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3D Printing in Pharmaceuticals: Regulatory Perspective.

Mohd A Mirza1, Zeenat Iqbal2

  • 1NZFulvic Ltd, Mount Maunganui, Tauranga 3116, New Zealand.

Current Pharmaceutical Design
|April 10, 2019
PubMed
Summary

3D printing (3DP) technology is revolutionizing pharmaceutical drug delivery by enabling personalized medicine. While regulatory frameworks are still developing, 3DP holds significant promise for customized drug products.

Keywords:
3DP technologyAdditive manufacturingUSFDA EMAcustomized medicine and 505 (b) (2) applicationspersonalized medicines.

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Area of Science:

  • Pharmaceutical Sciences
  • Biomedical Engineering
  • Additive Manufacturing

Background:

  • Significant advancements in pharmaceutical drug design and delivery have occurred over recent decades.
  • 3D printing (3DP), an additive manufacturing technology, has expanded from aerospace and biomedical fields into pharmaceuticals.
  • 3DP technology facilitates the creation of customized drug products, aligning with the principles of personalized medicine.

Purpose of the Study:

  • To review the current landscape of 3D printing technology in pharmaceutical applications.
  • To identify regulatory considerations and challenges associated with 3D printed pharmaceuticals.
  • To highlight the potential of 3DP for personalized medicine and customized drug delivery.

Main Methods:

  • Searched regulatory agency databases (USFDA, EMA) for guidelines and approved products.
  • Utilized academic search engines (PubMed, Google Scholar) to gather relevant publications.
  • Reviewed existing literature on 3D printing applications in the pharmaceutical industry.

Main Results:

  • Currently, only one 3D printed pharmaceutical product has received USFDA approval.
  • Regulatory agencies are actively developing guidelines and addressing technical challenges for 3DP pharmaceuticals.
  • The majority of research in this domain originates from the academic sector.

Conclusions:

  • New technologies like 3D printing face challenges and require validation for safety and efficacy.
  • The successful adoption of 3D printing in pharmaceuticals necessitates robust regulatory guidelines.
  • Concerted efforts are crucial to overcome hurdles and ensure the success of this transformative technology.