We have developed superior expertise and built an advanced instrumentation base to perform in vitro release testing (IVRT) and dissolution project analysis of all solid and semi-solid topical dosage forms:
Dissolution Testing for Solid Dose Formulations:
- 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 and validation of release rate studies for topical formulations, including creams, lotions, ointments, gels, pastes and less viscous solutions and suspensions, as well as transdermal patches.
Our services include:
- In-process testing for formulation optimization
- Quality control, lot to lot variability
- Skin penetration, depth profiling and absorption studies for Bioequivalence or Bioavailability evaluation
- In Vitro and analytical method development and validation in full complaince with SUPAC-SS 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 semi-solid, pulmonary and rectal/vaginal formulations. As well, our expertise extends to paddle over disk apparatus for transdermal patches. As a result we can meet the challenges of the most complex in vitro release tasks while keeping to strict timelines in a cost-effective manner.
