We have developed superior expertise and built an advanced instrumentation base to perform dissolution project analysis of all topical dosage forms:
Dissolution testing for solid dosage forms
- Testing for USP monograph articles
- Drug release testing
- Content Uniformity testing
- Immediate and controlled release testing
- Method Development and Validation
- Reformulation and Stability supporting testing
In Vitro Drug Release Studies for Topical Semi-solid Formulations
We have staff with superior scientific expertise dedicated to Method Development/Validation of release rate studies for the topical formulations: creams, lotions, ointments, gels, pastes and less viscous topical suspension solutions, as well as transdermal patches.
Our services include:
- In-process testing for formulation optimization
- Quality control, lot to lot variability
- Skin penetration studies for Bioequivalence/Bioavailability evaluation
- In Vitro and analytical Method Development & Validation in full complaince with SUPAC and FDA requirements
- In Vitro release comparison testing for pre- and post-changes formulations
- Data interpretation and FDA submission for approval of SUPAC-related changes.
Diteba's scientists possess in-depth expertise in operating Franz Cell and Enhanced Cell systems for semisolid formulation as well as Paddle over disk apparatus for trans-dermal patches. As a result we can meet the challenges of the most complex tasks while keeping to strict timelines in a cost-effective manner.