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3D Printing in Pharmaceuticals: Regulatory Perspective

Author(s):

Mohd. Aamir Mirza* and Zeenat Iqbal*   Pages 1 - 3 ( 3 )

Abstract:


Background- The last few decades have witnessed enormous advancements in the field of Pharmaceutical drug, designand delivery. One of the recent developments is the advent of 3DP technology. It has earlier been successfully employedin fields like aerospace, architecture, tissue engineering, biomedical research, medical device and others, has recently forayed into pharmaceutical industry.Commonly understood as an additive manufacturing technology, 3DP aims at delivering customized drug products and is the most acceptable form of“personalized medicine”.

Methods-Data bases and search engines of regulatory agencies like USFDA and EMA have been searched thoroughly for relevant guidelines and approved products. Other portals like PubMed and Google scholar were also ferreted for any relevant repository of publications are referred wherever required.

Results-So far only one pharmaceutical product has been approved in this category by USFDA and stringent regulatory agencies are working over the drafting of guidelines and technical issues. Major research of this category belongs to academic domain.

Conclusion- It is also implicit to such new technologies that there would be numerous challenges and doubts before these are accepted as safe and efficacious. The situation demands concerted and cautious efforts to bring in fool proof regulatory guidelines which would ultimately lead to the success of this revolutionary technology.

Keywords:

Additive manufacturing, personalized medicines, customized medicine and 505 (b) (2) applications.

Affiliation:

NZFulvic Ltd, Mount Maunganui, Tauranga 3116, Department of Pharmaceutics, SPER, JamiaHamdard, New Delhi



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