How To Get The Ideal Lyophilized Antibiotics Preparations?
How to get the ideal lyophilized antibiotics preparations? There are mainly three ways, improving the pre-freezing process, well controlling the temp. during the drying period, and choosing a lyophilization machine with ensured quality. The following is a detailed explanation.
How to get the ideal lyophilized antibiotics preparations — improving the pre-freezing process
The lyophilization process of antibiotics mainly includes three parts: pre-freezing, sublimation drying, and analytical drying. The pre-freezing process is a key step to control the particle size and shape. Common pre-freezing methods are divided into one-time pre-freezing and staged pre-freezing. There are two ways to pre-freeze at a time, fast pre-freezing and slow pre-freezing. Compared with the slow pre-freezing method, the fast pre-freezing method can obtain a smaller particle size of the freeze-dried preparation, and the lower the pre-freezing temperature, the faster the cooling rate, and the smaller the particle size of the obtained lyophilized antibiotics preparations. However, under rapid pre-freezing conditions, the viscosity of the suspension may increase more within 24 h. If the particle size is too small, the stability of the product may be affected. And some experiments have shown that the vial is easy to stick to the plate during rapid pre-freezing, and the bottom of the vial is prone to crack or drop. Therefore, it is often necessary to adjust the cooling rate step by step to achieve the purpose of controlling the particle size and shape during the freeze drying process in pharmaceutical.
How to get the ideal lyophilized antibiotics preparations —well controlling the temp. during the drying period
The drying period is important during the lyophilization process. In addition to the pre-freezing method, temperature control during the drying process is another key point to obtain ideal lyophilized antibiotics preparations. The heat required in the drying process comes from the heat transfer from the shelf to the freeze-dried preparation. If the heat is insufficient, the drying speed will decrease. but when the temperature of the freeze-dried preparation is higher than its eutectic point (triple point), the glassy skeleton will not be formed, and the freeze-dried preparation will collapse. Therefore, in order to obtain an ideal freeze-dried appearance, the drying temperature should be 5-10°C below the triple point. Under this premise, the higher the partition or drying temperature, the faster the sublimation speed and the shorter the drying time.
How to get the ideal lyophilized antibiotics preparations — choosing a high-quality freeze dryer
The two mentioned methods can both be tried during the freeze drying process in pharmaceutical. The last thing to mention is nothing to do with the process. That is, the performance of the freeze dryer lyophilizer. Different brands and models of freeze dryers have different performances. Freeze-drying equipment with good performance, low condenser temperature, large ice load capacity, the small temperature difference between each shelf, good uniformity; fast pumping speed, good and stable vacuum are the standard to judging a well-performance freeze dryer. The use of such a good machine not only saves freeze-drying time but also obtains high-quality lyophilized antibiotics preparations by optimizing the freeze-drying curve.