Zp patch technology
An alternative to mixing and injecting glucagon, a microneedle skin patch, is in development. This may be more user friendly in cases of glycemic emergencies. Microneedle technology as a method of transdermal through the skin drug delivery has received a great deal of attention in recent years. The ZP-Glucagon patch Zosano Pharma, Fremont, California is a coin-sized patch that, when applied to the skin using a reusable applicator, delivers glucagon through the skin to ultimately be absorbed into the blood.
The retainer ring is attached to the bottom of the applicator, which in turn, is activated through spring force. The applicator is positioned on the arm and depressed, causing the adhesive to break away from the retainer ring and the patch to be applied to the skin site.
When the patch is applied, the microneedles physically break the outermost layer of skin, and penetrate the epidermis layer below where the dry drug coating is dissolved in the surrounding interstitial fluid. The ZP-Glucagon patch is not yet commercially available in Canada or elsewhere. Individuals with type 1 diabetes and type 2 diabetes who are at increased risk of drug- or insulin-induced hypoglycemia, especially those who are attempting intensive control to achieve strict glycemic targets.
The Canadian clinical practice guidelines on diabetes recommend that a conscious person with severe hypoglycemia should be treated with oral ingestion of 20 g of a carbohydrate, preferably as glucose tablets or an equivalent. In Canada, exogenous glucagon is indicated for the emergency treatment of severe hypoglycemia in patients treated with insulin when unconsciousness prevents treatment with oral carbohydrates.
The recommended dose for adults and children weighing more than 20 kg is 1 mg glucagon administered by subcutaneous, intramuscular, or intravenous injection. The ZP-Glucagon patch is in early development and only one conference abstract 16 and a clinical trial registration 17 for a phase II study were identified.
The study compared the safety and efficacy of two dose levels 0. The primary outcome was the proportion of patients achieving normal blood glucose levels after 30 minutes.
Administration of 0. Both patch doses of glucagon had rapid onset of action and the time to response was similar for all four treatment groups. According to the conference abstract for the phase II study of the ZP-Glucagon patch, all treatments were well tolerated and no safety issues were reported. Given the limited evidence available, potential safety concerns with the patch are yet unknown.
Zosano Pharma is also developing ZP patch transdermal delivery systems for other conditions. Intranasal inhalation is also being investigated as an alternate route of glucagon administration. A recent randomized, crossover, non-inferiority study evaluated the efficacy and safety of a novel intranasal glucagon delivery system Locemia Solutions, Montreal, Quebec in comparison with standard intramuscular injection of glucagon for the treatment of insulin-induced hypoglycemia in adults with type 1 diabetes.
A more user-friendly delivery system for glucagon than is currently used could potentially reduce the use of emergency services, hospitalization, and product wastage a consequence of glucagon for injection being improperly mixed. The microneedle technology used in the ZP-patch system could have applicability to a wide range of therapeutic compounds e. The available evidence for efficacy and safety of the ZP-Glucagon patch is limited as the phase II trial enrolled only a small number of patients and although randomized, the study was designed as an open-label crossover trial.
Zosano Pharma had indicated plans to initiate a phase III trial in ; however, we found no information on this trial. As currently available exogenous glucagon requires reconstitution immediately before injection, the ZP-Glucagon patch has the potential to simplify the administration of glucagon and the treatment of severe hypoglycemia.
This may be especially beneficial in an emergency situation if the individual is unconscious and caregivers or bystanders are unfamiliar with how to prepare glucagon for injection or how to administer a subcutaneous or intramuscular injection. CADTH thanks the external reviewers who kindly provided comments on an earlier draft of this bulletin. Disclaimer: The information in this document is intended to help Canadian health care decision-makers, health care professionals, health systems leaders, and policy-makers make well-informed decisions and thereby improve the quality of health care services.
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Palylyk-Colwell E ,. Caitlyn Ford Search articles by 'Caitlyn Ford'. Ford C. Share this article Share with email Share with twitter Share with linkedin Share with facebook. Abstract The ZP-Glucagon patch uses novel microneedle technology to deliver glucagon through the skin to people who are experiencing severe hypoglycemia very low blood sugar.
There is very limited evidence, from one small study, comparing the ZP-Glucagon patch with glucagon injected intramuscularly. The evidence suggests that the correction of blood sugar levels is comparable between the ZP-Glucagon patch and the glucagon injected intramuscularly when tested in a controlled setting.
The ZP-Glucagon patch is not yet commercially available and the anticipated cost is unknown. In an emergency situation, the ZP-Glucagon patch may be a more user-friendly option than injecting glucagon. Published online: June 1, Summary The ZP-Glucagon patch uses novel microneedle technology to deliver glucagon through the skin to people who are experiencing severe hypoglycemia very low blood sugar. The Technology Microneedle technology as a method of transdermal through the skin drug delivery has received a great deal of attention in recent years.
Cost The anticipated cost of the ZP-Glucagon patch is yet unknown. The length of each individual microneedle is about 3 times the width of a human hair.
When the microneedle patch is applied, the microneedles penetrate the outermost layer of the epidermis stratum corneum. The shallow depth of penetration limits the likelihood of stimulating sensory nerve endings and causing pain. Interstitial fluid in the skin reconstitutes the drug and makes it available for rapid absorption into the bloodstream. There are instances where a drug cannot or should not be administered orally.
For example, some drugs have poor oral bioavailability. In other cases, patients may not be able to tolerate an orally administered drug. In addition, intestinal absorption following oral delivery can be slow, delaying the beneficial effects of a drug. Intracutaneous delivery allows systemic drug delivery without the use of a hypodermic needle.
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