Inhaled Insulin - Current Direction of Insulin Research.

Diabetes Mellitus (DM) is a metabolic disorder characterized by relative or absolute deficiency of insulin, resulting in hyperglycemia. Subcutaneous insulin and Oral Hypoglycaemic Agents (OHA) constitute the main treatment option for DM. Insulin is administered by injection or continuous infusion to control glucose levels mainly in Type I diabetes. Newer routes both oral and non oral, for insulin administration are current direction of insulin research as insulin injection therapy is burdensome and painful for many patients. Inhalational insulin is an attractive alternative for systemic administration of insulin given its accessibility and large alveolar-capillary network of lungs for drug absorption. Afrezza, inhaled insulin has been recently approved by Food and Drug Administration (FDA). It is a new, quicker acting inhalable insulin with a different and safer pharmacokinetic profile in comparison to previously failed inhaled form of insulin.

Technosphere insulin: inhaled prandial insulin.

INTRODUCTION: Insulin therapy is a mainstay for treatment of diabetes mellitus; however, many barriers to insulin exist. Insulin human inhalation powder (technosphere insulin) is a new FDA-approved alternative to subcutaneous bolus insulin. AREAS COVERED: This is an overview of technosphere insulin (TI). Pharmacokinetics, clinical efficacy, safety and tolerability are discussed. EXPERT OPINION: TI is more quickly absorbed than subcutaneous insulin therapies and has a shorter duration of action. It appears to be noninferior compared with subcutaneous insulin regimens, and is associated with less hypoglycemia. Thus, it may serve as an alternative insulin agent in patients reluctant to administer multiple subcutaneous injections of insulin daily or in patients who experience late postprandial hypoglycemia with subcutaneous insulin. Cough is the most common side effect, but tends to be mild and transient. A small decrease in the forced expiratory volume has been demonstrated, but does not appear to progress and is reversible. Patients should have periodic pulmonary function tests. TI is contraindicated in patients with chronic lung disease. The long-term risk of lung cancer is being monitored but at this point does not appear to be higher than the expected incidence of lung cancer in this population.

The failure of exubera: are we beating a dead horse?

Inhalation of insulin appears to have become an alternative for the subcutaneous injection of insulin for the time being. However, the recent withdrawal of one product that had already reached the marketplace or others that were close to approval raised severe concerns about the future of the pulmonary route for insulin administration. In view of the progress made with respect to the size of the inhaler and the many other options that would improve the pharmacodynamic properties of inhaled insulin, patient acceptance of this innovative approach, and (hopefully) a reduction in cost, we should begin with an open discussion about the future of inhaled insulin in order to avoid its premature death. This commentary discusses many of the advantages and disadvantages of inhaled insulin from the view of the patients, diabetologists, scientists, pharmaceutical industry, health care payers, and politicians. It is hoped that this unusual approach allows keeping an open mind about this interesting route of drug administration.

Recent challenges in insulin delivery systems: a review.

Relatively, a large percentage of world population is affected by diabetes mellitus, out of which approximately 5-10% with type 1 diabetes while the remaining 90% with type 2. Insulin administration is essential for type 1 patients while it is required at later stage by the patients of type 2. Current insulin delivery systems are available as transdermal injections which may be considered as invasive. Several non-invasive approaches for insulin delivery are being pursued by pharmaceutical companies to reduce the pain, and hypoglycemic incidences associated with injections in order to improve patient compliance. While any new insulin delivery system requires health authorities' approval, to provide long term safety profile and insuring patients' acceptance. The inhalation delivery system Exubera((R)) has already become clinically available in the United States and Europe for patients with diabetes as non-invasive delivery system.

Inhaled insulin: a clinical perspective with emphasis on EXUBERA®.

There is a Type 2 diabetes epidemic; however, unfortunately, even though insulin is an effective therapy, it is mostly used late and as a last resort. Type 1 diabetics find it difficult to administer extra insulin injections when needed owing to the inconvenience and, although most cope well, many dislike injecting themselves so frequently. The newly approved EXUBERA® inhaled insulin should help counteract the resistance of patients and physicians in instituting insulin in the Type 2 diabetic, and the Type 1 diabetic can take more than 1000 fewer injections per year, making their diabetes easier to live with. Pulmonary function tests have demonstrated clinically insignificant changes after years of monitoring. The increases of insulin antibodies found in those who use inhaled insulin have not affected diabetes control. Side effects of inhaled insulin are insignificantly different from injectable insulin except for a couple of mild coughs after an inhalation, which decrease quickly with time. The two dosage forms of EXUBERA insulin are 1 and 3 mg (equivalent to approximately 3 and 8 U of U-100 insulin, respectively), are adaptable to most regimens for both types of diabetes, and inhaled insulin is preferred by a significant majority of patients. Inhaled insulin should be cost effective if it allows earlier institution in the Type 2 diabetic thus improving diabetic control and lowering the expensive complications of diabetes.

Role of inhaled human insulin in the management of Type 1 and 2 diabetes.

Inhaled human insulin (Exubera®) has been approved by the FDA and other regulatory bodies for treatment in Type 1 and 2 diabetes in the USA. It is the first alternative to injectable insulin since the discovery of the insulin compound to treat diabetes. This article will review results of recent clinical studies that support the therapeutic efficacy and safety of inhalable insulin for use in patients with diabetes. The pharmacological profile of inhaled insulin with particular reference to inhaled human insulin and the potential to influence diabetes care is also discussed.