Drug Stability Research Group

Yvoir, Belgium

Drug Stability Research Group

Yvoir, Belgium
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Closset M.,Medical Laboratory | Hecq J.D.,CHU Dinant Godinne | Hecq J.D.,Drug Stability Research Group | Soumoy L.,CHU Dinant Godinne | And 7 more authors.
Annales Pharmaceutiques Francaises | Year: 2017

Background The intensive care department of the institution use drug solutions within higher concentration to avoid fluid overload. The purpose of the study is to prove the physical stability of different injectable drugs within high concentration (amiodarone 25 mg/mL, isosorbide 0.60 mg/mL, lorazepam 0.16 mg/mL, noradrenalin 0.120 and 0.240 mg/mL, salbutamol 0.06 mg/mL and sodium valproate 12 mg/mL) to ensure the patients safety. Methods Five of 30 or 50 mL polypropylene syringes were prepared for each solution under aseptic conditions and stored at room temperature. Immediately after the preparation (hour 0) and after 1, 4, 8, 24 and 48 hours, 2 mL of each solution were withdrawn from each syringe and placed in glass tubes to proceed to the stability test. All specimens were visually inspected in front of a black and of a white background and aliquots of each solution were centrifuged to proceed to microscopic inspection with a ten-fold magnification. The pH of each solution was measured with glass electrode pH-meter (Inolab level 1, WTW Weilhem, Germany with biotrode electrode, Hamilton, Bonaduz, Switzerland) and spectrophotometric measurements (Genesys 10 series, New-York, USA) were performed at three wavelengths (350, 410 and 550 nm) to avoid the apparition of turbidity. Results For all the drugs included in the study, there was no significant change in pH, no color change, no turbidity or opacity and no precipitation observed in the solutions during the storage at room temperature for 48 hours. No microaggregates were detected by microscope neither revealed by a change of absorbance. Conclusion Within these limits, the preparations of amiodarone in 5% glucose polypropylene syringes and isosorbide, lorazepam, noradrenalin, salbutamol, valproate in 0.9% sodium chloride polypropylene syringes are physically stable at room temperature for 48 hours. These results allow us to consider a study of chemical stability by high-performance liquid chromatography (HPLC). © 2016 Académie Nationale de Pharmacie


Introduction The aim of the study was to investigate the long-term stability of dexamethasone 10 mg associated with alizapride 100 mg or ondansetron 8 mg in 100 mL of 0.9% sodium chloride solution stored at 5 ± 3 °C. Method Solutions of 0.9% sodium chloride 100 mL in polyolefin bags (n = 5) containing approximately dexamethasone (DEX) 10 mg associated with alizapride (ALI) 100 mg or ondansetron (OND) 8 mg were prepared under aseptic conditions and stored about 30 days at 5 ± 3 °C. ALI, DEX and OND concentrations were measured by high-performance liquid chromatography (HPLC). Optic density measurement at different wavelengths, pH measurement and optic microscope observations were performed periodically during the storage. A forced degradation test with HCL 5M and NaOH 5M before and after heating at 100 °C was also performed. Solutions were considered stable if the 95% one-sided lower confidence limit of the concentration remains superior to 90% of the initial concentration or 95% of the initial concentration when any signs of physical instability exist as recently recommend. Results The calibration was linear over the following range from 20 to 1.25 mg/100 mL for DEX, from 200 to 12.5 mg/100 mL for ALI and from 20 to 1.25 mg/100 mL for OND with a calculated correlation coefficient (r2) of 0.998, 0.999 and 0.999, respectively. The inter- and intra-assay precision was below 10% for both mixtures. All formulations were physically stable during the storage. The lower confidence limit of the concentration for these solutions remains superior to 90% of the initial concentration at this date as recommended by the Food and Drug Administration (FDA) until 30 days. Conclusion The HPLC method is specific and reproducible and can easily be adopted for monitoring the quality control in the production of DEX-ALI and DEX-OND bags. Solutions of DEX-ALI and DEX-OND were physically and chemically stable for 30 days in polyolefin bags stored at 5 ± 3 °C and could therefore be prepared in advance. © 2016 Académie Nationale de Pharmacie


Hecq J.D.,CHU Dinant Godinne | Hecq J.D.,Drug Stability Research Group | Gonzalez E.,Drug Stability Research Group | Bihin B.,Drug Stability Research Group | And 4 more authors.
European Journal of Hospital Pharmacy | Year: 2017

Introduction An international alert from Becton Dickinson (BD) has noted the possibility of interaction between several molecules and some syringes. The Centralized IntraVenous Additives Service of the institution was using 3 mL BD syringes to store ketamine HCl. This study evaluated the interaction between ketamine and these syringes. Method A batch of BD syringes produced in Europe and left in quarantine from the day of the international alert has been tested at 22, 29, 36, 43 and 50 days of storage at room temperature. At each time, the pH of the solutions was measured. The solutions were inspected visually and by microscope, and spectrophotometric measurements were performed. The concentrations were measured by a validated ultra-high-performance liquid chromatography-diode array detector. Results Neither physical change nor pH modification was observed during the study. According to a lower limit of the 95% unilateral CI on the mean >90% of the theoretical concentration, the solutions remain stable for at least 50 days. Conclusion In our study conditions, ketamine can be stored for at least 50 days without risk of sorption with syringes. © Published by the BMJ Publishing Group Limited.


Huvelle S.,Medical Laboratory | Godet M.,Medical Laboratory | Godet M.,Drug Stability Research Group | Hecq J.-D.,CHU Dinant Godinne | And 6 more authors.
Annales Pharmaceutiques Francaises | Year: 2016

Introduction: Ketamine hydrochloride (Ketalar®) injection is often used as a general anesthetic agent. It is particularly suited to short-term interventions. It can also be used as an inducer of anesthesia before the administration of other anesthetic agents. The aim of this study was to evaluate the stability of ketamine hydrochloride in 3ml polypropylene syringes after storage for up to 180days at room temperature. Method: Syringes containing ketamine hydrochloride (50. mg/ml) were prepared and stored at room temperature (25. °C) for 180. days. The concentrations were measured by validated ultra-performance liquid chromatography-diode array detection at 0, 7, 14, 28, 60, 84, 112, 140 and 180. days. A degradation test was performed to evaluate the specificity of the analysis. At each time point, the pH, color and visible particles of each solution were also assessed. Results: Degradation tests proved no interfering peaks with ketamine. All solutions were physically stable during the storage. The lower confidence limit of the concentration for these solutions remains superior to 90% of the initial concentration at this date as recommended by the Food and Drug Administration (FDA) until 180. days (100%. ±. 2%). Conclusion: Solutions of ketamine (50. mg/ml) were chemically stable for 180. days in polypropylene syringes with storage at room temperature and could be prepared in advance by a centralized intravenous admixture service. © 2016 Académie Nationale de Pharmacie.


Dewulf J.,Medical Laboratory | Galanti L.,Medical Laboratory | Galanti L.,Drug Stability Research Group | Godet M.,Medical Laboratory | And 7 more authors.
Annales Pharmaceutiques Francaises | Year: 2015

Introduction: The aim of the study was to investigate the long-term stability of acyclovir 5. mg/mL (a generic product versus the brand name) in NaCl 0.9% after storage at 5. ±. 3. °C and to evaluate the influence of initial freezing and microwave thawing on this stability. Methods: Five bags of Acyclovir® Hospira 5mg/mL (A) and five bags of Zovirax® GSK 5mg/mL (B) were prepared under aseptic conditions and stored 3 months at -20°C, then thawed and stored 30 days at 4°C. Five bags of Acyclovir® 5mg/mL (C) and five bags of Zovirax® 5mg/mL (D) were also prepared under aseptic conditions and stored 30 days at 5±3°C. Optic density measurement at different wavelengths, pH measurement and optic microscope observations were performed periodically during the storage. A forced degradation test with HCl 12M and NaOH 5M before and after heating at 100°C was also performed. The concentrations were measured by HPLC-PDA. Results: The only one forced degradation test that yielded chromatograms with degradation products peak was the test with the acid solution heated at 100°C without interference with the native product. No significant change in pH values or optic densities were seen during the study for both products. No crystals were seen with the optic microscope during the study. Acyclovir® and Zovirax® solutions were stable for at least 21 days according to the FDA recommendations. Moreover, there was no statistical difference between regression lines of those two products and two storage conditions. Conclusion: Under the conditions of this study, Acyclovir® 5mg/mL in 100mL of NaCl 0.9% infusion remains stable at least for 21 days at 5±3°C with or without freezing at -20°C during the three previous months. There is no statistical difference between the brand name and a generic product. Acyclovir may be prepared in advanced by a centralized intravenous additive service, frozen in polyolefin bags and microwave thawed before storage under refrigeration until 21 days. © 2014 Elsevier Masson SAS.


Hecq J.-D.,Yvoir and Drug Stability Research Group | Lewis A.L.,Biocompatibles UK Ltd | Vanbeckbergen D.,Scientific Support Unit | Athanosopoulos A.,Drug Stability Research Group | And 4 more authors.
Journal of Oncology Pharmacy Practice | Year: 2013

Purpose: Evaluation of doxorubicin stability over time when stored into the DC Bead embolic agent, in various containers, which are used for the delivery of the doxorubicin-loaded beads to the patients for up to 14 days under refrigerated conditions.Methods: The doxorubicin was loaded through the ionic exchange mechanism into the calibrated polyvinyl alcohol-based hydrogel beads (DC Bead), with the loading process carried out either in the original DC Bead glass vials or within a polypropylene plastic syringe. The loaded samples were eluted at given time points and the extracted doxorubicin was analysed by high-performance liquid chromatography for concentration and chromatographic area response purity.Results: The variance on the doxorubicin concentration of the samples stored in the syringes under refrigerated conditions was less than 10% over the 14 days period. The chromatographic purity of doxorubicin eluted from the DC Bead in their primary glass vial packaging was measured at 99.7%. The dissolution test showed that the elution rate and amount recovered from samples stored in vials were statistically similar between Day 0 and Day 14. The chromatographic purity of the doxorubicin loaded into DC Bead in presence of non-ionic contrast medium was >99.0% for 7 days under refrigerated conditions.Conclusions: Doxorubicin-loaded DC Bead® are shown to have adequate physicochemical stability over a period of 14 days when stored in syringes or vials under refrigerated conditions for up to 14 days. The admixtures of doxorubicin-loaded beads with contrast medium are stable for up to 7 days under refrigerated conditions. © The Author(s) 2012 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.


PubMed | Medical Laboratory, CHU Dinant Godinne, Drug Stability Research Group and Scientific Support Unit
Type: Journal Article | Journal: Annales pharmaceutiques francaises | Year: 2016

Ketamine hydrochloride (Ketalar()) injection is often used as a general anesthetic agent. It is particularly suited to short-term interventions. It can also be used as an inducer of anesthesia before the administration of other anesthetic agents. The aim of this study was to evaluate the stability of ketamine hydrochloride in 3ml polypropylene syringes after storage for up to 180days at room temperature.Syringes containing ketamine hydrochloride (50mg/ml) were prepared and stored at room temperature (25C) for 180days. The concentrations were measured by validated ultra-performance liquid chromatography-diode array detection at 0, 7, 14, 28, 60, 84, 112, 140 and 180days. A degradation test was performed to evaluate the specificity of the analysis. At each time point, the pH, color and visible particles of each solution were also assessed.Degradation tests proved no interfering peaks with ketamine. All solutions were physically stable during the storage. The lower confidence limit of the concentration for these solutions remains superior to 90% of the initial concentration at this date as recommended by the Food and Drug Administration (FDA) until 180days (100%2%).Solutions of ketamine (50mg/ml) were chemically stable for 180days in polypropylene syringes with storage at room temperature and could be prepared in advance by a centralized intravenous admixture service.


PubMed | Medical Laboratory, CHU UCL Namur, Drug Stability Research Group and Scientific Support Unit
Type: Journal Article | Journal: Annales pharmaceutiques francaises | Year: 2016

The aim of the study was to investigate the long-term stability of dexamethasone 10mg associated with alizapride 100mg or ondansetron 8mg in 100mL of 0.9% sodium chloride solution stored at 53C.Solutions of 0.9% sodium chloride 100mL in polyolefin bags (n=5) containing approximately dexamethasone (DEX) 10mg associated with alizapride (ALI) 100mg or ondansetron (OND) 8mg were prepared under aseptic conditions and stored about 30 days at 53C. ALI, DEX and OND concentrations were measured by high-performance liquid chromatography (HPLC). Optic density measurement at different wavelengths, pH measurement and optic microscope observations were performed periodically during the storage. A forced degradation test with HCL 5M and NaOH 5M before and after heating at 100C was also performed. Solutions were considered stable if the 95% one-sided lower confidence limit of the concentration remains superior to 90% of the initial concentration or 95% of the initial concentration when any signs of physical instability exist as recently recommend.The calibration was linear over the following range from 20 to 1.25mg/100mL for DEX, from 200 to 12.5mg/100mL for ALI and from 20 to 1.25mg/100mL for OND with a calculated correlation coefficient (rThe HPLC method is specific and reproducible and can easily be adopted for monitoring the quality control in the production of DEX-ALI and DEX-OND bags. Solutions of DEX-ALI and DEX-OND were physically and chemically stable for 30 days in polyolefin bags stored at 53C and could therefore be prepared in advance.


PubMed | Medical Laboratory, Drug Stability Research Group and Scientific Support Unit
Type: Journal Article | Journal: Annales pharmaceutiques francaises | Year: 2015

The aim of the study was to investigate the long-term stability of acyclovir 5 mg/mL (a generic product versus the brand name) in NaCl 0.9% after storage at 53C and to evaluate the influence of initial freezing and microwave thawing on this stability.Five bags of Acyclovir Hospira 5 mg/mL (A) and five bags of Zovirax GSK 5 mg/mL (B) were prepared under aseptic conditions and stored 3 months at -20C, then thawed and stored 30 days at 4C. Five bags of Acyclovir 5 mg/mL (C) and five bags of Zovirax 5 mg/mL (D) were also prepared under aseptic conditions and stored 30 days at 53C. Optic density measurement at different wavelengths, pH measurement and optic microscope observations were performed periodically during the storage. A forced degradation test with HCl 12 M and NaOH 5 M before and after heating at 100C was also performed. The concentrations were measured by HPLC-PDA.The only one forced degradation test that yielded chromatograms with degradation products peak was the test with the acid solution heated at 100C without interference with the native product. No significant change in pH values or optic densities were seen during the study for both products. No crystals were seen with the optic microscope during the study. Acyclovir and Zovirax solutions were stable for at least 21 days according to the FDA recommendations. Moreover, there was no statistical difference between regression lines of those two products and two storage conditions.Under the conditions of this study, Acyclovir 5 mg/mL in 100 mL of NaCl 0.9% infusion remains stable at least for 21 days at 53C with or without freezing at -20C during the three previous months. There is no statistical difference between the brand name and a generic product. Acyclovir may be prepared in advanced by a centralized intravenous additive service, frozen in polyolefin bags and microwave thawed before storage under refrigeration until 21 days.

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