This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.Intravail' A3 is under development for use as an excipient (or enhancer) in intranasal drug formulations for administering protein drugs such as insulin, growth hormone and interferon to patients in the form of a simple nasal spray, thus eliminating the need for injection. In small animal studies, Intravail has been shown to be nearly as effective as injection. Intravail is a pure form of a very safe, non-toxic, non-irritating type of substance that is used as a food additive as well as in some cosmetics as an emulsifier. It is not currently used in intranasal drug formulations. In this study, recombinant human insulin (Lyspro insulin - Humalog - manufactured and sold by Eli Lilly as an injectable) will be reformulated and used to determine the effectiveness of the Intravail A3 excipient in a nasal spray formulation in male baboons. A standard nasal spray applicator manufactured by Pfeiffer and in current use in FDA approved products for treatment of human diseases (e.g., Miacalcin a nasally administered protein drug widely used for treatment of osteoporosis in menopausal women) will be used for administration of recombinant human insulin formulations with and without the Intravail excipient. The objective is to determine if Intravail can be used for nasal spray insulin for treatment of diabetes in adults and children. The results will also provide insights into the broader use of Intravail to create non-injected forms of other protein drugs for treatment of other diseases such as breast and prostate cancer, and pain related to metastatic bone cancers not responsive to opioids, endometriosis, and multiple sclerosis, anemia following chemotherapy, growth hormone deficiency, and osteoporosis, among others.
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