In-Vitro (IVRT and IVPT) Studies
Raptim Research, a leader in In-Vitro Release Test (IVRT) and In-Vitro Permeation Test (IVPT) studies, analytical method development, provides complete topical product development services utilizing in-vitro/in vivo penetration models and other scientific tools. We offer validation and testing services that continue to meet the fast-growing demand for these types of topical and transdermal drug analytical services with the most up to date regulatory requirements.
Here is a list of our areas of expertise:
- In-vitro Release Test (IVRT) & In-vitro Permeability Test (IVPT) – Raptim is one of the only CRO having extensive experience in IVRT & IVPT studies. We perform Method Development and Validation using Franz Diffusion cells and our dedicated lab is equipped with 11 Franz diffusion cell consoles of Logan with auto-sampler and 120 cells for multiple study conduct.
- In-vitro test with Human Cadaver skin and other types of synthetic membranes
- Mass Balance Studies with Human Cadaver Skin (quantifying drug present in different layers of skin)
- Developing and validating In-vitro permeability tests and accompanying high-end LC/MS-MS and HPLC methods for products with different routes of administration e.g. Topical, Sublingual, Buccal, Ophthalmic, Vaginal and Rectal
- In-vitro Binding Studies –
- Colesevelam Tablets and Colesevelam Suspension
- Sevelamer Tablet and Sevelamer Suspension
- Sucralfate suspension
- BCS Biowaiver studies – Drugs can be categorized into four classes of Biopharmaceutics Classification System (BCS) on the basis of permeability and solubility. For certain drugs, to replace the In-vivo Bioequivalence studies, the BCS-based biowaiver approach can be used. Raptim Research can conduct the BCS Biowaiver studies for your class I and III products.
- Using 20 model drugs, Caco-2 permeability method is established
- Studies conducted for Capecitabine, Ramelteon, Buspirone, Imatinib, and Dexamphetamine
- Feasibility done for Temozolomide, Varenicline, Levorphanol, Cyclophosphamide, and Ethinyl Estradiol
- In vitro Feeding Tube Studies – Individual product specific bioequivalence guidance recommends in-vitro feeding tube studies for products such as oral suspension and capsules containing pellets, granules or beads. This is prescribed for patients who have an underlying disease that makes it difficult to swallow or for intensive care patients.
- Comparative recovery testing
- Particle size distribution study
- Comparative acid resistance stability testing and
- Sedimentation volume testing studies
- Raptim developed this technique under different conditions which includes:
- Different sizes (8 FR to 20 FR) and materials of tubes (PVC, Silicone and Polyurethane)
- Different design (open or closed distal end)
- Different types of water or dispersion media, variations in soaking time prior to administration, and different rinsing volumes