(496g) Potential of 3D Printing in Precision Combination Therapy: A Case Study of Cardiovascular Polypills

Authors: 
Alayoubi, A., U.S. Food and Drug Administration
Asfari, S., U.S. Food and Drug Administration
Kopcha, M., U.S FDA
Ashraf, M., Office of Testing and Research, U.S. Food and Drug Administration
Cruz, C. N., U.S. Food and Drug Administration
Zidan, A., U.S. Food and Drug Administration
3D printing is one of the emerging manufacturing technologies that is well suited to produce precision (personalized) medicine. The unique versatility of 3D printing to engineer desired designs with specific geometry allows for achieving targeted release profiles of printed drugs. It has a high potential for individualization of drug therapy combination through the so called “Polypill printlets” by which all the drugs required for the therapy can be printed into a single dosage unit. In this regard, this presentation will highlight a case study of engineering and manufacturing a cardiovascular polypill of Metoprolol (MT) and Atorvastatin (AT) using 3D pneumatic assisted micro-extrusion (PAM) technique. The polypills were designed to provide extended release properties of MT and immediate release properties of AT. The effect of printing, geometrical and formulation parameters on breaking strength and disintegration of the polypills and release properties of the drugs will be discussed. Various designs of the polypills will be demonstrated to modulate the release rate of the drugs from the polypills. The design spaces for formulating these polypills will be discussed in terms of identifying the critical material attributes and key geometrical parameters that achieve independent release properties of both drugs from the polypills. In addition, the regulatory considerations and failure modes of the polypill printlets will be also shared.

DISCLAIMER

This abstract reflects the views of the presenter and should not be construed to represent FDA’s views or policies.