Pulmonary insulin delivery by means of the Technosphere™ drug carrier mechanism

Bibliography

• DIABETES CONTROL AND COMPICATIONS TRIAL (DCCT): The effect of intensive insulin treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl. J. Med. (1993) 329:977–986.
   Google Scholar
• UNITED KINGDOM PROSPECTIVE DIABETES STUDY (UKPDS) GROUP: Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with Type 2 diabetes. Lancet (1998) 352:837–853.
   Google Scholar
• SKINNER TC: Psychological barriers. Eur. Endocrinol (2004) 151\(Supp1.2):T13–17.
   Google Scholar
• MOLLEMA ED, SNOEK FJ, ADER HJ, HEINE RJ, VAN PLOEG HM: Insulin-treated diabetes patients with fear of self-injecting or fear of self-testing: psychological comorbidity and general well-being. J. Psychsorn. Res. (2001) 51:665–672.
   Google Scholar
• HEINEMANN L, PFIDTZNER A, HEISE T: Alternative routes of administration as an approach to improve insulin therapy: update on dermal, oral, nasal, and pulmonary insulin delivery. Curl: Phann. Des. (2001) 7:1327–1351.
   Google Scholar
• LAUBE BL, GEORGOPOULOS A, ADAMS GK: Preliminary study of the efficacy of insulin aerosol delivered by oral inhalation in diabetic patients. "AMA (1993) 269:2106–2109.
   Google Scholar
• WIGLEY FW, LONDONO JH, WOOD SH, SHIPP JC, WALDMAN RH: Insulin across respiratory mucosae by aerosol delivery. Diabetes (1971) 20:552–556.
   Google Scholar
• BYRON PR, PATTON JS: Drug delivery via the respiratory tract. J. Aerosol. Med. (1994) 7:49–75.
   Google Scholar
• ••Comprehensive presentation of pulmonarydrug delivery.
   Google Scholar
• BYRON PR: Prediction of residence times in regions of the human respiratory tract following aerosol inhalation. Phann. Li. (1986) 75:433–438.
   Google Scholar
• PATTON JS: Deep lung delivery of therapeutic proteins. Chnntech. (1997) 27:34–38.
   Google Scholar
• PATTON JS, BUKAR JG, ELDON JA: Clinical pharmacokinetics and pharmaco-dynamics of inhaled insulin. Clin. Pharmacokinet. (2004) 43:781–801.
   Google Scholar
• ••Excellent review on pulmonary insulin, slightly biased in favour of Exubera.
   Google Scholar
• SAKAGAMI M: Insulin disposition in the lung following oral inhalation in humans. A meta-analysis of its pharmacokinetics. Pharmacokinet. (2004) 43:539–552.
   Google Scholar
• •Another excellent review of the topic.
   Google Scholar
• QUATTRIN T, BELANGER A, BOHANNON NJ, SCHWARTZ S: EXUBERA PHASE STUDY GROUP: Efficacy and sefety of inhaled insulin (Exubera) compared with subcutaneous insulin therapy in patients with Type 1 diabetes: results of a 6-month, randomized, comparative trial. Diabetes Care (2004) 27:2622–2627.
   Google Scholar
• CEFALU WT, SERDAREVIC-PEHAR M; FOR THE EXUBERA PHASE STUDY GROUP: Long-term use of Exubera in Type 2 diabetes: observations on glycemic control, pulmonary function and antibody formation. Diabetes (2005) 54(Suppi.1):356-0R.
   Google Scholar
• DUMAS R, KRASNER AS, ENGLAND RD, RIESE RJ, TEETER JG FOR THE EXUBERA PHASE STUDY GROUP: Immunologic response to Exubera in patients with Type 1 diabetes is not associated with functional evidence of airway sensitization. Diabetes (2005) 54\(Supp1.1):437–P
   Google Scholar
• HEISE T, TUSEK C, STEPHAN JA et al: Insulin antibodies with inhaled insulin (Exubera): no evidence for impact om postprandial glucose control. Diabetes (2004) 53(Suppi.1):463–P
   Google Scholar
• SKYLER J; FOR THE EXUBERA PHASE STUDY GROUP: Sustained long-term efficacy and safety of inhaled insulin during 4 years of continuous therapy. Diabetes (2004) 53\(Suppl. 1):486–P
   Google Scholar
• LIAN H, STEINER SS, SOFIA RD et al: A self-complementary, self-assembling microsphere system: application of intravenous delivery of the antiepileptic and neuroprotectant compound felbamate. Phann. Sci. (2000) 89:867–875.
   Google Scholar
• MOHNIKE K, BRETSCHNEIDER O, BRUNELLE P et al: 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):5127.
   Google Scholar
• STEINER SS, PFLITZNER A, WILSON BR, HARZER O, HEINEMANN L, RAVE K: Technosphere/ Insulin - proof of concept study with a new insulin formulation for pulmonary delivery. Exp. Clirr. Endocrinol. Diabetes (2002) 110:17–21.
   Google Scholar
• •First clinical report about TI.
   Google Scholar
• PFLITZNER A, MANN AE, STEINER SS: TechnosphereTm/Insulin - a new approach for effective delivery of human insulin via the pulmonary route. Diab. Technol. Ther. (2002) 4:589–594.
   Google Scholar
• PFLITZNER A, FLACKE F, POHL R et al: Technopshere/PTH(1-34) - a new approach for effective pulmonary delivery of parathyroid hormone(1-34). Horm. Metab. Res. (2003) 35:319–323.
   Google Scholar
• RAVE KM, HEISE T, PFLITZNER A, STEINER S, HEINMANN L: Results of a dose-response study with a new pulmonary insulin formulation and inhaler. Diabetes (2000) 49\(Suppl. 1):A75.
   Google Scholar
• PFLITZNER A, SOMMERER K, MEYER T et al.: Lung distribution of radiolabeled Technosphere/Insulin. Diabetes (2003) 52\(Suppl. 1):A107.
   Google Scholar
• HEINEMANN L: Variability of insulin absorption and insulin action. Diab. 7Ochnol. Ther. (2002) 4:673–682.
   Google Scholar
• •First comprehensive literature review on Insulin variability.
   Google Scholar
• PFLITZNER A, HEISE T, STEINER S, HEINEMAN L, RAVE K: Inhaled TechnosphereTmfinsulin shows a low variability in metabolic action in Type 2 diabetic patients. Diabetes (2000) 49\(Suppl. 1):A121.
   Google Scholar
• PFLITZNER A, POHLMANN T, HOBERG C, STEINER SS, FORST T: Variability of insulin absorption after subcutaneous and pulmonary application on patients with Type 2 diabetes. Diabetes (2002) 51\(Suppl. 2):A47.
   Google Scholar
• BOSS A, HEISE T, RAVE K, CHEATHAM WW: The variability and time-action profile of inhaled Technosphere/Insulin compares favourably to that of subcutaneous human regular insulin. Diabetes (2005) 54\(Suppl. 1):358-0R.
   Google Scholar
• ROSENSTOCK J, BAUGHMAN RA, RIVERA-SCHAUB T et al: A randomized, double-blind, placebo controlled study of the efficiacy and safety of inhaled Technosphere/Insulin in patients with Type 2 diabetes (T2D). Diabetes (2005) 54\(Supp1.1):357-0R.
   Google Scholar
• BRUCE DG, CHISHOLM DJ, STORLIEN LH, KRAEGEN EW: Physiological importance of deficiency in early prandial insulin secretion in non-insulin-dependent diabetes. Diabetes (1988) 37:736–744.
   Google Scholar
• ••Interesting report about the impact of Intravenous restoration of first-phase Insulin secretion.
   Google Scholar
• BRUTTOMESSO D, PIANTA A, MARIA et al.: Restoration of early rise in plasma insulin levels improves the glucose tolerance of Type 2 diabetic patients. Diabetes (1999) 48:99–1054.
   Google Scholar
• •Insulin lispro in comparison with regular human insulin.
   Google Scholar
• PFLITZNER A, HEINEMANN L, STEINER S, FORST T, HEISE T, RAVE K: Influence of small dose i.v., s.c., and pulmonary insulin treatment on prandial glucose control in patients with Type 2 diabetes. Diabetologia (2001) 44\(Suppl. 1):A212.
   Google Scholar
• STEINER S, PFLITZNER A, HEINEMANN L, LOBIG M, HEISE T, FORST T: Intact but not total proinsulin predicts the successful imitation of first phase insulin release in patients with Type 2 diabetes. Diabetes (2003) 52\(Supp1.1):A544.
   Google Scholar
• PFLITZNER A, KUNT T, MONDOK A et al.: Fasting intact proinsulin is a highly specific predictor of insulin resistance in Type 2 diabetes. Diabetes Care (2004) 27:682–687.
   Google Scholar
• BOSS AH, GRANT ML, CHEATHAM WW: Mimicry of early phase insulin response in humans with rapidely available inhaled insulin accelerates postprandial glucose disposal compared to slower bioavailable insulin. Diabetes (2005) 54\(Suppl. 1):1373–P.
   Google Scholar
• SIMMS JR, CARBALLO I, AUGE CR et al: Assessment of immunotoxic effects on humoral and cellular immune parameters following repeated inhalation of Technosphere/insulin in the rat. Diabetes (2005) 54\(Supp1.1):2078-PO.
   Google Scholar
• FINEBERG SE, KAWABATA T, FINCO-KENT D et al: Antibody response to inhaled insulin in patients with Type 1 or Type 2 diabetes. An analysis of initial Phase II and III inhaled insulin (Exubera) trials and a two-year extension trial. J. Endocrinol. Metab. (2005); 90:3287–3294.
   Google Scholar
• PFLITZNER A, MONDOK A, FLACKE F et al: Dose response effect of pulmonary application of Technosphere/PTH(1–34). Exp. Clin. Endokrinol. Diabetes (2003) 111 (Suppl. 1):525.
   Google Scholar
• PFLITZNER A, MONDOK A, HOHBERG C et al.: Low variability of systemic PTH(1–34) uptake after repeated pulmonary delivery of Technosphere/ PTH(1–34). Exp. Clin. Endocrinol. Diabetes (2003) 111\(Suppl. 1):563.
   Google Scholar
• HEISE T, RAVE KM, BOTT S et al: Time-action profile of an inhaled insulin preparation in comparison to insulin lispro and regular insulin. Diabetes (2000) 49\(Suppl. 1):A10.
   Google Scholar
• OWENS DR: New horizons: alternative routes for insulin delivery. Nature Rev Drug Disc. (2002) 1:529–540.
   Google Scholar
• SAKAGAMI M: Insulin disposition in the lung following oral inhalation in humans - a meta-analysis of its pharmacokinetics. Cl/n. Pharmacokinet. (2004) 43:539–552.
   Google Scholar
• BRUNNER GA, BALENT B, ELLMERE M et al: Dose-response relation of liquid aerosol insulin in Type 1 diabetic patients. Diabeologia (2001) 44:305–308.
   Google Scholar
• HEISE T, SCHARLING B, BELLAIRE S et al: Dose-response of pulmonary insulin with the AERx insulin diabetes management system in healthy subjects. Diabetologia (2001) 44\(Suppl. 2):A212.
   Google Scholar
• RAVE K, NOSEK L, DELAPENA A et al: Dose response and dose equivalency of human insulin inhalation powder (HIIP) using the Lilly/Alkermes inhaled insulin system compared to subcutaneous (sc) insulin lispro. Diabetes (2005) 54\(Suppl. 1):360-0R.
   Google Scholar
• GARG S, ROSENSTOCK J, MUCHMORE D, DELAPENJA A, SUN B, SILVERMAN B: Safety and efficacy of preprandial human insulin inhalation powder (HIIP) delivered by the Lilly/Alkermes inhaled insulin system versus injectable insulin in patients with Type 1 diabetes (T 1 D) . Diabetes (2005) 54\(Supp1.1):361-0R.
   Google Scholar
• HAUSMANN M, DELLWEG S, HEINEMANN L, BUCHWALD A, HEISE T: Add-on therapy with Kos inhaled insulin dosed using a metered dose inhaler is as efficacious as add-on therapy with Lantus in poorly controlled Type 2 patients treated with sulphonylureas or metformin. Diabetes (2005) 54\(Supp1.1):417–P
   Google Scholar
• LIO Z, LIAO Y, LI Y, HU G, WENG J: Clinic pharmacokinetic study of inhaled insulin powder. Diabetes (2005) 54(Suppl. 1):2072-PO. Expert Op/n. Drug Deily (2005) 2(6)
   Google Scholar
• PERERA AD, KAPITZA C, NOSEK L et al: Absorption and metabolic effect of inhaled insulin: intrapatient variability after inhalation via the Aerodose insulin inhaler in patoents with Type 2 diabetes. Diabetes Care (2002) 25:2276–2281.
   Google Scholar