Paroxetine Hydrochloride

Profiles of Drug Substances, Excipients and Related Methodology

Volumn 38, Issue , 2013, Pages 367-406

  Germann, David ^a   Ma, George ^a   Han, Feixue ^a   Tikhomirova, Anna ^a  

^a Apotex Inc   (Canada)

Author keywords

Analysis; Anxiety; Depression; Inhibitor; Metabolism; Paroxetine hydrochloride; Pharmacokinetics; Review; Serotonin; Spectroscopy; SSRI; Stability; Synthesis

Indexed keywords

CIMETIDINE; CYTOCHROME P450 2D6; FLUOXETINE; PAROXETINE; PHENOBARBITAL; PHENYTOIN; SEROTONIN UPTAKE INHIBITOR; TRICYCLIC ANTIDEPRESSANT AGENT;

APPETITE; ARTICLE; CARBON NUCLEAR MAGNETIC RESONANCE; CHEMICAL COMPOSITION; CONSTIPATION; CRYSTALLOGRAPHY; DEPRESSION; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DETERMINATION; DRUG DISTRIBUTION; DRUG ELIMINATION; DRUG FORMULATION; DRUG HALF LIFE; DRUG IMPURITY; DRUG INDICATION; DRUG MECHANISM; DRUG METABOLISM; DRUG PROTEIN BINDING; DRUG RELEASE; DRUG SOLUBILITY; DRUG STABILITY; DRUG STRUCTURE; DRUG SYNTHESIS; DRUG TOLERABILITY; EJACULATION; GENERALIZED ANXIETY DISORDER; GYNECOLOGIC DISEASE; HETERONUCLEAR MULTIPLE BOND CORRELATION; HETERONUCLEAR SINGLE QUANTUM COHERENCE; HUMAN; IMPOTENCE; INFRARED SPECTROSCOPY; IONIZATION; LIBIDO; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; NAUSEA; NOMENCLATURE; OBSESSIVE COMPULSIVE DISORDER; PANIC; POSTTRAUMATIC STRESS DISORDER; PRIORITY JOURNAL; PROTON NUCLEAR MAGNETIC RESONANCE; SIDE EFFECT; SOCIAL PHOBIA; SOMNOLENCE; SUSPENSION; SWEATING; TABLET; THERMAL ANALYSIS; THIN LAYER CHROMATOGRAPHY; ULTRAVIOLET SPECTROSCOPY; XEROSTOMIA; YAWNING;

EID: 84878182725     PISSN: 18715125     EISSN: None     Source Type: Book Series    
DOI: 10.1016/B978-0-12-407691-4.00008-3     Document Type: Chapter

References (72)

1. The United States Pharmacopoeia 36 National Formulary, Rockville, Maryland, 31 pp. 4695-4698.
2. The European Pharmacopoeia, Strasbourg, 7.0, vol. 2, pp. 2672-2674.
3. Physician's Desk Reference, 63 ed. (2009) (Paxil CR®).
4. Remington: The Science and Practice of Pharmacy 2006, 1521. Lippincott Williams & Wilkins, Baltimore. 21st ed. D.B. Troy (Ed.).
5. Martindale: The Complete Drug Reference 2009, vol. 1:414. Pharmaceutical Press, London. 36th ed. S.C. Sweetman (Ed.).
6. Source: Drugs@FDA (), Paroxetine, NDA#'s 020031, 020710 and 020936, Paxil®, GlaxoSmithKline. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm.
7. J.A. Christensen, R.F. Squires, US Patent 4,007,196.
8. G.T. Borrett, European Patent 0 219 934.
9. F.E. Ali, European Patent 0 223 334.
10. Clarke's Analysis of Drugs and Poisons 2011, vol. 2:1865. Pharmaceutical Press, London. fourth ed. J. Watts (Ed.).
11. Paroxetine, entry 7043, The Merck Index, 14 ed., Merck & Co. Inc., Whitehouse Station, NJ, (accessed September 2012). http://www.medicinescomplete.com/.
12. Borman P.J., Chatfield M.J., et al. Development, validation and transfer into a factory environment of a liquid chromatography tandem mass spectrometry assay for the highly neurotoxic impurity FMTP (4-(4-fluorophenyl)-1-methyl-1,2,3,6-tetrahydropyridine) in paroxetine active pharmaceutical ingredient (API). J. Pharm. Biomed. Anal. 2008, 48:1082-1089.
13. Mandrioli R., et al. Determination of the antidepressant paroxetine and its three main metabolites in human plasma by liquid chromatography with fluorescence detection. Anal. Chim. Acta 2007, 591:141-147.
14. Munigela N., Babu J.M., Yerramilli A., et al. Spectral characterization of degradation impurities of paroxetine hydrochloride hemihydrate. Sci. Pharm. 2008, 76:653-661.
15. Surekha M.L., et al. A validated RP-HPLC method for the estimation of paroxetine hydrochloride in bulk and tablet dosage form. J. Pharm. Res. 2012, 5:1768-1770.
16. Zukowski J., et al. Chiral HPLC method for chiral purity determination of paroxetine drug substance. Chirality 2003, 15:600-604.
17. Sharma R.N., et al. Validated TLC densitometric method for the quantification of paroxetine hydrochloride in solid dosage form. Ind. J. Pharm. Sci. 2007, 69:436-438.
18. Venkatachalam A., Chatterjee V.S. Stability-indicating high performance thin layer chromatography determination of paroxetine hydrochloride in bulk drug and pharmaceutical formulations. Anal. Chim. Acta 2007, 598:312-317.
19. Misztal G., Hopkala H., Slawik T. Chromatographic analysis (TLC) of FLU, doxepine, imipramine and opipramol in human plasma. Acta Pol. Pharm. 1997, 54:257-259.
20. Gondová T., et al. Simultaneous analysis of new antidepressants by densitometric thin-layer chromatography. J. Liq. Chromatogr. Rel. Technol. 2008, 31:2429-2441.
21. Oztunc A., Onal A. 7,7,8,8-Teetracyanoquinodimethane as a new derivatization reagent for high-performance liquid chromatography and thin-layer chromatography: rapid screening of plasma for some antidepressants. J. Chromatogr. B Biomed. Sci. Appl. 2002, 774:149-155.
22. Ansermot N., Brawand-Amey M., Eap C.B. Simultaneous qualification of selective serotonin reuptake inhibitors and metabolites in human plasma by liquid chromatography-electrospray mass spectrometry for therapeutic drug monitoring. J. Chromatogr. B 2012, 885-886:117-130.
23. Samanidou V.F., et al. Rapid HPLC method for the simultaneous monitoring of duloxetine, venlaflaxine, fluoxetine and paroxetine in biofluids. Bioanalysis 2009, 1:905-917.
24. McIntyre I.M., King C.V., et al. Dual UV wavelength high-performance liquid chromatographic method for the forensic or clinical analysis of seventeen antidepressants and some selected metabolites. J. Chromatogr. B 1993, 621:215-223.
25. Joron S., Robert H. Simultaneous determination of antidepressant drugs and metabolites by HPLC. Design and validation of a simple and reliable analytical procedure. Biomed. Chromatogr. 1994, 8:158-164.
26. Aymard G., Livi P., Pham Y.T., Diquet B. Sensitive and rapid method for the simultaneous quantification of five antidepressants with their respective metabolites in plasma using high-performance liquid chromatography with diode-array detection. J. Chromatogr. B 1997, 700:183-189.
27. Peterson K.L., Logan B.K., et al. Sequential-injection extraction for sample preparation. Anal. Chim. Acta 1997, 337:99-106.
28. Casamenti G., Mandrioli R., et al. Development of an HPLC method for the toxicological screening of central nervous system drugs. J. Liq. Chromatogr. Rel. Technol. 2000, 23:1039-1059.
29. Skibinski R., Misztal G., Olajossy M. High performance liquid chromatographic determination of fluvoxamine and PAR in plasma. Chem. Anal. Warsaw 2000, 45:815-823.
30. Gronhaug T., Christensen H., et al. Automated on-line dialysis, trace enrichment and high-performance liquid chromatography (HPLC) determination of two selective serotonin re-uptake inhibitors (SSRI) in plasma. J. Pharm. Belg. 1994, 53:192.
31. Lucca A., Gentilini G., et al. Simultaneous determination of human plasma levels of four selective serotonin reuptake inhibitors by high-performance liquid chromatography. Ther. Drug Monit. 2000, 22:271-276.
32. Lacassie E., Gaulier J.M., et al. Method for the determination of seven selective serotonin reuptake inhibitors and three active metabolites in human serum using high-performance liquid chromatography and GC. J. Chromatogr. B Biomed. Sci. Appl. 2000, 742:229-238.
33. Spratt E., Vallaro G.M. LC/MS with a particle beam interface in forensic toxicology. Clin. Lab. Med. 1998, 18:651-663.
34. Goeringer K.E., McIntyre I.M., Drummer O.H. LC-MS analysis of serotonergic drugs. J. Anal. Toxicol. 2003, 27:30-35.
35. Kollroser M., Schober C. An on-line SPE-liquid chromatography-tandem MS method for the analysis of citalopram, fluvoxamine, and PAR in human plasma. Chromatographia 2003, 57:133-138.
36. Hostetter A.L., Stowe Z.N., et al. A novel system for the determination of antidepressant concentration in human breast milk. Ther. Drug Monit. 2004, 26:47-52.
37. Bickeboeller-Friedrich J., Maurer H.H. Screening for detection of new antidepressants, neuroleptics, hypnotics, and their metabolites in urine by GC-MS developed using rat liver microsomes. Ther. Drug Monit. 2001, 23:61-70.
38. Malfara W.R., Bertucci C., et al. Reliable HPLC method for therapeutic drug monitoring of frequently prescribed tricyclic and nontricyclic antidepressants. J. Pharm. Biomed. Anal. 2007, 44:955-962.
39. Titier K., Castaing N., et al. High-performance liquid chromatographic method with DAD for identification and qualification of the eight new antidepressants and five of their active metabolites in plasma after overdose. Ther. Drug Monit. 2003, 25:581-587.
40. Lacassie E., Ragot S., et al. A specific analytical method for the analysis of 24 antidepressants using GC-MS (GC/MS). Acta Clin. Belg. 1999, 54:20-24.
41. Foglia J.P., Sorisio D., Kirsher M., Pollock B.G. Quantitative determination of paroxetine in plasma by high-performance liquid chromatography and ultraviolet detection. J. Chromatogr. B 1997, 693:147-151.
42. Zhu Z., Neirinck L. High-performance liquid chromatography-mass spectrometry method for the determination of paroxetine in human plasma. J. Chromatogr. B 2002, 780:295-300.
43. Gupta R.N. Column liquid chromatographic determination of paroxetine in human serum using solid-phase extraction. J. Chromatogr. B 1994, 661:362-365.
44. López-Calull C., Dominguez N. Determination of paroxetine in plasma by high-performance liquid chromatography for bioequivalence studies. J. Chromatogr. B 1999, 724:394-398.
45. Shin J.-G., et al. Rapid simple high-performance liquid chromatographic determination of paroxetine in human plasma. J. Chromatogr. B 1998, 713:452-456.
46. Knoeller J., et al. A simple and robust HPLC for the determination of paroxetine in human plasma. J. Pharm. Biomed. Anal. 1995, 13:635-638.
47. önal A., öztunç A. Determination of paroxetine in human plasma by high-performance liquid chromatography using 7,7,8,8-tetracyanoquinodimethane as the derivatization reagent. Ther. Drug Monit. 2006, 28:180-184.
48. Shah H.J., et al. Quantitation of paroxetine in human plasma by liquid chromatography coupled with electrospray ionization tandem mass spectrometry. J. AOAC Int. 2010, 93:141-149.
49. Stowe Z.N., et al. Paroxetine in human breast milk and nursing infants. Am. J. Psychiatry 2000, 157:185-189.
50. Begg E.J., et al. Paroxetine in human milk. Br. J. Clin. Pharmacol. 2000, 48:142-147.
51. Segura M., et al. Quantitative determination of paroxetine and its 4-hydroxy-3-methoxy metabolite in plasma by high-performance liquid chromatography/electrospray ion trap mass spectrometry: application to pharmacokinetic studies. Rapid Commun. Mass Spectrom. 2003, 17:1455-1461.
52. Jhee O.H., et al. Determination of paroxetine in plasma by liquid chromatography coupled to tandem mass spectrometry for pharmacokinetic and bioequivalence studies. Arzneim.-Forsch. (Drug Res.) 2007, 57:455-461.
53. Tsuruta T., et al. Determination of paroxetine in human saliva by reversed-phase high-performance liquid chromatography with UV detection. Jpn. J. Neuropsychopharmacol. 2007, 27:9-12.
54. Gilles M., et al. Paroxetine serum concentrations in depressed patients and response to treatment. Pharmacopsychiatry 2005, 38:118-121.
55. He J., Zhou Z., Li H. Simultaneous determination of fluoxetine, citalopram, paroxetine, venlafaxine in plasma by high performance liquid chromatography-electrospray ionization mass spectrometry. J. Chromatogr. B 2005, 820:33-39.
56. Kaye C.M., et al. A review of the metabolism and pharmacokinetics of paroxetine in man. Acta Psychiatr. Scand. 1989, 80(Suppl. 350):60-75.
57. Bourin M., et al. Paroxetine: a review. CNS Drug Rev. 2001, 7:25-47.
58. De Vane C.L. Metabolism and pharmacokinetics of selective serotonin reuptake inhibitors. Cell. Mol. Neurobiol. 1999, 19:443-466.
59. van Harten J. Clinical pharmacokinetics of selective serotonin reuptake inhibitors. Clin. Pharmacokinet. 1993, 24:203-220.
60. Dechant K.L., Clissold S.P. Paroxetine. A review of its pharmacodynamics and pharmacokinetic properties, and therapeutic potential in depressive illness. Drugs 1991, 41:225-253.
61. Lund J., et al. Paroxetine: pharmacokinetics, tolerance and depletion of blood 5HT in man. Acta Pharmacol. Toxicol. 1979, 44:289-295.
62. Lund J., et al. Paroxetine: pharmacokinetics and cardiovascular effects after oral and intravenous single doses in man. Acta Pharmcol. Toxicol. 1982, 51:351-357.
63. Greb W.H., et al. Absorption of paroxetine under various dietary conditions and following antacid intake. Acta Psychiatr. Scand. 1989, 80(Suppl. 350):99-101.
64. Haddock R.E., et al. Metabolic pathway of paroxetine in animals and man and the comparative pharmacological properties of its metabolites. Acta Psychiatr. Scand. 1989, 80(Suppl. 350):24-26.
65. Bloomer J.C., et al. The role of cytochrome P4502D6 in the metabolism of paroxetine by human liver microsomes. Br. J. Clin. Pharmacol. 1992, 33:521-523.
66. Sindrup S.H., et al. Pharmacokinetics of the selective serotonin reuptake inhibitor paroxetine: nonlinearity and relation to the sparteine oxidation polymorphism. Clin. Pharmacol. Ther. 1992, 51:288-295.
67. Ghose K. The pharmacokinetics of paroxetine in elderly depressed patients. Acta Psychiatr. Scand. 1989, 80(Suppl. 350):87-88.
68. Doyle G.D., et al. The pharmacokinetics of paroxetine in renal impairment. Acta Psychiatr. Scand. 1989, 80(Suppl. 350):89-90.
69. Krastev Z., et al. the pharmacokinetics of paroxetine in patients with liver cirrhosis. Acta Psychiatr. Scand. 1989, 80(Suppl. 350):91-92.
70. Tulloch I.F., Johnson A.M. The pharmacologic profile of paroxetine, a new selective serotonin reuptake inhibitor. J. Clin. Psychiatry 1993, 53:7-12.
71. Johnson A.M. Paroxetine: a pharmacological review. Int. Clin. Psychopharmacol. 1992, 6:15-24.
72. Marks D.M., et al. Paroxetine: safety and tolerability issues. Expert Opin. Drug Saf. 2008, 7:783-794.