Pulmonary delivery of therapeutic compounds for treating CNS disorders

Therapeutic Delivery

Volumn 2, Issue 9, 2011, Pages 1125-1140

  Noymer, Peter ^a   Biondi, Sherri ^a   Myers, Dan ^a   Cassella, James ^a  

^a Alexza Pharmaceuticals   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALPRAZOLAM; ANALGESIC AGENT; ANTIDOTE; APOMORPHINE; ATROPINE; DIAZEPAM; DIHYDROERGOTAMINE MESILATE; ERGOTAMINE DERIVATIVE; ERGOTAMINE TARTRATE; FENTANYL; LEVODOPA; LOXAPINE; MIDAZOLAM; MORPHINE; NICOTINE; NICOTINE DERIVATIVE; NICOTINE PYRUVATE; NICOTINE TARTRATE; PLACEBO; PROCHLORPERAZINE; SUMATRIPTAN; TEMAZEPAM; TRIPTAN DERIVATIVE; UNCLASSIFIED DRUG; ZALEPLON;

AGITATION; AIRWAY IRRITATION; ANALGESIA; ANXIETY DISORDER; BEHAVIOR DISORDER; BIPOLAR DISORDER; BLOOD BRAIN BARRIER; CENTRAL NERVOUS SYSTEM DISEASE; CONDENSATION AEROSOL INHALER; COUGHING; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DELIVERY SYSTEM; DRUG DOSAGE FORM COMPARISON; DRUG MEGADOSE; DYSGEUSIA; HUMAN; INHALER; INSOMNIA; LOADING DRUG DOSE; MAXIMUM PLASMA CONCENTRATION; METERED DOSE INHALER; MIGRAINE; NEBULIZER; NONHUMAN; PAIN; PANIC; PARKINSON DISEASE; PHARMACODYNAMICS; POSTOPERATIVE PAIN; POWDER INHALER; PRIORITY JOURNAL; RESPIRATORY TRACT DISEASE; REVIEW; SCHIZOAFFECTIVE PSYCHOSIS; SCHIZOPHRENIA; SEDATION; SEIZURE; SMOKING CESSATION; SOFT MIST INHALER; SYSTEMIC CIRCULATION; TIME TO MAXIMUM PLASMA CONCENTRATION;

EID: 80052978717     PISSN: 20415990     EISSN: 20416008     Source Type: Journal    
DOI: 10.4155/tde.11.90     Document Type: Review

References (80)

1. Patton JS, Platz RM. Pulmonary delivery of peptides and proteins for systemic action. Adv. Drug Deliv. Rev. 8, 179-196 (1992).
2. West JB. Respiratory Physiology: the Essentials. Seventh Edition. Chapter 1. Lippincott, Williams & Wilkins (2005).
3. Guyton AC, Hall JE. Textbook of Medical Physiology, 9th Edition. Chapter 37. WB Saunders Company (1996).
4. Guyton AC, Hall JE. Textbook of Medical Physiology, 9th Edition. Chapter 33. WB Saunders Company (1996).
5. Heyder J. Particle transport onto human airway surfaces. Eur. J. Respir. Dis. 63(Suppl. 119), 29-50 (1982).
6. Finlay WH. The Mechanics of Inhaled Pharmaceutical Aerosols. Chapter 7. Academic Press (2001).
7. Patton JS, Fishburne S, Weers JG. The lungs as a portal of entry for systemic drug delivery. Proc. Am. Thor. Soc. 1, 338-344 (2004).
8. Mittapalli RK, Manda VK, Adkins CE, Geldenhuys WJ, Lockman PR. Exploiting nutrient transporters at the blood-βrain barrier to improve brain distribution of small molecules. Therapeutic Delivery 1, 775-784 (2010).
9. Deng CX. Targeted drug delivery across the blood-βrain barrier using ultrasound technique. Therapeutic Delivery 1, 819-848 (2010).
10. Barnes PJ, Drazen JM, Rennard S, Thomson NC (Eds).Chapter 1. In: Asthma and COPD: Basic Mechanisms and Clincal Management. Academic Press (2002).
11. Weiner JR, Toy EL, Sacco P, Duh MS. Costs, quality of life and treatment compliance associated with antibiotic therapies in patients with cystic fibrosis: a review of the literature. Expert Opin. Pharmacother. 9, 751-766 (2008).
12. Pressler T. Review of recombinant human deoxyribonuclease (rhDNase) in the management of patients with cystic fibrosis. Biologics 2, 611-617 (2008).
13. Gessler T, Seeger W, Schmehl T. Inhaled prostanoids in the therapy of pulmonary hypertension. J. Aerosol Med. 21, 1-12 (2008).
14. Byron PR. Determinants of drug and polypeptide bioavailability from aerosols delivered to the lung. Adv. Drug Deliv. Rev. 5, 107-132 (1990).
15. Patton JS. Mechanisms of macromolecule absorption by the lung. Adv. Drug Deliv. Rev. 19, 3-36 (1996).
16. Gonda I. Systemic delivery of drugs to humans via inhalation. J. Aerosol Med. 19, 47-53 (2006).
17. Portenoy RK, Burton AW, Gabrail N, Taylor D. A multicenter, placebo-controlled, double-βlind, multiple-crossover study of fentanyl pectin nasal spray (FPNS) in the treatment of breakthrough cancer pain. Pain 151, 617-624 (2010).
18. Paech MJ, Lim CB, Banks SL, Rucklidge MW, Doherty DA. A new formulation of nasal fentanyl spray for postoperative analgesia: a pilot study. Anaesthesia 58, 740-744 (2003).
19. Barnes MP. Sativex: clinical efficacy and tolerability in the treatment of symptoms of multiple sclerosis and neuropathic pain. Expert Opin. Pharmacother. 7, 607-615 (2006).
20. Cipolla D, Chan H-K, Schuster J, Farina D. Personalizing aerosol medicine: development of delivery systems tailored to the individual. Therapeutoc Delivery 1, 667-682 (2010).
21. Rabinowitz JD, Wensley M, Lloyd P et al. Fast onset medications through thermally generated aerosols. J. Pharmacol. Exp. Ther. 309, 769-775 (2004).
22. Nordstrom K. Inhaled loxapine for acute agitation in schizophrenia and bipolar disorder. Future Neurol. 4, 539-545 (2009).
23. Spyker DA, Munzar P, Cassella JV. Pharmacokinetics of loxapine following inhalation of a thermally generated aerosol in healthy volunteers. J. Clin. Pharmacol. 50, 169-179 (2010).
24. Allen MH, Feifel D, Lesem MD et al. Efficacy and safety of loxapine for inhalation in the treatment of agitation in patients with schizophrenia: a randomized, double-βlind, placebo-controlled trial. J. Clin. Psychiatry DOI: 10.4088/JCP.10m06011yel. Epub ahead of print (2011).
25. Lesem MD, Tran-Johnson TK, Riesenberg RA et al. Rapid acute treatment of agitation in individuals with schizophrenia: multicentre, randomised, placebo-controlled study of inhaled loxapine. Br. J. Psychiatry 198, 51-58 (2011).
26. Fishman R, Cassella J, Spyker D. Inhaled loxapine rapidly improves acute agitation in patients with bipolar disorder. Presented at: American Psychiatric Association Conference, CA, USA 13-16 September 2009.
27. Crooks J, Stephen SA, Brass W. Clinical trial of inhaled ergotamine tartrate in migraine. Br. Med. J. 1, 221-224 (1964).
28. Shrewsbury S, Cook R, Taylor G, Edwards C, Ramadan N. Safety and pharmacokinetics of dihydroergotamine mesylate administered via a novel (TEMPO®) inhaler. Headache 48, 355-367 (2008).
29. Shrewsbury SB, Kori SH, Miller SD, Pedinoff A, Weinstein S. Randomized, double-βlind, placebo-controlled study of the safety, tolerability and pharmacokinetics of MAP0004 (orally inhaled DHE) in adult asthmatics. Curr. Med. Res. Opin. 24, 1977-1985 (2008).
30. Forst A, Febbraro S, Kellerman D et al. An open-label, two-period, crossover study comparing the pharmacokinetics and tolerability of LEVADEX® (MAP0004, orally-inhaled DHE, 1.0 mg) in smoking and non-smoking adult volunteers. Presnted at: 53rd Annual Scientific Meeting of the American Headache Society, DC, USA, 2-5 June 2011.
31. Aurora SK, Rozen TD, Kori SH, Shrewsbury SB. A randomized, double-βlind, placebo-controlled study of MAP0004 in adult patients with migraine. Headache 49, 826-837 (2009).
32. Aurora SK, Silberstein SD, Kori SH et al. MAP0004, orally inhaled DHE: a randomized, controlled study in the acute treatment of migraine. Headache 51, 507-517 (2011).
33. Sharma S, Prasad A, Nehru R et al. Efficacy and tolerability of prochlorperazine buccal tablets in treatment of acute migraine. Headache 42, 896-902 (2002).
34. Kostic MA, Gutierrez FJ, Rieg TS, Moore TS, Gendron RT. A prospective, randomized trial of intravenous prochlorperazine versus subcutaneous sumatriptan in acute migraine therapy in the emergency department. Ann. Emerg. Med. 56, 1-6 (2010).
35. Avram MJ, Spyker DA, Henthorn TK, Cassella JV. The pharmacokinetics and bioavailability of prochlorperazine delivered as a thermally generated aerosol in a single breath to volunteers. Clin. Pharmacol. Ther. 85, 71-77 (2009).
36. Cassella J, Spyker D, Skowronski R et al. Novel inhalation technology delivers intravenous-like pharmacokinetics of prochlorperazine in healthy volunteers. Presented at: 47th Annual Scientific Meeting of the American Headache Society, PA, USA, 23-26 June 2005.
37. Cassella J, Spyker D, Mei L, Houghton W. Inhaled prochlorperazine reduces headache pain in patients having an acute migraine attack. Presented at: 48th Annual Scientific Meeting of the American Headache Society, CA, USA, 22-25 June 2006.
38. Cassella J, Spyker D, Mei L, Munzar P, Houghton W. Efficacy and tolerability profile of AZ-001 (Staccato® prochlorperazine) in paitents with migraine headache. Presented at: 49th Annual Scientific Meeting of the American Headache Society, IL, USA, 7-10 June 2007.
39. Cassella J, Fishman R, Spyker D. Inhaled loxapine, a dopamine antagonist, reduces headache pain in paitents having an acute migraine attack. Presented at: 50th Annual Scientific Meeting of the American Headache Society. MA, USA, 26-29 June 2008.
40. Trescot AM, Datta S, Lee M, Hansen H. Opioid pharmacology. Pain Physician 11(2 Suppl.), S133-S153 (2008).
41. Cleary JF. Pharmacokinetic and pharmacodynamic issues in the treatment of breakthrough pain. Seminars in Oncology. 24(Suppl. 16), 516 (1997).
42. Portenoy RK, LeSage P. Management of cancer pain. Lancet 353, 1695-1700 (1999).
43. Farr SJ, Otulana BA. Pulmonary delivery of opioids as pain therapeutics. Adv. Drug Deliv. Rev. 58, 1076-1088 (2006).
44. Worsley MH, MacLeod AD, Brodie MJ, Asbury AJ, Clark C. Inhaled fentanyl as a method of analgesia. Anaesthesia 45, 449-451 (1990).
45. Miner JR, Kletti MD, Herold M, Hubbard D, Biros MH. Randomized clinical trial of nebulized fetnanyl citrate versus iv. fentanyl citrate in children presenting to the emergency department with acute pain. Acad. Emerg. Med. 14, 895-898 (2007).
46. Furyk JS, Grabowski WJ, Black LH. Nebulized fentanyl versus intravenous morphine in children with suspected limb fractures in the emergency department: a randomized controlled trial. Emerg. Med. Australas. 3, 203-209 (2009).
47. Bartfield JM, Flint RD, McErlean M, Broderick J. Nebulized fentanyl for relief of abdominal pain. Acad. Emerg. Med. 3, 215-218 (2003).
48. Higgins MJ, Asbury AJ, Brodie MJ. Inhaled nebulised fentanyl for postoperative analgesia. Anaesthesia 46, 973-976 (1991).
49. Boyle F, Mather LE, Lam J et al. Inhaled fentanyl via the AERx system for the treatment of breakthrough cancer pain. Proceedings of the 19th Annual Scientific Meeting, American Pain Society (2000).
50. Mather LE, Woodhouse A, Ward ME, Farr SJ, Rubsamen RA, Eltherington LG. Pulmonary administration of aerosolised fentanyl: pharmacokinetic analysis of systemic delivery. Br. J. Clin. Pharmacol. 46, 37-43 (1998).
51. Overhoff KA, Clayborough R, Crowley M. Review of the TAIFUN multidose dry powder inhaler technology. Drug Dev. Ind. Pharm. 34, 960-965 (2008)
52. Macleod DB, Spyker DA, Houghton WC, Ikeda K, Gan TJ. Pharmacokinetic profiles of fentanyl delivered by intravenous and inhaled thermal aerosol routes. Anesthesiology 107, (Abstract A733) (2007)
53. Macleod DB, Spyker DA, Habib A, Ho KY, Gan TJ. Pharmacodynamic response to fentanyl delivered by intravenous and inhaled thermal aerosol routes. Anesthesiology 107, (Abstract A1093) (2007).
54. Hung, OR, Whynot SC, Varvel JR, Shafer SL, Mezel M. Pharmacokinetics of inhaled liposome-encapsulated fentanyl. Anesthesiology 83, 227-284 (1995).
55. Chisholm KC, Rossiter-Rooney M, Ganapathy S et al. Inhaled liposome-encapsulated fentanyl (AeroLEF) for post-operative pain after orthopedic surgery. Presented at: American Society of Anesthesiologists Annual Meeting, Poster A1191, IL, USA, 14-18 October 2006.
56. Ward ME, Woodhouse A, Mather LE et al. Morphine pharmacokinetics after pulmonary administration from a novel aerosol delivery system. Clin. Pharmacol. Ther. 62, 596-609 (1997).
57. Dershwitz M, Walsh JL, Morishige RJ et al. Pharmacokinetics and pharmacodynamics of inhaled versus intravenous morphine in healthy volunteers. Anesthesiology 93, 619-28 (2000).
58. Thipphawong JB, Babul N, Morishige RJ et al. Analgesic efficacy of inhaled morphine in patients after bunionectomy surgery. Anesthesiology 99, 693-700 (2003).
59. Biondi S, Devereaux C, Rappoport V et al. A thermally-generated aerosol for delivery of fentanyl in a hand-held device. In: RDD Europe 2007. Dalby RN, Byron PR, Peart J, Suman JD (Eds).235-238 (2007).
60. Rose JE, Turner JE, Murugesan T, Behm FM, Laugesen M. Pulmonary delivery of nicotine pyruvate: sensory and pharmacokinetic characteristics. Exp. Clin. Psychopharmacol. 18, 385-394 (2010).
61. Caldwell B, Dickson S, Burgess C et al. A pilot study of nicotine delivery to smokers from a metered-dose inhaler. Nicotine & Tobacco Research 11, 342-347 (2009).
62. Cipolla DC, Bruinenberg P, Eliahu P et al. Development of an inhaled AERx Essence® nicotine product for smoking cessation. In: Respiratory Drug Delivery 2008. Byron PR, Peart J, Suman JD, Farr SJ, Young PM (Eds).365-369 (2008).
63. Simis K, Lei M, Lu AT et al. Nicotine aerosol generation from thermally reversible zinc halide complexes using the Staccato system. Drug Dev. Ind. Pharm. 34, 936-942 (2008).
64. Myers D, Eliahu P, Cassella J et al. The generation of nicotine aerosol for pulmonary delivery using the Staccato system. Presented at: Society for Research on Nicotine and Tobacco 17th Annual Meeting, Poster POS5-65, Ontario, Canada, 16-19 February 2011.
65. Rose JE, Hickman CS. Citric acid aerosol as a potential smoking cessation aid. Chest 92, 1005-1008 (1987).
66. Levin ED, Behm F, Carnahan E, LeClair R, Shipley R, Rose JE. Clinical trials using ascorbic acid aerosol to aid smoking cessation. Drug Alcohol Depend. 33, 211-223 (1993).
67. Kanai A, Kumaki C, Niki Y, Suzuki A, Tazawa T, Okamoto H. Efficacy of a metered-dose 8% lidocaine pump spray for patients with post-herpetic neuralgia. Pain Med. 10, 902-909 (2009).
68. Xue FS, Liu HP, He N et al. Spray-alpha;s-you-go airway topical anesthesia in patients with a difficult airway: a randomized, double-βlind comparison of 2% and 4% lidocaine. Anesth. Analg. 108, 536-543 (2009).
69. Stevens JB, Vories PA, Walker SC. Nebulized tetracaine attenuates the hemodynamic response to tracheal intubation. Acta Anaesthesiol. Scand. 40, 757-759 (1996).
70. Fee JP, Collier PS, Launchbury AP, Clarke RS. The influence of particle size on the bioavailability of inhaled temazepam. Br. J. Clin. Pharmacol. 33, 641-644 (1992).
71. McCormick, ASM, Thomas VL, Berry D, Thomas PW. Plasma concentrations and sedation scores after nebulized and intranasal midazolam in healthy volunteers. Br. J. Anaesth. 100, 631-636 (2008).
72. Rabinowitz JD, Lloyd PM, Munzar P et al. Ultra-fast absorption of amorphous pure drug aerosols via deep lung inhalation. J. Pharm. Sci. 95, 2438-51 (2006).
73. Bartus RT, Emerich D, Snodgress-Belt P et al. A pulmonary formulation of l-dopa enhances its effectiveness in a rat model of Parkinson's disease. J. PET 310, 828-835 (2004).
74. Grosset KA, Morgan FG, Main MJ, Lee AJ, Grosset DG. Oral inhalation of apomorphine provides rapid rescue from off periods in Parkinson's disease (PD): a Phase IIA clinical study. Presented at: 10th International Congress of Parkinson's Disease and Movement Disorders. 5-8 March 2006.
75. Orma PS, Middleton RK. Aerosolized atropine as an antidote to nerve gas. Ann. Pharmacother. 26, 937-938 (1992).
76. Reynolds ER, Wijetunge P, Oakum CD, Vyas B, Cook RO. Method development for the determination of the aerodynamic particle size distribution of inhaled atropine sulfate from the MicroDose dry powder inhaler by the next generation impactor. In: Respiratory Drug Delivery 2010. Byron PR, Peart J, Suman JD, Farr SJ, Young PM (Eds).687-690 (2010).
77. Liu YX, Wang MZ, Sun MZ, Niao SX. Rapid arrest of seizures with an inhalation aerosol containing diazepam. Epilepsia 35, 356-358 (1994).
78. Center for Drug Evaluation and Research. Guidance for Industry: Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products: Chemistry, Manufacturing, and Controls Documentation. Food and Drug Administration (1998).
79. Committee for Medicinal Products for Human Use. Guideline on the Pharmaceutical Quality of Inhalation and Nasal Products. European Medicines Agency (2006).
80. Stewart B, Garley M, Koester A. Toxicity evaluation of inhaled loxapine in the rat. Presented at: Society of Toxicology Annual Meeting 2011. Poster 1882, DC, USA, 6-10 March 2011.