In vitro studies are critical to the drug and wellness product development due to their ability to provide a basis for clinical in vivo studies for predicting best delivery model to take Go/No-Go decision. Our solution on in vitro analyses can provide proof of concept on delivery dosage form in the early stages or reverse pharmacology development of the active process, when the selectivity and possible interactions of the candidate drug towards the desired therapeutic target are established. Our team can provide solution map on case to case basis for your specific requirement.
In vitro Models are important as alternatives to animal & human testing and are key to efficacy & safety assessment activities.In vitro evaluation provides a complete suite of drug release assays and biowaiver 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 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.
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