Invention Title:

SOLID DOSAGE FORM PRODUCTION

Publication number:

US20240156739

Publication date:
Section:

Human necessities

Class:

A61K9/2095

Inventor:

Assignee:

Applicant:

Drawings (4 of 36)

Smart overview of the Invention

The invention employs 3D printing technology, specifically fused filament fabrication (FFF), to create solid dosage forms such as pharmaceutical tablets. It utilizes innovative filaments containing active ingredients, which are robust and allow for various formulations to be produced directly from a 3D printer. This approach enables the on-site production of personalized medicines tailored to individual patient needs. Additionally, the invention includes specialized software for operating the printer and systems for real-time monitoring of multiple printers to ensure regulatory compliance and facilitate error detection.

Components and Methodology

The apparatus comprises an FFF 3D printer, a build platform, and active ingredient-containing filaments, which may include additional filaments as needed. A computer controls the printer, potentially using specialized software connected to databases for managing the printing process. The method involves providing the apparatus, operating the 3D printer to print the dosage form on the build platform, and optionally performing further processing steps such as coating or modifying the printed form.

Background and Challenges

Solid dosage forms like tablets are widely preferred for their ease of administration and stability. However, traditional manufacturing is complex and cost-effective only at large scales, limiting customization options for patients. Previous attempts at using 3D printing faced challenges like regulatory approval, limited drug solubility in inks, and complexity due to multiple ingredients. This invention aims to address these issues by simplifying production with fewer variables and enhancing stability.

Objectives

  • Provide improved methods for producing solid dosage forms.
  • Enable dose customization on demand with minimal complexity.
  • Enhance storage stability of input materials and products.
  • Facilitate aesthetic customization without compromising integrity.
  • Support prototyping and formulation research in pharmaceuticals.

Advantages

The invention offers significant advantages over traditional methods by allowing high-dose actives, customizable drug release profiles, and improved user-friendliness. It reduces the likelihood of manufacturing errors and enhances regulatory viability. By enabling pharmacies to produce customized dosages on-site, it reduces workload and manual operations while expanding treatment options for healthcare professionals.