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Year 2019, Volume: 2 Issue: 2, 75 - 83, 30.12.2019

Abstract

References

  • Alsante M, Ando A, Brown R, Ensing J, Hatajik TD, Kong W, Tsuda Y (2007). The role of degradant profiling in active pharmaceutical ingredients and drug products. Adv Drug Deliv Rev 59(1): 29-37.
  • Brown SA, D’Amico EJ, McCarthy DM, Tapert SF (2001). Four year outcomes from adolescent alcohol and drug treatment. J Stud Alcohol 62: 381–388.
  • Klick S, Muijselaar PG, Waterval JCM, Eichinger T, Korn C, Gerding KT, Debets AJ, Griend CS, Beld C, Somsen GW, De Jong GJ (2005). Toward a generic approach for : Stress testing of drug substances and drug products. Pharm Technol 29(2): 48-66.
  • Lee JD, Friedmann PD, Kinlock TW, Nunes EV, Boney TY, Hoskinson RA, Wilson D, McDonald R, Rotrosen J, Gourevitch MN, Gordon M, Fishman M, Chen DT, Bonnie RJ, Cornish JW, Murphy SM, O’Brien CP (2016). Extended-Release Naltrexone to Prevent Opioid Relapse in Criminal Justice Offenders. N Engl J Med 374(13): 1232–1242.
  • Modesto-Lowe V, Van Kirk J (2002). Clinical uses of naltrexone: A review of the evidence. Exp Clin Psychopharmacol 10(3): 213-227.
  • Volkow ND, Li TK (2004). Drug addiction: the neurobiology of behaviour gone awry. Nat Rev Neurosci 5(12): 963-970.

Forced degradation studies of new formulation containing naltrexone

Year 2019, Volume: 2 Issue: 2, 75 - 83, 30.12.2019

Abstract

Naltrexone is one of the classical opioid antagonists. In substantially lower than standard doses, they apply different pharmacodynamics. A daily dose of 1 to 5 mg is considered as low-dose naltrexone (LDN). Clinical reports of LDN have demonstrated its possible benefits in diseases such as fibromyalgia, Crohn’s disease, multiple sclerosis, complex-regional pain syndrome, Hailey-Hailey disease, and cancer.
The aim of the present study was to establish the inherent stability of naltrexone and stability indicating assay method for simultaneous determination of naltrexone after being subjected to acidic and basic stress.
A forced degradation study of naltrexone in its tablet form was conducted under the acidic and basicconditions in order to develop a rapid and sensitive stability indicating UV-Visible method for the quantification of naltrexone. Quantification was achieved by UV detection at 286.60 nm, on the basis of peak area. Naltrexone was found to be unstable and degraded in the acidic and basic buffer up to 3 hours. 

References

  • Alsante M, Ando A, Brown R, Ensing J, Hatajik TD, Kong W, Tsuda Y (2007). The role of degradant profiling in active pharmaceutical ingredients and drug products. Adv Drug Deliv Rev 59(1): 29-37.
  • Brown SA, D’Amico EJ, McCarthy DM, Tapert SF (2001). Four year outcomes from adolescent alcohol and drug treatment. J Stud Alcohol 62: 381–388.
  • Klick S, Muijselaar PG, Waterval JCM, Eichinger T, Korn C, Gerding KT, Debets AJ, Griend CS, Beld C, Somsen GW, De Jong GJ (2005). Toward a generic approach for : Stress testing of drug substances and drug products. Pharm Technol 29(2): 48-66.
  • Lee JD, Friedmann PD, Kinlock TW, Nunes EV, Boney TY, Hoskinson RA, Wilson D, McDonald R, Rotrosen J, Gourevitch MN, Gordon M, Fishman M, Chen DT, Bonnie RJ, Cornish JW, Murphy SM, O’Brien CP (2016). Extended-Release Naltrexone to Prevent Opioid Relapse in Criminal Justice Offenders. N Engl J Med 374(13): 1232–1242.
  • Modesto-Lowe V, Van Kirk J (2002). Clinical uses of naltrexone: A review of the evidence. Exp Clin Psychopharmacol 10(3): 213-227.
  • Volkow ND, Li TK (2004). Drug addiction: the neurobiology of behaviour gone awry. Nat Rev Neurosci 5(12): 963-970.
There are 6 citations in total.

Details

Primary Language English
Subjects Chemical Engineering
Journal Section Research Article
Authors

Golnaz Yaghoubnezhadzanganeh This is me

E. Vildan Burgaz

Publication Date December 30, 2019
Published in Issue Year 2019 Volume: 2 Issue: 2

Cite

APA Yaghoubnezhadzanganeh, G., & Burgaz, E. V. (2019). Forced degradation studies of new formulation containing naltrexone. EMU Journal of Pharmaceutical Sciences, 2(2), 75-83.
AMA Yaghoubnezhadzanganeh G, Burgaz EV. Forced degradation studies of new formulation containing naltrexone. EMUJPharmSci. December 2019;2(2):75-83.
Chicago Yaghoubnezhadzanganeh, Golnaz, and E. Vildan Burgaz. “Forced Degradation Studies of New Formulation Containing Naltrexone”. EMU Journal of Pharmaceutical Sciences 2, no. 2 (December 2019): 75-83.
EndNote Yaghoubnezhadzanganeh G, Burgaz EV (December 1, 2019) Forced degradation studies of new formulation containing naltrexone. EMU Journal of Pharmaceutical Sciences 2 2 75–83.
IEEE G. Yaghoubnezhadzanganeh and E. V. Burgaz, “Forced degradation studies of new formulation containing naltrexone”, EMUJPharmSci, vol. 2, no. 2, pp. 75–83, 2019.
ISNAD Yaghoubnezhadzanganeh, Golnaz - Burgaz, E. Vildan. “Forced Degradation Studies of New Formulation Containing Naltrexone”. EMU Journal of Pharmaceutical Sciences 2/2 (December 2019), 75-83.
JAMA Yaghoubnezhadzanganeh G, Burgaz EV. Forced degradation studies of new formulation containing naltrexone. EMUJPharmSci. 2019;2:75–83.
MLA Yaghoubnezhadzanganeh, Golnaz and E. Vildan Burgaz. “Forced Degradation Studies of New Formulation Containing Naltrexone”. EMU Journal of Pharmaceutical Sciences, vol. 2, no. 2, 2019, pp. 75-83.
Vancouver Yaghoubnezhadzanganeh G, Burgaz EV. Forced degradation studies of new formulation containing naltrexone. EMUJPharmSci. 2019;2(2):75-83.