The design and performance of the Exubera® pulmonary insulin delivery system

Diabetes Technology and Therapeutics

Volumn 9, Issue SUPPL. 1, 2007, Pages

  Harper, Nancy J ^a   Gray, Steven ^b   De Groot, Jennifer ^b   Parker, Joann M ^a   Sadrzadeh, Negar ^b   Schuler, Carlos ^b   Schumacher, Jacqueline D ^a   Seshadri, Sangita ^b   Smith, Adrian E ^b   Steeno, Gregory S ^a   Stevenson, Cynthia L ^b   Taniere, Romain ^b   Wang, May ^b   Bennett, David B ^b  

^a PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United States)

^b NEKTAR THERAPEUTICS   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

INSULIN;

CONFERENCE PAPER; DEVICE; DRUG DELIVERY SYSTEM; DRUG DESIGN; DRUG FORMULATION; DRUG PACKAGING; DRY POWDER; INSULIN TREATMENT; PRIORITY JOURNAL;

ADMINISTRATION, INHALATION; AEROSOLS; EQUIPMENT DESIGN; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN; LUNG; THERMODYNAMICS; TREATMENT OUTCOME;

EID: 34250788087     PISSN: 15209156     EISSN: None     Source Type: Journal    
DOI: 10.1089/dia.2007.0222     Document Type: Conference Paper

References (20)

1. Ashurst I, Malton A, Prime D, Sumby B: Latest advances in the development of dry powder inhalers. Pharm Sci Technol Today 2000;3:246-256.
2. White S, Bennett DB, Cheu S, Conley PW, Guzek DB, Gray S, Howard S, Malcolmnson R, Parker JN, Roberts P, Sadrzadeh N, Schumacher JD, Seshadri S, Sluggett GW, Stevenson CL, Harper NJ: Exubera: pharmaceutical development of a novel product for pulmonary delivery of insulin. Diabetes Technol Ther 2005;7:896-912.
3. Sadrzadeh N, Miller DP, Lechuga-Ballesteros D, Harper NJ, Stevenson CL, Bennett DB: Chemical kinetics and structural relaxation modeling of solid-state stability of spray-dried insulin powder for inhalation. J Pharm Sci 2007 (in press).
4. st International Symposium on Controlled Release of Bioactive Materials. Honolulu: Controlled Release Society, 2004.
5. rd ASME/JSME Fluids Engineering Conference. San Francisco: ASME Technical Publishing, 1999:1-14.
6. Gray S, Parker J, deGroot J, Ozawa L, Chwa T, Harper N: Performance robustness characteristics of insulin powder for inhalation using a pneumatic inhalation device. In: Drug Delivery to the Lungs 15. London: The Aerosol Society, 2004:202-205.
7. White S, Bennett D, Stevenson C, Harper N: Exubera: development of a novel technology solution for pulmonary delivery of insulin. Respir Drug Deliv Europe 2005;1:225-228.
8. Taniere R, de Groot JS, Gray S, White S, Parker JM, Harper NJ: Exubera pulmonary inhaler performance: a demonstration of robustness using simulated use and misuse scenarios. Respir Drug Deliv 2006;3:703-708.
9. Wang M, Harper N, Sadrzadeh N, de Groot J, Schumacher JD, Gray S: Evaluation of Exubera environmental robustness. Respir Drug Deliv Europe 2007;2 (in press).
10. de Groot J, Gray S, Saba D, Cecka W, Mulligan N, Parker J, Harper N: Exubera insulin release unit performance: a demonstration of robustness using simulated use and misuse scenarios. Respir Drug Deliv 2006;3:709-712.
11. de Groot JS, Gray S, Wang M, Taniere R, Ozawa L, Pisias L, Kang J, Corkery K, Parker JM, Harper NJ: Exubera insulin pulmonary inhaler: a comparison of aerosol performance following simulated long-term use and real-time patient use. Respir Drug Deliv 2006;3:713-716.
12. American Association of Clinical Endocrinologists: State of diabetes in America: striving for better control 2005. http://www.aace.com/public/awareness/ stateofdiabetes/DiabetesAmericaReport.pdf (accessed March 14, 2007).
13. Rosenstock J; the EXUBERA® Phase III Study Group: Mealtime rapid-acting inhale insulin (EXUBERA®) improves glycemic control in patients with type 2 diabetes failing combination oral agents: a 3-month, randomized, comparative trial [abstract]. Diabetes 2002;51:A132.
14. Gelfand RA, Schwartz SL, Horton M, Law CG, Pun EF: Pharmacological reproducibility of inhaled human insulin dosed pre-meal in patients with type 2 diabetes mellitus [abstract]. Diabetes 2002;51: A202.
15. Quattrin T, Belanger A, Bohannon NJV, Schwartz SL: Efficacy and safety of inhaled insulin (EXUBERA) compared with subcutaneous insulin therapy in patients with type 1 diabetes. Diabetes Care 2004;27: 2622-2627.
16. Hollander PA, Blonde L, Rowe R, Mehta AE, Milburn JL, Hershon KS, Chaisson JL, Levin SR: Efficacy and safety of inhaled insulin in patients with type 2 diabetes: a 6-month, randomized, comparative trial. Diabetes Care 2004;27:2356-2362.
17. Skyler JS, Weinstock RS, Raskin P, Yale J-F, Barrett E, Gerich JE, Gerstein HC; Inhaled Insulin Phase 3 Type 1 Diabetes Study Group: Use of inhaled insulin in a basal/bolus insulin regimen in type 1 diabetic subjects: a 6-month, randomized, comparative trial. Diabetes Care 2005;28:1630-1635.
18. Skyler JS, Jovanovic L, Klioze S, Reis J, Duggan W; Inhaled Human Insulin Type 1 Diabetes Study Group: Two-year safety and efficacy of inhaled human insulin (Exubera) in adult patients with type 1 diabetes. Diabetes Care 2007;30:579-585.
19. Gelfand RA, Schwartz S, Horton M, Gordon LC, Pun EF: Pharmacological reproducibility of inhaled human insulin pre-meal dosing in patients with type 2 diabetes mellitus (NIDDM) [abstract]. Diabetes 1998; 47(Suppl 1):A95.
20. Balanger A; EXUBERA® Phase 3 Study Group: Efficacy and safety of inhaled insulin (EXUBERA®) compared to subcutaneous insulin therapy in an intensive insulin regimen in patients with type 2 diabetes: results of a 6-month, randomized, comparative trial [abstract]. Diabetologia 2002;45:A260.