Disintegrative Lactose Composition for Tablet Hardness and Disintegration Balance
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Solution Overview
Problem
Existing orally-disintegrating tablets face a challenge in achieving an optimal balance between tablet hardness and disintegrability, with conventional compositions not adequately meeting the requirements of sufficient hardness and rapid disintegration.
Innovation Solution
A disintegrative particulate composition comprising milled lactose or granulated lactose, combined with micro-fibrillated cellulose and starch, which enhances tablet moldability and disintegrability, achieving a balance of tablet hardness and disintegration time.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If molding pressure is increased to increase tablet hardness, then tablet strength is improved, but disintegration time is prolonged
Solution Approach 1:
The invention uses a composite particulate composition containing multiple components (lactose, microcrystalline cellulose, and starch) in specific ratios. This composite structure allows the tablet to achieve sufficient hardness through the mechanical strength of the composite particles while maintaining rapid disintegration through the hydrophilic and disintegrating properties of the individual components, particularly starch and microcrystalline cellulose.
Solution Approach 2:
The invention optimizes the particle size distribution of the particulate composition, specifying a D90 value of 150 μm or less. This parameter control ensures that the particles are fine enough to facilitate rapid disintegration while still providing adequate tablet hardness when compressed, resolving the contradiction between strength and disintegration speed.
2Loss of time
If molding pressure is reduced to shorten disintegration time, then disintegrability is improved, but tablet hardness is reduced
Solution Approach 1:
The composite particulate composition leverages the synergistic effects of its components: lactose provides bulk and compressibility, microcrystalline cellulose contributes to tablet strength and disintegration, and starch enhances disintegration through its hydrophilic nature. This composite approach enables achieving rapid disintegration without requiring high molding pressures that would compromise hardness.
Solution Approach 2:
By controlling the particle size parameter (D90 ≤ 150 μm) and the compositional ratios of the components, the invention enables tablets to disintegrate rapidly even at moderate compression forces, while still maintaining adequate hardness for handling and transportation.
3Ease of manufacture
If conventional particulate compositions are used, then manufacturing simplicity is maintained, but optimal balance between tablet hardness and disintegrability is not achieved
Solution Approach 1:
The invention provides a specific composite formulation with defined component ratios (lactose: microcrystalline cellulose: starch) that can be directly used in tablet manufacturing without complex processing. This composite material delivers reliable and consistent tablet performance with optimal balance between hardness and disintegrability, eliminating the need for complex granulation or processing steps.
Data Source
AI summary
The purpose of the present invention is to provide a new disintegrative particulate composition having an optimal balance between the tablet hardness and disintegrability that are mutually opposing properties, and disintegrating tablets for pharmaceuticals and various kinds of foods comprising said composition.The present invention relates to a disintegrative particulate composition comprising milled lactose and/or granulated lactose as an excipient, and to a disintegrating tablet for pharmaceuticals or foods, comprising the disintegrative particulate composition, especially the tablet having tablet hardness of from 20 to 200 N, and disintegration time in water of from 1 to 60 sec.