European Databases on Stability and Compatibility of Injectable Medicinal Products in Europe

Hecq, Jean-Daniel; Krämer, Irene; Vigneron, Jean

doi:10.1515/pthp-2019-0012

Cited by 8 publications

(4 citation statements)

References 18 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Pharmacotherapy, including antiemetic treatment, is very often a complex procedure that requires the utilisation of various drugs. As a consequence of the complications that can 2 of 11 occur, therapy regimens are growing in their complexity One-third of patients have been prescribed three injectable drugs to be administered at the same time [6], which in turn has limited parenteral access. In the absence of confirmed compatibility in the pharmaceutical phase, these drugs must be administered through separate catheters, however due to the dosing regimen and frequent administration by continuous infusion, this practice becomes not only impractical but also impossible to administer.…”

Section: Introductionmentioning

confidence: 99%

Antiemetic Drugs Compatibility Evaluation with Paediatric Parenteral Nutrition Admixtures

et al. 2023

View full text Add to dashboard Cite

Chemotherapy-induced nausea and vomiting are defined as the most common of side effects of treatment and, at the same time, are very difficult to accept for patients’, frequently causing changes in the therapy regimen, significantly reducing its effectiveness. Thus, an antiemetic prophylactic is essential to the provision of such a therapy for the patient. Pharmacotherapy often includes various drugs, including antiemetics, with the administration of such drugs by injection through two separate catheters being the preferred method. However, the co-administration of drugs and parenteral nutrition admixtures (PNAs) requires the consideration of compatibility, stability and potential negative interactions. To meet the purposes of clinical pharmacy, a compatibility test of ondansetron, dexamethasone and hydrocortisone with paediatric PNAs was conducted. PNAs differ in the composition of amino acid source (Primene® or Aminoplasmal Paed® 10%) and the type of injectable lipid emulsion (Lipidem® 200 mg/mL, Clinoleic® 20%, SMOFlipid® 200 mg/mL, Intralipid® 20%). An in vitro evaluation was performed in a static way as a simulated co-administration through a Y-site. The drug PNA ratios were determined based on the extreme infusion rates contained in the characteristics of medicinal products. All calculations were performed for a hypothetical patient aged 7 years weighing 24 kg. As a result of this study, it can be concluded that all tested PNAs showed the required stability in the range of parameters such as pH, osmolality, turbidity, zeta potential, MDD and homogeneity. The co-administration of antiemetic drugs does not adversely affect lipid emulsion stability. This combination was consistently compatible during the evaluation period.

show abstract

Section: Introductionmentioning

confidence: 99%

Antiemetic Drugs Compatibility Evaluation with Paediatric Parenteral Nutrition Admixtures

et al. 2023

View full text Add to dashboard Cite

show abstract

“…Therapy regimens in hospital wards are growing in complexity . According to Hecq et al, 32 and 13% of patients are prescribed three or four injectable drugs to be administered at the same time, respectively . These drugs must be delivered to the patient within a limited time frame, frequently as continuous infusions, and through a limited number of intravenous (i.v.)…”

Section: Introductionmentioning

confidence: 99%

Co-administration of Intravenous Drugs: Rapidly Troubleshooting the Solid Form Composition of a Precipitate in a Multi-drug Mixture Using On-Site Raman Spectroscopy

et al. 2023

View full text Add to dashboard Cite

Intravenous drugs are often co-administrated in the same intravenous catheter line due to which compatibility issues, such as complex precipitation processes in the catheter line, may occur. A well-known example that led to several neonatal deaths is the precipitation due to coadministration of ceftriaxone-and calcium-containing solutions. The current study is exploring the applicability of Raman spectroscopy for testing intravenous drug compatibility in hospital settings. The precipitation of ceftriaxone calcium was used as a model system and explored in several multi-drug mixtures containing both structurally similar and clinically relevant drugs for co-infusion. Equal molar concentrations of solutions containing ceftriaxone and calcium chloride dihydrate were mixed with solutions of cefotaxime, ampicillin, paracetamol, and metoclopramide. The precipitate formed was collected as an "unknown" material, dried, and analyzed. Several solid-state analytical methods, including X-ray powder diffraction, Raman spectroscopy, and thermogravimetric analysis, were used to characterize the precipitate. Raman microscopy was used to investigate the identity of single sub-visual particles precipitated from a mixture of ceftriaxone, cefotaxime, and calcium chloride. X-ray powder diffraction suggested that the precipitate was partially crystalline; however, the identity of the solid form of the precipitate could not be confirmed with this standard method. Raman spectroscopy combined with multi-variate analyses (principal component analysis and soft independent modelling class analogy) enabled the correct detection and identification of the precipitate as ceftriaxone calcium. Raman microscopy enabled the identification of ceftriaxone calcium single particles of sub-visual size (around 25 μm), which is in the size range that may occlude capillaries. This study indicates that Raman spectroscopy is a promising approach for supporting clinical decisions and especially for compatibility assessments of drug infusions in hospital settings.

show abstract

“…The literature provides a lot of references about the stability of 5-FU. [7][8][9] The parameters influencing the stability of the molecule are various (container, solvent, concentration, brand, storage temperature, exposure to light and study period). The specific conditions of bands of 700 and 800 mg stored in polyolefin bags at 23 ± 2°C, classically used in clinics, have never been studied.…”

Section: Introductionmentioning

confidence: 99%

Long-term physicochemical stability of 5-fluorouracil at selected standardised rounded doses in polyolefin bags

Closset

Onorati

Colsoul

et al. 2023

J Oncol Pharm Pract

Self Cite

View full text Add to dashboard Cite

Background Chemotherapy doses are usually prescribed on the basis of body surface area but dose banding is emerging as an efficient alternative. Dose banding presents the possibility of in-advance preparation in a Centralized Intravenous Admixture Service. Aim of the study To evaluate the long-term stability of 5-fluorouracil at banded doses (700 mg and 800 mg) in polyolefin bags. Materials and methods Ten polyolefin bags were prepared under aseptic conditions and stored at 23 ± 2°C for 24 days. Five of them were composed of 14 mL 5-fluorocuracil (700 g) in 100 mL 0.9% sodium chloride solution and the five other of 16 mL 5-fluorouracil (800 mg) in 100 mL 0.9% sodium chloride solution. At defined times, physical stability parameters were assessed: optical densities, pH measurements, visual and microscopical inspections. Solutions concentrations were measured using high-performance liquid chromatography coupled with a photodiode array detector. Results No change was observed on pH and optical density measurements during the study period. Visual and microscopical inspections remained free of colour change, precipitate, microagregate or crystal. The concentrations of 5-Fluorouracil in 800 mg bags remained stable for 24 days while the concentration in 700 mg bags showed a stability of at least 17 days. Conclusion Five-fluorouracil at banded doses of 700 and 800 mg in polyolefin bags is physicochemically stable for at least 17 days at 23 ± 2°C. These results support the possibility of in advance centralised preparation.

show abstract

European Databases on Stability and Compatibility of Injectable Medicinal Products in Europe

Cited by 8 publications

References 18 publications

Antiemetic Drugs Compatibility Evaluation with Paediatric Parenteral Nutrition Admixtures

Antiemetic Drugs Compatibility Evaluation with Paediatric Parenteral Nutrition Admixtures

Co-administration of Intravenous Drugs: Rapidly Troubleshooting the Solid Form Composition of a Precipitate in a Multi-drug Mixture Using On-Site Raman Spectroscopy

Long-term physicochemical stability of 5-fluorouracil at selected standardised rounded doses in polyolefin bags

Contact Info

Product

Resources

About