Predictability of intranasal pharmacokinetics in man using pre-clinical pharmacokinetic data with a dopamine 3 receptor agonist, PF-219061

References

• Basson R. 2001. Female sexual response: the role of drugs in the management of sexual dysfunction. Obstet Gynecol 98(2):350–3.
   PubMedGoogle Scholar
• Bechara A, Bertolino MV, Casabe A, Fredotovich N. 2004. A double-blind randomized placebo control study comparing the objective and subjective changes in female sexual response using sublingual apomorphine. J Sex Med 1(2):209–14.
   PubMedGoogle Scholar
• Blagg J, Allerton CM, Batchelor DV, Baxter AD, Burring DJ, Carr CL, Cook AS, Nichols CL, Phipps J, Sanderson VG et al. 2007. Design and synthesis of a functionally selective D3 agonist and its in vivo delivery via the intranasal route. Bioorg Med Chem Lett 17(24):6691–6.
   Google Scholar
• Brown AD, Blagg J, Reynolds DS. 2007. Designing drugs for the treatment of female sexual dysfunction. Drug Discov Today 12:757–66.
   PubMed Web of Science ®Google Scholar
• Cass LM, Efthymiopoulos C, Bye A. 1999. Pharmacokinetics of zanamivir after intravenous, oral, inhaled or intranasal administration to healthy volunteers. Clin Pharmacokinet 36 Suppl. 1:1–11.
   PubMed Web of Science ®Google Scholar
• Collins SL, Evans SM, Foltin RW, Haney M. 2007. Intranasal cocaine in humans: Effects of sex and menstrual cycle. Pharmacol Biochem Behav 86:117–24.
   PubMed Web of Science ®Google Scholar
• Costantino HR, Illum L, Brandt G, Johnson PH, Quay SC. 2007. Intranasal delivery: physicochemical and therapeutic aspects. Int J Pharm 337:1–24.
   PubMed Web of Science ®Google Scholar
• Eriksen J, Jensen NH, Kamp-Jensen M, Bjarno H, Friis P, Brewster D. 1989. The systemic availability of buprenorphine administered by nasal spray. J Pharm Pharmacol 41:803–5.
   PubMed Web of Science ®Google Scholar
• Gardner IB, Walker DK, Lennard MS, Smith DA, Tucker GT. 1995. Comparison of the disposition of two novel combined thromboxane synthase inhibitors/thromboxane A2 receptor antagonists in the isolated perfused rat liver. Xenobiotica 25:185–97.
   PubMed Web of Science ®Google Scholar
• Gobry V BG, Carrupt P-A, Testa B, Girault HH. 2000. Physicochemical characterization of sildenafil: ionization, lipophilicity behaviour, and ionic-partition diagram studied by two-phase titration and electrochemistry. Helvetica Chimica Acta 83:1465–74.
   Web of Science ®Google Scholar
• Harrison A, Betts A, Fenner K, Beaumont K, Edgington A, Roffey S, Davis J, Comby P, Morgan P. 2004. Nonlinear oral pharmacokinetics of the alpha-antagonist 4-amino-5-(4-fluorophenyl)-6,7-dimethoxy-2-[4-(morpholinocarbonyl)-perhydr o-1,4-diazepin-1-yl]quinoline in humans: use of preclinical data to rationalize clinical observations. Drug Metab Dispos 32:197–204.
   PubMed Web of Science ®Google Scholar
• Hochhaus G, Mollmann H. 1992. Pharmacokinetic/pharmacodynamic characteristics of the beta-2-agonists terbutaline, salbutamol and fenoterol. Int J Clin Pharmacol Ther Toxicol 30:342–62.
   PubMedGoogle Scholar
• Hussain AA. 1998. Intranasal drug delivery. Adv Drug Deliv Rev 29:39–49.
   PubMed Web of Science ®Google Scholar
• Jogani VV, Shah PJ, Mishra P, Mishra AK, Misra AR. 2007. Nose-to-brain delivery of tacrine. J Pharm Pharmacol 59:1199–205.
   PubMed Web of Science ®Google Scholar
• Jones HM, Gardner IB, Watson KJ. 2009. Modelling and PBPK simulation in drug discovery. AAPS J 11(1):155–66.
   PubMed Web of Science ®Google Scholar
• Laumann EO, Paik A, Rosen RC. 1999. Sexual dysfunction in the United States: prevalence and predictors. J Am Med Assoc 281:537–44.
   PubMed Web of Science ®Google Scholar
• Lowry OH, Rosebrough NJ, Farr AL, Randall RJ. 1951. Protein measurement with the Folin phenol reagent. J Biol Chem 193:265–75.
   PubMed Web of Science ®Google Scholar
• Neef C, Van Laar T. 1999. Pharmacokinetic–pharmacodynamic relationships of apomorphine in patients with Parkinson’s disease. Clin Pharmacokinet 37:257–71.
   PubMed Web of Science ®Google Scholar
• Omura T, Sato R. 1964. The carbon monoxide-binding pigment of liver microsomes. I. Evidence for its hemoprotein nature. J Biol Chem 239:2370–8.
   PubMed Web of Science ®Google Scholar
• Pasqualotto EB, Pasqualotto FF, Sobreiro BP, Lucon AM. 2005. Female sexual dysfunction: the important points to remember. Clinics 60:51–60.
   PubMedGoogle Scholar
• Pinter MM, Pogarell O, Oertel WH. 1999. Efficacy, safety, and tolerance of the non-ergoline dopamine agonist pramipexole in the treatment of advanced Parkinson’s disease: a double blind, placebo controlled, randomised, multicentre study. J Neurol Neurosurg Psych 66:436–41.
   PubMed Web of Science ®Google Scholar
• Ragucci KR, Culhane NS. 2003. Treatment of female sexual dysfunction. Ann Pharmacother 37:546–55; quiz 603–4.
   PubMedGoogle Scholar
• Sam E, Jeanjean AP, Maloteaux JM, Verbeke N. 1995. Apomorphine pharmacokinetics in parkinsonism after intranasal and subcutaneous application. Eur J Drug Metab Pharmacokinet 20:27–33.
   PubMed Web of Science ®Google Scholar
• Samolinski BK, Grzanka A, Gotlib T. 2007. Changes in nasal cavity dimensions in children and adults by gender and age. Laryngoscope 117:1429–33.
   PubMedGoogle Scholar
• Segraves RT. 2003. Emerging therapies for female sexual dysfunction. Expert Opin Emerg Drugs 8:515–22.
   PubMedGoogle Scholar
• Segraves RT, Clayton A, Croft H, Wolf A, Warnock J. 2004. Bupropion sustained release for the treatment of hypoactive sexual desire disorder in premenopausal women. J Clin Psychopharmacol 24:339–42.
   PubMed Web of Science ®Google Scholar
• Shen DD, Kunze KL, Thummel KE. 1997. Enzyme-catalyzed processes of first-pass hepatic and intestinal drug extraction. Adv Drug Deliv Rev 27:99–127.
   PubMed Web of Science ®Google Scholar
• Stopher D, McClean S. 1990. An improved method for the determination of distribution coefficients. J Pharm Pharmacol 42:144.
   PubMed Web of Science ®Google Scholar
• Van der Graaf PH WC, Baxter AD, Cook AS, Wong SKF. 2003. Selective dopamine D3 receptor agonists for the treatment of sexual dysfunction. PCT Int. Appl. WO 2003051370
   Google Scholar
• Van Giersbergen PL, Dingemanse J. 2003. Multiple-dose pharmacokinetics of intranasally administered IS-159 in healthy subjects. Eur J Drug Metab Pharmacokinet 28:49–54.
   PubMedGoogle Scholar
• Wermeling DP, Miller JL, Archer SM, Manaligod JM, Rudy AC. 2001. Bioavailability and pharmacokinetics of lorazepam after intranasal, intravenous, and intramuscular administration. J Clin Pharmacol 41:1225–31.
   PubMed Web of Science ®Google Scholar
• Zhang X, Zhang QY, Liu D, Su T, Weng Y, Ling G, Chen Y, Gu J, Schilling B, Ding X. 2005. Expression of cytochrome p450 and other biotransformation genes in fetal and adult human nasal mucosa. Drug Metab Dispos 33:1423–8.
   PubMed Web of Science ®Google Scholar