Humans insulin administration

Bioavailability of human insulin assessed from pharmacological data. After extravascu-lar administration only the time course governs the observed pharmacological effects. The pharmacological data was translated into theoretical plasma-concentration data using the PK/PD model. The results of the PK/PD analysis indicate that the doses administered can be accurately predicted from pharmacological data... 

The first drug to be produced using recombinant DNA methods was insulin. In 1979, researchers at Eli Lilly and Company devised a procedure for synthesizing insulin using the common bacterium E. coli. The procedure was approved by the U.S. Food and Drug Administration in 1982, and genetically modified human insulin became commercially available in that year under the trade name of Humulin . 

Hypogiycemic reactions Hypoglycemia when using this concentrated insulin can be prolonged and severe. As with other human insulin preparations, hypoglycemia reactions may be associated with the administration of concentrated insulin. However, deep secondary hypoglycemic reactions may develop 18 to 24 hours after the original injection of concentrated insulin. 

Insulin Aspart is a second fast-acting engineered human insulin analogue now approved for general medical use. It differs from native human insulin in that the proline residue has been replaced by aspartic acid. This single amino acid substitution also decreases the propensity of individual molecules to self-associate, ensuring that they begin to enter the bloodstream from the site of injection immediately upon administration. 

Insulin Preparations. Since diabetes mellitus is a defect of one or more of insulin production, secretion, or action, the administration of insulin replacement as a treatment for diabetes in the 1920s was a landmark discovery. Historically, most commercial insulin came from either bovine or porcine sources. Beef insulin differs from human insulin by three amino acid substitutions pork insulin differs by only one residue. For many years, standard insulin preparations were 70% beef and 30% porcine. However, the biosynthesis of human insulin has now displaced the animal insulins, especially bovine insulin which was more antigenic. Mass production of human insulin by recombinant DNA methods is achieved by inserting the human proinsulin gene into either E. coli or yeast and treating the resulting proinsulin to yield the human insulin molecule. Insulin preparations may be divided into four major types ... 

Administration to market genetically engineered human insulin. 1982 The U.S. Food and Drug Administration approves the first genetically engineered drug, a form of human insulin produced by bacteria. 

Al-Achi, A., and R. Greenwood. 1993. Buccal administration of human insulin in streptozocin-diabetic rats. Res Commun Chem Pathol Pharmacol 82 297. 

Replacement Therapy. If the endogenous production of a hormone is deficient or absent, therapeutic administration of the hormone can be used to restore normal endocrine function.30 35 The exogenous hormone can be obtained from natural sources, such as extracts from animal tissues, or from chemical synthesis. In addition, new recombinant DNA techniques are being used to produce hormones from cell cultures, and these techniques have shown great promise in being able to generate hormones like human insulin. 

The biotechnology industry has evolved significantly since the introduction in 1982 of human insulin synthesized in Escherichia coli—the first Food and Drug Administration (FDA)-approved recombinant therapeutic agent in the United States. Since then, over 75 other recombinant proteins have been introduced. The list is comprised of cytokines, hormones, monoclonal antibodies, and vaccines. There are more than 1100 companies competing for this market, and the current sale of these products comprises approximately 10% of the sales of all therapeutic products sold in the United States. One such product, erythropoietin, an erythropoiesis-stimulating factor also known... 

Dose reproducibility Several human studies comparing aerosol insulin administration to subcutaneously administered insulin showed that the variability in glucose response from a liquid nebulizer that utilized the standing cloud concept was equivalent or better than that seen with insulin injection. Inhale Therapeutics Systems, Inc. has adopted this standing cloud concept for its dry powder inhaler to achieve reproducibility of delivery of macromolecules to the systemic circulation that is equivalent to subcutaneous injections. 

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