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IN VITRO AND IN VIVO SCREENING OF INTRANASAL INSULIN FORMULATIONS. Cohen, A.S., Sileno, A.P., Peddakota, L.R., Forseth, K.T., Slater, A., Haugaard, D., Foerder, C.A., Brandt, G.C., Quay, S.C., and Costantino, H.R. Nastech Pharmaceuticals, Bothell, WA. Presented at the American Association of Pharmaceutical Scientists (AAPS) Biotechnology Conference, Boston, MA, June 18-21, (2006).

Keywords: Cellular toxicity, Diabetes, ELISA , EpiAirway, In Vivo/In Vitro comparison, Insulin formulation, MTT assay, Nasal administration, Nasal delivery, Permeation, Permeation enhancement, Pharmacodynamic (PD) data, Pharmacokinetic (PK) data, TER Reduction, Transepithelial electrical resistance (TEER)

Materials Tested: Insulin

Summary:
This study demonstrated that MatTek's EpiAirway in vitro human tissue equivalents can be used by pharmaceutical companies to develop intranasal drug formulations that provide improved permeation in vivo of Active Pharmaceutical Ingredients (API's).

Nasal delivery of insulin provides an attractive option for a non-invasive diabetes treatment. To identify a suitable formulation for this application, Nastech Pharmaceuticals Co. used the MatTek EpiAirway in vitro model system to monitor reduction in transepithelial electrical resistance (TER), cellular toxicity, and permeation.

Among all of the formulations studied in vitro, selected formulations were also tested in vivo in a rabbit model to measure intranasal pharmacokinetics and pharmacodynamics.

Using MatTek’s EpiAirway human airway tissue equivalents, Nastech has identified intranasal (IN) insulin formulations that provide improved permeation in vitro and in vivo compared with insulin in a simple formulation devoid of enhancers.

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