title: Dropwise additive manufacturing of pharmaceutical products for melt-based dosage forms.
abstract: The US Food and Drug Administration introduced the quality by design approach and process analytical technology guidance to encourage innovation and efficiency in pharmaceutical development, manufacturing, and quality assurance. As part of this renewed emphasis on the improvement of manufacturing, the pharmaceutical industry has begun to develop more efficient production processes with more intensive use of online measurement and sensing, real-time quality control, and process control tools. Here, we present dropwise additive manufacturing of pharmaceutical products (DAMPP) as an alternative to conventional pharmaceutical manufacturing methods. This mini-manufacturing process for the production of pharmaceuticals utilizes drop on demand printing technology for automated and controlled deposition of melt-based formulations onto edible substrates. The advantages of drop-on-demand technology, including reproducible production of small droplets, adjustable drop sizing, high placement accuracy, and flexible use of different formulations, enable production of individualized dosing even for low-dose and high-potency drugs. In this work, DAMPP is used to produce solid oral dosage forms from hot melts of an active pharmaceutical ingredient and a polymer. The dosage forms are analyzed to show the reproducibility of dosing and the dissolution behavior of different formulations.
authors: School of Chemical Engineering, Purdue University, West Lafayette, Indiana.
authors: Elçin
authors: E
authors: Içten
authors: Arun
authors: A
authors: Giridhar
authors: Lynne S
authors: LS
authors: Taylor
authors: Zoltan K
authors: ZK
authors: Nagy
authors: Gintaras V
authors: GV
authors: Reklaitis
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods*; D004304:Dosage Forms; D004364:Pharmaceutical Preparations / Q000138:chemical synthesis*; D012995:Solubility; D014961:X-Ray Diffraction
chemical_list: D004304:Dosage Forms; D004364:Pharmaceutical Preparations
keywords: dissolution; drug delivery systems; oral drug delivery; polymers; process analytical technology; processing; quality by design; solid dispersion; solid dosage form; surfactants