Polyalkylene Oxide Particles Viscosity Control
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Solution Overview
Problem
Polyalkylene oxide particles exhibit varying aqueous solution viscosity based on particle size, leading to performance fluctuations in pharmaceutical preparations, particularly in drug dissolution, which worsens with disturbances in particle uniformity due to vibration or transfer.
Innovation Solution
Developing polyalkylene oxide particles with a specific viscosity ratio (66% to 150%) by controlling the 1 mass% aqueous solution viscosity of particles with different sizes, ensuring consistent performance even when particle uniformity is disturbed.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If polyalkylene oxide particles with controlled particle size distribution are used as binders, then the binder function for pharmaceutical preparations is improved, but the aqueous solution viscosity varies depending on particle size leading to performance variation in preparations
Solution Approach 1:
The patent changes the parameter of aqueous solution viscosity by controlling particle size to resolve the contradiction. Specifically, it defines that particles with Dv(0.1) of 10 μm or more and Dv(10) of 300 μm or less, with Dv(50) between 50-200 μm, achieve both good binder function and consistent performance. This parameter optimization ensures that viscosity variation across different particle sizes is minimized, allowing the material to function effectively as a binder while maintaining preparation performance consistency.
Solution Approach 2:
The patent segments the particle size distribution into specific ranges to resolve the contradiction between binder function and performance consistency. By dividing the particle size into controlled segments (Dv(0.1) ≥ 10 μm, Dv(10) ≥ 300 μm, 50 ≤ Dv(50) ≤ 200 μm), it ensures that each segment contributes appropriately to binder function while the overall distribution maintains viscosity consistency, preventing performance variation in pharmaceutical preparations.
2Productivity
If polyalkylene oxide particles are transferred or vibrated during handling, then the manufacturing process is completed, but segregation or breakdown of uniformity occurs leading to increased variation in preparation dissolution
Solution Approach 1:
The patent applies beforehand cushioning by pre-establishing a robust particle size distribution that is resistant to segregation and breakdown. By controlling particles to have Dv(0.1) ≥ 10 μm, Dv(10) ≥ 300 μm, and 50 ≤ Dv(50) ≤ 200 μm before transfer or vibration occurs, the uniformity is protected in advance. This pre-optimized distribution acts as a cushion against the harmful effects of handling, ensuring dissolution consistency is maintained even when segregation or breakdown occurs during transfer.
Data Source
AI summary
Provided are polyalkylene oxide particles that can reduce the variation in the degree of dissolution of preparations, and that can make variation less likely to occur in the degree of dissolution of preparations even if the uniformity of the polyalkylene oxide particles is disturbed by vibration or the like. The polyalkylene oxide particles of the present invention satisfy a viscosity ratio A (%) of 66% or more and 150% or less, wherein the viscosity ratio A is represented by the following formula: A=A1/A2×100 wherein A1 is the 1 mass% aqueous solution viscosity (mPa·s) of particles having a particle size of 150 µm or more, and A2 is the 1 mass% aqueous solution viscosity (mPa·s) of particles having a particle size of less than 150 µm.