Variable Density Orally Disintegrating Tablets via RF Energy
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Solution Overview
Problem
There is a need for aesthetically pleasing and stable chewable and orally disintegrating tablets that can be produced using compression-based tableting machines, which typically result in highly friable tablets that are not suitable for packaging, shipping, and storage.
Innovation Solution
A machine and process utilizing radiofrequency (RF) energy to form tablets with varying levels of hardness and thickness, involving a die platen with forming cavities, RF electrodes, and forming tools to heat and shape a powder blend into a dosage form that disintegrates in the mouth within 30 seconds.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If compression-based tableting machines are used to produce chewable and orally disintegrating tablets at low compression forces, then the tablets are softer and easier to chew or disintegrate, but the tablets become highly friable and unstable during packaging, shipping, and storage
Solution Approach 1:
The patent applies RF energy to change the physical and chemical parameters of the tablet after compression. The RF energy modifies the molecular structure and bonding characteristics of the tablet material, transforming it from a friable state to a stable state while preserving the softness and chewability characteristics. This parameter change allows the tablet to maintain both ease of operation (chewing) and reliability (stability).
Solution Approach 2:
The patent replaces conventional mechanical strengthening methods (such as increasing compression force or adding binders) with RF energy treatment. The RF energy acts on the molecular level to create stable cross-linking and bonding structures, eliminating the need for additional mechanical processing steps that would compromise tablet stability without affecting the soft chewable properties.
2Reliability
If high compression forces are applied to produce stable tablets, then the tablets are hard and stable, but they are not suitable for chewable or orally disintegrating formulations
Solution Approach 1:
The patent uses RF energy to change the physical and chemical parameters of the compressed tablet. By applying RF energy, the tablet structure is modified to create stable molecular bonding while maintaining the macroscopic softness and chewability characteristics. This allows the tablet to be both stable (like a hard tablet) and easy to chew (like a soft tablet).
Solution Approach 2:
The patent creates a composite structure within the tablet through RF energy treatment, combining the stability of highly compressed regions with the softness of lightly compressed regions. The RF energy generates varying degrees of molecular cross-linking and bonding throughout the tablet, creating a composite material structure that exhibits both stability and chewability properties simultaneously.
3Ease of operation
If complex processing steps are used to produce soft tablets with good bite-through, then the tablets are softer and easier to chew, but the processing becomes complex and costly
Solution Approach 1:
The patent replaces complex mechanical processing steps (such as multiple compression stages, coating operations, or extrusion processes) with a single RF energy treatment step. The RF energy directly modifies the molecular structure of the compressed tablet to achieve softness and good bite-through properties without requiring additional mechanical processing steps, thereby simplifying the overall manufacturing process.
Solution Approach 2:
The RF energy treatment serves multiple functions simultaneously: it strengthens molecular bonding for stability, maintains softness for chewability, and eliminates the need for additional processing steps. This multi-functionality of the RF energy process simplifies the overall manufacturing process while achieving the desired tablet properties.
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 RF energy process enables the production of stable, chewable, and orally disintegrating tablets with controlled hardness and thickness, improving consumer experience and compliance, especially for pediatric and geriatric patients, while maintaining physical and chemical stability.
Implementation Method 1
the first RF electrode and the second RF electrode are arranged within the machine such that when RF energy is conducted between the first RF electrode and the second RF electrode, the RF energy passes through the portion of the forming cavity adapted to form the dosage form
Data Source
AI summary
The present invention features the present invention features a tablet including at least one pharmaceutically active ingredient, wherein the shape of said tablet includes at least one major face wherein: (i) the peak penetration resistance at the perimeter of said major face of the tablet is at least about 10% greater than the peak penetration resistance at the center of said major face; and (ii) the tablet disintegrates in the mouth when placed on the tongue in less than about 30 seconds, and a machine and method for manufacture of such tablet.