Membrane Emulsification and Sedimentation Microsphere Preparation Technology

CD Formulation can provide customers with membrane emulsification and sedimentation microsphere preparation technology, which combines the advantages of membrane emulsification and microfluidic methods, avoiding the shortcomings of each method, and also realizing the continuous production of microspheres. The membrane emulsification sedimentation microsphere production process fills the gap of microsphere production technology, microspheres from small pilot to pilot, or from pilot to production, can be achieved by unchanging the device and relying on the extension of production time.

Fig.1 Diagram of membrane emulsification and sedimentation process.

What is Membrane Emulsification and Sedimentation Microsphere Preparation Technology

The membrane emulsification and sedimentation method is based on the SPG membrane emulsification method. In order to avoid the destruction of the microspheres without the use of mechanical stirring and other methods of external force, but to make the embryonic microspheres through their own gravity, in the water solution containing emulsifier natural settlement, in the longer settlement process of organic solvent extraction, the embryonic microspheres can be cured, after it settles to the bottom of the container transferred to the water cleaning, packaging, lyophilization, and then the finished microspheres can be obtained. It avoids the collision between embryonic microspheres and the destruction of shearing force such as stirring, which simplifies the process of microsphere enlargement and solves the problems of difficult aseptic production and higher equipment cost due to the operation of lyophilization, sieving and dry powder canning.

How to Improve the Process of Microsphere Preparation

Due to the existence of magnetic stirring in the membrane emulsification experimental equipment, the excessive shear force for the microspheres that have not been completely cured will lead to adhesion between the microspheres resulting in particle size inhomogeneity, and even easy to cause drug leakage and thus affect the encapsulation rate. Under the action of nitrogen, the dispersed phase is extruded from the SPG membrane pores to form uniform emulsion droplets, which enter the long glass column filled with external aqueous phase, and the emulsion droplets gradually solidify and harden while falling by their own gravity, and then sink to the bottom to complete the initial curing and become "embryonic microspheres". filling. One of the advantages of this process is to reduce the loss of protein peptide drugs caused by magnetic stirring and other shearing forces, and the collision and adhesion of microspheres; on the other hand, the design concept of integration without stirring is applied in industry to simplify the operation of asepsis and other operations, and the realization of mass production.

How to Produce Microspheres

1. Porous membrane conditioning to form microspheres, colostrum through the uniform micropores in the membrane to form uniform size embryonic microspheres;
2. Settling-assisted microsphere curing, where the embryonic microspheres extract organic solvents during settling in the external aqueous phase and the microspheres are cured in a moderate, agitation-free environment;
3. Microsphere collection.

Advantages of the Membrane Emulsification Settling Microsphere Preparation Process

• Microsphere preparation process becomes self-consistent and parsimonious, allowing for the production of microspheres on a large scale;
• Stir-free integration design concept for self-regulation and quality control of microsphere preparation;
• Better protection of protein drugs, on the one hand the drug does not come into contact with
• Better protection of protein drugs, on the one hand, the drug does not come into contact with the oil-water interface, and on the other hand, the loss of protein-peptide drugs due to shear forces is avoided.
• Exploring suitable process parameters, we can obtain long-lasting slow-release microspheres with high encapsulation rate, uniform particle size, ideal release profile and high reproducibility, and achieve process simplification and quality reproduction of microsphere preparation at pilot scale validation level.

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