Magazine article Drug Topics

Clinical Q&A: Can Insulin Be Administered Via Nonparenteral Routes?

Magazine article Drug Topics

Clinical Q&A: Can Insulin Be Administered Via Nonparenteral Routes?

Article excerpt

A Diabetes mellitus (DM) is a (chronic disease that affects approximately 16 million Americans and as many as 120 million people worldwide. In addition to complications associated with the progression of the disease, management of diabetes is another factor that impairs a patient's quality of life. An important step that promises to improve the QOL for these patients is the development of alternative routes for administration of insulin.

Insulin is a hormone secreted by the beta cells of the pancreatic islets of Langerhans. Commercially available preparations of the hormone are prepared either by extracting the active principles from beef or pork pancreas or by using biosynthetic or semisynthetic processes in producing insulin that is structurally identical to human insulin. Because of its protein nature, insulin is destroyed in the gastrointestinal tract and is currently administered only parenterally. The discomfort and noncompliance associated with daily insulin injections lead researchers to seek a more convenient mode of insulin administration.

Insulin via the lungs

Furthest in development are delivery systems intended to administer insulin via the lungs or through the mucosa of the mouth. Currently, there are at least three U.S. pharmaceutical companies developing such products for intrapulmonary administration.

Dura Pharmaceuticals has collaborated with Eli Lilly to develop a pulmonary delivery system for insulin using the company's proprietary Spiros drug-delivery technology for proteins and peptides. The product is still in a preclinical phase.

Aradigm completed phase II trials in Europe and in the United States using its AERx pulmonary delivery system. The product is licensed to Novo Nordisk, which has exclusive worldwide rights.

The dry-powder insulin formulation under development by Inhale Therapeutic System is in ongoing phase III clinical trials at 177 sites, incorporating 1,000 Type 1 and Type 2 patients with diabetes. In a phase II trial involving 70 patients with Type 1 diabetes, inhaled insulin was administered before each meal; in addition, injections of slow-acting insulin were administered at night. Glycemic control in the inhaled-- insulin group was similar to the group receiving insulin injections two to three times daily. The inhaled drug was well tolerated. In another phase II trial, 69 Type 2 diabetics refractory to oral treatment received inhaled insulin in addition to their previous regimens. The addition of the inhaled insulin resulted in a significant reduction in HbA^sub 1c^ levels. Inhales product is being developed in collaboration with Pfizer. …

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