Enhanced solubility of a poorly soluble drug from oral administration

Situation: The client requested three strengths of immediate release capsules for a blinded study using a drug with extremely poor solubility across the pH range. In addition, a simple dry blend method of manufacture in combination with the three strengths compounded with the lack of wettability of the drug, created distinct processability and uniformity problems.

Task: We needed to increase the solubility of the drug to achieve immediate release (NLT 75% at 60 minutes).

Action: We were able to improve wettability using a GRAS surfactant which could be incorporated into a dry blend process. This resulted in improved dissolution rate (from 40% to 100% release at 60 minutes) within the restraints of a dry blend method of manufacture.

Result: This contributed to the client's product being successfully formulated and manufactured for clinical trials.