Sinoway has been committed to new high-technology in pharmaceutical industry, serving all customers. Today, we will introduce Supercritical CO2 Crystallization Technology .

What is Supercritical CO2 Crystallization Technology ?

By dissolving the API in a suitable organic solvent to form a solution, and Supercritical CO2 is used as antisolvent to precipitate solid particles quickly, so as to form fine particles with good flowability.

Characteristics of Supercritical CO2 Crystallization

● FDA approved technology

● The process can be rapid scaled up

● Low residual solvent and good secondary processing behaviour

● Well control of particle size (200nm -10um)

● Very good flowability

Applications of Supercritical CO2 Crystallization

1. Single step process with low cost of manufacture, which can change crystallization form

2. Improve the performance of both small molecule and biological medicines(large molecule), e.g. solid form control, poorly soluble drugs, optimising inhaled delivery;

3. Control particle size by uniforming morphology;

4. Transform natural extracts which are difficult to crystallize - very sticky extractum (containing>20% water) into dry powder by Single step process

5. Functional excipients or API can also be introduced into the Supercritical CO2 Crystallization process, to produce formulated particles enabling product features such as controlled release, coated particles for taste masking and combination therapy (combination products to make scalable co-crystals)

6. Vaccine programme - reformulating an injectable biotherapeutic for Dry Powder Inhalation (DPI)

7. Optimising for solubility, stability, bioavailability, targeted delivery

8. Biopharmaceuticals: attractive alternative to complex spray and freeze drying technologies (Opportunities for sterile processing)

9. Potentially able to eliminate impurities by exploiting different solubility.

10. Ability to crystallise materials that cannot be conventionally crystallised.

Sinoway is well-prepared for receiving CDMO projects using this particular Supercritical CO2 Crystallization technology, please be free to send inquiries if it can help with your on-going projects.