Additive Manufacturing with 3D Printing: Progress from Bench to Bedside

Abstract

Three-dimensional (3D) printing was discovered in the 1980s, and many industries have embraced it, but the pharmaceutical industry is slow or reluctant to adopt it. Spiritam® is the first and only 3D-printed drug product approved by FDA in 2015. Since then, the FDA has not approved any 3D-printed drug product due to technical and regulatory issues. The 3D printing process cannot compete with well-established and understood conventional processes for making solid dosage forms. However, pharmaceutical companies can utilize it where mass production is not required; rather, consistency, precision, and accuracy in quality are paramount. There are many 3D printing technologies available, and not all of them are amenable to pharmaceutical manufacturing. Each 3D technology has certain prerequisites in terms of material that it can handle. Some of the pertinent technical and regulatory issues are as follows: Current Good Manufacturing Practice, in-process tests and process control, and cleaning validation. Other promising area of 3D printing use is printing medications for patients with special needs in a hospital and/or pharmacy setting with minimum regulatory oversight. This technology provides a novel opportunity for in-hospital compounding of necessary medicines to support patient-specific medications. However, aspects of the manufacturing challenges and quality control considerations associated with the varying formulation and processing methods need to be fully understood before 3D printing can emerge as a therapeutic tool. With these points in mind, this review paper focuses on 3D technologies amenable for pharmaceutical manufacturing, excipient requirement, process understanding, and technical and regulatory challenges.

How to Formulate for Structure and Texture via Medium of Additive Manufacturing-A Review

“…To differentiate themselves, various manufacturers often use different acronyms for describing the same process, and, therefore, similar techniques might have different names [43]. These have all been previously compared and reviewed comprehensively [17,[44][45][46], and many of these techniques have been individually reviewed in high detail including powder-based electron beam additive manufacturing (EBAM) technology [47], and the Fused Filament Fabrication (FFF) process, also termed, Fused Deposition Modelling (FDM) [48,49].…”

“…There is an abundance of evidence that suggests AM will be promising in the following areas [15,16]: (1) customised healthcare products for improving health and quality of life. There are several reports on amenable 3D printing technologies for pharmaceutical manufacturing [17,18], which are applicable to different drug development phases (early-phase screening, testing, manufacturing, and dispensing) [19]. Human medicine, as well as veterinary medicine, can benefit from technological advances in 3D printing [20][21][22][23][24].…”

Recent Applications of Three Dimensional Printing in Cardiovascular Medicine

“…In current practice, custommade devices, which are manufactured in accordance with a specific prescription for a specific Over the years, more than 80 3D printed medical devices have been approved by the FDA's center CDRH through 510(k) process [138]. Most of these devices are used in dental, orthopedic and cranio-maxillofacial fields (i.e., dental crowns, hearing aids, bone tether plates, skull plates, hip cups, spinal cages, facial implants, and screws), and are produced using powder bed fusion techniques (83%), stereolithography (12%), extrusion (3%), and jetting (2%) [138,139]. A postmarket analysis of the FDA's approved devices, conducted on the manufacturer and user facility device experience (MAUDE) database, evidenced that the principal reasons for product-related adverse events were improper size or incompatibility with other components of the device (46%), device fracture or shaving (45%), incorrect device size for the patient (5%), implant wear (2%) and incorrect device implanted (2%) [138].…”

A Sustainability Assessment of Smart Innovations for Mass Production, Mass Customisation and Direct Digital Manufacturing

“…Prices and times to print large objects increase exponentially. Even though 3D printed health aids are becoming available, regulating the conformity and quality of products in general is problematic [45]. Other technical challenges include timeconsuming 3D object design, limited types of usable materials, low precision and productivity [46].…”