title: A new chapter in pharmaceutical manufacturing: 3D-printed drug products.
abstract: FDA recently approved a 3D-printed drug product in August 2015, which is indicative of a new chapter for pharmaceutical manufacturing. This review article summarizes progress with 3D printed drug products and discusses process development for solid oral dosage forms. 3D printing is a layer-by-layer process capable of producing 3D drug products from digital designs. Traditional pharmaceutical processes, such as tablet compression, have been used for decades with established regulatory pathways. These processes are well understood, but antiquated in terms of process capability and manufacturing flexibility. 3D printing, as a platform technology, has competitive advantages for complex products, personalized products, and products made on-demand. These advantages create opportunities for improving the safety, efficacy, and accessibility of medicines. Although 3D printing differs from traditional manufacturing processes for solid oral dosage forms, risk-based process development is feasible. This review highlights how product and process understanding can facilitate the development of a control strategy for different 3D printing methods. Overall, the authors believe that the recent approval of a 3D printed drug product will stimulate continual innovation in pharmaceutical manufacturing technology. FDA encourages the development of advanced manufacturing technologies, including 3D-printing, using science- and risk-based approaches.
authors.affiliation: Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA.
authors.forename: James
authors.initials: J
authors.lastname: Norman
authors.affiliation: Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA.
authors.forename: Rapti D
authors.initials: RD
authors.lastname: Madurawe
authors.affiliation: Merck Research Laboratories, 770 Sumneytown Pike, West Point, PA 19486, USA.
authors.forename: Christine M V
authors.initials: CM
authors.lastname: Moore
authors.affiliation: Irma Lerma Rangel College of Pharmacy, Texas A&M Health Science Center, 159 Reynolds Medical Building College Station, TX 77843-1114, USA.
authors.forename: Mansoor A
authors.initials: MA
authors.lastname: Khan
authors.affiliation: Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA. Electronic address: akm.khairuzzaman@fda.hhs.gov.
authors.forename: Akm
authors.initials: A
authors.lastname: Khairuzzaman
mesh_terms: D015195:Drug Design; D006801:Humans; D066330:Printing, Three-Dimensional; D013678:Technology, Pharmaceutical
keywords: 3D printed drug products; 3D printing technology; On-demand manufacturing; Personalization