title: Dropwise additive manufacturing of pharmaceutical products for amorphous and self emulsifying drug delivery systems.
abstract: The improvements in healthcare systems and the advent of the precision medicine initiative have created the need to develop more innovative manufacturing methods for the delivery and production of individualized dosing and personalized treatments. In accordance with the changes observed in healthcare systems towards more innovative therapies, this paper presents dropwise additive manufacturing of pharmaceutical products (DAMPP) for small scale, distributed manufacturing of individualized dosing as an alternative to conventional manufacturing methods A dropwise additive manufacturing process for amorphous and self-emulsifying drug delivery systems is reported, which utilizes drop-on-demand printing technology for automated and controlled deposition of melt-based formulations onto inert tablets. The advantages of drop on demand technology include reproducible production of droplets with adjustable sizing and high placement accuracy, which enable production of individualized dosing even for low dose and high potency drugs. Flexible use of different formulations, such as lipid-based formulations, allows enhancement of the solubility of poorly water soluble and highly lipophilic drugs with DAMPP. Here, DAMPP is used to produce solid oral dosage forms from melts of an active pharmaceutical ingredient and a surfactant. The dosage forms are analyzed to show the amorphous nature, self-emulsifying drug delivery system characteristics and dissolution behavior of these formulations.
authors.affiliation: Amgen Inc., Cambridge, MA, USA. Electronic address: eicten@amgen.com.
authors.forename: Elçin
authors.initials: E
authors.lastname: Içten
authors.affiliation: Industrial and Physical Pharmacy, Purdue University, West Lafayette, IN, USA.
authors.forename: Hitesh S
authors.initials: HS
authors.lastname: Purohit
authors.affiliation: Graduate Medical Sciences, Boston University, Boston, MA, USA.
authors.forename: Chelsey
authors.initials: C
authors.lastname: Wallace
authors.affiliation: School of Chemical Engineering, Purdue University, West Lafayette, IN, USA.
authors.forename: Arun
authors.initials: A
authors.lastname: Giridhar
authors.affiliation: Industrial and Physical Pharmacy, Purdue University, West Lafayette, IN, USA.
authors.forename: Lynne S
authors.initials: LS
authors.lastname: Taylor
authors.affiliation: School of Chemical Engineering, Purdue University, West Lafayette, IN, USA.
authors.forename: Zoltan K
authors.initials: ZK
authors.lastname: Nagy
authors.affiliation: School of Chemical Engineering, Purdue University, West Lafayette, IN, USA.
authors.forename: Gintaras V
authors.initials: GV
authors.lastname: Reklaitis
mesh_terms: D002626:Chemistry, Pharmaceutical; D016503:Drug Delivery Systems; D004655:Emulsions / Q000032:analysis*; D008055:Lipids; D004364:Pharmaceutical Preparations / Q000032:analysis*; D012995:Solubility; D013607:Tablets
chemical_list: D004655:Emulsions; D008055:Lipids; D004364:Pharmaceutical Preparations; D013607:Tablets
keywords: Amorphous; Drug printing; Oral drug delivery; Processing; Quality by design (QbD); Self-emulsifying drug delivery system; Solid dispersion; Solid dosage form; Surfactants