Polyalkylene Oxide Dissolution Control via Gel Strength
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Solution Overview
Problem
Existing solid dosage forms struggle to control the dissolution rate of active ingredients without altering the preparation process, which is costly and time-consuming due to the need for equipment changes and multiple dissolution tests.
Innovation Solution
A polyalkylene oxide with specific properties, including a polydispersity of 3 to 5, a gel strength of 22500 Pa or more, and an erosion of 40 to 48%, is used to control the drug dissolution rate in solid dosage forms.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If the dissolution rate is controlled by changing the type and amount of excipients, then the dissolution rate can be finely controlled, but the production equipment must be cleaned and multiple dissolution tests must be conducted, taking enormous time and money
Solution Approach 1:
The invention changes the molecular weight distribution parameters of the polyalkylene oxide (specifically polydispersity ratio of 3-5) to achieve controlled dissolution rate. By controlling the gel strength (22500 Pa or more) and erosion rate (40-48%), the dissolution can be precisely controlled without requiring multiple iterative tests, thus reducing time loss while maintaining manufacturing precision.
2Manufacturing precision
If the dissolution rate is controlled by changing the type and amount of excipients, then the dissolution rate can be finely controlled, but the production equipment must be cleaned due to changes in substances and blending amounts
Solution Approach 1:
Instead of changing excipient types and amounts, the invention changes the molecular weight distribution parameters of a single polyalkylene oxide component. This approach maintains the same production process and excipient formulation, eliminating the need for equipment cleaning between batches while achieving precise dissolution rate control through parameter optimization.
3Manufacturing precision
If the dissolution rate is controlled by changing the shape and size of solid dosage forms, then the dissolution rate can be controlled, but the design and equipment must be changed, which is not realistic from the viewpoint of cost
Solution Approach 1:
The invention achieves dissolution rate control by changing the molecular weight distribution parameters of the polyalkylene oxide rather than altering the physical shape or size of the dosage forms. This approach maintains existing equipment designs and manufacturing processes, avoiding the costly and complex equipment modifications that would be required for shape/size-based dissolution control.
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 polyalkylene oxide effectively controls the drug dissolution rate, allowing for sustained release and reducing the number of doses required, while maintaining constant blood levels of active ingredients and minimizing side effects.
Implementation Method 1
a gel strength of 22500 Pa or more
Implementation Method 2
an erosion of 40 to 48%
Data Source
AI summary
A polyalkylene oxide that can be suitably used to easily control a drug dissolution rate, a solid dosage form composition comprising the polyalkylene oxide and a method for producing the same, and a sustained-release dosage form composition are provided. The polyalkylene oxide has a polydispersity of 3 to 5, a gel strength of 22,500 Pa or more, and an erosion of 40 to 48%. The solid dosage form composition includes at least the polyalkylene oxide, an active component, and an excipient.