Technosphere™/insulin - A new approach for effective delivery of human insulin via the pulmonary route

Diabetes Technology and Therapeutics

Volumn 4, Issue 5, 2002, Pages 589-594

  Pfützner, Andreas ^a   Mann, Alfred E ^b   Steiner, Solomon S ^b  

^a PDC Europe   (Germany)

^b MannKind Corporation   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

INSULIN; TECHNOSPHERE; ANTIDIABETIC AGENT; MICROSPHERE;

ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG ACTIVITY; DRUG BIOAVAILABILITY; DRUG DELIVERY SYSTEM; DRUG DESIGN; DRUG EFFICACY; DRUG FORMULATION; DRUG INDUCED DISEASE; DRUG MECHANISM; DRUG SAFETY; DRUG TOLERABILITY; DRUG UPTAKE; GLUCOSE CLAMP TECHNIQUE; HUMAN; HUMAN EXPERIMENT; INHALER; INSULIN TREATMENT; NON INSULIN DEPENDENT DIABETES MELLITUS; NORMAL HUMAN; PRIORITY JOURNAL; RESPIRATORY EPITHELIUM; SYSTEMIC CIRCULATION; AREA UNDER THE CURVE; BIOAVAILABILITY; DOSE RESPONSE; INHALATIONAL DRUG ADMINISTRATION; PARTICLE SIZE; SCANNING ELECTRON MICROSCOPY;

ADMINISTRATION, INHALATION; AREA UNDER CURVE; BIOLOGICAL AVAILABILITY; DIABETES MELLITUS, TYPE 2; DOSE-RESPONSE RELATIONSHIP, DRUG; GLUCOSE CLAMP TECHNIQUE; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN; MICROSCOPY, ELECTRON, SCANNING; MICROSPHERES; PARTICLE SIZE;

EID: 0036025088     PISSN: 15209156     EISSN: None     Source Type: Journal    
DOI: 10.1089/152091502320798204     Document Type: Article

References (22)

1. Anderson JH, Koivisto VA: Clinical studies on insulin lispro. Drugs Today 1998;34:37-50.
2. Olsen CL, Liu G, Charles A: Novel routes for insulin delivery. In: Marshall SM, Home PD, eds. The Diabetes Annual. Elsevier: Amsterdam, 1994:243-276.
3. Heinemann L, Pfützner A, Heise T: Alternative routes of administration as an approach to improve insulin therapy: Update on dermal, oral, nasal, and pulmonary insulin delivery. Curr Pharm Des 2001;7:1327-1351.
4. Duckworth WC, Bennett RG, Hamel FG: Insulin degradation: Progress and potential. Endocr Rev 1998;19:608-624.
5. Hilsted J, Madsbad S, Hvidberg A, Rasmussen MH, Krarup T, Ipsen H, Hansen B, Pedersen M, Djurup R, Oxenbull B: Intransal insulin therapy: The clinical realities. Diabetologia 1995;38:680-684.
6. Wigley FW, Londono JH, Wood SH, Shipp JC, Waldmann RH: Insulin across respiratory mucosae by aerosol delivery. Diabetes 1971;20:552-556.
7. Kohler D, Schluter KJ, Kerp L, Matthys H: Nicht radioaktives Verfahren zur messung der lungenpermiabilitaet: Inhalation von Insulin. Atemwegs Lungenkrankheiten 1987;13:230-232.
8. Laube BL, Georgopoulos A, Adams GKL: Preliminary study of the efficacy of insulin aerosol delivered by oral inhalation in diabetic patients. JAMA 1993;269:2106-2109.
9. Byron PR, Patton JS: Drug delivery via the respiratory tract. J Aerosol Med 1994;7:49-75.
10. Heise T, Rave K, Bott S, Sha S, Willavize SA, Carroll RS, Gruber S, Lee JD, Heinemann L: Time-action profile of an inhaled insulin preparation in comparison to insulin lispro and regular insulin [abstract]. Diabetes 2000;49(Suppl 1):A10.
11. Skyler JS, Cefalu WT, Kourides IA, Landschulz WH, Balagtas CC, Cheng SL, Gelfand RA: Efficacy of inhaled human insulin in Type 1 diabetes mellitus: A randomised proof of concept study. Lancet 2001;357:331-335.
12. Cefalu WT, Skyler SS, Kourides IA, Landschulz WH, Balagta CC, Cheng SL, Gelfand RA: Inhaled human insulin treatment in patients with Type 2 diabetes mellitus. Ann Intern Med 2001;134:203-207.
13. Lian H, Steiner SS, Sofia RD, Woodhead JH, Wolf HH, White HS, Shen GS, Rhodes CA, McCabe RT: A self-complementary, self-assembling microsphere system: Application of intravenous delivery of the antiepileptic and neuroprotectant compound felbamate. J Pharm Sci 2000;89:867-875.
14. Mohnike K, Bretschneider O, Brunelle P, Nihoul-Fekete C, Flacke F, Günther G, Pfützner A, Saudubray JM, Steiner SS: Continuous s.c. infusion with glucagon and intermittent s.c. treatment with octreotide in persistent hyperinsulinaemic hypoglycemia of infancy (PHHI). Exp Clin Endocrinol Diabetes 2000;108(Suppl 1):S127.
15. Pfützner A, Heise T, Steiner S, Heineman L, Rave K: Inhaled technosphere™/insulin shows a low variability in metabolic action in Type 2 diabetic patients [abstract]. Diabetes 2000;49(Suppl 1):A121.
16. Pohl R, Muggenburg BA, Wilson BR, Woods RJ, Burell BE, Steiner SS: A dog model as predictor of the temporal properties of pulmonary technosphere/insulin in humans. Respir Drug Delivery 2000;VII:463-465.
17. Rave KM, Heise T, Pfützner A, Steiner S, Heinmann L: Results of a dose-response study with a new pulmonary insulin formulation and inhaler [abstract]. Diabetes 2000;49(Suppl 1):A75.
18. Steiner SS, Pfützner A, Wilson BR, Harzer O, Heinemann L, Rave K: Technosphere/insulin-proof of concept study with a new insulin formulation for pulmonary delivery. Exp Clin Endocrinol Diabetes 2002;110:17-21.
19. Heinemann L, Traut T, Heise T: Time-action profile of inhaled insulin. Diabet Med 1997;14:63-72.
20. Pfützner A, Pohlmann T, Hoberg C, Steiner SS, Forst T: Variability of insulin absorption after subcutaneous and pulmonary application in patients with Type 2 diabetes [abstract]. Diabetes 2002;51(Suppl 2):A47.
21. Brunner GA, Balent B, Ellmerer M, Schaupp L, Siebenhofer A, Jendle JH, Okikawa J, Pieber TR: Dose response relation of liquid aerosol inhaled insulin in Type 1 diabetic patients. Diabetologia 2001;44:305-308.
22. Fishman RS, Guinta D, Chambers F, Quintana R, Shapiro D: Insulin administration via the AeroDose™ inhaler: Comparison to subcutaneously injected insulin [abstract]. Diabetes 2000;49(Suppl 1):A9.