Dissolution is a key quality attribute for solid dosage forms and needs careful attention during pharmaceutical development.
Whether the dosage form is immediate release or modified release, we offer dissolution method development support, using state-of-the-art USP-1, USP-2 and USP-4 equipment.
Our dissolution testing services span all phases of drug development:
- For early clinical phase projects, especially where enabling formulation technologies are applied, we develop bio-relevant dissolution methods.
- For late clinical phase projects, we develop robust and discriminative methods. For this purpose, often aberrant drug product batches are manufactured to support the dissolution method development.
- For drug products reaching commercial phase registration, we offer the necessary dissolution services to meet regulatory requirements.