Pharmacokinetic characterization of the novel pulmonary delivery excipient fumaryl diketopiperazine

Journal of Diabetes Science and Technology

Volumn 4, Issue 5, 2010, Pages 1164-1173

  Potocka, Elizabeth ^a   Cassidy, James P ^a   Haworth, Pamela ^b   Heuman, Douglas ^c   Van Marle, Sjoerd ^d   Baughman Jr , Robert A ^a  

^a MannKind Corporation   (United States)

^b MannKind Corporation   (United States)

^c VETERANS AFFAIRS MEDICAL CENTER   (United States)

^d PRA International   (Netherlands)

Author keywords

Chronic liver disease; Diabetic nephropathy; Fumaryl diketopiperazine; Inhalation; Technosphere

Indexed keywords

3,6 BIS(N FUMARYL N(N BUTYL)AMINO) 2,5 DIKETOPIPERAZINE; 3,6-BIS(N-FUMARYL-N(N-BUTYL)AMINO)-2,5-DIKETOPIPERAZINE; EXCIPIENT; FUMARIC ACID DERIVATIVE; MICROSPHERE; PIPERAZINE DERIVATIVE;

ADULT; AGED; ARTICLE; CHRONIC DISEASE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIABETIC NEUROPATHY; DRUG DELIVERY SYSTEM; FEMALE; HUMAN; INHALATIONAL DRUG ADMINISTRATION; INTRAVENOUS DRUG ADMINISTRATION; KIDNEY; LIVER DISEASE; MALE; METABOLISM; METHODOLOGY; MIDDLE AGED;

ADMINISTRATION, INHALATION; ADULT; AGED; CHRONIC DISEASE; DIABETIC NEUROPATHIES; DRUG DELIVERY SYSTEMS; EXCIPIENTS; FEMALE; FUMARATES; HUMANS; INJECTIONS, INTRAVENOUS; KIDNEY; LIVER DISEASES; MALE; MICROSPHERES; MIDDLE AGED; PIPERAZINES;

EID: 79952200239     PISSN: None     EISSN: 19322968     Source Type: Journal    
DOI: 10.1177/193229681000400515     Document Type: Article

References (14)

1. Leone-Bay A, Grant M. Technosphere/insulin: mimicking endogenous insulin release. 2nd ed. In: Rathbone MJ, Hadgraft M, Roberts M, Lane M, editors. Modified release drug delivery technology. Vol 2. New York: Informa Healthcare USA, Inc.; 2008. p. 673-9.
2. Rave K, Potocka E, Boss AH, Marino M, Costello D, Chen R. Pharmacokinetics and linear exposure of AFRESA compared with the subcutaneous injection of regular human insulin. Diabetes Obes Metab. 2009;11(7):715-20.
3. Marino MT, Costello D, Baughman R, Boss A, Cassidy J, Damico C, van Marle S, van Vliet A, Richardson PC. Pharmacokinetics and pharmacodynamics of inhaled GLP-1 (MKC253): proof-of-concept studies in healthy normal volunteers and in patients with type 2 diabetes. Clin Pharmacol Ther. 2010;88(2):243-50.
4. Boss AH, Yu W, Ellerman K. Prandial insulin: is inhaled enough? Drug Dev Res. 2008;69:138-42.
5. Grant ML, Greene S, Stowell GW, Daniels S, Smithson A, Villanueva S, Leone-Bay A. Mimicking endogenous peptide secretion by inhalation [poster]. Presented at: 21st American Peptide Symposium; June 7-12, 2009; Bloomington, IN.
6. Angelo R, Rousseau K, Grant M, Leone-Bay A, Richardson P. Technosphere insulin: defining the role of Technosphere particles at the cellular level. J Diabetes Sci Technol. 2009;3(3):545-54.
7. Phillips M, Amin N, Boss AH, Richardson P. Pulmonary functions (over 2 years) in diabetic subjects treated with Technosphere insulin or usual antidiabetic treatment [abstract]. Diabetologia. 2009;52(Suppl 1):S361. Abstract 920.
8. Rosenstock J, Lorber DL, Gnudi L, Howard CP, Bilheimer DW, Chang PC, Petrucci RE, Boss AH, Richardson PC. Prandial inhaled insulin plus basal insulin glargine versus twice daily biaspart insulin for type 2 diabetes: a multicentre randomised trial. Lancet. 2010;375(9753):2244-53.
9. Peyrot M, Rubin RR. Patient reported outcomes in adults with type 2 diabetes using mealtime insulin monomer human (rDNA origin) inhalation powder (Technosphere insulin inhalation powder) or metformin + secretagogue or both [abstract]. Diabetologia. 2009;52(Suppl 1):S396. Abstract 1009.
10. National Kidney Foundation. Part 5. Evaluation of laboratory measurements for clinical assessment of kidney disease. Am J Kidney Dis. 2002;39(2 Suppl 1):S76-10.
11. Murray KF, Carithers RL Jr; AASLD. AASLD practice guidelines: evaluation of the patient for liver transplantation. Hepatology. 2005;41(6):1407-32.
12. Morgan DJ, McLean AJ. Clinical pharmacokinetic and pharmacodynamic considerations in patients with liver disease. An update. Clin Pharmacokinet. 1995;29(5):370-91.
13. Verbeeck RK. Pharmacokinetics and dosage adjustment in patients with hepatic dysfunction. Eur J Clin Pharmacol. 2008;64(12):1147-61.
14. Siekmeier R, Scheuch G. Inhaled insulin - does it become reality? J Physiol Pharmacol. 2008;59 (Suppl 6):81-113.