final product performance including drug-excipient interactions. Unsurprisingly, variability of excipients has been well researched within specific focus areas. This review article aims to look at how different pharmaceutical processes are influenced by the differences in excipient properties as well as advanced analytical and statistical modeling techniques used in their development and characterization.
authors.forename: Josephine Lay
authors.initials: JL
authors.lastname: Peng Soh
authors.forename: Celine Valeria
authors.initials: CV
authors.lastname: Liew
authors.affiliation: GEA-NUS PPRL, Department of Pharmacy, National University of Singapore, 18 Science Drive 4, Singapore 117543. phapaulh@nus.edu.sg.
authors.forename: Paul Wan
authors.initials: PW
authors.lastname: Sia Heng
mesh_terms: D002626:Chemistry, Pharmaceutical; D004304:Dosage Forms / Q000592:standards*; D005079:Excipients / Q000737:chemistry*; D006801:Humans; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D011208:Powders / Q000737:chemistry*; D013678:Technology, Pharmaceutical / Q000379:methods*
chemical_list: D004304:Dosage Forms; D005079:Excipients; D004364:Pharmaceutical Preparations; D011208:Powders