Drug In Vitro Testing


CD Bioparticles offers one-stop drug-carrier complex analysis package service including drug in vitro testing using advanced techniques. Our experienced scientists have created a comprehensive platform to measure the drug in vitro testing from different perspectives.

The Importance of Drug In Vitro Testing

A fully validated dissolution in vitro release method is one of the control tools to ensure that quality and clinical performance are maintained throughout the lifecycle of the drug products. For example, in vitro release methods may aid in the characterization of liposome integrity, and in quantifying free versus encapsulated drugs. Like drug products without nanomaterials, drug products containing nanomaterials should have dissolution/in vitro release methods capable of discriminating formulation and manufacturing differences which may impact the clinical performance of the drug product. In addition to in vitro drug release, drug in vitro testing also includes in vitro toxicity test, in vitro drug sensitivity tests and so on.

In Vitro Drug Release

Dialysis tube diffusion technique has been used widely to measure drug release in vitro. The dialysis bag membrane should be selected following the screening of various membranes, no drug adsorption may occur and the membrane should be freely permeable to the active ingredients. Some milliliters aliquot of bioparticles suspension is placed in the dialysis bag, hermetically tied and dropped in the receptor compartment containing the dissolution medium. Samples of the dialysate are taken at various time intervals and assayed for the drug analysis by High Performance Liquid Chromatography (HPLC), spectrophotometer or any other convenient methods. Our dialysis tube diffusion technique platform could help our client to collect the information of in vitro drug release rate with high accuracy and rapid turnaround time.

Figure 1. The chart of in vitro release models (Flavian S. R., et al. Farmacia. 2015, 63(2): 211-217.)

In Vitro Toxicity Test

It is essential to evaluate the toxicology potential of drug candidates at an early stage to save time and investment before clinical trials. Nanoparticle might affect drug toxicity due to its formulation composition, thus toxicity assessment becomes a more important parameter to characterize. Various tests in vitro have been recommended by most regulatory authorities with advantages including lower cost, high-efficiency, and minimum ethical concerns. Assessment can be subdivided into proliferation assay, apoptosis assay, necrosis assay, oxidative stress assay, and DNA damage assay.

The Method of In Vitro Toxicity Test

In Vitro Drug Sensitivity Tests

The collagen gel droplet-embedded culture drug sensitivity test (CD-DST) is a method for embedding cells within a collagen matrix which allows analysis in a small number of cells. A characteristic and reproducible pattern of organization and growth occurs: the cells rearrange themselves and produce duct-like structures extending into the matrix, resulting in a three-dimensional outgrowth. Further, a detection model for drug sensitivity in vitro is formed. Our CD-DST platform could help our client to test the drug sensitivity with good correlation to other methods like immunohistochemistry or cDNA microarray.

Figure 2. Immuno-CD-DST for evaluation of the sensitivity to anticancer drugs. (Eiji M. et al. Oncology Reports. 2013, 30: 2845-2851)

CD Bioparticles offers a full set of service for drugs in vitro testing, including in vitro drug release, in vitro toxicity test, and in vitro drug sensitivity tests. For more detailed information, please feel free to contact us or directly send us an inquiry.

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References:
1. Eiji M., et al. Protein-bound polysaccharide-K augments the anticancer effect of fluoropyrimidine derivatives possibly by lowering dihydropyrimidine dehydrogenase expression in gastrointestinal cancers. Oncology Reports. 2013, 30: 2845-2851.
2. Flavian S. R., et al. Comparative in vitro drug release evaluations of new hydrogels containing oxicams. Farmacia. 2015, 63(2): 211-217.
3. A. Laouini, et al. Preparation, Characterization and applications of liposomes: state of the art. Journal of Colloid Science and Biotechnology. 2012, 1: 147–168.

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