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Assessing the effect of sodium lauryl sulphate on the performance of e-tongue sensors
Abstracts / International Journal of Pharmaceutics 511 (2016) 1127–1150
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not affect the attributed scores. Similarly, the results did not differ among nurses and physicians. Conclusions: Pulverized brand-names and generics containing either amlodipine or candesartan did not differ with respect to their taste acceptability [3]. These first results among adult healthy volunteers should be confirmed among a limited sample of children.
Conclusion: Exposure of the sensors with SLS did not damage sensor membranes. Even if the sensor response was altered, concentration dependent analysis of QH samples is still possible.
http://dx.doi.org/10.1016/j.ijpharm.2016.06.082
Phenobarbital accuracy errors after educational strategy implementation
Abstract ID: 19 Assessing the effect of sodium lauryl sulphate on the performance of e-tongue sensors I. Immohr 1,∗ , R. Turner 2 , M. Pein-Hackelbusch 1 1
Institute of Pharmaceutics and Biopharmaceutics, Heinrich-Heine-University Düsseldorf, Universitätsstrasse 1, 40225 Düsseldorf, Germany 2 Novartis Pharma AG, Basel, Switzerland E-mail address: [email protected] (I. Immohr). Introduction: Oral liquid drug formulations often require tastemasking to ensure palatability. Taste assessment by electronic tongue (ET) is restricted to substances interacting with the sensor membranes without damaging or interfering with their electrical output. Therefore, complex formulations may not be analyzed by ET. Purpose: To evaluate sensor performance to harmful excipients, exemplary sodium lauryl sulphate (SLS), when performing an ET taste assessment study. Method: Two self-developed PVC-based ET sensor sets were prepared for use on the Insent Taste Sensing System SA402B (Sensor 010, 011, 012, 013). One sensor set (stressed) was used in a taste assessment study (Table 1), the other sensor set was not exposed to the excipients. Each sample measurement was followed by a calibration assessment with QH to evaluate the sensor performance. Results: All sensors (Sensors 010–013) showed linear dependency of sensor responses to QH concentrations. Sensor response to QH was similar from both sensor sets when exposed to taste assessment samples containing QH or CP only (Fig. 1A). This sensor response changed after the sensors were exposed to samples containing SLS (Fig. 1B). The slopes of the calibration curves of stressed sensors increased resulting in an improvement of their sensitivity. Table 1 Sequence of samples. Run
Sample
1 2 3 4 5 6 7
QH (1 mM quinine hydrocholdride dihydrate) CP (1% cherry powder) SLS (1%) MP (0.2% methyl paraben) QH, SLS QH, SLS, MP QH, SLS, MP, CP
http://dx.doi.org/10.1016/j.ijpharm.2016.06.083 Abstract ID: 20
Ainara Campino ∗ , Maria Cruz Lopez-Herrera, Casilda Arranz, Beatriz Sordo, María Unceta, Pilar Pascual, Elena Santesteban Introduction: Accuracy preparation error is a type of medication error rarely studied. Unavailability of drug preparations and equipment for dilution specifically adapted for neonates makes preparation process prone to accuracy errors. Phenobarbital is used mainly in neonates in status epilecticus. Purpose: Measure intravenous phenobarbital accuracy preparation error rate in Neonatal Intensive Care Units (NICUs) and Hospital Pharmacy Service (HPS) (control group), implement an educational strategy and measure again phenobarbital accuracy error in both services. Method: Randomized prospective observational study conducted in two phases in seven level III Spanish NICUs. Accuracy error was defined as deviation higher than ±10% between theoretical concentration and that measured in the laboratory. Medicine preparation in HPS was considered the gold standard because medicine preparation standardization and health professionals specialized in medicine manipulation. Phase I: phenobarbital samples of diluted drugs ready to be administrated in the NICUs and several samples prepared in the HPS only for the study were collected. The procedure was assessed using a survey where staff indicated which material they had used and the mathematical calculations. The critical points were identified through studying: the handling process, math calculations, the drug levels assay and reviewing of clinical practice through recorded video and existing protocols. Several interventions, based on the standardization of the concentrations preparation protocols and training of health professionals in drugs preparation techniques were implanted. Phase II: after implantation of improvement strategies phenobarbital random samples were collected in the NICUs and HPS. Phenobarbital bioassay was performed by Competitive direct chemiluminescent immunoassay using an ADVIA Centaur Xp (Siemens) analyzer, analytical sensitivity was 0.4 g/mL and imprecision (CV %) 11.6%. Results:
Phase I Phase II
NICUs error
HPS error
89.5% (17/19) 25.0% (3/12) P < 0.001
40.0% (8/20) 10.0% (1/10) p = 0.091
p < 0.001 p = 0.364
Conclusions: Intravenous drugs preparation is a weak chain in drug use in the NICUs. The lack of commercial preparations adapted for neonatal dose requires several manipulations to get the right dose to be administered. Standardization of protocols and staff training has proven to be valid strategies in order to reduce accuracy error rate. Factors such as inadequate space for preparation or excessive workload may have contributed to continuing with the error continue despite the intervention. While this kind of error was lower in the HPS than in the NICU, further work is needed on health professionals formation in drug preparation techniques. Fig. 1. Performance of sensor 010. Calibration curve of QH (A) after treatment with QH and CP (run 1 + 2) and (B) after exposure with SLS (run 3–7). (n = 4, mean ± s).
http://dx.doi.org/10.1016/j.ijpharm.2016.06.084
1137
not affect the attributed scores. Similarly, the results did not differ among nurses and physicians. Conclusions: Pulverized brand-names and generics containing either amlodipine or candesartan did not differ with respect to their taste acceptability [3]. These first results among adult healthy volunteers should be confirmed among a limited sample of children.
Conclusion: Exposure of the sensors with SLS did not damage sensor membranes. Even if the sensor response was altered, concentration dependent analysis of QH samples is still possible.
http://dx.doi.org/10.1016/j.ijpharm.2016.06.082
Phenobarbital accuracy errors after educational strategy implementation
Abstract ID: 19 Assessing the effect of sodium lauryl sulphate on the performance of e-tongue sensors I. Immohr 1,∗ , R. Turner 2 , M. Pein-Hackelbusch 1 1
Institute of Pharmaceutics and Biopharmaceutics, Heinrich-Heine-University Düsseldorf, Universitätsstrasse 1, 40225 Düsseldorf, Germany 2 Novartis Pharma AG, Basel, Switzerland E-mail address: [email protected] (I. Immohr). Introduction: Oral liquid drug formulations often require tastemasking to ensure palatability. Taste assessment by electronic tongue (ET) is restricted to substances interacting with the sensor membranes without damaging or interfering with their electrical output. Therefore, complex formulations may not be analyzed by ET. Purpose: To evaluate sensor performance to harmful excipients, exemplary sodium lauryl sulphate (SLS), when performing an ET taste assessment study. Method: Two self-developed PVC-based ET sensor sets were prepared for use on the Insent Taste Sensing System SA402B (Sensor 010, 011, 012, 013). One sensor set (stressed) was used in a taste assessment study (Table 1), the other sensor set was not exposed to the excipients. Each sample measurement was followed by a calibration assessment with QH to evaluate the sensor performance. Results: All sensors (Sensors 010–013) showed linear dependency of sensor responses to QH concentrations. Sensor response to QH was similar from both sensor sets when exposed to taste assessment samples containing QH or CP only (Fig. 1A). This sensor response changed after the sensors were exposed to samples containing SLS (Fig. 1B). The slopes of the calibration curves of stressed sensors increased resulting in an improvement of their sensitivity. Table 1 Sequence of samples. Run
Sample
1 2 3 4 5 6 7
QH (1 mM quinine hydrocholdride dihydrate) CP (1% cherry powder) SLS (1%) MP (0.2% methyl paraben) QH, SLS QH, SLS, MP QH, SLS, MP, CP
http://dx.doi.org/10.1016/j.ijpharm.2016.06.083 Abstract ID: 20
Ainara Campino ∗ , Maria Cruz Lopez-Herrera, Casilda Arranz, Beatriz Sordo, María Unceta, Pilar Pascual, Elena Santesteban Introduction: Accuracy preparation error is a type of medication error rarely studied. Unavailability of drug preparations and equipment for dilution specifically adapted for neonates makes preparation process prone to accuracy errors. Phenobarbital is used mainly in neonates in status epilecticus. Purpose: Measure intravenous phenobarbital accuracy preparation error rate in Neonatal Intensive Care Units (NICUs) and Hospital Pharmacy Service (HPS) (control group), implement an educational strategy and measure again phenobarbital accuracy error in both services. Method: Randomized prospective observational study conducted in two phases in seven level III Spanish NICUs. Accuracy error was defined as deviation higher than ±10% between theoretical concentration and that measured in the laboratory. Medicine preparation in HPS was considered the gold standard because medicine preparation standardization and health professionals specialized in medicine manipulation. Phase I: phenobarbital samples of diluted drugs ready to be administrated in the NICUs and several samples prepared in the HPS only for the study were collected. The procedure was assessed using a survey where staff indicated which material they had used and the mathematical calculations. The critical points were identified through studying: the handling process, math calculations, the drug levels assay and reviewing of clinical practice through recorded video and existing protocols. Several interventions, based on the standardization of the concentrations preparation protocols and training of health professionals in drugs preparation techniques were implanted. Phase II: after implantation of improvement strategies phenobarbital random samples were collected in the NICUs and HPS. Phenobarbital bioassay was performed by Competitive direct chemiluminescent immunoassay using an ADVIA Centaur Xp (Siemens) analyzer, analytical sensitivity was 0.4 g/mL and imprecision (CV %) 11.6%. Results:
Phase I Phase II
NICUs error
HPS error
89.5% (17/19) 25.0% (3/12) P < 0.001
40.0% (8/20) 10.0% (1/10) p = 0.091
p < 0.001 p = 0.364
Conclusions: Intravenous drugs preparation is a weak chain in drug use in the NICUs. The lack of commercial preparations adapted for neonatal dose requires several manipulations to get the right dose to be administered. Standardization of protocols and staff training has proven to be valid strategies in order to reduce accuracy error rate. Factors such as inadequate space for preparation or excessive workload may have contributed to continuing with the error continue despite the intervention. While this kind of error was lower in the HPS than in the NICU, further work is needed on health professionals formation in drug preparation techniques. Fig. 1. Performance of sensor 010. Calibration curve of QH (A) after treatment with QH and CP (run 1 + 2) and (B) after exposure with SLS (run 3–7). (n = 4, mean ± s).
http://dx.doi.org/10.1016/j.ijpharm.2016.06.084