Selective Laser Sintering for Solid Pharmaceutical Dosage Forms
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Solution Overview
Problem
Current 3D printing technologies, such as FDM, are not suitable for producing a wide variety of dosage forms like films or fast-dissolving tablets for sublingual administration, limiting their application in drug formulation.
Innovation Solution
Powder bed fusion selective laser 3D printing is used to create solid pharmaceutical dosage formulations by sintering a mixture of drugs and excipients, where at least one component absorbs electromagnetic radiation, allowing for the production of diverse dosage forms including tamper-resistant forms, immediate release tablets, and buccal films.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If FDM technology is used for 3D printing, then it can produce dosage forms, but it cannot produce films or fast-dissolving tablets for sublingual administration
Solution Approach 1:
The patent replaces the mechanical extrusion-based FDM system with a laser-based powder bed fusion system. The laser selectively melts and fuses powder particles according to a digital model, enabling the production of diverse dosage forms including films and fast-dissolving tablets that are not achievable with FDM technology.
Solution Approach 2:
The patent changes the fundamental processing parameters from mechanical extrusion and layer deposition (FDM) to laser irradiation, selective melting, and powder fusion. This parameter change enables the system to produce a wider range of dosage forms with different structural requirements, including thin films and rapidly disintegrating tablets.
2Adaptability or versatility
If powder bed fusion selective laser 3D printing is used, then versatility in dosage forms is improved, but drug or excipient degradation may occur due to laser radiation
Solution Approach 1:
The patent introduces an intermediary approach by using a powder bed system where the laser selectively melts and fuses particles. The powder particles act as a medium that absorbs and distributes the laser energy, enabling controlled fusion while minimizing direct thermal exposure to the drug substance. This intermediary mechanism allows versatility in dosage form production while maintaining drug stability.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This method offers greater versatility in drug administration and performance, enabling personalized dosing, tamper-resistant formulations, and rapid disintegration tablets, while maintaining the advantages of 3D printing like unique shapes and personalized medicine.
Implementation Method 1
at least one of said drug and said excipient absorbs electromagnetic radiation at a wavelength emitted by the laser
Implementation Method 2
powder bed fusion selective laser 3-dimensional printing
Implementation Method 3
selective laser sintering 3-dimensional printing
Data Source
AI summary
A process for producing a solid pharmaceutical dosage formulation, said process comprising powder bed fusion selective laser 3-dimensional printing of a mixture comprising: (a)a drug; and (b)an excipient; whereinat least one of said drug and said excipient absorbs electromagnetic radiation at a wavelength emitted by the laser; or (a)a drug; (b)an excipient; and (c)an absorbent material which absorbs electromagnetic radiation at a wavelength emitted by the laser.