- About this Journal ·
- Aims and Scope ·
- Article Processing Charges ·
- Author Guidelines ·
- Bibliographic Information ·
- Citations to this Journal ·
- Contact Information ·
- Editorial Board ·
- Editorial Workflow ·
- Free eTOC Alerts ·
- Publication Ethics ·
- Recently Accepted Articles ·
- Reviewers Acknowledgment ·
- Submit a Manuscript ·
- Subscription Information ·
- Table of Contents
Volume 2012 (2012), Article ID 582375, 9 pages
Studies on Paliperidone in OROS Tablets: Extraction Procedure and Chromatographic Analysis
1Laboratório de Pesquisa em Desenvolvimento e Controle de Qualidade de Medicamentos, Universidade Federal do Pampa (UNIPAMPA), BR 472 Km 585, Prédio Administrativo, 97500-970 Uruguaiana, RS, Brazil
2Laboratório 402, Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul (UFRGS), Avenida Ipiranga 2752, 90610-000 Porto Alegre, RS, Brazil
3Programa de Pós-graduação em Bioquímica, Universidade Federal do Pampa (UNIPAMPA), BR 472 Km 585, Prédio Administrativo, 97500-970 Uruguaiana, RS, Brazil
Received 2 January 2012; Accepted 23 January 2012
Academic Editors: B. Carbonnier, C. Fente Sampayo, and A. Namera
Copyright © 2012 Fábio Barbosa et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
- E. Richelson and T. Souder, “Binding of antipsychotic drugs to human brain receptors focus on newer generation compounds,” Life Sciences, vol. 68, no. 1, pp. 29–39, 2000.
- D. J. Cada, D. E. Baker, and T. Levien, “Paliperidone,” Hospital Pharmacy, vol. 42, no. 7, pp. 637–647, 2007.
- J. Kane, F. Canas, M. Kramer et al., “Treatment of schizophrenia with paliperidone extended-release tablets: a 6-week placebo-controlled trial,” Schizophrenia Research, vol. 90, no. 1-3, pp. 147–161, 2007.
- J. A. Fowler, T. L. Bettinger, and T. R. Argo, “Paliperidone extended-release tablets for the acute and maintenance treatment of schizophrenia,” Clinical Therapeutics, vol. 30, no. 2, pp. 231–248, 2008.
- M. Vermeir, I. Naessens, B. Remmerie et al., “Absorption, metabolism, and excretion of paliperidone, a new monoaminergic antagonist, in humans,” Drug Metabolism & Disposition, vol. 36, no. 4, pp. 769–779, 2008.
- M. D. P. Corena-McLeod, A. Oliveros, C. Charlesworth et al., “Paliperidone as a mood stabilizer: a pre-frontal cortex synaptoneurosomal proteomics comparison with lithium and valproic acid after chronic treatment reveals similarities in protein expression,” Brain Research, vol. 1233, pp. 8–19, 2008.
- R. Karlsson, E. Dencker, S. Nyber, et al., “Pharmacokinetics and dopamine D2 and serotonin 5-HT2A receptor occupancy of paliperidone in healthy subjects,” Basic Neuroscience Part 1, p. S386, 2005.
- Janssen-Cilag, Invega Paliperidona, São Paulo, 2007.
- R. Luthringer, “Sleep assessments in patients with schizophrenia following treatment with paliperidone extended-release tablets,” European Neuropsychopharmacology, vol. 16, supplement 4, p. S224, 2006.
- B. Green, “Paliperidone: a clinical review,” Current Drug Therapy, vol. 4, no. 1, pp. 7–11, 2009.
- A. Cleton, S. Rossenu, A. Vermeulen et al., “A pharmacokinetic model to document the interconversion between Paliperidone's enantiomers,” Clinical Pharmacology & Therapeutics, vol. 79, no. 2, Part 2, article 72, p. P55, 2006.
- M. Davidson, R. Emsley, M. Kramer et al., “Efficacy, safety and early response of paliperidone extended-release tablets (paliperidone ER): results of a 6-week, randomized, placebo-controlled study,” Schizophrenia Research, vol. 93, no. 1–3, pp. 117–130, 2007.
- S. R. Marder, M. Kramer, L. Ford et al., “Efficacy and safety of paliperidone extended-release tablets: results of a 6-week, randomized, placebo-controlled study,” Biological Psychiatry, vol. 62, no. 12, pp. 1363–1370, 2007.
- C. Canuso, J. Carothers, B. Dirks, Y. Zhu, A. Schreiner, and C. Kosik-Gonzalez, “A double-blind placebo-controlled trial comparing paliperidone ER and quetiapine in patients with a recent acute exacerbation of schizophrenia,” Schizophrenia Research, vol. 102, no. 1–3 ,supplement 2, p. 252, 2008.
- D. L. Dunner, C.A. Bossie, I. Turkoz, and C. M. Canuso, “Paliperidone extended-release (ER) in patients with schizoaffective disorder presenting with manic or depressive symptomatology,” Journal of Affective Disorders, vol. 122, supplement 1, p. S61, 2010.
- G. Marchese, B. Pittau, G. Casu et al., “A comparison of continuous subcutaneous paliperidone infusion and repeated subcutaneous injection of risperidone free-base in rats,” European Psychiatry, vol. 25, no. 2, pp. 92–100, 2010.
- M. De Meulder, B. M. M. Remmerie, R. de Vries et al., “Validated LC-MS/MS methods for the determination of risperidone and the enantiomers of 9-hydroxyrisperidone in human plasma and urine,” Journal of Chromatography B, vol. 870, no. 1, pp. 8–16, 2008.
- K. M. Kirschbaum, S. Finger, F. Vogel et al., “LC with column-switching and spectrophotometric detection for determination of risperidone and 9-hydroxyrisperidone in human serum,” Chromatographia, vol. 67, no. 3-4, pp. 321–324, 2008.
- R. Mandrioli, L. Mercolini, D. Lateana, G. Boncompagni, and M. A. Raggi, “Analysis of risperidone and 9-hydroxyrisperidone in human plasma, urine and saliva by MEPS-LC-UV,” Journal of Chromatography B, vol. 879, no. 2, pp. 167–173, 2010.
- I. Locatelli, A. Mrhar, and I. Grabnar, “Simultaneous determination of risperidone and 9-hydroxyrisperidone enantiomers in human blood plasma by liquid chromatography with electrochemical detection,” Journal of Pharmaceutical and Biomedical Analysis, vol. 50, no. 5, pp. 905–910, 2009.
- C. Danel, P. Chaminade, P. Odou et al., “Enantioselective analysis of the antipsychotic 9-hydroxyrisperidone, main metabolite of risperidone, by chiral capillary EKC using dual CDs,” Electrophoresis, vol. 28, no. 15, pp. 2683–2692, 2007.
- C. Danel, C. Barthélémy, D. Azarzar et al., “Analytical and semipreparative enantioseparation of 9-hydroxyrisperidone, the main metabolite of risperidone, using high-performance liquid chromatography and capillary electrophoresis. Validation and determination of enantiomeric purity,” Journal of Chromatography A, vol. 1163, no. 1-2, pp. 228–236, 2007.
- C. Danel, N. Azaroual, A. Brunel et al., “Configurational stability of 9-hydroxyrisperidone. Kinetics and mechanism of racemization,” Tetrahedron Asymmetry, vol. 20, no. 10, pp. 1125–1131, 2009.
- USP, “United States Pharmacopoeia,” 31 ed., US Pharmacopeial Convention, 2008.
- FDA, US Food and Drug Administration, Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations, 2011.
- A. S. Mandal, N. Biswas, K. M. Karim et al., “Drug delivery system based on chronobiology-A review,” Journal of Controlled Release, vol. 147, no. 3, pp. 314–325, 2010.
- ICH Q2 (R1), “Validation of Analytical Procedure: text and Methodology,” in Proceedings of the International Conference on Harmonization, 2005.
- ICH Q1A (R2), “Stability Testing of New Drug Substance and Products: text and Methodology,” in Proceedings of the International Conference on Harmonization, 2003.
- A. H. Kibbe, Handbook of Pharmaceutical Excipients, Pharmaceutical Association, Washington, DC, USA, 3rd edition, 2000.
- S. Chandran and R. S. P. Singh, “Comparison of various international guidelines for analytical method validation,” Pharmazie, vol. 62, no. 1, pp. 4–14, 2007.
- B. N. Singh and K. H. Kim, “Drug delivery-oral route,” in Encyclopedia of Pharmaceutical Technology, J. Swarbrick, Ed., pp. 886–899, London, UK, 2002.
- K. H. Reza, N. Sancheti Vikram, and R. Kumaravelrajan, “Formulation and optimization of aceclofenac monolithic osmotic pump,” International Journal of Pharmaceutical Sciences Review and Research, vol. 6, no. 2, pp. 42–47, 2011.
- F. Theeuwes, “Elementary osmotic pump,” Journal of Pharmaceutical Sciences, vol. 64, no. 12, pp. 1987–1991, 1975.
- G. Santus and R. W. Baker, “Osmotic drug delivery: a review of the patent literature,” Journal of Controlled Release, vol. 35, no. 1, pp. 1–21, 1995.
- Y. Liu, H. Nguyen, S. Wang, and J. Yeh, “High-throughput determination of OROS drug release rate profile using micro parallel liquid chromatography,” Journal of Pharmaceutical and Biomedical Analysis, vol. 43, no. 5, pp. 1654–1659, 2007.
- B. R. Pezzini, M. A. S. Silva, and H. G. Ferraz, “Formas farmacêuticas sólidas orais de liberação prolongada: sistemas monolíticos e multiparticulados,” Brazilian Journal of Pharmaceutical Sciences, vol. 43, no. 4, pp. 491–502, 2007.
- M. Wallace and J. Thipphawong, “Open-label study on the long-term efficacy, safety, and impact on quality of life of oros hydromorphone ER in patients with chronic low back pain,” Pain Medicine, vol. 11, no. 10, pp. 1477–1488, 2010.
- S. B. Wigal, T. Wigal, S. Schuck et al., “Academic, behavioral, and cognitive effects of OROS methylphenidate on older children with attention-deficit/hyperactivity disorder,” Journal of Child and Adolescent Psychopharmacology, vol. 21, no. 2, pp. 121–131, 2011.
- J. Ermer, “Requirements of (chromatographic) data in pharmaceutical analysis,” in Quantification in LC and GC, H. Kuss and S. Kromidas, Eds., pp. 321–339, Wiley-VCH, Weinheim, Germany, 2009.
- M. Feinberg, “Validation of analytical methods based on accuracy profiles,” Journal of Chromatography A, vol. 1158, no. 1-2, pp. 174–183, 2007.
- C. Nilsen, “Analytical methods validation: design and execution,” Pharmaceutical Formulation & Quality, February/March, pp. 29–32, 2010.
- G. Ngwa, “Forced degradation as an integral part of HPLC stability-indicating method development,” Drug Delivery Technology, vol. 10, no. 5, pp. 56–59, 2010.
- FDA, Food and Drug Administration, Guidance for industry—Analytical procedures and methods validation (draft guidance), 2000.