Quality of intrathecal baclofen from different sources.
PM R
; 4(3): 182-9, 2012 Mar.
Article
en En
| MEDLINE
| ID: mdl-22322047
ABSTRACT
OBJECTIVE:
To compare the quality of intrathecal baclofen obtained from a national compounding pharmacy (AnazaoHealth) with the manufactured product (Lioresal) with regard to accuracy and precision of baclofen concentration, and the content of the baclofen degradation product, 4-(4-chlorophenyl)-2-pyrrolidinone (PYR).DESIGN:
Samples of baclofen used for refilling intrathecal pumps were placed in 1.2-mL silicone gasket-sealed cryogenic vials and stored at or lower than -25°C. Each sample was a different lot number (Lioresal) or prescription number (AnazaoHealth). The laboratory was blinded to the source of the solutions. Coupled with electrospray ionization-mass spectrometry analyte confirmation, quantitation of baclofen and PYR in each sample was performed in duplicate by using high-performance liquid chromatography with ultraviolet detection via a photodiode array detector.SETTING:
Outpatient clinic.PARTICIPANTS:
Patients with intrathecal baclofen pumps. MAIN OUTCOMEMEASURES:
Accuracy and precision of baclofen concentration, and concentration of PYR.RESULTS:
The difference of mean concentrations from expected concentrations of 500 and 2000 µg/mL were significantly greater for samples from AnazaoHealth compared with Lioresal. Values are shown as mean (± standard error), with n the number samples, for AnazaoHealth compared with Lioresal (537.1 ± 6.7 µg/mL [n = 8] versus 515.6 ± 0.82 µg/mL [n = 5]; P = .034, respectively) and (2211.4 ± 21.6 µg/mL [n = 12] versus 2055.3 ± 8.7 µg/mL [n = 4]; P = .004, respectively). AnazaoHealth samples with expected concentration of 4000 µg/mL were 3987.7 ± 79.9 µg/mL, n = 7. All 9 Lioresal samples were within 5% of the expected concentration. Of 27 AnazaoHealth samples, 22 were more than 5%, and 8 were more than 10% different from the expected concentration. No PYR was detected in any sample from AnazaoHealth. All samples of Lioresal contained PYR, but all solutions contained less PYR than 1% of the baclofen concentration.CONCLUSIONS:
Lioresal was more accurate in concentration and more precise among batches than compounded intrathecal baclofen but had higher levels of PYR.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Baclofeno
/
Relajantes Musculares Centrales
/
Espasticidad Muscular
Límite:
Adult
/
Female
/
Humans
/
Middle aged
Idioma:
En
Revista:
PM R
Asunto de la revista:
MEDICINA FISICA
/
REABILITACAO
/
TRAUMATOLOGIA
Año:
2012
Tipo del documento:
Article
País de afiliación:
Estados Unidos