THE VALUE OF A FUNCTIONAL EXCIPIENT ADDITIVE TO HUMAN INSULIN THERAPIES: FROM MANUFACTURE TO HUMAN CLINICAL TRIAL

THE VALUE OF A FUNCTIONAL EXCIPIENT ADDITIVE TO HUMAN INSULIN THERAPIES: FROM MANUFACTURE TO HUMAN CLINICAL TRIAL

Bibliographic Details
Main Author: El Sanadi, Caroline Elizabeth
Language:English
Published: Case Western Reserve University School of Graduate Studies / OhioLINK 2015
Subjects:
Medicine
Health Sciences
Biomedical Research
Biology
Insulin
Diabetes
Type 1 Diabetes
Type 2 Diabetes
Liver
Biotechnology
Pharmaceutical
Functional Excipient Additive
Online Access:http://rave.ohiolink.edu/etdc/view?acc_num=case1450286879
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spelling ndltd-OhioLink-oai-etd.ohiolink.edu-case14502868792021-08-03T06:34:36Z THE VALUE OF A FUNCTIONAL EXCIPIENT ADDITIVE TO HUMAN INSULIN THERAPIES: FROM MANUFACTURE TO HUMAN CLINICAL TRIAL El Sanadi, Caroline Elizabeth Medicine Health Sciences Biomedical Research Biology Insulin Diabetes Type 1 Diabetes Type 2 Diabetes Liver Biotechnology Pharmaceutical Functional Excipient Additive While many effective therapeutics exist for management of diabetes mellitus, repeatedinsulin usage leads to its own potential associated physiologic side effects such asvascular disease and kidney failure. Current insulin therapeutics are designed in such away that recombinant DNA insulin and insulin analogs must be injected into the body’ssubcutaneous tissue. This exogenous insulin gradually suffuses until an appreciableamount eventually reaches the adipose, muscle, and the liver. A clinical need exists for analternative that makes delivery of insulin to the bloodstream (and then liver) a moreefficient process so that patients may ultimately use less insulin to manage their disease.This work describes preclinical development, manufacturing, and early-stage clinical trialprocess for a vesicular nano-carrier system comprised of lipid components and a liver(hepatocyte) -specific targeting molecule. It also describes the unique value of thistechnology, its financial value, and a business analysis of the technology. ThisHepatocyte-Directed Vesicle (HDV) platform can be combined with any commercialinsulin therapy and is currently the only functional excipient additive in the clinical trialprocess that directly targets insulin to the liver for the treatment of Type 1 diabetes. Thescope of this work primarily focuses on the application of this HDV-Insulin technologyfor insulin therapies in diabetic populations. 2015 English text Case Western Reserve University School of Graduate Studies / OhioLINK http://rave.ohiolink.edu/etdc/view?acc_num=case1450286879 http://rave.ohiolink.edu/etdc/view?acc_num=case1450286879 unrestricted This thesis or dissertation is protected by copyright: all rights reserved. It may not be copied or redistributed beyond the terms of applicable copyright laws.
collection NDLTD
language English
sources NDLTD
topic Medicine
Health Sciences
Biomedical Research
Biology
Insulin
Diabetes
Type 1 Diabetes
Type 2 Diabetes
Liver
Biotechnology
Pharmaceutical
Functional Excipient Additive
spellingShingle Medicine
Health Sciences
Biomedical Research
Biology
Insulin
Diabetes
Type 1 Diabetes
Type 2 Diabetes
Liver
Biotechnology
Pharmaceutical
Functional Excipient Additive
El Sanadi, Caroline Elizabeth
THE VALUE OF A FUNCTIONAL EXCIPIENT ADDITIVE TO HUMAN INSULIN THERAPIES: FROM MANUFACTURE TO HUMAN CLINICAL TRIAL
author El Sanadi, Caroline Elizabeth
author_facet El Sanadi, Caroline Elizabeth
author_sort El Sanadi, Caroline Elizabeth
title THE VALUE OF A FUNCTIONAL EXCIPIENT ADDITIVE TO HUMAN INSULIN THERAPIES: FROM MANUFACTURE TO HUMAN CLINICAL TRIAL
title_short THE VALUE OF A FUNCTIONAL EXCIPIENT ADDITIVE TO HUMAN INSULIN THERAPIES: FROM MANUFACTURE TO HUMAN CLINICAL TRIAL
title_full THE VALUE OF A FUNCTIONAL EXCIPIENT ADDITIVE TO HUMAN INSULIN THERAPIES: FROM MANUFACTURE TO HUMAN CLINICAL TRIAL
title_fullStr THE VALUE OF A FUNCTIONAL EXCIPIENT ADDITIVE TO HUMAN INSULIN THERAPIES: FROM MANUFACTURE TO HUMAN CLINICAL TRIAL
title_full_unstemmed THE VALUE OF A FUNCTIONAL EXCIPIENT ADDITIVE TO HUMAN INSULIN THERAPIES: FROM MANUFACTURE TO HUMAN CLINICAL TRIAL
title_sort value of a functional excipient additive to human insulin therapies: from manufacture to human clinical trial
publisher Case Western Reserve University School of Graduate Studies / OhioLINK
publishDate 2015
url http://rave.ohiolink.edu/etdc/view?acc_num=case1450286879
work_keys_str_mv AT elsanadicarolineelizabeth thevalueofafunctionalexcipientadditivetohumaninsulintherapiesfrommanufacturetohumanclinicaltrial
AT elsanadicarolineelizabeth valueofafunctionalexcipientadditivetohumaninsulintherapiesfrommanufacturetohumanclinicaltrial
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