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Selective Laser Sintering 3D Printing a?? An Overview of the Technology and Pharmaceutical Applications

DOI:10.1080/03639045.2020.1764027 期刊:Drug Development and Industrial Pharmacy 出版年份:2020 更新时间:2025-09-23 15:21:01
摘要: Food and Drug Administration (FDA) has approved a drug product (Spritam?) and many medical devices manufactured by 3-dimensional printing (3DP) processes for human use. There is immense potential to print personalized medicines using 3DP. Many 3DP methods have been reported in the literature for pharmaceutical applications. However, selective laser sintering (SLS) printing has remained least explored for pharmaceutical applications. There are many advantages and challenges in adopting a SLS method for fabrication of personalized medicines. Solvent free nature, availability of FDA approved thermoplastic polymer/excipients (currently used in hot melt-extrusion process), minimal/no post-processing step, etc. are some of the advantages of the SLS printing process. Major challenges of the technology are requirement of at least one thermoplastic component in the formulation and thermal stability of drug and excipients. This review provides an overview of the SLS printing method, excipient requirements, process monitoring, quality defects, regulatory aspects and potential pharmaceutical applications.
作者: Naseem A. Charoo,Sogra F. Barakh Ali,Eman M. Mohamed,Mathew A. Kuttolamadom,Tanil Ozkan,Mansoor A. Khan,Ziyaur Rahman
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To provide an overview of the selective laser sintering (SLS) 3D printing technology and its pharmaceutical applications, highlighting the advantages and challenges of adopting this method for the fabrication of personalized medicines.

SLS 3D printing offers a promising approach for the fabrication of personalized medicines, with advantages such as solvent-free processing and minimal post-processing steps. However, challenges related to material requirements and thermal stability need to be addressed. The technology has potential applications in producing dosage forms for pediatric, geriatric, or special populations, and in developing specialized dosage forms like amorphous solid dispersions and abuse deterrent formulations. Regulatory pathways for SLS printed formulations are available, and as the technology evolves, cGMP compliant printers for pharmaceutical applications are expected to become available.

The major challenges of the SLS technology include the requirement of at least one thermoplastic component in the formulation and the thermal stability of drug and excipients. Other limitations are the recycling/reuse of unprinted raw material after the printing process, the impact of recycling on the quality and purity of materials, and the need for in-process monitoring to ensure product quality.

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