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Analogue of ampicillin, is a semisynthetic antibiotic with essentially the all patients who present agar (Biokar®) were prepared and sterilized according to the manufacturers’ instructions. Another drug and may not reflect the rates.

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Capsule mox

If the pancreatitis resolves after discontinuation of the drug, suspicion for drug-induced

pancreatitis

increases. A firm diagnosis can be reasonably established with a rechallenge of the offending drug that results in the recurrence of pancreatitis symptoms [1,2,3,4]. Very few cases, less than 5 total cases, were documented in the literature regarding ampicillin, penicillin, and amoxicillin/clavulanic acid induced acute pancreatitis with true mechanism still being unidentified [7,8,9,10,

11]

.

Table 2 shows the comparison between our patient’s case with published data in the literature.

Drug-induced acute pancreatitis remains rare but should not be disregarded when medical practitioners are faced with a patient presenting with acute pancreatitis with no obvious cause. Being familiar with reports of drugs causing acute pancreatitis can be helpful in identifying the causality and association with a certain drug.

Despite the fact that DIP can have a benign course with good prognosis, fatal outcomes still occur and thus DIP should not be overlooked.

This case describes a patient with DIP after the intake of amoxicillin/clavulanic acid and when all other common causes of acute pancreatitis were excluded.

We again stress on the importance of identifying and reporting cases of DIP to raise awareness among physicians and clinicians. We also stress on the importance of encouraging scientists and researchers to better understand the mechanism of developing drug-induced acute pancreatitis. Overcoming stability challenges during continuous intravenous administration of high-dose amoxicillin using portable elastomeric pumps. Contributed equally to this work with: Guillaume Binson, Claire Grignon.

Roles Investigation, Methodology, Writing – original draft.

Affiliations Department of Pharmacy, University Hospital of Poitiers, Poitiers, France, CIC Inserm, Poitiers, France. Contributed equally to this work with: Guillaume Binson, Claire Grignon.

Roles Investigation, Methodology, Writing – original draft.

Affiliation Department of Pharmacy, University Hospital of Poitiers, Poitiers, France.

Roles Conceptualization, Writing – review & editing.

Affiliation Department of Infectious Diseases, University Hospital of Poitiers, Poitiers, France. Affiliation Department of Pharmacy, University Hospital of Poitiers, Poitiers, France. Affiliation Department of Pharmacokinetics, University Hospital of Poitiers, Poitiers, France. Affiliation Department of Infectious Diseases, University Hospital of Poitiers, Poitiers, France.

Roles Methodology, Validation, Writing – review & editing.

Affiliations CIC Inserm, Poitiers, France, Department of Pharmacokinetics, University Hospital of Poitiers, Poitiers, France. Roles Conceptualization, Methodology, Project administration, Supervision, Writing – review & editing.

Affiliations Department of Pharmacy, University Hospital of Poitiers, Poitiers, France, CIC Inserm, Poitiers, France. Overcoming stability challenges during continuous intravenous administration of high-dose amoxicillin using portable elastomeric pumps.

Guillaume Binson, Claire Grignon, Gwenael Le Moal, Pauline Lazaro, Jeremy Lelong, France Roblot, Nicolas Venisse, Antoine Dupuis. Published: August 16, 2019 https://doi.org/10.1371/journal.pone.0221391. Article Authors Metrics Comments Media Coverage Peer Review. While treatment of serious infectious diseases may require high-dose amoxicillin, continuous infusion may be limited by lack of knowledge regarding the chemical stability of the drug.

Therefore, we have performed a comprehensive study so as to determine the chemical stability of high-dose amoxicillin solutions conducive to safe and effective continuous intravenous administration using portable elastomeric pumps.

First, amoxicillin solubility in water was assessed within the range of 25 to 300 mg/mL.

Then, amoxicillin solutions were prepared at different concentrations (25, 50, 125, 250 mg/mL) and stored in different conditions (5±2°C, 25±1°C, 30±1°C and 37±1°C) to investigate the influence of concentration and temperature on the chemical stability of amoxicillin.

Finally, its stability was assessed under optimized conditions using a fully validated HPLC-UV stability-indicating method. Degradation products of amoxicillin were investigated by accurate mass determination using high-resolution mass spectrometry.

Amoxicillin displayed limited water solubility requiring reconstitution at concentrations below or equal to 150 mg/mL. Amoxicillin degradation were time, temperature as well as concentration-dependent, resulting in short-term stability, in particular at high concentrations.

Four degradation products of amoxicillin have been identified. Among them, amoxicilloic acid and diketopiperazine amoxicillin are at risk of allergic reaction and may accumulate in the patient.

Optimized conditions allowing for continuous infusion of high-dose amoxicillin has been determined: amoxicillin should be reconstituted at 25 mg/mL and stored up to 12 hours at room temperature (22 ± 4°C) or up to 24 hours between 4 and 8°C. Citation: Binson G, Grignon C, Le Moal G, Lazaro P, Lelong J, Roblot F, et al.

(2019) Overcoming stability challenges during continuous intravenous administration of high-dose amoxicillin using portable elastomeric pumps.

Editor: Jose das Neves, University of Porto, PORTUGAL. Received: June 19, 2019; Accepted: August 7, 2019; Published: August 16, 2019. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Data Availability: All relevant data are within the manuscript.

Funding: The authors received no specific funding for this work.

Competing interests: The authors have declared that no competing interests exist.

The management of several serious infectious diseases such as bone and joint

infections

as well as infective endocarditis, requires intravenous administration of high-dose amoxicillin (100–300 mg/kg/day) over a prolonged period, ranging from a few weeks to several months [1–4].

?-Lactams are time-dependent antibiotics, meaning that their efficacy depends on the time that free serum concentrations remain above the minimal inhibitory concentration (MIC) during the dosing interval [5].

It has been demonstrated that continuous infusion maintains concentrations above the MIC for a longer period of time within the dosing interval [6].

Moreover, mounting evidence from clinical studies indicates that continuous infusion of time-dependent ?-lactam antibiotics may improve clinical success [7–9]. Therefore it may be well-founded to administrate ?-Lactams using continuous infusion in patients suffering from serious infectious disease. However, despite the possible clinical benefits of this mode of administration, one of the practical concerns related to continuous infusion is the limited stability of certain antibiotic agents. Indeed, stability issues have to be taken into consideration when implementing drug administration, in order to ensure drug efficacy and safety. Regarding ?-lactam antibiotics, not knowing how long they remain stable during infusion may be a limiting factor for continuous administration [10,11]. Furthermore, for several decades, intravenous antimicrobials have been administered increasingly in outpatient settings, in particular thanks to the use of portable devices [12,13]. Outpatient parenteral antimicrobial therapy (OPAT) allows for early hospital discharge, and further reduces costs with fewer nursing and clinic visits [14].

Moreover, OPAT improves quality of life, and

portable

elastomeric pumps gives patients more flexibility and control over

their

treatment [15]. Among the important aspects described in OPAT practice guidelines, drug stability has been underlined as a crucial point to be taken into consideration to ensure efficacy and safety of antimicrobial therapy [12,16,17]. In a recent survey, osteomyelitis, prosthetic joint infections and endocarditis were the most commonly reported indications for OPAT [18]. In treatment of these infectious diseases, continuous infusion of high-dose amoxicillin may be limited by lack of knowledge of the chemical stability of the drug.

Indeed, very few studies are available in the literature regarding the stability of amoxicillin in aqueous solution for intravenous administration and results regarding long-term stability have been inconsistent [19–23].

The aim of this work was to propose safe and effective conditions for continuous intravenous administration of high-dose amoxicillin using portable elastomeric pumps.

For that purpose we performed a comprehensive study designed to determine the chemical stability of high-dose amoxicillin solutions.

Amoxicillin powder used for calibration of the method was purchased from Sigma-Aldrich (Sigma-Aldrich, France) while amoxicillin sodium powder for solution for injection, equivalent to amoxicillin 2 g, was used for the pharmaceutical preparation (Panpharma, France).

HPLC-grade methanol was obtained from Carlo Erba (Carlo Erba, France) and ultrapure water was provided using a Millipore Direct-Q 3 UV water purification system (MerckMillipore, France). Sterile water and 0.9% sodium chloride for injection were obtained from B.Braun (B.Braun, France). Portable elastomeric pumps Infusor (48 mL, 2 mL/h) and FOLFusor (240 mL, 10 mL/h), were obtained from Baxter (Baxter, France) and portable elastomeric pumps Accufuser (480 mL, 20 mL/h) from Wym (Wym, France).

The Infusor and FOLFusor reservoirs are made of synthetic polyisoprene and the Accufuser reservoir is made of medical silicone. Amoxicillin solubility was assessed within the range 25 to 300 mg/mL by dissolving a vial of amoxicillin

sodium

, equivalent to amoxicillin 2 g, in adequate volume of sterile water for injection. The vial was vortexed for 10 min, centrifugated at 3500 G for 10 min and the amoxicillin concentration was determined in the supernatant. To determine the optimal volume of dilution for amoxicillin reconstitution, we investigated the influence of the concentration on the chemical stability of amoxicillin.

Amoxicillin solutions were prepared at different concentrations in various infusion devices (Table 1). The filled elastomeric pumps were stored at 25 ± 1°C for 24 hours in a climate chamber without humidity control (Air concept, FirLabo, France). Samples (n = 3) were collected at different times

over

the 24-hour storage period and determination of the amoxicillin concentration was performed immediately. To determine the best storage conditions during amoxicillin infusion we investigated the influence of temperature on the chemical stability of amoxicillin. Amoxicillin solutions were prepared at a concentration of 125 mg/mL (6 g of amoxicillin were reconstituted with 48 ml of sterile water for injection), in order to fill an Infusor (nominal volume of 48 mL, flow rate of 2 mL/h). The filled elastomeric pumps were then stored for 24 hours at different temperature conditions: 5 ± 2°C in a refrigerated chamber (Precision, Thermo Scientific, France), 25 ± 1°C, 30 ± 1°C and 37 ± 1°C, in a climate chamber (Air concept, FirLabo, France). Samples (n = 3) were collected at different times over the 24-hour storage period and determination of the amoxicillin concentration was performed immediately. Finally, the stability of amoxicillin was assessed under optimized conditions. For this purpose, amoxicillin solutions were prepared at a concentration of 25 mg/mL (12 g of amoxicillin were reconstituted using 240 ml of sterile water for injection and 240 mL of 0.9% sodium choride for injection), in order to fill elastomeric pumps (Accufuser, nominal volume of 480 mL, flow rate of 20 mL/h).

The filled elastomeric pumps were then stored for 24 hours at room temperature (22 ± 4°C) or between 4 and 8°C in a refrigerated bag. Samples (n = 3) were collected at different times over the storage period and determination of the amoxicillin concentration was performed immediately.

The degradation rate was estimated using the slope of the linear regression curve corresponding to amoxicillin remaining (% of initial concentration) versus time profile. Stability was defined as less than 10% disappearance of the amoxicillin concentration, in compliance with the provisions of the US Pharmacopoeia concerning the acceptable limit of content of drug preparation settled at 90% [24], and with the European Pharmacopoeia, requiring that ?-Lactams solutions always contain at least 90% of intact molecule [25].

All samples were diluted to a concentration of 100 ?g/mL with ultrapure

water

and assayed for amoxicillin concentration using a high-performance liquid chromatography method coupled to UV detection (HPLC-UV). The Elite LaChrom system (VWR, France) included a binary pump (Primaid 1110) used in isocratic mode, a single wavelength ultraviolet detector (L-2400), and an autosampler (L-2200) and was controlled using

EZChrom

Elite 3.3 software.

Separation was performed using a Nucleosil C8 analytical column (5 ?m, 150 x 4.6 mm, VWR, France).

Mobile phase consisted of 20% methanol and 80% ultrapure water; flow rate was set at 1 mL/min and 10 ?L of

the

diluted sample were injected onto the column.

Quantification was performed by integration of the peak at a detection wavelength of 225 nm.

The stability-indicating HPLC-UV method was validated in accordance with the guidelines of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Q2(R1) [26]. Briefly, the method was linear over the range 0–200 ?g/mL (r 2 > 0.9993) and the limit of quantification of amoxicillin was equal to 12.5 ?g/mL.

Precision of the method was high, according to intra-day and inter-day coefficients of variation, calculated at low and high concentrations, equal to or less than 4.4% and to the trueness, assessed using the bias, ranging from 88 to 108%. To ensure that the method could be regarded as suitably stability-indicating, we checked to be sure that the decomposition products obtained from amoxicillin solution subjected to severe stress (90°C, pH 1, pH10)

did

not coelute with the intact drug. Degradation products of

amoxicillin

were investigated by accurate mass determination using high-resolution mass spectrometry (HRMS). Briefly, amoxicillin solutions (50 mg/mL, extemporaneous and kept stored 48 hours at 37°C) were injected onto the HPLC system connected to an ultra-high definition quadrupole time-of-flight mass spectrometer (Xevo QTof, Waters, France).

The mass spectrometer was equipped with electrospray source, operating in positive ion mode,

using

the following operating parameters: capillary voltage: 0.5 kV; sample cone voltage: 20 V; source temperature: 120°C; desolvation temperature: 600°C; cone gas flow: 50L/h; desolvatation gas flow: 1000L/h.



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