Psychobiology Research Group Pharmacokinetics and Phamacogenetics Hamish McAllister-Williams PhD, MD, FRCPsych Reader in Clinical Psychopharmacology Newcastle University Hon. Consultant Psychiatrist Regional Affective Disorders Service Declaration of Interests • I have received: Speaker fees from: • Astra Zeneca, BMS, Eli Lilly, GSK, Janssen-Cilag, Lundbeck, Organon, Pfiser, Wyeth Consultancy fees from: • Astra Zeneca, BMS, Cyberonics, Eli Lilly, JanssenCilag, Lundbeck, Servier, Wyeth Independent investigator led research support from: • Astra Zeneca, Eli Lilly and Wyeth 2 Pharmacokinetics Barriers to drug delivery and effect BBB or other Half-life Volume of distribution Absorption Membrane transport Dose Clearance Conc in plasma Conc in target organ Effect Pharmacodynamics: -EC50, slope -Effect delay Membrane transport -Tolerance First pass metabolism 4 Pharmacokinetics and Pharmacodynamics 5 Pharmacokinetics • Absorption • Metabolism • Elimination General principles Clinically relevant examples Theoretical plasma concentrations of three drugs with different rates of absorption 1 AUC Increased risk of toxicity Plasma concentration (proportion of dose) 0.8 Peak concentration (Cmax) 0.6 Minimum effective conc. 0.4 0.2 0 t max Time Absorption of TCAs • tmax tertiary amines: secondary amines: 1 - 3 hours 4 - 8 hours • Clinical relevance: shorter tmax leads to higher Cmax most side effects (e.g. sedation, postural hypotension, membrane stabilisation) are dependent on the plasma concentration therefore give sedative TCA all in one dose at night (and postural hypotension occurs while lying down!) secondary amines often associated with fewer side effects Quetiapine IR vs XL Datto et al. 2009 Clinical Therapeutics 31, 492 9 Quetiapine IR vs XL Datto et al. 2009 Clinical Therapeutics 31, 492 10 Quetiapine IR vs XL Datto et al. 2009 Clinical Therapeutics 31, 492 11 Quetiapine IR vs XL Datto et al. 2009 Clinical Therapeutics 31, 492 12 Sedation with quetiapine IR and XL Before treatment Datto et al. 2009 Clinical Therapeutics 31, 492 After 5 days treatment 13 Drugs 15 Fluoxetine 16 Drug Metabolism Type 1 metabolism Cytochrome P450’s Oxidation etc Type 2 metabolism Conjugation Gluconurilation etc Conjugation O Polar species Elimination Non-polar species Biliary elimination 17 Metabolism of TCAs - 1 • Type 1 metabolism converts tertiary to secondary amines, eg. Amitriptyline Imipramine Clomipramine Nortiptyline Desipramine Desmethylclomipramine • Tertiary amines generally more potent 5-HT uptake blockers, secondary amines more potent NA uptake blockers Up to 70% of clomipramine may be converted to desmethylclomipramine • may lead to lack of efficacy in OCD Metabolism of fluoxetine Cytochrome P450 2D6 Morphine Morphine glucuronate 19 http://medicine.iupui.edu/clinpharm/ddis 20 21 22 23 CYP 450 – 1A2 interaction examples • Substrates: Tertiary amine TCAs Clozapine • Inhibitors Fluvoxamine, Ciprafloxacin • Inducers Brocolli, Brussel sprouts, tobacco, modafanil 24 CYP 450 – 2D6 interaction examples • Substrates TCAs, paroxetine, haloperidol, risperidone • Inhibitors Fluoxetine, paroxetine Duloxetine Cimetidine, sertraline • Inducers Dexamethasone 25 CYP 450 – 3A4,5,7 interaction examples • Substrates Many and varied drugs Dexamethasone, tamoxifen • Inducers St John’s wort Glucocorticoids 26 Elimination of drugs • Primarily via the kidney Metabolism of drug usually has to occur first to produce a water soluble compound This is usually the rate limiting step Factors slowing metabolism will increase the elimination time • Kinetics Usually ‘first order’ Influences the dosing schedule Influences the possibility of withdrawal problems Plasma alcohol concentration (mg/dl) Zero order kinetics 200 150 100 50 0 0 1 2 3 4 5 6 Time (hours) 7 8 9 10 • The rate of elimination is independent of plasma concentration • A small change in dose can produce a big change in plasma concentration • Rare except if elimination process is saturated (can occur with TCAs) First order kinetics Plasma warfarin concentration (ug/ml) 40 • The rate of elimination is proportional to the plasma concentration • Elimination rate quantified by ‘half life’ • The majority of drugs have first order kinetics 30 20 10 t1/2 t1/2 0 0 10 20 30 40 50 Time (hours) 60 70 Theoretical plasma concentration of a first order drug after single or repeated doses Doses Plasma Drug Concentration (proportion of dose) 2 1 0 0 1 2 3 4 Time (number of half-lives) 5 6 Effect of reduced metabolism of a drug on its steady state concentration t 1/2 = 4 hours (due to reduced Plasma drug concentration clearance) t 1/2 = 2 hours 0 4 8 12 Time (hours) 16 20 24 Half lives of TCAs Half Life Metabolite (hours - approx) Amitriptyline 16 Nortriptyline Imipramine 12 Desipramine Clomipramine 18 DMC Nortriptyline 60 Desipramine 50 DMC 45 Lofepramine 5 Desipramine “…prescribing phenothiazines and tricyclic antidepressants three times a day is simply a public display of pharmacological ignorance…” R.E. Kendell (1993) Companion to Psychiatric Studies, 5th Ed. p 419 Effect of varying dose and frequency of administration of a first order drug 1.8 Increased risk of side effects Plasma drug concentration 1.6 1.4 Half dose, 1.2 twice as often 1 Control 0.8 0.6 Half dose, 0.4 same freq. 0.2 0 0 1 2 3 4 Time (number of half-lives) 5 6 Half lives of SSRIs - 1 Half life (hrs) (Active metab.) Fluoxetine 45-72 (150-200) Sertraline 25 (66) Citalopram 36 (?) Paroxetine 10-20 Fluvoxamine 15 • Note inter-drug and -individual variation • Fluoxetine and paroxetine t1/2 increases with dose and time Half lives of SSRIs - 2 Clinical Relevance • Fluoxetine/norfluoxetine long half life consequences: 5+ weeks to steady state late emergence of plasma level dependent side effects prolonged washout period • N.B. delayed CYP2D6 inhibition benefit for poor compliers little risk of discontinuation syndrome • Paroxetine short half life SSRI most prone to discontinuation • N.B. also anti-cholinergic Pharmacokinetics Conclusions • A knowledge of pharmacokinetics can improve the clinical usage of drugs e.g. by: minimising side effects associated with Cmax • split dosages • choice of drug (secondary versus tertiary TCA, IR vs XR) adjusting dosages appropriately for age and sex avoiding pharmacokinetic interactions being aware of discontinuation phenomena