When a drug must be preserved over a long period under uncontrolled conditions, pharma developers turn to lyophilization. By removing residual moisture without applying intense heat, safeguards active pharmaceutical ingredients (APIs) in the five following ways:
1. It increases the stability of your API.
Lyophilized APIs remain stable much longer than that traditionally processed drugs, because the lack of moisture in the vial prevents degradation.
2. It lengthens the room-temperature shelf life of your drug.
A lyophilized drug never has to be placed in cold storage in order to remain stable. It can retain its efficacy for weeks or even months at room temperature.
3. It reduces the weight and volume of your formulation.
While lyophilized drugs lose none of their potency, they do lose a significant amount of their weight and volume, making them less expensive to transport.
4. It guarantees the sterility of your API.
A lyophilized API remains sterile until its vial is opened, whether it’s stored in a locked freezer or on a room-temperature shelf.
Lyophilization presents a wide range of challenges. At VxP, we’re adept at overcoming them.
