Spray-Dried Particle Formulations for Low-Force High-Concentration Injections
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Pharmaceutical formulations containing high concentrations of active pharmaceutical ingredients (APIs) like proteins require high injection forces due to their high viscosity, making them difficult to administer through standard auto-injectors or needles.
Innovation Solution
The development of an injectable formulation that includes a vehicle and spray-dried powders with a tapped density greater than 0.45 g/mL, suspended at greater than or equal to 40 wt.%, allowing for injection through a 27 gauge needle with a glide force of less than or equal to 100N.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If high concentration of API is used in injectable formulation, then dose concentration is improved, but injection force becomes excessive
Solution Approach 1:
The patent changes the physical-chemical parameters of the API particles by controlling spray drying conditions (temperature, pressure, atomization) to achieve specific particle properties (tapped density > 0.45 g/mL, specific size distribution). These parameter changes enable high API concentration formulations to have reduced viscosity and injection force while maintaining high dose concentration.
Solution Approach 2:
The patent utilizes phase transition from liquid to solid through spray drying process. The API solution or suspension is atomized and rapidly dried to form solid microparticles with controlled morphology and density. This phase transition enables the API to be delivered in a dry powder form that can be reconstituted to high concentrations with acceptable injection characteristics.
2Quantity of substance
If spray drying is used to increase tapped density, then particle density is improved, but process complexity increases
Solution Approach 1:
The patent replaces complex mechanical particle densification methods with a spray drying process that uses thermal and mass transfer mechanisms. By controlling drying conditions (temperature, pressure, atomization rate), the process achieves high tapped density particles through controlled phase transition and solvent removal rather than mechanical compression or densification equipment.
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
This approach enables the creation of injectable formulations with high API concentrations that can be administered with reduced injection forces, improving patient experience and reducing healthcare costs.
Implementation Method 1
The particles may be dried from solution by spray drying
Implementation Method 2
spray drying under vacuum enables lower outlet temperatures and slower rates of drying
Implementation Method 3
spray drying under vacuum enables lower outlet temperatures and slower rates of drying that may result in an increase in tapped density
Data Source
AI summary
Systems and methods are provided for an injectable formulation. The injectable formulation includes a vehicle and dried particles. The dried particles have a tapped density greater than 0.45 mg/mL and are suspend in the vehicle at greater than or equal to 40 wt. %. The injectable formulation is injectable using a glide force of less than or equal to 100N.