Preformulation characteristics of the opioid growth factor antagonist-naltrexone hydrochloride: Stability and lipophilicity studies

Journal of Drug Delivery Science and Technology

Volumn 21, Issue 2, 2011, Pages 157-163

  Abdelkader, H ^a,b   Wu, Z ^a   Al Kassas, R ^a   Brown, J E ^c   Alany, R G ^a,c  

^a UNIVERSITY OF AUCKLAND   (New Zealand)

^b Minia University   (Egypt)

^c KINGSTON UNIVERSITY   (United Kingdom)

Author keywords

Chemical stability; Diabetic keratopathy; Naltrexone hydrochloride; Partition coefficient; Preformulation

Indexed keywords

ATENOLOL; METOPROLOL; NALTREXONE; OCTANOL; PRACTOLOL; PROPRANOLOL; TIMOLOL;

ACCURACY; AQUEOUS SOLUTION; ARTICLE; CHEMICAL REACTION KINETICS; DRUG DEGRADATION; DRUG OXIDATION; DRUG STABILITY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; LIPOPHILICITY; MASS SPECTROMETRY; PARTITION COEFFICIENT; PREFORMULATION;

EID: 79955456647     PISSN: 17732247     EISSN: None     Source Type: Journal    
DOI: 10.1016/S1773-2247(11)50017-6     Document Type: Article

References (35)

1. rd ed., London, Churchill-Livingstone, 2007, pp. 336-360.
2. Blumberg H., Dayton H.B. - Naloxone, naltrexone and related noroxymorphones.- In: Braude M.C., Harris L.S., May E.L., Smith J.P., Villareal J.E. (Eds.), Narcotic Antagonists Advances in Biochemical Psychopharmacology, New York, Raven Press, 1973, pp. 33-43.
3. Renault P.F. - Treatment of heroin-dependent persons with antagonists: current status. - In: Willette R.E., Barnett G. (Eds.), Natlional Institute on Drug Abuse Research Monograph, Series 28, National Institute on Drug Abuse, 1981, pp. 21-32.
4. Zagon I.S., Sassani J.W., Myers R.L., McLaughlin P.J. - Naltrexone accelerates healing without compromise of adhesion complexes in normal and diabetic corneal epithelium. - Br. Res. Bull., 72, 18-24, 2007.
5. Zagon I.S., Sassani J.W., McLaughlin P.J. - Re-epithelialization of the rat cornea is accelerated by blockade of opioid receptors. - Brain Res., 798, 254-260, 1998. (Pubitemid 28342043)
6. Schultz R., Van Horn D., Peters M., Kiewin K.M., Schutten W.H. - Diabetic keratopathy. - Trans. Am. Ophthalmol. Soc., 79, 180-199, 1981.
7. McLaughlin P.J., Sassani J.W., Klocek M.S., Zagon I.S. - Diabetic keratopathy and treatment by modulation of the opioid growth factor (OGF)-OGF receptor (OGFr) axis with naltrexone: a review. - Br. Res. Bull., 81, 236-247, 2010.
8. Abdelkader H., Patel D., McGhee C., Alany R.G. - New therapeutic approaches in treatment of diabetic keratopathy. - Clinic Experimental Opthalmol., in press.
9. Crabtree B. - Review of naltrexone, a long-acting opioate antagonist. - Clin. Pharm., 3, 273-279, 1984.
10. Galichet L.Y., Moffat A.C., Osselton M.D., Widdop B. - Naltrexone. - In: Galichet L.Y., Moffat A.C., Osselton M.D., Widdop B. (Eds.), Clarke's Analysis of Drugs and Poisons, New York, Pharmaceutical Press, 2006.
11. Kaufman J.J., Semo N.M., Koski W.S. - Microelectrometric titration measurement of the pKa's and partition and drug distribution coefficients of narcotics and narcotics antagonists and their pH and temperature dependence. - J. Med. Chem., 18, 647-655, 1975.
12. Fawcett J.P., Morgan N.C., Woods D.J. - Formulation and stability of naltrexone oral liquid for rapid withdrawal from methadone. - Ann. Pharmacother., 31, 1291-1295, 1997.
13. Shah V.P., Midha K.K., Dighe S., Mcgilveray I.L., Skelly J.P., Jacobi A. - Analytical methods validation: bioavailability, bioequivalence, and pharmacokinetic studies. - J. Pharm. Sci., 81, 309-312, 1992.
14. nd ed., John Wiley & Sons, 1997, pp. 59-99.
15. Reynolds D.W., Facchine K.L., Mullaney J.F., Alsante K.M., Hatajik T.D., Motto M.G. - Available guidance and best practices for conducting forced degradation studies. - Pharm. Technol., 48-56, 2002.
16. Alsante K.M., Martin L., Baertschi S.W. - A stress testing benchmarking study. - Pharm. Technol., 60-72, 2003.
17. Lachman L., DeLuca P., Akers M.J. - Kinetic principles and stability testing. - In: Lachman L., Lieberman H.A., Kanig J.L. (Eds.), The Theory and Practice of Industrial Pharmacy, Philadelphia, Lea & Febiger, 1986, pp. 760-802.
18. Schoenwald R.D., Huang H.S. - Corneal penetration behavior of beta blocking agents. I. Physichochemical factors. - J. Pharm. Sci., 72, 1266-1272, 1983.
19. Florence A.T., Attwood D. - The solubility of drugs. - In: Florence A.T., Attwood D. (Eds.), Physichochemical Principles of Pharmacy, London, McMillan Press, 1998, pp. 152-197.
20. Wu Z., Tucker I.G., Razzak M., Medlicott N. - Physichochemical characterisation of ricobendazole. I. Solubility, lipophilicity and ionization charactersitics. - J. Pharm. Sci., 94, 983-993, 2005.
21. Leo A., Hansch C., Elkins D. - Partition coefficients and their uses. - Chem. Rev., 71, 525-616, 1971.
22. Albert A., Serjeant E.P. - Introduction. - In: Albert A., Serjeant E.P. (Eds.), The Determination of Ionization Constants, London, Chapman and Hall, 1971, pp. 1-8.
23. ICH. - Guidance for Industry: Q2B Validation of Analytical Procedures: Methodology. - FDA, Center for Evaluation and Research, 1996.
24. Gleditsch E., Waaler P.J. - Accelerated stability studies of morphine injections in plastic ampoules. - Int. J. Pham., 212, 275-287, 2001.
25. th ed., New York, John Wiley and Sons, 1992, pp. 449-460.
26. rd ed., London, Macmillan Press, 1998, p. 101-151.
27. Waterman K.C., Adami R.C., Alsante K.M., Hong J., Landis M.S., Lombardo F. et al. - Stabilization of pharmaceuticals to oxidative degradation. - Pharm. Dev. Technol., 7, 1-32, 2002.
28. USP32/NF27. - Naltrexone hydrochloride. - The United States Pharmacopoeial Convention, Rockville, 2009, pp. 3028-3029.
29. Yeh S., Lach J.L. - Stability of morphine in aqueous solution. III. Kinetics of morphine degradation in aqueous solution. - J. Pharm. Sci., 50, 30-34, 1961.
30. Johnson D.M., Gu L.C. - Autoxidation and antioxidants. - In: Swarbrick J., Boylan J.C. (Eds.), Encyclopedia of Pharmaceutical Technology, New York, Marcel Dekker, 1988, pp. 415-449.
31. Lang J.C., Roehrs R.E., Rodeheaver D.P., Missel P.J., Jani R., Chowhan M.A. - Design and evaluation of ophthalmic pharmaceutical products. - In: Banker G.S., Rhodes C.T. (Eds.), Modern Pharmaceutics, New York, Marcel Dekker, 2002, pp. 626-717.
32. Kennon L. - Use of models in determining chemical pharmaceutical stability. - J. Pharm. Sci., 53, 815-818, 1964.
33. Schoenwald R.D., Ward R.L. - Relationship between steroid permeability across excised rabbit cornea and octanol-water partition coefficients. - J. Pharm. Sci., 67, 786-788, 1978.
34. Huang H.S., Schoenwald R.D., Lach J.L. - Corneal penetration behavior of beta blocking agents. II. Assessment of barrier contributions. - J. Pharm. Sci., 72, 1272-1279, 1983.
35. Kaur I.P., Smitha R. - Penetration enhancers and ocular bioadhesives: two new avenues for ophthalmic drug delivery. - Drug Dev. Ind. Pharm., 28, 353-369, 2002.