Dried blood spot testing: a novel approach for the therapeutic drug monitoring of ziprasidone-treated patients
Abstract
Background: A novel analytical approach, based on dried blood spot (DBS) testing, has been developed, validated and applied for the first time to the analysis of ziprasidone (ZPR) for the therapeutic drug monitoring (TDM) of schizophrenic patients. DBS represent a more feasible but reliable matrix, alternative to blood and plasma. Methods: The assays were carried out using an HPLC method with native fluorescence. Blood drops were applied to DBS cards and dried by microwaves, an internal standard solution was added to the DBS and 5-mm punches were cut out for analysis. ZPR was extracted from DBS with methanol, giving good extraction yields, precision and selectivity results. Results: The method was applied with satisfactory results to DBS samples from psychiatric patients to determine ZPR levels for therapy optimization. Conclusion: This innovative methodology provides reliable and significant TDM information, with important advantages over classical blood sampling in terms of collection, storage and processing.
Papers of special note have been highlighted as: • of interest; •• of considerable interest
References
- 1 . Comparative effectiveness of atypical antipsychotics in schizophrenia: what have real-world trials taught us? CNS Drugs 26, 491–508 (2006).Crossref, Google Scholar
- 2 Drugs@FDA. Geodon approval letter (NDA 020825). www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20825ltr.pdfGoogle Scholar
- 3 A comparison of the receptor binding and HERG channel affinities for a series of antipsychotic drugs. Eur. J. Pharmacol. 450, 37–41 (2002).Crossref, Medline, CAS, Google Scholar
- 4 A PET study of dopamine D2 and serotonin 5-HT2 receptor occupancy in patients with schizophrenia treated with therapeutic doses of ziprasidone. Am. J. Psychiatry 161, 818–825 (2004).Crossref, Medline, Google Scholar
- 5 Ziprasidone: a novel antipsychotic agent with a unique human receptor binding profile. Eur. J. Pharmacol. 425, 197–201 (2001).Crossref, Medline, CAS, Google Scholar
- 6 . The psychopharmacology of ziprasidone: receptor-binding properties and real-world psychiatric practice. J. Clin. Psychiatry 64, 6–12 (2003).Crossref, Google Scholar
- 7 Pfizer Inc. Geodon Prescribing Information, Document LAB-0273-21.0. http://labeling.pfizer.com/ShowLabeling.aspx?id=584Google Scholar
- 8 The AGNP-TDM expert group consensus guidelines: therapeutic drug monitoring in psychiatry, update 2011. Pharmacopsychiatry 44, 195–235 (2011).Crossref, Google Scholar
- 9 . Metabolism and excretion of a new antipsychotic drug, ziprasidone, in humans. Drug Metab. Dispos. 25, 863–872 (1997).Medline, CAS, Google Scholar
- 10 . Ziprasidone and the QTc interval: pharmacokinetic and pharmacodynamic considerations. Psychopharmacol. Bull. 35, 66–79 (2001).Medline, CAS, Google Scholar
- 11 Atypical antipsychotics: pharmacokinetics, therapeutic drug monitoring and pharmacological interactions. Curr. Med. Chem. 11, 279–296 (2004).Crossref, Medline, CAS, Google Scholar
- 12 Therapeutic drug monitoring of common antipsychotics. Ther. Drug Monit. 34, 629–651 (2012).Crossref, Medline, CAS, Google Scholar
- 13 The AGNP-TDM Expert Group consensus guidelines: therapeutic drug monitoring in psychiatry. Pharmacopsychiatry 37, 243–265 (2004).Crossref, Medline, CAS, Google Scholar
- 14 Advances in therapeutic drug monitoring of atypical antipsychotic drugs. Med. Chem. Rev. 1, 299–316 (2004).CAS, Google Scholar
- 15 . Therapeutic drug monitoring: chemical–clinical correlations of atypical antipsychotic drugs. Curr. Med. Chem. 9, 1397–1409 (2002).•• Interesting overview of recent studies on the determination of atypical antipsychotics for therapeutic drug monitoring purposes.Crossref, Medline, CAS, Google Scholar
- 16 . The convergence of conventional therapeutic drug monitoring and pharmacogenetic testing in personalized medicine: focus on antidepressants. Clin. Pharmacol. Ther. 81, 899–902 (2007).Crossref, Medline, CAS, Google Scholar
- 17 . Therapeutic drug monitoring of atypical antipsychotics. CNS Drugs 13, 167–171 (2004).Crossref, Google Scholar
- 18 Therapeutic drug monitoring in Italian psychiatry. Pharmacopsychiatry 44, 259–262 (2011).Crossref, Medline, CAS, Google Scholar
- 19 Therapeutic drug monitoring use in clinical practice of a mental health service. Pharmacopsychiatry 21, A12–A12 (2011).Google Scholar
- 20 Analysis of cocaine and two metabolites in dried blood spots by liquid chromatography with fluorescence detection: a novel test for cocaine and alcohol intake. J. Chromatogr. A 1217, 7242–7248 (2010).•• Describes an innovative application of dried blood spot analysis and the correlations with plasma levels.Crossref, Medline, CAS, Google Scholar
- 21 Dried blood spots: liquid chromatography-mass spectrometry analysis of Δ9-tetrahydrocannabinol and its main metabolites. J. Chromatogr. A 1271, 33–40 (2013).•• Application study of the dried blood spot technique, focusing on analyte stability.Crossref, Medline, CAS, Google Scholar
- 22 Determination of plasma ziprasidone using liquid chromatography with fluorescence detection. J. Chromatogr. B 799, 201–208 (2004).Crossref, Medline, CAS, Google Scholar
- 23 . Automated determination of ziprasidone by HPLC with column switching and spectrophotometric detection. Ther. Drug. Monit. 27, 158–162 (2005).Crossref, Medline, CAS, Google Scholar
- 24 Rapid liquid chromatography–tandem mass spectrometry method for quantification of ziprasidone in human plasma. Biomed. Chromatogr. 20, 365–368 (2006).Crossref, Medline, CAS, Google Scholar
- 25 . Quantitative determination of forty-eight antidepressants and antipsychotics in human serum by HPLC tandem mass spectrometry: a multi-level, single-sample approach. J. Chromatogr. B 843, 100–113 (2006).Crossref, Medline, CAS, Google Scholar
- 26 . Simultaneous determination of five antipsychotic drugs in rat plasma by high performance liquid chromatography with ultraviolet detection. J. Chromatogr. B. 856, 20–28 (2007).Crossref, Medline, CAS, Google Scholar
- 27 . Determination of ziprasidone in human plasma by liquid chromatography–electrospray tandem mass spectrometry and its application to plasma level determination in schizophrenia patients. J. Chromatogr. B 847, 237–244 (2007).Crossref, Medline, CAS, Google Scholar
- 28 . Liquid chromatography/tandem mass spectrometry method for the simultaneous determination of olanzapine, risperidone, 9-hydroxyrisperidone, clozapine, haloperidol and ziprasidone in rat plasma. Rapid Commun. Mass Spectrom. 21, 920–928 (2007).Crossref, Medline, CAS, Google Scholar
- 29 . Determination of the lipophilic antipsychotic drug ziprasidone in rat plasma and brain tissue using liquid chromatography–tandem mass spectrometry. Biomed. Chromatogr. 22, 770–778 (2008).Crossref, Medline, CAS, Google Scholar
- 30 . Quantification of antidepressants and antipsychotics in human serum by precipitation and ultra high pressure liquid chromatography–tandem mass spectrometry. J. Chromatogr. B 879, 123–128 (2011).Crossref, Medline, CAS, Google Scholar
- 31 . Potentiometric assay of antipsychotic drug (ziprasidone hydrochloride) in pharmaceuticals, serum and urine. Int. J. Electrochem. Sci. 6, 3036–3056 (2011).CAS, Google Scholar
- 32 Use of a new ziprasidone-selective electrode in mixed solvents and its application in the analysis of pharmaceuticals and biological fluids. Sensors 11, 8813–8825 (2011).Crossref, Medline, CAS, Google Scholar
- 33 . Sensitive liquid chromatography/tandem mass spectrometry method for the simultaneous determination of olanzapine, risperidone, 9-hydroxyrisperidone, clozapine, haloperidol and ziprasidone in rat brain tissue. J. Chromatogr. B 858, 276–281 (2007).Crossref, Medline, CAS, Google Scholar
- 34 United States Pharmacopeia. 32th Edition. United States Pharmacopeial Convention, MD, USA, 734 (2009). • Describes analytical assays and specification that constitutes legal standards.Google Scholar
- 35 Bioanalytical method validation – a revisit with a decade of progress. Pharm. Res. 17, 1551–1557 (2000).•• Illustrates the current view on bioanalytical method validation.Crossref, Medline, CAS, Google Scholar
- 36 Analysis of risperidone and 9-hydroxyrisperidone in human plasma, urine and saliva by MEPS–LC–UV. J. Chromatogr. B 879, 167–173 (2011).Crossref, Medline, CAS, Google Scholar
- 37 Simultaneous analysis of classical neuroleptics, atypical antipsychotics and their metabolites in human plasma. Anal. Bioanal. Chem. 388, 235–243 (2007).• Illustrates the development and validation of an analytical method for the therapeutic drug monitoring of psychiatric patients subjected to polypharmacy with different antipsychotics.Crossref, Medline, CAS, Google Scholar
- 38 A fast and feasible microextraction by packed sorbent (MEPS) procedure for HPLC analysis of the atypical antipsychotic ziprasidone in human plasma. J. Pharmaceut. Biomed. 88, 467–471 (2014).Crossref, Medline, CAS, Google Scholar
- 39 . Dried blood spot methods in therapeutic drug monitoring: methods, assays, and pitfalls. Ther. Drug Monit. 31, 327–336 (2009).Crossref, Medline, Google Scholar
- 40 . Hematocrit and its impact on quantitative bioanalysis using dried blood spot technology. Agilent application note 990–9630EN (2011). www.chem.agilent.com/Library/applications/5990--9630EN.pdfGoogle Scholar
- 41 . Homogeneity of Dried Blood Spots, Agilent application note 5990-8306EN (2011). www.chem.agilent.com/Library/applications/5990--8306EN.pdfGoogle Scholar
- 42 . Prediction of the in vitro intrinsic clearance determined in suspensions of human hepatocytes by using artificial neural networks. Eur. J. Pharm. Sci. 39, 310–321 (2010).Crossref, Medline, CAS, Google Scholar
- 43 Stability-indicating spectrofluorimetric method for the assay of ziprasidone in capsules. J. Fluoresc. 21, 1659–1667 (2011).Crossref, Medline, CAS, Google Scholar

