Formulation of Sterile Powders

• Formulation of Sterile Powders involves designing dry, aseptic drug products for reconstitution before injection, ensuring stability and sterility.
• Formulation of Sterile Powders requires strict aseptic processing, suitable excipients, and lyophilization to maintain product integrity.
• Sterile powders are prepared by removing moisture from a solution or suspension to produce a dry product that can be reconstituted before use.

Steps in Formulation of Sterile Powders:

1. Preparation of the Solution:

   • The drug and excipients are dissolved or suspended in a suitable vehicle.
   • Common excipients include stabilizers, bulking agents (e.g., mannitol), and buffers.

2. Sterilization:

   • The solution is sterilized by filtration or heat to ensure microbial absence.

3. Freeze-Drying (Lyophilization):

   • The sterilized solution is frozen, and water is removed by sublimation under reduced pressure.
   • Lyophilization maintains drug stability, especially for heat-sensitive biologics or peptides.

4. Packaging:

   • The powder is filled into sterile vials under aseptic conditions and sealed with rubber stoppers and aluminum caps.

Advantages of Sterile Powders:

• Enhanced stability for drugs sensitive to hydrolysis.
• Extended shelf life.
• Convenient storage and transportation.

Examples:

• Antibiotics like ceftriaxone, vaccines, and certain biologics.

Thank you for reading from Firsthope's notes, don't forget to check YouTube videos!