Why most oral insulin formulations do not reach clinical trials.
Oral insulin able to induce an efficient antihyperglycemic effect either to replace or complement diabetes mellitus therapy is the major goal of health providers, governments and diabetic patients. Oral therapy is associated not only with the desire to exclude needles from the daily routine of diabetic patient but also with the physiological provision of insulin they would get. Despite numerous efforts over the past few decades to develop insulin delivery systems, there is still no commercially available oral insulin. The reasons why the formulations developed to administer insulin orally fail to reach clinical trials are critically discussed in this review. The principal features of nanoformulations used so far are also addressed as well as the undergoing clinical trials.
CNC Center for Neuroscience & Cell Biology, University of Coimbra, 3000-548 Coimbra, Portugal.|Faculty of Pharmacy, University of Coimbra, 3000-548 Coimbra, Portugal.
Marlene
M
Lopes
CNC Center for Neuroscience & Cell Biology, University of Coimbra, 3000-548 Coimbra, Portugal.|Faculty of Pharmacy, University of Coimbra, 3000-548 Coimbra, Portugal.
Susana
S
Simões
CNC Center for Neuroscience & Cell Biology, University of Coimbra, 3000-548 Coimbra, Portugal.|Faculty of Pharmacy, University of Coimbra, 3000-548 Coimbra, Portugal.
Francisco
F
Veiga
Laboratory of Physiology, IBILI, Faculty of Medicine, University of Coimbra, Coimbra, Portugal.
Raquel
R
Seiça
Faculty of Pharmacy, University of Coimbra, 3000-548 Coimbra, Portugal.|I3S, Instituto de Investigação e Inovação em Saúde, Group Genetics of Cognitive Dysfunction, IBMC - Instituto de Biologia Molecular e Celular, Rua do Campo Alegre 823, 4150-180 Porto, Portugal.
António
A
Ribeiro
D000284:Administration, Oral; D002626:Chemistry, Pharmaceutical; D002986:Clinical Trials as Topic; D003920:Diabetes Mellitus / Q000188:drug therapy*; D004337:Drug Carriers; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000627:therapeutic use*; D007328:Insulin / Q000008:administration & dosage* / Q000627:therapeutic use*
D004337:Drug Carriers; D007004:Hypoglycemic Agents; D007328:Insulin