In-Vitro 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)

In-vitro Release Test (IVRT) & In-vitro Permeability Test (IVPT) – Raptim is one of the only CRO having 5 USFDA approvals for IVPT studies and having extensive experience in IVRT & IVPT studies. We perform Method Development and Validation using Franz Diffusion cells and our dedicated lab is equipped with 14 Franz diffusion cell consoles of Logan with auto-sampler and 288 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 Hydrochloride and Carbonate Tablet and Sevelamer Suspension.

Sucralfate suspension and Sucralfate Tablet Sucroferic oxyhydroxide Tablet

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, Dexamphetamine, Velbenazene, Pimavanserin, Migalastat, Cevimiline, Guanfacine, Amitriptyline, Brivaricetam, Lofexidine, Vareniciline, Levorphanol, Cyclophosphamide, Solriamfetol, Lormetazepam and Propranalol.
  • Feasibility done for Temozolomide, Roxulitinib,

Drug Characterisation for Nasal spray and Inhalation products

In vitro BA and BE for locally acting drugs delivered by nasal aerosol or nasal spray are usually characterized using seven tests-

  1. Single Actuation Content Through Container Life,
  2.  Droplet Size Distribution by Laser Diffraction,
  3. Drug in Small Particles/Droplets, or Particle/Droplet Size Distribution by Cascade Impactor,
  4. Drug Particle Size Distribution by Microscopy,
  5. Spray Pattern,
  6. Plume Geometry and
  7. Priming and Repriming.

Raptim has performed method developed for few products and can conduct studies to demonstrate equivalence of two products.

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 design (open or closed distal end)
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