Potassium-Sodium Tartrate Tetrahydrate Water-Free Granulation
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
The wet granulation process in pharmaceutical manufacturing is hindered by the need for a drying step, which is energy-intensive and costly, and is not suitable for moisture-sensitive excipients and active ingredients.
Innovation Solution
A platform formulation using Potassium-Sodium tartrate Tetrahydrate (PST) as a water-releasing excipient, which allows for granulation without adding a liquid, by applying thermal energy to release water for nucleation and recrystallization, thereby eliminating the need for a drying step.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If water is added to a raw powder mixture to guarantee particle growth through nucleation, then granulation is achieved, but a drying step is required which is energy-intensive and costly
Solution Approach 1:
The patent extracts the water needed for granulation from the crystal structure of PST (potassium-sodium tartrate tetrahydrate) through thermal energy application, separating the water function from external liquid addition and eliminating the need for subsequent drying
Solution Approach 2:
The patent utilizes phase transition of water from crystalline state (bound in PST) to liquid state (free water for granulation) through thermal energy input, enabling water release without requiring external liquid addition or subsequent evaporation
2Ease of manufacture
If water is added to a raw powder mixture to guarantee particle growth through nucleation, then granulation is achieved, but the process requires additional time for drying
Solution Approach 1:
The patent performs preliminary action by incorporating PST with bound water into the powder mixture before granulation, which then releases water in-situ during the granulation process itself, eliminating the need for separate drying time
3Adaptability or versatility
If conventional wet granulation is used for moisture-sensitive excipients and active ingredients, then granulation can be performed, but the process is not suitable due to moisture sensitivity
Solution Approach 1:
The patent uses PST as an intermediary substance that provides water in a controlled manner through thermal decomposition, enabling granulation of moisture-sensitive materials without exposing them to external liquid water that would cause moisture sensitivity issues
4Productivity
If fluidized bed drying is used to perform drying in continuous manufacturing, then continuity is improved, but equipment complexity and cost increase
Solution Approach 1:
The patent extracts the drying function from the manufacturing process by incorporating water release into the granulation step itself through PST decomposition, eliminating the need for separate drying equipment and enabling true continuous processing without fluidized bed dryers
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
This approach results in stable, non-hygroscopic dry granulates with high tensile strengths suitable for tableting, and can be used for continuous water-free granulation of active ingredients, simplifying product development and manufacturing processes.
Implementation Method 1
PST is releasing its water of hydration by the application of the previous described energy input methods
Implementation Method 2
applying thermal energy, such as heat, IR-waves, or microwaves to the powder mixture
Implementation Method 3
provide free water for nucleation and profit of the recrystallisation of the salt resulting in dry granulates
Implementation Method 4
profit of the recrystallisation of the salt resulting in dry granulates
Data Source
AI summary
The present invention relates to a powder mixture for the preparation of a granulate comprising as constituent at least a filler or at least an active ingredient or both and as granulation aid potassium sodium tartrate tetrahydrate (PST). Optionally constituents of the powder mixture to be granulated are binders, disintegrants and further customary auxiliaries. It was an object of the present invention to provide a powder mixture which can be granulated without adding a liquid but where the water for the granulation is released in-situ from PST. An additional drying step is not required.