Are you working with complex dosage forms?
Emerging formulations and novel drug delivery technologies require a revised approach to in-vitro drug release testing. Due to the complex nature of these formulations, extensive testing and development are crucial to ensure patient safety and efficacy.
Long Acting Injectables (LAI) such as microspheres, liposomes, injectable suspensions, and other complex dosage forms like ophthalmic suspensions, coated medical devices (e.g., stents), creams, gels, and implants are becoming increasingly common. They offer unique advantages such as sustained drug release, targeted delivery, improved bioavailability, and reduced side effects. However, their complex nature requires extensive testing and development to ensure safety, efficacy, and regulatory compliance.
To optimize development and minimize time to market, SOTAX Pharma Services offers a wide range of services to support you in the development of complex release profiles and the appropriate analytical methods:
- IVRT Method Development
- Microdialysis-based IVRT
- Q3 Characterization
- IVIVC
- and many more
Set in a US FDA-inspected facility, with a cGMP-compliant environment, the scientific expertise of the SOTAX Pharma Services staff paired with state-of-the-art instrumentation ensures best in class services and ease of regulatory compliance for you.
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