Pharmacokinetics and Pharmacodynamics of Intranasal Insulin Administered to Patients with Type 1 Diabetes: A Preliminary Study

Leary, Angelina V.; Stote, Robert M.; Cussen, Kathleen; OʼBrien, Jackie; Leary, W. P.; Buckley, Brendan M.

doi:10.1089/dia.2006.8.81

Cited by 27 publications

(11 citation statements)

References 12 publications

(15 reference statements)

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“…The residence time of the formulation on mucosa is important because the half-life of the clearance for nonadhesive formulations is only 15-20 minutes. Many penetration enhancers have been studied clinically for peptide delivery, for example, cyclopenta delactone (insulin) (Leary et al, 2006), hydroxyl fatty acid esters of polyethylene glycol (CriticalSorb, insulin, teriparatide) (Lewis et al, 2009), alkylsaccharides (cyclic PTH 1-31 ) (Illum, 2012), and chitosan (Chisys, goserelin) (Illum, 2012). However, the development of many of these enhancers has been terminated or data have not been published (Illum, 2012).…”

Section: A Development Challenges Of Peptide Delivery Formulationsmentioning

confidence: 99%

“…CPEX Pharmaceuticals (Exeter, NH) developed Nasulin spray for intranasal insulin administration using cyclopenta delactone to enhance its absorption (Leary et al, 2006). The relative bioavailability to subcutaneous insulin in type 1 diabetes patients was 17%-20% in the first 2 hours (Leary et al, 2005(Leary et al, , 2006, but further development was halted in 2010.…”

Section: A Development Challenges Of Peptide Delivery Formulationsmentioning

confidence: 99%

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Novel Delivery Systems for Improving the Clinical Use of Peptides

et al. 2015

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Section: A Development Challenges Of Peptide Delivery Formulationsmentioning

confidence: 99%

Section: A Development Challenges Of Peptide Delivery Formulationsmentioning

confidence: 99%

Novel Delivery Systems for Improving the Clinical Use of Peptides

et al. 2015

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“…37 Nasal insulin preparations have bioavailability of about 15-25% with the onset of action ~10-20 min. 38,39 The substances such as bile salt, surfactant and fatty acid derivatives are being investigated to enhance mucosal permeability of insulin but they increase the risks for local irritation, nasal secretion, sneezing or burning sensation. 39,40 Nasal insulin crosses the blood brain barrier hence it has a hypothesized effect on memory function.…”

Section: ) Intra -Nasal Insulinmentioning

confidence: 99%

Insulin delivery: what is new in the queue?

Rahman

Kawatra

2017

Int J Basic Clin Pharmacol

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Diabetes Mellitus (DM) is a cluster of metabolic disorders with the shared feature of hyperglycemia which may be due to discrete etiopathogenesis. India stands to be the diabetic capital of the world, second only to China. After its discovery by Banting and Best, it has been established that insulin plays a fundamental role in the management of DM. In spite of insulin being in the market for so long, what still remains a challenge is the invasive approach of its administration. Conventional pharmacotherapeutic approaches of insulin delivery that have been available over the years are insulin syringes, pumps and pens. Upcoming innovative modes of insulin delivery include oral insulin, inhaled insulin, colonic insulin delivery, transdermal insulin, intra-peritoneal insulin, intra-nasal insulin, nano-technology etc. Constant research has been going on since many years to discover a route of administration for insulin that is minimally or noninvasive, effective, safe, convenient and cost-effective for patients. If successful, alternative routes of administration could revolutionize the treatment of DM and help improve patients’ quality of life.

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“…For example, Bentley Pharmaceuticals is in phase 2 human clinical testing of Nasulin TM , which employs the permeation enhancer technology CPE-215 s , a pentadecalactone, to facilitate delivery of insulin through the nasal mucosa. Nasulin achieves a bioavailability of 15-20% over 2 h relative to subcutaneous rapid acting insulin [Leary et al, 2005[Leary et al, , 2006. Nastech Pharmaceutical Company has developed formulations of insulin that enhance permeation and improve bioavailability.…”

Section: Intranasal Delivery Of Insulinmentioning

confidence: 99%

Intranasal insulin: PK profile designed specifically for prandial treatment of Type 2 Diabetes

Mitchell

Costantino

Sileno

et al. 2008

Drug Development Research

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Insulin is the most effective therapy for lowering glycosylated hemoglobin (A1c) levels in Type 2 diabetics, and yet it is typically the last therapeutic option employed. Currently, the vast majority of marketed prandial insulin products require frequent injections, which may be a barrier among patients and physicians to initiating this medically important therapy. Beyond the inconvenience, concerns about potential weight gain and hypoglycemia may also limit the early use of insulin therapy. None of the approved insulin formulations (including rapid-acting products) provide a PK response fast enough to mimic the endogenous first-phase insulin release that is seen following bolus intravenous glucose infusion and that is associated with downregulation of gluconeogenesis. Delayed absorption of insulin from subcutaneous injection results in a relatively broad plasma insulin peak and a prolonged duration of action, potentially increasing the risk of hypoglycemia. We are developing an intranasal insulin formulation that provides a well-tolerated and efficient means of delivering prandial insulin more rapidly than fast-acting injectable insulin. With its fast onset and short duration of action, Nastech's intranasal insulin exhibits pharmacokinetic and pharmacodynamic properties that take advantage of the known benefits of delivering a rapid and transient burst of insulin at mealtime. This review discusses the current development of intranasal formulations and compares the characteristics of intranasal insulin to other noninvasive insulin delivery efforts, including pulmonary, oral, and transdermal formulations. Drug Dev Res 69: 143-152, 2008.

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Pharmacokinetics and Pharmacodynamics of Intranasal Insulin Administered to Patients with Type 1 Diabetes: A Preliminary Study

Abstract: This intranasal formulation was generally well tolerated, and relatively well absorbed as demonstrated by a rapid rise in serum insulin level and concomitant reduction of plasma glucose levels.

Cited by 27 publications

References 12 publications

Novel Delivery Systems for Improving the Clinical Use of Peptides

Novel Delivery Systems for Improving the Clinical Use of Peptides

Insulin delivery: what is new in the queue?

Intranasal insulin: PK profile designed specifically for prandial treatment of Type 2 Diabetes

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