Orodispersible Tablets With Internal Cavities for API Stability
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Solution Overview
Problem
Existing rapidly-orodispersible dosage forms face challenges in accommodating a wide range of API compounds while maintaining sufficient hardness, friability, and rapid disintegration, often resulting in API waste and inefficiencies in manufacturing.
Innovation Solution
The development of porous articles with internal cavities, formed using additive manufacturing, that incorporate a bound-powder matrix and can contain various payload materials, including medicaments and excipients, allowing for efficient production with minimal waste and rapid disintegration in a small volume of liquid.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Speed
If rapidly-orodispersible dosage forms are produced using conventional compression or freeze-drying methods, then disintegration speed is improved, but manufacturing complexity increases and API waste occurs
Solution Approach 1:
The patent changes the manufacturing parameters by using additive manufacturing (3D printing) instead of conventional compression or freeze-drying. This involves depositing powder layers selectively and binding them with liquid binder to create porous structures with controlled architecture, achieving rapid disintegration while simplifying the manufacturing process and reducing API waste through precise material placement
Solution Approach 2:
The patent creates dosage forms with controlled porous architecture through additive manufacturing. The porous structure is formed by selective deposition and binding of powder particles, creating interconnected voids that allow rapid liquid penetration and disintegration while maintaining structural integrity during manufacturing
2Quantity of substance
If high dosage forms are produced to accommodate all API compounds, then API capacity is improved, but swallowing difficulty increases
Solution Approach 1:
The patent divides the dosage form into a porous matrix structure formed by additive manufacturing. The API is distributed throughout the porous architecture, allowing high API capacity in a compact form that can be easily swallowed. The segmented porous structure enables rapid disintegration in the mouth, converting the large-volume solid into small particles
Solution Approach 2:
The patent uses additive manufacturing to create three-dimensional porous architectures with controlled pore sizes and distributions. This dimensional control allows high API loading capacity while maintaining a small external footprint and rapid disintegration, resolving the conflict between API capacity and swallowing ease
3Speed
If porous structures are created to enable rapid disintegration, then disintegration speed is improved, but structural strength decreases
Solution Approach 1:
The patent applies local quality by creating regions of different porosity and binding density within the dosage form. The additive manufacturing process allows selective deposition and binding, creating a gradient structure where certain regions have higher structural strength while others have higher porosity for rapid liquid penetration, achieving both strength and fast disintegration
Solution Approach 2:
The patent creates a composite structure combining bound powder particles with controlled porous architecture. The binding liquid creates strong interparticle bonds while maintaining void spaces, resulting in a composite material that has both structural integrity for handling and rapid disintegration capability when exposed to liquid
4Productivity
If conventional manufacturing methods are used, then production volume is improved, but API waste increases
Solution Approach 1:
The patent changes the manufacturing approach from conventional high-volume production with significant waste to additive manufacturing with precise material placement. The 3D printing process deposits powder and binder only where needed, creating dosage forms layer by layer with minimal excess material, thereby reducing API waste while maintaining production efficiency
Solution Approach 2:
The additive manufacturing process is self-correcting and material-efficient, building the dosage form exactly to specification without generating excess waste that requires disposal. The unbound powder can be easily removed and reused, and the precise layer-by-layer construction ensures minimal API waste throughout production
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
The solution enables the formation of rapidly-orodispersible tablets with improved chemical stability, hardness, and rapid disintegration, accommodating a broader range of API compounds with minimal waste and enhanced manufacturing efficiency.
Implementation Method 1
The bound powder material can comprise an interconnected matrix of particles of a powder material and a binder material
Implementation Method 2
Rapidly-orodispersible dosage forms can disperse or disintegrate in the mouth in a minimal amount of saliva or water
Data Source
AI summary
A rapidly-orodispersible dosage form comprising a porous, bound-powder matrix and one or more internal cavities is provided, as well as three-dimensional printing methods for making the same. Each internal cavity is configured to contain one or more payloads, particularly pharmaceutical medicaments, while isolating the payloads from the external environment outside of the dosage form. Each payload can be contained within its cavity in its native form without having to be combined with the bound-powder matrix or binding liquid. Dosage forms can disintegrate in water or saliva in less than two minutes, independently of the payload(s) or medicament(s) contained within. The dosage forms can be formed as unitary tablets, or as two-piece tablets comprising a container body and a lidding body that are secured together to isolate the one or more cavities and their payloads inside.