In vitro, in vivo assessments

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In vitro assessments

ANALYSTES

Methods development
  • Assay method development or variation (HPLC, spectrophotometer, TLC, burette)
  • Assay method transfer
  • Dissolution method development or variation (USP2- USP4)
  • Dissolution method transfer
  • Development of HPLC method for dissolution
  • Development of spectrometric method for dissolution
  • Water content method development.

BIOPOLE-2010-011

Analytical validation
  • Assay method validation according to ICH Q2R
  • Validation of HPLC and spectrometric method for dissolution
  • Data analysis using a 21CFR part 11 software (e-Noval)
  • Analysis of customer data
Quality control
  • Identification (HPLC, TLC, Colorimetric)
  • pH, density
  • Extractable volume, average volume
  • Water content (Karl Fischer)
  • Average mass, mass uniformity
  • Assay: active ingredient
  • Assay: preservatives
  • Assay: relative substances
  • Content uniformity – mass variation
  • Dissolution (spectrophotometer)
  • Microbiology
Stability studies according to ICH conditions
  • 25°C, 60% RH
  • 30°C, 65% RH
  • 40°C, 75% RH
  • 5°C

In vivo assessments

  • Ex vivo: transdermal and transmucosal permeation using biopsies
  • In vivo: administration to rats, rabbits or mini-pigs of injectable depot (microspheres, implants and microcrystals), buccal bioadhesive tablets, nasal solutions and transdermal gels and creams.
  • Development of LC-MS assays

Examples:

implants              Insuline level in rabbit.png

Download the list of equipment