Daprodustat Immediate Release Tablet Tensile Strength Optimization
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Solution Overview
Problem
Daprodustat tablets require enhanced mechanical strength to withstand handling and storage without crumbling, while maintaining suitable disintegration for oral administration, as existing formulations struggle with tensile strength and friability.
Innovation Solution
An immediate release tablet formulation of daprodustat with a tablet tensile strength of at least 1.7 MPa, achieved by compaction pressures between 200 to 290 MPa, and optimized using a non-solvated crystalline form of daprodustat without glidants in the compartment, ensuring robustness and effective disintegration within 45 minutes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If compaction pressure is increased to improve tablet tensile strength, then tablet robustness improves, but disintegration time may be delayed
Solution Approach 1:
The patent optimizes compaction pressure within a specific range (200-290 MPa) to achieve the desired balance between tablet tensile strength and disintegration time. This parameter optimization allows the formulation to withstand handling and storage while maintaining suitable disintegration for oral administration.
Solution Approach 2:
The patent uses a composite formulation containing daprodustat, microcrystalline cellulose, and other excipients that work together to provide both mechanical strength and disintegration properties. The combination of these materials allows the tablet to achieve tensile strength ≥1.7 MPa while disintegrating within 45 minutes.
2Reliability
If tablet formulation is optimized for mechanical strength, then handling robustness improves, but manufacturing complexity increases
Solution Approach 1:
The patent specifies a compaction pressure range (200-290 MPa) that achieves reliable tablet strength without requiring excessively complex manufacturing equipment or processes. This parameter optimization simplifies manufacturing while ensuring robustness.
Solution Approach 2:
The patent uses conventional, readily available excipients like microcrystalline cellulose that are easy to manufacture and handle, avoiding the need for specialized or complex materials that would increase manufacturing complexity.
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 formulation provides tablets with improved tensile strength and disintegration profile, ensuring stability during processing and administration, while maintaining therapeutic efficacy for treating anemia due to chronic kidney disease.
Implementation Method 1
following compaction of the tablet core at a pressure in the range of 200 to 290 MPa
Data Source
AI summary
The present disclosure relates to an immediate release tablet of daprodustat having good tensile strength. In other aspects, medical uses of the immediate release tablet and dosage regimens for using the immediate release tablet are disclosed.