Soft-Chew Tablet Formulation for Rotary Press Production
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Solution Overview
Problem
Existing methods for manufacturing soft-chewable tablets are cumbersome, complex, and not suitable for large-scale production using conventional pharmaceutical equipment, leading to issues with weight and physical form control, and require excessive conditioning.
Innovation Solution
A simplified process using conventional pharmaceutical equipment, such as a rotary tablet press, to formulate soft-chewable tablets with low hardness and high moisture content, incorporating palatability agents and texturing agents to enhance texture and flavor, while maintaining dimensional stability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If conventional compression machines are used to manufacture chewable tablets, then tablets can be produced with sufficient hardness (>10 kp), but the tablets become gritty and unappealing to patients
Solution Approach 1:
The patent changes the formulation parameters by incorporating specific excipients including hydrocolloids (xanthan gum, guar gum, locust bean gum), lipids (carnauba wax, beeswax, soy lecithin), and plasticizers (glycerin, propylene glycol, sorbitol) to create a soft-chewable matrix that achieves acceptable hardness (<10 kp) while maintaining a smooth, non-gritty texture that patients find appealing
2Object-affected harmful factors
If hardness is reduced to improve palatability, then tablets become more appealing, but friability increases beyond acceptable ranges
Solution Approach 1:
The patent employs a composite formulation combining multiple hydrocolloids (xanthan gum, guar gum, locust bean gum) with lipids (carnauba wax, beeswax, soy lecithin) and plasticizers (glycerin, propylene glycol, sorbitol) to create a synergistic matrix that provides both softness for palatability and structural integrity to control friability within acceptable ranges
3Shape
If extruders and rotary molding machines are used to manufacture soft-chew tablets, then tablets can be formed with desired shape, but weight and physical form control becomes difficult and excessive conditioning is required
Solution Approach 1:
The patent extracts the complex conditioning and shaping steps from the manufacturing process by using conventional compression machine technology that inherently produces tablets with controlled weight, shape, and physical form without requiring extrusion, rotary molding, or excessive drying/curing operations
4Ease of manufacture
If conventional tablet compression techniques are used, then manufacturing is simplified, but tablets produce gritty texture and unappealing mouthfeel
Solution Approach 1:
The patent modifies the formulation parameters by incorporating hydrocolloids, lipids, and plasticizers in specific combinations and proportions to transform the mouthfeel characteristics of conventionally compressed tablets from gritty and unappealing to smooth and pleasant, while maintaining the simplicity of conventional compression manufacturing
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 process enables efficient, reliable, and consistent production of soft-chew tablets with low hardness and low friability, providing a pleasant mouthfeel and palatable taste, suitable for involuntary subject populations.
Implementation Method 1
Tablets compressed on a compression machine are formulated to produce tablets having a hardness of more than ten kiloponds (10 kp)
Data Source
AI summary
A product and process of manufacturing an edible soft-chewable dosage form for the delivery of pharmaceutically active ingredients or nutritional agents orally to an animal or human subject, by forming a granulated soft-chew mass by appropriate mixing and sifting steps, and forming tablets with a compression press. Such soft-chew dosage forms have hardness of less than about two kilopond (2 kp) and friability of less than about one percent (1%) at three-hundred (300) rotations when measured according to the United States Pharmacopeia (USP) test. The process for manufacturing such compressed soft-chew tablets employs compression (tablet) pressing equipment to produce soft-chew tablets of consistent weight and texture.