Oral Suspension Viscosity Control for Venous Insufficiency
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Solution Overview
Problem
Current treatments for venous insufficiency require high doses of flavonoid fractions, which are metabolized significantly in the gastrointestinal tract, necessitating easy administration forms that are also suitable for elderly patients and those consuming medication outside the home without water.
Innovation Solution
A high-dose drinkable oral suspension in a sachet containing a purified and micronized flavonoid fraction, primarily diosmin, combined with xanthan gum as an excipient, providing specific rheological properties for stability and ease of use, without the need for water and maintaining viscosity across temperature and shear conditions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If high doses of flavonoid fraction are administered to treat venous insufficiency, then treatment effectiveness is improved, but patient compliance deteriorates due to difficult administration
Solution Approach 1:
The invention changes the physical state of the flavonoid fraction from powder to a ready-to-drink liquid suspension, eliminating the need for patients to measure and mix powder with water. This parameter change from solid to liquid form directly improves ease of administration while maintaining the high therapeutic dose, thereby resolving the contradiction between treatment effectiveness and patient compliance
Solution Approach 2:
The invention uses single-use pre-filled sachets containing the liquid suspension. Each sachet is a disposable unit that requires no preparation, making it extremely easy for patients to administer the correct high dose. This disposable format eliminates compliance issues related to dosing errors or improper preparation while ensuring the full therapeutic dose is delivered
2Adaptability or versatility
If flavonoid fraction is administered in powder form requiring water for preparation, then dosing flexibility is improved, but ease of administration deteriorates for elderly patients and those without water access
Solution Approach 1:
The invention segments the dosing system into individual single-use sachets, each containing a pre-measured high dose of flavonoid fraction in liquid form. This segmentation eliminates the need for water-based preparation while maintaining precise dosing control. Each sachet is a self-contained unit that can be administered anywhere without water, directly resolving the contradiction between dosing flexibility and ease of administration
Solution Approach 2:
The invention performs preliminary action by pre-mixing the flavonoid fraction with liquid carriers and stabilizing agents in the factory to create a ready-to-administer suspension. This preliminary preparation eliminates the need for patients to perform any mixing or preparation steps, making administration as simple as opening and drinking, thereby resolving the contradiction between dosing flexibility and ease of operation
3Stability of the object's composition
If xanthan gum is added to prevent sedimentation, then suspension stability is improved, but viscosity increases potentially affecting flow properties
Solution Approach 1:
The invention optimizes the concentration parameter of xanthan gum to a specific range (0.3-0.6% w/w) that provides sufficient suspension stability while maintaining acceptable flow properties. This precise parameter control allows the formulation to achieve both high suspension stability and adequate pourability, resolving the contradiction between these two opposing requirements
Solution Approach 2:
The invention uses a composite thickening system combining xanthan gum with other excipients including cellulose derivatives and possibly protein-based stabilizers. This composite approach creates a synergistic effect where the combination of materials provides superior suspension stability at lower overall concentrations than any single thickening agent alone, thereby maintaining good flow properties while ensuring long-term stability
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 suspension ensures stable viscosity and particle distribution over time, preventing sedimentation and maintaining efficacy, thus enhancing patient compliance and treatment effectiveness for venous insufficiency.
Implementation Method 1
The viscosity of the suspension must not depend on the time during which it is subjected to shear forces. It is necessary that the suspension regains its initial viscosity after application of a stress regardless of its duration of application.
Implementation Method 2
the suspension regains its initial viscosity after application of a stress regardless of its duration of application... allow, on the other hand, the flavonoid fraction not to sediment in the sachet and to be stable over time
Implementation Method 3
The viscosity of the suspension must not depend on the time during which it is subjected to shear forces... The viscosity of the suspension must therefore be reversible over the range 0.01 and 1000s -1
Implementation Method 4
Furthermore, it appears necessary that the viscosity of the suspension is independent of the temperature over the interval 15°C-60°C, the ad hoc temperature range at the end of production and during the stages of transport, processing and packaging of the final product.
Data Source
AI summary
A pharmaceutical composition in the form of an oral suspension comprising diosmin and xanthan gum. Use of the pharmaceutical composition according to the invention in the treatment of venous insufficiency.