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Training and certification of personnel in capsule preparation are essential procedures, overseen by the pharmacist who delegates these tasks. These procedures aim not only to ensure the efficacy and safety of operations but also to establish a clear chain of responsibility. They align with established best practices. Certification grants formal authorization to qualified individuals to perform specific tasks. For new hires, a comprehensive training program is designed to facilitate their integration and empower them from the onset. We propose training objectives structured around a competency-based approach, highlighting objective evaluation criteria applicable in real-world practical settings. These training objectives address critical aspects such as the handling of hazardous substances, weighing and mixing of powders, and capsule filling. They also emphasize the importance of documentation and traceability. Specialized preparations and tools are offered to facilitate the assessment of learning outcomes.

Ceftazidime (CZ) and Vancomycin (VM) are used to treat bacterial keratitis; however, their physicochemical incompatibility does not allow their co-administration. This incompatibility can be managed by buffering the mixture at an alkaline pH or by using cage molecules such as cyclodextrins (CD). The objective of this work was to compare the stability during 168 days of frozen storage of two formulations combining VA and CZ at a final concentration of 25 mg/mL: a CD-free formulation, at a pH=8.5 and a formulation with CD.

Infliximab diluted solutions have been shown to be physicochemically stable for long periods, however the adsorption of infliximab during infusions has not been readily investigated. This study aimed to evaluate potential adsorption phenomena of infliximab during administration through Polyvinylchloride (PVC) and Polyurethane (PU) infusion sets.

Water-soluble vitamins are often included simultaneously in pharmaceutical formulations as food complements or in parenteral nutrition mixtures. Given their sensitivity to heat, light or pH variations, it is important to study their stability using validated stability indicating methods. We thus aimed to validate a liquid chromatography (LC) stability-indicating method for the simultaneous quantification of 5 water-soluble vitamins.

Preservative free ophthalmic formulations need to be packaged either as single doses, or using specially designed sterility preserving multidose eyedroppers. Our objective was to evaluate potential sorption phenomena between a device with a silicone sterility preserving membrane and the delivered drops of several ophthalmic solutions. Cyclosporine, rifamycin, latanoprost, timolol and norfloxacin were used as model drugs. Quantification of the active substance in delivered drops (1 to 4 drops per day) from low density polyethylene (LDPE) bottles without any sterility preserving device and from LDPE bottles with a sterility preserving silicone membrane (LDPE-Si) was performed for 14 days (n≥3), using validated HPLC methods. For cyclosporine, mean concentrations did not vary by more than 10 % from reference concentrations for either LDPE or LDPE-Si eyedroppers, but for LDPE-Si, the concentrations of the 1 mg.ml-1 cyclosporine micellar solution were found to be significantly lower than for those from LDPE eyedroppers (p=0.0127). For LDPE-Si, rifamycin mean concentrations decreased by 11.2 % throughout the 14 day study period, but didn’t vary by more than 10 % for LDPE and glass eyedroppers. However, rifamycin concentrations from LDPE-Si were not significantly different from those from LDPE eyedroppers. For latanoprost, whilst mean concentrations did not vary by more than 10 % from reference concentration for LDPE eyedroppers, for LDPE-Si eyedroppers concentrations decreased by 76.4 % at their lowest concentration and never returned to their initial level. For timolol and norfloxacin, mean concentrations did not vary by more than 10 % for either LDPE or LDPE-Si eyedroppers and no significant difference was found between the 2 eyedroppers concentrations. Our results are in favor of an absence of significant sorption between LDPE-Si eyedroppers for timolol or norfloxacin ophthalmic solutions. Further studies should be performed on cyclosporine ophthalmic micellar solutions and rifamycin ophthalmic solutions before any definite conclusions can be made. Finally, our results show that latanoprost ophthalmic solutions shouldn’t be used with LDPE-Si eyedroppers as the loss of active substance would cause a sever under-dosing.

Introduction: Medical syringes are widely used in hospitals to store and administer drugs, and the contact time between the drugs and these syringes can vary from a few minutes to several weeks like for pharmaceutical preparations. The aim of this comparative study was to evaluate the potential sorption phenomena occurring between three drugs (paracetamol, diazepam and insulin aspart) and polypropylene syringes (PP) or syringes made of Cyclic Olefin Copolymer (COC). Materials and methods: 50 mL 3-part syringes made of either COC with crosslinked silicone on the barrel inner surface (COC-CLS) and a bromobutyl plunger seal, or PP lubricated with silicone oil (PP-SOL) with a polyisoprene plunger seal were used. Results: COC-CLS syringes induced less sorption of diazepam and insulin than PP-SOL syringes and the plunger seal material seemed to be the main cause of these interactions. An alkalinization of the medications in contact with the PP-SOL syringes was observed. It could be caused by leachable compounds and should be investigated further. Conclusion: This work shows once again that it is essential to consider content-container interactions to help improve the safe use of parenteral drugs. [ABSTRACT FROM AUTHOR]

Coring of a medication vial’s rubber stopper has been reported as a major cause of visible particle presence in injectable preparations. In this study, we investigated and quantified visible particle formation caused by coring associated with four potential causal factors.

Infusion medical devices (MDs) used in hospitals are often made of plasticized polyvinylchloride (PVC). These plasticizers may leach out into infused solutions during clinical practice, especially during risk-situations, e.g multiple infusions in Intensive Care Units and thus may enter into contact with the patients. The migrability of the plasticizers is dependent of several clinical parameters such as temperature, contact time, nature of the simulant, etc… However, no data is available about the influence of the flow rate at which drug solutions are administrated. In this study, we evaluated the impact of different flow rates on the release of the different plasticizers during an infusion procedure in order to assess if they could expose the patients to more toxic amounts of plasticizers. Migration assays with different PVC infusion sets and extension lines were performed with different flow rates that are used in clinical practice during 1h, 2h, 4h, 8h and 24h, using a lipophilic drug simulant. From a clinical point of view, the results showed that, regardless of the plasticizer, the faster the flow rate, the higher the infused volume and the higher the quantities of plasticizers released, both from infusion sets and extension lines, leading to higher patient exposure. However, physically, there was no significant difference of the migration kinetics linked to the flow rate for a same medical device, reflecting complex interactions between the PVC matrix and the simulant. The migration was especially dependent on the nature and the composition of the medical device. [ABSTRACT FROM AUTHOR]

Objectives: To assess the impact of disparities in production and analytical control processes on the quality of parenteral nutrition (PN) preparations produced in the Auvergne-Rhône-Alpes region., Methods: This study was carried out in four hospital pharmacies of the Auvergne-Rhône-Alpes region. To assess the impact of production processes, each centre produced ten PN preparations from the same prescription. Analytical controls (sodium, potassium and calcium dosage) were carried out on all the preparations. To assess the impact of the control processes, a batch of ten preparations was produced from the same prescription. Samples were sent to the four hospital pharmacies for analytical control (sodium, potassium and calcium dosage)., Results: Measurements of relative production bias show that there is a significant difference between the preparations from the four centres in terms of sodium and potassium content. Each centre had at least one production bias for one of the three electrolytes measured. Concerning analytical controls, there was a significant difference between the four centres in the sodium and potassium levels measured. With the exception of calcium, all the centres reported measurements within the usual specifications of±10% of the target value. The results obtained have no clinically significant impact., Conclusion: The diversity of NP practices has a real impact on the quality of the preparations made. A regional collaboration should be envisaged to standardise patient care., (Copyright © 2023 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.)