Formulation considerations for the development of medications with abuse potential

Drug and Alcohol Dependence

Volumn 83, Issue SUPPL. 1, 2006, Pages

  Mansbach, Robert S ^a   Moore Jr , Richard A ^a  

^a NEUROCRINE BIOSCIENCES INC   (United States)

Author keywords

Drug abuse; Formulation; Scheduling

Indexed keywords

ALPRAZOLAM; BENZODIAZEPINE DERIVATIVE; BUPRENORPHINE; BUPRENORPHINE PLUS NALOXONE; CENTRAL DEPRESSANT AGENT; COCAINE; CYTOCHROME P450 INHIBITOR; EXCIPIENT; FENOFIBRATE; HYDROMORPHONE; KETOCONAZOLE; LOFIBRA; METHYLPHENIDATE; OXYCODONE; POLYMER; PRODRUG; QUINIDINE; WAX;

AGE DISTRIBUTION; AREA UNDER THE CURVE; ARTICLE; CONTROLLED RELEASE FORMULATION; DELAYED RELEASE FORMULATION; DRUG ABSORPTION; DRUG ALCOHOL INTERACTION; DRUG BIOAVAILABILITY; DRUG DELIVERY SYSTEM; DRUG DEPENDENCE; DRUG DEPENDENCE TREATMENT; DRUG DIFFUSION; DRUG DOSE REGIMEN; DRUG FORMULATION; DRUG INDICATION; DRUG METABOLISM; DRUG PENETRATION; DRUG SOLUBILITY; EXTENDED RELEASE FORMULATION; HUMAN; HYDROPHILICITY; IMMEDIATE RELEASE FORMULATION; MEDICAL RESEARCH; PRIORITY JOURNAL; RECEPTOR OCCUPANCY; RISK ASSESSMENT; STANDARDIZATION; SUSTAINED RELEASE FORMULATION;

BIOLOGICAL AVAILABILITY; CHEMISTRY, PHARMACEUTICAL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG AND NARCOTIC CONTROL; HUMANS; PRESCRIPTIONS, DRUG; SUBSTANCE-RELATED DISORDERS; UNITED STATES;

EID: 33646046832     PISSN: 03768716     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.drugalcdep.2005.10.018     Document Type: Article

References (25)

1. Abreu M.E., Bigelow G.E., Fleisher L., and Walsh S.L. Effect of intravenous injection speed on responses to cocaine and hydromorphone in humans. Psychopharmacology 154 (2001) 76-84
2. Arfken C.L., and Cicero T.J. Postmarketing surveillance for drug abuse. Drug Alcohol Depend. 70 Suppl. (2003) S97-S106
3. Balster R.L., and Schuster C.R. Fixed-interval schedule of cocaine reinforcement: effect of dose and infusion duration. J. Exp. Anal. Behav. 20 (1973) 119-129
4. Brady K.T., Lydiard R.B., and Brady J.V. Assessing abuse liability in clinical trials. Drug Alcohol Depend. 70 Suppl. (2003) S87-S96
5. Chait L.D., and Burke K.A. Preference for high- versus low-potency marijuana. Pharmacol. Biochem. Behav. 49 (1994) 643-647
6. de Wit H., Dudish S., and Ambre J. Subjective and behavioral effects of diazepam depend on its rate of onset. Psychopharmacology 112 (1993) 324-330
7. Food and Drug Administration (U.S.), 1997. Guidance for industry: extended release oral dosage forms: development, evaluation, and application of in vitro/in vivo correlations. http://www.fda.gov/cder/guidance/1306fnl.pdf.
8. Food and Drug Administration (U.S.), 2000. Guidance for industry: waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system. http://www.fda.gov/cder/guidance/3618fnl.pdf.
9. General Accounting Office (U.S.), 2003. Prescription drugs: oxycontin abuse and diversion and efforts to address the problem. Report GAO-04-110.
10. Griffiths R.R., Bigelow G.E., and Ator N.A. Principles of initial experimental drug abuse liability assessment in humans. Drug Alcohol Depend. 70 Suppl. (2003) S41-S54
11. Hintz R.B., and Johnson K.C. The effect of particle size on dissolution rate and oral absorption. Int. J. Pharm. 51 (1989) 9-17
12. Johanson C.E., and Schuster C.R. A choice procedure for drug reinforcers: cocaine and methylphenidate in the rhesus monkey. J. Pharmacol. Exp. Ther. 193 (1975) 676-688
13. Kathiramalainathan K., Kaplan H.L., Romach M.K., Busto U.E., Li N.-Y., Säwe J., Tyndale R.F., and Sellers E.M. Inhibition of cytochrome P450 2D6 modifies codeine abuse liability. J. Clin. Psychopharmacol. 20 (2000) 435-444
14. Lipinski C.A., Lombardo F., Dominy B.W., and Feeney P.J. Experimental and computational approaches to estimate solubility and permeability in drug discovery and development settings. Adv. Drug Deliv. Rev. 23 (1997) 3-25
15. Mansbach R.S., Feltner D.E., Gold L.H., and Schnoll S.H. Incorporating the assessment of abuse liability into the drug discovery and development process. Drug Alcohol Depend. 70 Suppl. (2003) S73-S86
16. McNeil Consumer and Specialty Pharmaceuticals citizen petition to FDA, 2004a. Docket number 2004P-0139, March 19, 2004. http://www.fda.gov/ohrms/dockets/dailys/04/mar04/031904/04p-0139-cp00001-01-vol1.pdf.
17. McNeil Consumer, Specialty Pharmaceuticals citizen petition to FDA, 2004b, Supplement to Docket number 2004P-0139, September 17, 2004. http://www.fda.gov/ohrms/dockets/dailys/04/sep04/092004/04p-0139-sup0002-01-vol6.pdf.
18. Mumford G.R., Evans S.M., Fleishaker J.C., and Griffiths R.R. Alprazolam absorption kinetics affects abuse liability. Clin. Pharmacol. Ther. 57 (1995) 356-365
19. Roset P.N., Farré M., de la Torre R., Mas M., Menoyo E., Hernández C., and Camí J. Modulation of rate of onset and intensity of drug effects reduces abuse potential in healthy males. Drug Alcohol Depend. 64 (2001) 285-298
20. Stitzer M.L., McCaul M.E., Bigelow G.E., and Liebson I. Oral methadone self-administration: effects of dose and alternative reinforcers. Clin. Pharmacol. Ther. 34 (1983) 29-35
21. St. John, B., 2000. Controlled delivery oral dosage forms in the new millennium. Pharmaceut. Manufact. Packing Sourcer.
22. Volkow N.D., Ding Y., Fowler J.S., Wang G.J., Logan J., Gatley J.S., Dewey S.L., Ashby C., Lieberman J., Hitzemann R., and Wolf A.P. Is methylphenidate like cocaine? Studies on their pharmacokinetics and distribution in human brain. Arch. Gen. Psychiat. 52 (1995) 456-463
23. Volkow N.D., and Swanson J.M. Variables that affect the clinical use and abuse of methylphenidate in the treatment of ADHD. Am. J. Psychiat. 160 (2003) 1909-1918
24. Wright, C., et al., 2006, this volume.
25. In: Yalkowsky S.H. (Ed). Techniques of Solubilization of Drugs (1981), Marcel Dekker, New York