Insulin, human inhalation powder

Human insulin inhalation powder glucose metabolism... 

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. 

The client with diabetes is prescribed Exubera, insulin human (rDNA origin) inhalation powder. Which statement indicates the client needs more medication teaching ... 

Insulin, human (recombinant DNA 5.8 origin) inhalation powder,... 

A composition based on diketopiperazine derivatives (3,6-bis (N-fumaryl-N-(n-butyl) amino-2, 5-diketopiperazine) has been investigated as a pulmonary drug delivery system, termed Technospheres (Pharmaceutical Discovery Corp., Elmsford, NY) (Pohl et al. 2000 Steiner et al. 2002). The diketopiperazine derivatives self-assemble into microparticles at low pH with a mean diameter of approximately 2 pm. During self-assembly, diketopiperazine derivatives microencapsulate peptides present in the solution. Insulin incorporated in diketopiperazine derivatives (TI) was administered to five healthy humans by the use of a capsule-based inhaler with a passive powder deagglomeration mechanism. Relative and absolute bioavailability of TI in the first 3 hours (0-180 min) were 26 12% and 15 5%, and for 6 hours (0-360 min) 16 8% and 16 6%, respectively (Steiner et al. 2002). The time to peak action for glucose infusion rates was shorter with both IV (14 6 min) injection and inhalation (39 36 min), as compared to SC administration (163 25 min). This rapid absorption of insulin would be beneficial for diabetic patients who need to rapidly affect their glucose levels. 

Rave, K. Nosek, L. Heinemann, L. Gonzales, C Ernest, C.S. Chien, J. Muchmore, D. Inhaled micronized crystalline human insulin using a dry powder inhaler dose-response and time-action profiles. Diabet. Med. 2001, 21 (7), 763-768. 

Therapeutic peptides and proteins are far more stable in the solid state compared to the liquid state. Delicate proteins often significantly degrade within hours when held at room temperature in the liquid state. All FDA approved therapeutic proteins for human use are injectable products, except Exubera the first inhaleable insulin. A recent survey has shown that 12 of the 30 commercial products are available only as dry powder and 28 of the 30 require refrigeration (49). Not having to refrigerate a pharmaceutical product greatly increases convenience and significantly reduces transportation and distribution costs, this is particularly true for vaccines, where an alternative to break the so called distribution cold chain is badly needed in third world countries. 

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