TDM 200 Kit System

Therapeutic Drug Monitoring (TDM) by LC-MS/MS

The RECIPE 200 Kit System opens a wide range of clinical relevant substances for a patient oriented Therepeutic Drug Management. Only one column to cover the most relevant drug classes.

One step sample prep

TDM 200 Kit System

The TDM 200 Kit System offers you the possibility to determine more than 156 different analytical parameters with one Kit System (sample preparation, mobile phases and analytical column).

The analytes are separated and determined by LC-MS/MS analysis.

Benefits

  • flexible expansion of the add-on sets
  • improves the individual therapeutic regimen for the patient
  • no new validation necessary
  • regular addition of new drug classes to adopt fast growing medical need

Components of the TDM 200 Kit System

1 Analytical Column

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2 Mobile Phases

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8 different Add-on Sets

Simplify your lab-routine

The TDM 200 Kit System is also available as TDMi Kit Solution with direct injection of matrix.
  • By direct injection of matrix
  • Retention times < 7 min.
  • Small sample volume needed < 20 μl

Available Analyte Panel

BZP

BZP – Benzodiazepines

Clinical Background

Benzodiazepines are a group of psychoactive drugs with a broad range of therapeutic effects. They act as anxiolytics, sedatives and anticonvulsants and belong to the most frequently prescribed drugs all over the world. Currently around 50 different benzodiazepines are globally marketed. The drugs differ in pharmacokinetics and metabolic properties. Long-term administration of benzodiazepines requires therapeutic drug monitoring (TDM).

Therapeutic drug monitoring (TDM) is the clinical laboratory practice to determine drug concentrations in blood to optimise a personalised pharmacotherapy, especially in indications with a small therapeutic range. Drug interactions, efficacy, toxicity avoidance and the surveillance of compliance are typical indications where TDM is requested. The RECIPE analytical method provides the reliable quantification of 35 different benzodiazepines.

Analytes 
3-HydroxybromazepamFlunitrazepam
7-AminoclonazepamFlurazepam
N-1-Desalkylflurazepam
7-AminoflunitrazepamLorazepam
7-AminonitrazepamLormetazepam
α-HydroxyalprazolamMedazepam
desmethyldiazepam, temazepam plus oxazepam
α-HydroxymidazolamMidazolam
α-HydroxytriazolamNitrazepam
AlprazolamNorclobazam (Desmethylclobazam)
BromazepamNordiazepam
(Nordazepam)
ChlordiazepoxideOxazepam
ClobazamPrazepam
ClonazepamTemazepam
DemoxepamTetrazepam
DesalkylflurazepamTrazodone
DesmethylflunitrazepamTriazolam
Diazepam plus
N-Desmethyldiazepam (Nordiazepam)
Zaleplon
EstazolamZolpidem
Zopiclone

bzp chromatogramm
Direct Injection
chroma-benzodiazepines

Want to learn more?

BZP – Benzodiazepines in Serum/Plasma Technote
Download (PDF)

ADP

ADP – Antidepressants

Clinical background

Many adults are affected by major depressive disorders (MDD) at some point during their lifetime. Treatment for MDD is often started in a primary care setting, and patients generally receive drugs as the standard treatment. In addition to the classical tricyclic antidepressants (TCAs) a variety of newer antidepressants (ADP) is available for the treatment of MDD. These include selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs, NRIs) as well as tetracyclic antidepressants (TeCAs).

Therapeutic drug monitoring (TDM), i.e. the quantification of serum concentrations of medications for dose optimization, is required to ensure a patient-matched psychopharmacotherapy and to avoid side effects. Uncertain drug adherence, suboptimal tolerability, non-response at therapeutic doses, or pharmacokinetic drug-drug interactions are typical situations when measurement of medication concentrations is helpful. The RECIPE analytical method provides the reliable quantification of 37 different antidepressants.

Analytes 
AgomelatineMilnacipran
AtomoxetineMirtazapine
BupropionMoclobemide
CitalopramNefazodone
ClomethiazoleO-Desmethyltramadol
DesmethylcitalopramO-Desmethylvenlafaxine
DesmethylfluoxetineOpipramol
Desmethylmianserine Paroxetine
DesmethylmirtazapineReboxetine
DesmethylsertralineRitalinic Acid
DosulepinSertraline
Duloxetinethreo-Dihydro-Bupropion
erythro-Dihydro-BupropionTianeptine
FluoxetineTramadol
FluvoxamineTranylcypromine
GuanfacineTrazodone
HydroxybupropionVenlafaxine
MethylphenidateVortioxetine
Mianserine

adp chromatogramm
Direct Injection
chroma-antidepressiva

AED

AED – Antiepileptic Drugs

Clinical Background

Epilepsy is a chronic neurological disorder, characterised by recurrent epileptic seizures. The frequency and the rhythm of seizures are hardly predictable. Therefore, seizures are not only a considerable psychological and physical burden for the patient, they may also lead to grave and even life-threatening hurts (e.g. craniocerebral injuries in case of falls). Brain damages may result in case of a hypoxia. Today, a variety of antiepileptic drugs (AEDs) with different pharmacological properties is available.

Therapeutic drug monitoring (TDM) is the clinical laboratory practice to determine drug concentrations in blood to optimise a personalised pharmacotherapy, especially in indications with a small therapeutic range. Drug interactions, efficacy, toxicity avoidance and the surveillance of compliance are typical indications where TDM is requested. The RECIPE analytical method provides the reliable quantification of 27 AEDs.

Analytes 
10-OH-CarbamazepinePerampanel
BrivaracetamPhenobarbital
CarbamazepinePhenytoin
Carbamazepine-diolPregabaline
Carbamazepine-epoxidePrimidone
EthosuximideRetigabine
FelbamateRufinamide
GabapentineStiripentol
LacosamideSulthiame
LamotrigineTiagabine
LevetiracetamTopiramate
N-DesmethylmethsuximideValproic Acid
OxcarbazepineZonisamide
Phenylethylmalonamide (PEMA)

aed chromatogramm
Direct Injection
chroma-antiepileptic

Want to learn more?

AED – Antiepileptic Drugs in Serum/Plasma
Download (PDF)

AMC

AMC – Antimycotics

Clinical Background

Invasive fungal infections, predominantly aspergillosis and candidiasis, are the most important causes of morbidity and mortality in immunocompromised patients. Primarily, patients with acute leukemia undergoing myelosuppressive chemotherapy and allogeneic stem cell transplant recipients are affected. Up to 60 % of patients with invasive aspergillosis, the most common invasive mycosis among patients with hematologic malignancies, may still die of their infection, once it has become clinically overt.

Antimycotics (antifungal drugs, antifungals) are a class of drugs that are used for the treatment and prophylaxis of fungal infections.

Therapeutic drug monitoring (TDM) is the clinical laboratory practice to determine drug concentrations in blood to optimise a personalised pharmacotherapy, especially in indications with a small therapeutic range. Drug interactions, efficacy, toxicity avoidance and the surveillance of compliance are typical indications where TDM is requested.

The RECIPE analytical method provides the reliable quantification of 11 antimycotics.

Analytes 
5-FluorocytosineKetoconazole
Amphotericin BMicafungin
AnidulafunginOH-Itraconazole
FluconazolePosaconazole
IsavuconazoleVoriconazole
Itraconazole

amc chromatogramm
Direct Injection
chroma-antimycotic

Want to learn more?

AMC – Antimycotics in Serum/Plasma
Download (PDF)

MPA

MPA – Mycophenolic Acid

Clinical background

Mycophenolic acid (MPA) is the active metabolite of the prodrug mycophenolate mofetil (MMF, proprietary names CellCept and Myfortic) and is used for the immunosuppressive therapy in patients who are undergoing solid organ transplantation. MPA is widely used along with other standard drug regimens such as with tacrolimus, cyclosporine and/or corticosteroids to ensure that graft rejection does not occur.

Following oral MMF administration, MPA is rapidly absorbed and distributed in blood and tissues. MPA peak concentrations usually are observed within an hour. In the liver MPA is metabolised whereby the phenolic glucuronide MPAG (mycophenolic acid glucuronide) forms the main fraction:

MMF → MPA → MPAG

MPAG is pharmacologically inactive. However, MPA may be reformed from MPAG by entero-hepatic recirculation (EHR). As a result secondary MPA plasma peaks are frequently observed (6-12 h post oral dose) even after the absorption from the oral dose has ceased to exist.

The clinical pharmacokinetics of MPA are characterized by a high inter- and intraindividual variability. Reasons for interindividual pharmacokinetic variability include differences in albumin concentrations, bilirubin and hemoglobin concentrations, renal and hepatic function (impairment), co-administration of cyclosporine, comorbidities such as cystic fibrosis, body weight, exposure to concomitant medication, time after transplantation, gender, race, and genetic polymorphisms in drug-metabolising enzymes.

The administration of MMF therefore requires a therapeutic drug monitoring (TDM) in order to provide an optimal therapeutic efficacy, i.e. to maximise drug efficacy while minimising drug toxicity and is strongly recommended in pediatric transplantation patients.

Although a global consensus on TDM has not been established for MPA, there has been a suggestion of maintaining MPA threshold levels in a 12 h dosing interval to achieve an AUC for MPA of approximately 30–60 mg × h/l for an effective prophylaxis. RECIPE´s analytical method ensures the quantification of MPA and MPAG and provides an adequate chromatographic separation of both analytes. Besides the monitoring of secondary MPA an adequate separation ensures to avoid false positive MPA values caused by ion-source fragmentation of MPAG.

Analytes 
Mycophenolic acidMycophenolic acid glucuronide

mpa chromatogramm

NLP

NLP – Neuroleptics

Clinical background

Neuroleptics belong to the class of psychoactive drugs and are administered in the therapy of psychoses, in particular the symptomatic treatment of schizophrenia. The longterm administration of neuroleptics gradually reduces schizophrenic reactions such us split personality, hallucinations, delusional ideas, and as a consequence the patient’s level of suffering is decreased.

Neuroleptics are classified in different substance groups such as phenothiazines, butyrophenones, dibenzazepines and so called “atypical” neuroleptics. All neuroleptics have in common that the acute onset effect correlates with the current blood-level concentration. Higher dosages lead to apathy and sleep, the acute intoxication (e.g. by suicidal intent) results in delirium, coma and even death due to circulatory failure and respiratory paralysis. Therapeutic drug monitoring (TDM) is recommended for treatment with neuroleptics.

TDM is the quantification of the drug concentration in serum. It is carried out in order to find the optimal drug level for the patient and thus to ensure the best psychoactive drug therapy for the patient with the lowest possible amount of side effects. Uncertain drug adherences, suboptimal tolerability, non-response at therapeutic doses, or pharmacokinetic drug-drug interactions are typical situations when measurement of medication concentrations is helpful. The RECIPE analytical method provides the reliable quantification of 28 different neuroleptics.

Analytes 
AmisulprideOlanzapine
AripiprazolePaliperidone (9-OH-Risperidone)
ChlorpromazinePerazine
ChlorprothixenePipamperone
ClozapinePromethazine
Dehydro-AripiprazoleProthipendyl
DesmethylolanzapineQuetiapine
FlupentixolRisperidone
FluphenazineSertindole
HaloperidolSulpiride
LevomepromazineThioridazine
MelperoneZiprasidone
NorclozapineZotepine
NorquetiapineZuclopenthixol

nlp chromatogramm
Direct Injection
chroma-neuroleptics

TCA

TCA – Tricyclic Antidepressants

Clinical background

Tricyclic antidepressants (TCAs) are a group of psychoactive drugs which are mainly used for the therapy of endogene depressions, anxiety and pain management. Their name is derived from a common chemical structure with a tripartite ring system.

TCAs are widely established compounds since the 1960s, however due to their side effects they have a narrow therapeutic range, which requires therapeutic drug monitoring (TDM). The consequences of overdosing may vary from mild agitation or drowsiness to delirium and coma resulting in death.

The drug monitoring is mainly performed from serum. Besides dosage optimisation, the monitoring is used for the verification of compliance as well as for the early detection of pharmacokinetic changes of the compound.

RECIPE’s analytical method provides the reliable quantification of 13 TCAs and two atypical neuroleptics and their metabolites.

Analytes 
AmitriptylineNorclozapine
ClomipramineNordoxepin
ClozapineNormaprotiline
DesipramineNortrimipramine
DoxepinNortriptyline
ImipramineProtriptyline
MaprotilineTrimipramine
Norclomipramine

tca chromatogramm
Direct Injection
chroma-tricyclic-antidepressants

ISD

ISD – Immunosuppressants*

Clinical background

Immunosuppressive drugs have an inhibitory effect on the immune system. They are used in organ transplantations with the aim of suppressing immune reactions of the recipient. Therefore a regular monitoring of the drug concentration in blood is necessary.

Common drug classes are the selective immunosuppressants sirolimus, everolimus and mycophenolic acid as well as the calcineurin inhibitors cyclosporine A and tacrolimus. All of those drugs have a narrow therapeutic range, so underdosing leads to rejection of the transplanted organ and overdosing to life-threatening, toxic side effects. By using the RECIPE TDM 200 Kit System for measuring immunosuppressant blood concentrations on a regular basis, the ideal target concentration of the drugs can be achieved. The Immunosuppressants Add-on Set includes the four most common drugs cyclosporine A, sirolimus, everolimus and tacrolimus.

* For Research Use only

Analytes 
Cyclosporine ASirolimus
EverolimusTacrolimus

isd chromatogramm