Osmotic Pump Composition for Controlled Dissolution Start Time
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Solution Overview
Problem
Existing controlled drug release preparations face challenges in controlling the initial drug dissolution speed, particularly the dissolution start time, due to the complexity and cost associated with changing the type and amount of drugs, polymers, and semipermeable membranes, which require extensive process changes and testing.
Innovation Solution
Incorporating polyalkylene oxide particles with specific particle size distributions, such as 40 mass% or less of particles larger than 300 µm, into the drug and pump layers of osmotic pump preparations, allowing for controlled drug release compositions that can easily adjust the dissolution start time.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If the type and amount of drug are adjusted to control dissolution speed, then the dissolution speed can be controlled, but the preparation becomes specific to intended use and loses flexibility
Solution Approach 1:
The patent changes the particle size parameter of the polymer instead of changing the drug type or amount. By controlling the particle size distribution of polyalkylene oxide particles (specifically having 40 mass% or less of particles with 300 μm or more diameter), the dissolution speed can be adjusted while keeping the drug composition constant, thus maintaining preparation flexibility.
2Manufacturing precision
If the shape and size of preparation are changed to control dissolution speed, then the dissolution speed can be adjusted, but the equipment must be changed and it takes enormous time and money
Solution Approach 1:
Instead of changing the macroscopic shape and size of the preparation which would require different manufacturing equipment, the patent changes the microscopic particle size parameter of the polymer particles within the existing preparation structure. This allows dissolution speed control using the same equipment while significantly reducing production complexity.
3Manufacturing precision
If the semipermeable membrane substance, penetrant, or polymer type and amount are changed to control dissolution speed, then the dissolution speed can be finely adjusted, but cleaning process is required and extensive testing is needed
Solution Approach 1:
The patent changes the particle size parameter of the polymer particles rather than changing the chemical composition of semipermeable membranes, penetrants, or polymer types. This physical parameter change eliminates the need for cleaning processes and extensive testing that would be required when changing chemical substances, while still achieving fine control over dissolution speed.
4Manufacturing precision
If enteric coating is applied to delay dissolution start time, then the dissolution start time can be controlled, but the process is lengthened and cost increases
Solution Approach 1:
Instead of applying an additional enteric coating layer which would lengthen the production process and increase cost, the patent controls the dissolution start time by adjusting the particle size parameter of the polyalkylene oxide particles in the existing formulation. This eliminates the need for additional coating steps while achieving the same dissolution control effect.
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 use of polyalkylene oxide particles enables simple and effective control of the initial drug dissolution speed, reducing production time and cost while ensuring uniform drug release over a long period.
Implementation Method 1
osmotic pump preparation having an osmotic pump structure with a core part and a coating layer coating the core part, the core part having a drug layer containing a drug, and a pump layer containing an osmotic agent
Data Source
Figure 1~2
Figure 3
AI summary
Provided is a controlled drug release preparation composition that can control the initial drug dissolution speed of a controlled drug release preparation by simple means, and the controlled drug release preparation. The osmotic pump controlled drug release preparation composition of the present invention comprises polyalkylene oxide particles D, and polyalkylene oxide particles D comprise 40 mass% or less of polyalkylene oxide particles having a particle size of 300 µm or more.