Tamsulosin Solid Dosage Using Segmented Polyethylene Oxide
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Solution Overview
Problem
Current pharmaceutical compositions of tamsulosin face challenges in achieving stable drug content uniformity and satisfactory drug release profiles, often requiring expensive excipients and complex manufacturing processes, particularly with high molecular weight polyethylene oxide which can be difficult to handle due to sticky properties.
Innovation Solution
A solid pharmaceutical composition comprising granules with tamsulosin and a hydrogel-forming polymer like polyethylene oxide, combined with an extragranular phase of polyethylene oxide, which allows for improved gelling and drug release without the need for water-soluble hydrophilic bases, enabling a simple and quick manufacturing process.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of moving object
If high molecular weight polyethylene oxide is used as hydrogel-forming polymer, then sustained drug release is achieved, but manufacturing difficulty increases due to sticky properties
Solution Approach 1:
The polyethylene oxide is divided into two distinct molecular weight fractions: a first fraction (average molecular weight 10,000 to 1,000,000) for granulation and a second fraction (average molecular weight 1,000,000 to 10,000,000) for sustained release. This segmentation allows each fraction to perform its specific function effectively without the handling difficulties of using only high molecular weight polymer.
Solution Approach 2:
The invention changes the molecular weight parameter of polyethylene oxide by using a mixture of different molecular weight fractions rather than a single uniform molecular weight. This parameter change enables the polymer to exhibit both good processability (from lower molecular weight fraction) and sustained release properties (from higher molecular weight fraction).
2Duration of action of moving object
If polyethylene oxide is used as hydrogel-forming polymer, then controlled release is achieved, but tableting properties deteriorate due to stickiness
Solution Approach 1:
The polyethylene oxide is segmented into two molecular weight fractions with distinct roles: the first fraction (lower molecular weight) provides good tableting properties and processability, while the second fraction (higher molecular weight) provides controlled release characteristics. This segmentation resolves the contradiction between tableting properties and controlled release.
3Duration of action of moving object
If water-soluble hydrophilic bases are used to improve gelling, then drug release is enhanced, but manufacturing complexity and cost increase
Solution Approach 1:
The invention extracts and eliminates the need for water-soluble hydrophilic bases from the formulation. Instead, it uses a combination of two polyethylene oxide fractions with different molecular weights to achieve both gelling and drug release functions, thereby simplifying the manufacturing process and reducing costs while maintaining effective drug release.
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 composition achieves good drug content uniformity and sustained drug release without the use of expensive excipients, with improved gelling properties and reduced manufacturing complexity, ensuring consistent drug delivery over prolonged periods.
Implementation Method 1
hydrogel-forming polymer, namely polyethylene oxide
Data Source
AI summary
The present invention relates to a pharmaceutical composition comprising tamsulosin or a pharmaceutically acceptable salt or solvate thereof in a solid dosage form and to a process for preparing such a composition.