In-vitro Models are important as alternatives to animal & human testing and are key to efficacy & safety assessment activities. In-vitro evaluation, we provide a complete suite of drug release assays and biowavier studies for a variety of dosage forms ranging from simple tablets to transdermal formulations.
As drug products continue to increase in complexity, there has been a growing initiative to enhance evaluation by introducing the concepts of quality target product profile (QTPP) and quality by design (QbD). By complementing the traditional paradigm of ‘equivalence by testing,’ the current framework encourages the use of appropriate surrogates to target ‘pharmaceutical equivalence by design.
In-vitro binding studies for Systematic & non systematic drugs:
>In-vitro studies for quantitative capsule rupture test (QCRT) :
Nasogastric and gastronomy (NG) tube in- vitro studies:
Topical and transdermal in-vitro release testing (IVRT)
In vitro release of API from topical and transdermal products, and subsequent permeation through a membrane, can be tested in a vertical diffusion cell (i.e. Franz diffusion cell). In this apparatus, formulation is applied or put in contact with a membrane that is in contact with a receiving medium. The receiving medium is sampled as a function of time and API is quantities to determine a permeation/flux profile. Membrane materials include synthetic polymer, tissue constructs. The choice of membrane is driven by the purpose of the test (i.e. development vs. quality control) and robustness of the model. This technique is applicable not only to externally applied topical formulations, but also to products that deliver via the vaginal, rectal, buccal, or nasal routes.
Micro bail In-Vitro evaluation:
- In-vitro microbial kill rate study as per USFDA guidance
- In-vitro Evaluation of the Antimicrobial properties for various application.
Further Questions :
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