Food effects on the pharmacokinetics of morphine sulfate and naltrexone hydrochloride extended release capsules

Advances in Therapy

Volumn 27, Issue 11, 2010, Pages 846-858

  Johnson, Franklin ^a   Ciric, Sabrina ^b   Boudriau, Sophie ^b   Swearingen, Dennis ^c   Stauffer, Joseph ^a,d  

^a Alpharma Pharmaceuticals LLC   (United States)

^b MDS Inc   (Canada)

^c CELERION   (United States)

^d JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Bioavailability; Extended release; Food effect; Morphine sulfate; Naltrexone hydrochloride; Opioids; Pharmacokinetic

Indexed keywords

EMBEDA; MORPHINE SULFATE; NALTREXOL; NALTREXONE; UNCLASSIFIED DRUG;

ADULT; AREA UNDER THE CURVE; ARTICLE; ASTHENIA; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED RELEASE FORMULATION; CONTROLLED STUDY; DIASTOLIC BLOOD PRESSURE; DIET RESTRICTION; DIZZINESS; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG FATALITY; DRUG INDUCED HEADACHE; DRUG WITHDRAWAL; FEMALE; FOOD; FOOD DRUG INTERACTION; HUMAN; HUMAN EXPERIMENT; MACULOPAPULAR RASH; MALE; MAXIMUM PLASMA CONCENTRATION; NAUSEA; NORMAL HUMAN; OXYGEN SATURATION; PRURITUS; PULSE RATE; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SINGLE DRUG DOSE; SYSTOLIC BLOOD PRESSURE; VOMITING;

ADULT; AREA UNDER CURVE; BIOLOGICAL AVAILABILITY; CROSS-OVER STUDIES; DELAYED-ACTION PREPARATIONS; DIETARY FATS; DRUG TOXICITY; FASTING; FEEDING BEHAVIOR; FEMALE; FOOD-DRUG INTERACTIONS; HUMANS; MALE; MIDDLE AGED; MORPHINE; NALTREXONE;

EID: 78649320958     PISSN: 0741238X     EISSN: None     Source Type: Journal    
DOI: 10.1007/s12325-010-0074-x     Document Type: Article

References (28)

1. R. Chou G.J. Fanciullo P.G. Fine 2009 Opioid treatment guidelines. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain J Pain. 10 113 130 1:CAS:528:DC%2BD1MXhtlCgsb0%3D 10.1016/j.jpain.2008.10. 008 19187889
2. B.H. McCarberg R.L. Barkin 2001 Long-acting opioids for chronic pain: pharmacotherapeutic opportunities to enhance compliance, quality of life, and analgesia Am J Ther. 8 181 186 1:STN:280:DC%2BD3MzkvVSnuw%3D%3D 10.1097/00045391-200105000-00006 11344385
3. E. Kalso L.G. Allan P.L. Dellemijn 2003 Recommendations for using opioids in chronic non-cancer pain Eur J Pain. 7 381 386 1:CAS:528:DC%2BD3sXmsVCntrY%3D 10.1016/S1090-3801(02)00143-X 12935789 (Pubitemid 37101777)
4. J.R. Caldwell R.J. Rapoport J.C. Davis 2002 Efficacy and safety of a once-daily morphine formulation in chronic, moderate-to-severe osteoarthritis pain: results from a randomized, placebo-controlled, double-blind trial and an open-label extension trial J Pain Symptom Manage. 23 278 291 1:CAS:528:DC%2BD38XosFSmur8%3D 10.1016/S0885-3924(02)00383-4 11997197 (Pubitemid 34462941)
5. P. Sloan N. Babul 2006 Extended-release opioids for the management of chronic non-malignant pain Expert Opin Drug Deliv. 3 489 497 1:CAS:528:DC%2BD28XmslSksr8%3D 10.1517/17425247.3.4.489 16822224
6. Office of National Drug Control Policy, Executive Office of the President. Prescription for danger: a report on the troubling trend of prescription and over-the-counter drug abuse among the nation's teens. Available at: http://www.theantidrug.com/pdfs/prescription-report.pdf. Accessed January 31, 2010.
7. B.M. Kuehn 2007 Opioid prescriptions soar: increase in legitimate use as well as abuse JAMA 297 249 251 1:CAS:528:DC%2BD2sXotVCguw%3D%3D 10.1001/jama.297.3.249 17227967 (Pubitemid 46143290)
8. Substance AbuseMental Health Services Administration. 2010 Results from the 2007 National Survey on Drug Use and Health: National Findings US Department of Health and Human Services, Office of Applied Studies Rockville, MD Substance Abuse and Mental Health Services Administration. Results from the 2007 National Survey on Drug Use and Health: National Findings. Rockville, MD: US Department of Health and Human Services, Office of Applied Studies, NSDUH Series H-34, DHHS Publication No. SMA 08-4343. Available at: http://oas.samhsa.gov/. Accessed January 31, 2010.
9. C. Wright E.D. Kramer M.A. Zalman M.Y. Smith J.D. Haddox 2006 Risk identification, risk assessment, and risk management of abusable drug formulations Drug Alcohol Depend. 83 suppl.1 S68 S76 1:CAS:528: DC%2BD28Xjs1Gqsbk%3D 10.1016/j.drugalcdep.2005.12.012 16581201
10. Embeda [package insert]. Bristol, TN: King Pharmaceuticals, Inc.; June 2009.
11. N.P. Katz S. Sun F.K. Johnson J. Stauffer 2010 ALO-01 (morphine sulfate and naltrexone hydrochloride) extended release capsules in the treatment of chronic pain of osteoarthritis of the hip or knee: pharmacokinetics, efficacy, and safety J Pain. 11 303 311 1:CAS:528:DC%2BC3cXjvFygtLw%3D 10.1016/j.jpain.2009.07.017 19944650
12. J. Stauffer B. Setnik M. Sokolowska M. Romach F. Johnson E. Sellers 2009 Subjective effects and safety of whole and tampered morphine sulfate and naltrexone hydrochloride (ALO-01) extended-release capsules versus morphine solution and placebo in experienced non-dependent opioid users: a randomized, double-blind, placebo-controlled, crossover study Clin Drug Investig. 29 777 790 1:CAS:528:DC%2BD1MXhs1WitbvF 10.2165/11530800-000000000-00000 19888784
13. Kadian [package insert]. Elizabeth, NJ: Actavis Elizabeth LLC; February 2009.
14. A. Broomhead R. West L. Eglinton 1997 Comparative single-dose pharmacokinetics of sustainedrelease and modified-release morphine sulfate capsules under fed and fasting conditions Clin Drug Invest. 13 162 170 1:CAS:528:DyaK2sXisFWqurk%3D 10.2165/00044011-199713030-00006
15. A. Broomhead R. West G. Kadirgamanathan K. Knox D. Krueger J. Malick 1997 Comparative bioavailability of sustained-release morphine sulfate capsules versus pellets Clin Drug Invest. 14 137 145 1:CAS:528:DyaK2sXls1yhtbg%3D 10.2165/00044011-199714020-00008
16. US FoodDrug Administration. 2002 Guidance for Industry: Food-Effect Bioavailability and Fed Bio-equivalence Studies Center for Drug Evaluation and Research Rockville, MD US Food and Drug Administration. Guidance for Industry: Food-Effect Bioavailability and Fed Bio-equivalence Studies. Rockville, MD: Center for Drug Evaluation and Research; December 2002. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/ucm070241.pdf. Accessed January 31, 2010.
17. US FoodDrug Administration. 2010 Good laboratory practice for nonclinical laboratory studies U.S. Government Printing Office Washington, DC US Food and Drug Administration. Good laboratory practice for nonclinical laboratory studies. Title 21, Code of Federal Regulations, section 58 (21 CFR 58). Washington, DC: U.S. Government Printing Office. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart= 58&showFR=1. Accessed January 31, 2010.
18. International Conference on Harmonisation. ICH Harmonised Tripartite Guideline: Guideline for Good Clinical Practice E6(R1) [Step 4 version]. June 10, 1996. Available at: http://www.ich.org/LOB/media/MEDIA482.pdf. Accessed January 31, 2010.
19. US FoodDrug Administration. 2010 Institutional review boards U.S. Government Printing Office Washington, DC US Food and Drug Administration. Institutional review boards. Title 21, Code of Federal Regulations, section 56 (21 CFR 56). Washington, DC: U.S. Government Printing Office. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart= 56&showFR=1. Accessed January 31, 2010.
20. US FoodDrug Administration. 2003 Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products-General Considerations Center for Drug Evaluation and Research Rockville, MD US Food and Drug Administration. Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products-General Considerations. Rockville, MD: Center for Drug Evaluation and Research; March 2003. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/UCM070124.pdf. Accessed January 31, 2010.
21. US FoodDrug Administration. 2001 Guidance for Industry: Statistical Approaches to Establishing Bioequivalence Center for Drug Evaluation and Research Rockville, MD US Food and Drug Administration. Guidance for Industry: Statistical Approaches to Establishing Bioequivalence. Rockville, MD: Center for Drug Evaluation and Research; January 2001. Available at: http://www.fda.gov/ downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070244.pdf. Accessed January 31, 2010.
22. C. Maccarrone R.J. West A.F. Broomhead G.P. Hodsman 1994 Single dose pharmacokinetics of Kapanol™, a new oral sustained-release morphine formulation Drug Invest. 7 262 274
23. Misra AL. Current status of preclinical research on disposition, pharmacokinetics, and metabolism of naltrexone. In: Willette RE, Barnett G, eds. Naltrexone Research Monograph 28. National Institute on Drug Abuse. 1980:132-146.
24. M.C. Meyer A.B. Straughn M.W. Lo W.L. Schary C.C. Whitney 1984 Bioequivalence, dose-proportionality, and pharmacokinetics of naltrexone after oral administration J Clin Psychiatry 45 15 19 1:CAS:528:DyaL2cXmt1ajsb4%3D 6469932
25. M.C. Ko M.F. Divin H. Lee J.H. Woods J.R. Traynor 2006 Differential in vivo potencies of naltrexone and 6beta-naltrexol in the monkey J Pharmacol Exp Ther. 316 772 779 1:CAS:528:DC%2BD28XhtlWqtrk%3D 10.1124/jpet.105.094409 16258020 (Pubitemid 43131005)
26. F.K. Johnson J.G. Stark F.A. Bieberdorf J. Stauffer 2010 Relative oral bioavailability of morphine and naltrexone derived from crushed morphine sulfate and naltrexone hydrochoride extended release capsules versus intact product and versus naltrexone solution: a single-dose, randomized sequence, open-label, three-way crossover trial in healthy volunteers ClinTher. 32 6 1149 1164 1:CAS:528:DC%2BC3cXpsVGhs7o%3D
27. Wong DF, Ye W, Zhou Y, et al. In vivo human opiate receptor occupancy of naltrexone: a doseresponse analysis. Abstract presented at: Annual Meeting of the Society for Neuroscience; October 14-18, 2006; Atlanta, GA.
28. REVIA™ (naltrexone hydrochloride) product monograph. Pomona, NY: Duramed Pharmaceuticals, Inc.; May 9, 2003.