Gadobenate Dimeglumine Spray-Drying Process for Solid Form Stability
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current methods for preparing solid forms of contrast agents like gadobenate dimeglumine often result in undesirable structural or chemical changes, such as polymorphic changes, solvate formation, or glassy forms, which can affect the purity, stability, and handling of the final product.
Innovation Solution
A spray-drying process is employed to convert a liquid composition of gadobenate dimeglumine into a solid form, using a two-fluid nozzle or pressure nozzle, with controlled inlet and outlet temperatures, and co-current flow of a drying gas, achieving high yields and maintaining the specifications of the starting composition.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If selective precipitation, evaporation, lyophilisation or crystallization methods are used to obtain solid form of gadobenate dimeglumine, then the product can be obtained in solid form, but undesirable structural or chemical changes such as polymorphic changes, solvate formation, or glassy forms occur
Solution Approach 1:
The patent changes the physical parameters of the drying process by using spray-drying with controlled inlet temperature (120-200°C) and outlet temperature (40-80°C), along with controlled residence time and atomization parameters, to obtain the solid form without undesirable polymorphic changes or solvate formation that occur with conventional methods
Solution Approach 2:
The patent replaces the conventional mechanical isolation and purification techniques (filtration, centrifugation, multiple drying steps) with a spray-drying process that achieves solid form conversion in a single integrated operation, eliminating the need for subsequent isolation and purification steps
2Stability of the object's composition
If multiple isolation and purification techniques are employed to convert liquid or oily product into solid form, then the solid form is obtained, but the process complexity and time increase
Solution Approach 1:
The patent combines multiple operations (isolation, purification, and solid form conversion) into a single spray-drying step, where the liquid composition is atomized and dried to produce the solid powder in one continuous process, eliminating the need for separate filtration and drying steps
Solution Approach 2:
The patent performs preliminary optimization of the spray-drying parameters (inlet temperature, outlet temperature, feed rate, atomization pressure) before the actual process to ensure that the solid form is obtained directly with the desired properties, avoiding the need for subsequent adjustments or reprocessing
3Quantity of substance
If conventional drying methods are used, then the product can be dried, but the handling and storage convenience is reduced due to glassy forms or solvate formation
Solution Approach 1:
The patent optimizes the drying parameters including inlet temperature (120-200°C), outlet temperature (40-80°C), and residence time to produce a free-flowing powder with optimal particle size distribution, avoiding glassy forms and solvates that compromise handling convenience
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 process produces a stable, water-soluble powder with optimal particle size and purity, suitable for pharmaceutical use, maintaining quality and safety standards, and allowing for convenient storage and administration.
Implementation Method 1
A spray-drying process is employed to convert a liquid composition of gadobenate dimeglumine into a solid form
Implementation Method 2
with controlled inlet and outlet temperatures, and co-current flow of a drying gas, achieving high yields and maintaining the specifications of the starting composition
Data Source
AI summary
The present invention discloses a process for the preparation of gadobenate dimeglumine complex in a solid form. In particular, said solid form is conveniently obtained by spray-drying a corresponding liquid suspension at a given temperature and concentration. The present invention is particularly advantageous for the industrial scale as the solid form may be obtained by employing water as a solvent, which is a non-toxic solvent, easy to handle and basically not requiring troublesome health or safety precautions.