3D Printing: A review on technology, role in novel dosage forms and regulatory perspective Hemanth KG1, Hemamanjushree S1, Abhinaya N1, Pai Raveendra2, Pai Girish K1* 1Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka-576104, India 2Formulation Development, Glenmark Pharmaceuticals Limited, Taloja, Maharashtra-410208, India. *Corresponding Author E-mail: girish.pai@manipal.edu
Online published on 22 April, 2021. Abstract The existence of 3D printing (3DP) ways back to 1992, and its sound presence in the pharmaceutical industry was made in 2015 by the launch of 1st 3D printed drug, Spritam was manufactured by Aprecia Pharmaceuticals. Implementation of 3DP is escalating in the number of industries, including the pharmaceutical industry. The purpose of this review paper is to briefly discuss types of 3DP and their role in formulating novel dosage forms. Binder jet printing, VAT polymerization, powder bed fusion, and material extrusion are briefly explained along with an example of their implementation in the formulation of the dosage form. A few novel dosage forms which can bypass the first-pass metabolism and how 3D printing is useful in formulating them as been discussed. It also includes a comparison of the process of 3D printed tablets and conventional methods of manufacturing. The significance of 3D printing in novel dosage form and augmenting 3DP with hot-melt extrusion (HME) method is discussed. The regulatory concerns in adopting this technology on a large-scale are addressed. 3DP technology could rapidly print transdermal needles, buccal patches, and different shapes of vaginal rings and proved it can be a versatile tool in formulation technology. As the pharmaceutical industry involves stringent regulations, certain aspects need to be considered by regulatory authorities before implementing this tool into commercial-scale manufacturing. Top Keywords 3D printing, Additive manufacturing, 3D scanner, Novel Dosage Forms, HME, Regulatory perspective. Top |