Dextran Solid Dose Formulations: 80 MPa Strength for Needle-Free Delivery
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Solution Overview
Problem
Existing solid dose formulations for needle-free parenteral delivery lack sufficient mechanical strength and are unsuitable for patient comfort, often requiring needle assistance due to inadequate manufacturing processes.
Innovation Solution
A solid dose formulation comprising 0.01-60% therapeutic/prophylactic agent and 40.0%-99.99% dextran, with specific excipient combinations, achieves a compressive strength of at least 80 MPa, enabling needle-free delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If solid dose formulations are produced for oral administration using conventional methods, then manufacturing process is simple and cost-effective, but mechanical strength is insufficient for needle-free parenteral delivery
Solution Approach 1:
The patent changes the formulation parameters by incorporating specific excipients (sodium carboxymethylcellulose salt, mannitol, magnesium stearate) in optimized ratios and controlling particle size distribution to achieve the required compressive strength of at least 80 MPa for needle-free delivery while maintaining manufacturing feasibility
Solution Approach 2:
The patent creates a composite solid dose formulation combining the therapeutic agent with multiple excipients (sodium carboxymethylcellulose salt as binder, mannitol as filler, magnesium stearate as lubricant) to achieve the required mechanical strength properties that cannot be obtained with single materials alone
2Ease of operation
If solid dose formulations are made with smaller size for patient comfort, then ease of administration is improved, but mechanical strength becomes insufficient
Solution Approach 1:
The patent optimizes the size parameter to 0.5-2.0 mm diameter range that balances patient comfort with sufficient mechanical strength, and changes formulation parameters including excipient ratios and particle size distribution to ensure the smaller doses achieve at least 80 MPa compressive strength
Solution Approach 2:
The patent segments the solid dose into small individual units (0.5-2.0 mm diameter) suitable for needle-free delivery, where each segment is independently formulated with appropriate excipients to maintain sufficient mechanical strength despite the reduced size
3Ease of operation
If liquid formulations are used for parenteral delivery, then rapid delivery is achieved, but patient discomfort and health risks from needles increase
Solution Approach 1:
The patent replaces the needle-based mechanical injection system with a needle-free solid dose delivery system that uses compressed gas or spring mechanism to propel the solid dose through the skin, eliminating needle-related discomfort and health risks while maintaining reliable parenteral delivery
4Reliability
If solid dose formulations are produced with sufficient mechanical strength for needle-free delivery, then delivery reliability is improved, but manufacturing precision requirements increase
Solution Approach 1:
The patent establishes specific parameter ranges for excipient ratios (sodium carboxymethylcellulose salt 1-10%, mannitol 5-20%, magnesium stearate 0.1-2%), particle size distribution, and compression force (5-20 kN) that ensure sufficient mechanical strength while providing clear manufacturing guidelines to control precision requirements
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 consistent dosing with improved mechanical strength and patient comfort, suitable for needle-free administration, maintaining stability and effectiveness of therapeutic agents.
Implementation Method 1
a solid dose formulation having a compressive strength of equal to or greater than 80 MPa for needle-free delivery
Data Source
AI summary
The present disclosure relates to solid dose formulations for needle-free delivery comprising 0.01 to 60 (w/w) of one or more therapeutic agent and/or prophylactic agent; and 40.0% to 99.99% (w/w) of dextran. The invention further concerns methods of producing a solid dose formulation tablet and application its particular medical uses, in particular as a vaccine.