In Vitro Studies

 

Raptim Research Private Limited is a global, independent and internationally accredited Contract Research Organization (CRO), established in 2005 with state-of-the-art clinical research facilities at Mumbai and Gandhinagar.

Our services span early development, clinical development and post-approval and include comprehensive CRO capabilities.

At Raptim Research, we believe that In-Vitro Studies can be considered as a tool to meet regulatory requirements for demonstrating bioequivalence (BE).

Raptim provides different types of In-Vitro services to demonstrate Bioequivalence

  1. In Vitro Release Test (IVRT) and In Vitro Permeation Test (IVPT) for topical products
  2. BCS Bio-waiver studies
  3. In Vitro Binding Studies
  4. In Vitro Feeding Tube Studies

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1. In Vitro Release Test (IVRT) and In Vitro Permeation Test (IVPT) for Topical Products

  • Raptim Research, a leader in IVRT and IVPT studies, provides complete topical product development services utilizing in-vitro/in-vivo penetration models and other scientific tools.
  • We offer full compliance method development, validation and testing services with SUPAC-SS (as per FDA) and USP general chapter <1724> guidance that continue to meet the fast-growing demand for these type of topical and transdermal drug analytical services with the most up to date regulatory requirements.
  • We perform Method Development and Validation using Franz Diffusion cells. Our dedicated lab is equipped with:
    • 11 fully automated Franz diffusion cells system with 192 cells from Logan and Hanson and with this set up we can handle multiple studies at a time
    • In-vitro test with Human Cadaver skin / Nail (IVPT) and with synthetic membranes (IVRT)
    • Mass Balance Studies with Human Cadaver Skin quantifying drug present in different layers of skin (i.e. Stratum conium, Epidermis & Dermis)
    • Developing and validating in-vitro permeability method for products with different routes of administration e.g. Topical (Cream, Ointment, Lotion, Gel, Suspension, Pump spray, foam, Nail Lacquers), Sublingual, Buccal, Ophthalmic, Vaginal and Rectal

Raptim experience (Please reach out to us for complete details):

IVRT Studies

  • Acyclovir Ointment
  • Diclofenac Gel
  • Lidocaine Gel
  • Dapsone Gel 5% and 7.5%

IVPT Studies

  • Tacrolimus
  •  Rivastigmin Patch
  • Penciclovir Cream

2. BCS Bio-waiver Studies

Raptim Research’s Proposed Methodology:
  • Feasibility:
    • Evaluation of bidirectional permeability of test drug at two concentrations
  • Development and Pre-study Assessment:
    • Optimization of Assay method for permeability assessment
    • Tolerance of the test drug (at 100% drug concentration) by the cell monolayer
    • Bidirectional Permeability to evaluate drug transport
    • Nonspecific binding of the test drug
    • Quantity of drug and maximum time required to reach equilibrium to evaluate solubility class
    • Analytical method development on HPLLC and LCMS
  • Pivotal Studies:
    • Unidirectional permeability without permeability markers.
    • Bidirectional permeability at three concentrations of test drug (1%, 10% and 100% of the highest dose of test drug) with permeability markers
    • Solubility study (USP buffers, range 1 to 6.8) at 37 ± 1°C
    • Gastro-intestinal stability of test drug
    • Analytical method validation

Raptim experience (Please reach out to us for complete details):

Bio-waiver studies using Caco2 cell Lines

  • Buspirone – 2 studies (Approved by USFDA – 3rd May 2018 and 16th Apr 2019)
  • Ramelteon (Approved by USFDA) 10th Apr 2020
  • Imatinib (2 studies)
  • Varenicline (3 studies)

3. In Vitro Binding Studies (Please reach out to us for complete details)

  • The BE approach is not applicable for locally acting gastro intestinal drugs such as Sevelamer carbonate Lanthanum carbonate, Colesevelam, sucroferric oxide since they are not intended to be absorbed into the systemic circulation
  • The drug concentration needs to be estimated at the local GI tract site. USFDA has developed product specific guidelines for In-vitro BE studies.
  • The In-vitro equilibrium and kinetic binding studies to compare the extent and rate of binding affinity between Test and Reference formulations. Assay to be performed with minimum 12 replicates
  • The in-vitro binding studies have to be conducted at various pH conditions
  • Equilibrium and kinetic studies also include acid pretreatment condition (pH 1.2)

Raptim experience

  • Colesevelam Tablets and Colesevelam Suspension
  • Sevelamer Tablet and Sevelamer Suspension
  • Sucralfate suspension

4. In Vitro Feeding Tube Studies

At Raptim Research, we have developed and established in-vitro feeding tube studies which include:

  • Comparative recovery testing
  • Particle size distribution study
  • Comparative acid resistance stability testing
  • Sedimentation volume testing

Raptim experience

  • Mycophenolate mofetil oral suspension
  • Lansoprazole delayed release capsule
  • Dexlansoprazole delayer release capsule
  • Ticagrelor tablet