Freeze Drying Of Pharmaceuticals And Biopharmaceuticals
Illustrated By The Case Of Freeze Drying Of Leeches
In the freeze drying of pharmaceuticals and biopharmaceuticals, we take the lyophilization of leeches as an example to fully show you the whole drying process.
Lyophilization of biopharmaceuticals (leeches) — background
The body of leech contains hirudin, heparin, and antithrombotic. It can be used to treat cardiovascular and cerebrovascular diseases, unexplained swelling and pain, and tumors.
There are several processing techniques of this biopharmaceutical, but vacuum freeze-drying is the best for its uncomparable advantages: 95%-99% moisture excluded, long shelf life after sealing; light weight, easy to carry and transport; a large available interior and surface area.; little-lost material composition; non-damaged proteins, cells, and other heat-sensitive substances; stable structure and unchanged biologic activity; good rehydration and high efficacy.
Lyophilization of biopharmaceuticals (leeches) — introduction
In the lyophilization of leeches as a biopharmaceutical, the leeches are pre-frozen, cut into blocks, and installed in a tray; the tray is placed in a lyophilization machine to freeze the inside water, sublimate and dry in a high vacuum state, so that the water content of the leeches drops below 10%, and then heat the leeches for the vacuum drying stage to drop the content further until it reaches the requirement. The leech after drying in this process retains the active ingredients and active substances, and has low water content.
Lyophilization of biopharmaceuticals (leeches) — notes
1. Arrange the leeches monolayer neatly, and pre-freeze them until the central temperature of this biopharmaceutical is below 0°C, -3°C is better.
2. The cutting time should be as short as possible to prevent the loss of juice after the temperature rises.
3. In the freeze drying of pharmaceuticals and biopharmaceuticals (leech), slow freezing should be adopted: maintain the layer temperature separately for half an hour when it is 0°C, -10°C, -20°C and -30°C, and finally maintain it for 1.5 hours when the layer is reduced to -40°C. The temperature of the leech after freezing should be lower than -20°C, -20°C is better.
4. During the freeze drying process, the temperature of the leech should not be higher than -20°C, -30°C is preferred.
5. During the vacuum drying stage of the freeze drying process in pharmaceutical (leeches), slow heating should be adopted. After the vacuum drying, the temperature of the leech should not be higher than 3°C., preferably 1°C.
Lyophilization of biopharmaceuticals (leeches) — procedure
The freeze drying process in pharmaceutical, here we take that of leeches as an example, is shown below:
1. Pre-freeze the leeches monolayer on the shelf until the central temperature of the leeches drops to -30°C.
2. Take out the freezing leeches quickly and cut them into pieces, with the largest face of the piece no more than 1 cm².
3. Put the leeches in a vacuum freeze drying machine, turn on the layer temperature control, set the layer temperature to 0 °C, -10 °C, -20 °C, -30 °C, and maintain for half an hour respectively, and finally set the layer temperature to -40°C and keep it for 1.5 hours. This freezing stage takes 3 hours and the central temperature of the leech drops to -38°C;
4. The cold trap is then cooled to -40°C and maintained for 10 minutes. Turn on the vacuum pump and start to evacuate. When the pressure reaches 30Pa, increase the layer temperature to supplement the heat required for water sublimation, so that the temperature of the leech will not too low; at the same time, ensure the temperature no higher than -3°C. The water content of the leech is reduced to 10% in this process.
5. Set the layer temperature to 0°C and -30°C successively, and maintain each temp. for 3 hours This process takes 6 hours. After re-pressing, the leeches were taken out, and the water content was tested to be 3%.
Above is all we can say regarding the freeze drying of pharmaceuticals and biopharmaceuticals: background, introduction, notes that require attention and finally the freeze drying process in pharmaceutical (leeches). Wish this article could help you!