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Homogeneity and Stability in Drinking Water of Oral Nonsteroidal Anti-Inflammatory Drugs Labelled for Swine in Europe­

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Homogeneity and Stability in Drinking Water of Oral Nonsteroidal Anti-Inflammatory Drugs Labelled for Swine in Europe­ Original research Peer reviewed Homogeneity and stability in drinking water of oral nonsteroidal anti-inflammatory drugs labelled for swine in Europe Irene Mayós, PhD; Jaume Bosch, DVM; Emili Fadurdo, BS; Josep Homedes, DVM, P hD Summary at three standard depths in the tank (high, Implications: When NSAIDs in drinking- Objectives: To verify the stability and homo- medium, and low) at 5 minutes, 12 hours, water tanks are used to treat farm animals, geneity in drinking water of five nonsteroidal and 24 hours post mixing. variability in dose may occur if the water is not adequately stirred after product addi- anti-inflammatory drugs (NSAIDs) labeled Results: No time-related statistically tion. Lack of homogeneity may produce for pigs in Europe, including oral solutions of significant differences were observed in overdose or underdose, thereby increasing ketoprofen (300 mg per mL) and paracetamol active-principle concentrations. However, the risk of adverse events and violative (200 mg per mL) and soluble powders of significant differences were detected at dif- residues in the carcasses or the possibility of sodium salicylate 100%, paracetamol (200 mg ferent sampling depths for sodium salicylate lack of efficacy, respectively. This situation is per g), and acetylsalicylic acid 100%, under and paracetamol powder and solution. Some more evident when the added product is a field conditions. variability was observed for acetylsalicylic soluble powder rather than a solution. Materials and methods: A solution of each acid, but differences were not statistically product was prepared according to label significant. Concentrations obtained at Keywords: swine, ketoprofen, paracetamol, instructions in a 300-L farm tank, without all time points and sampling depths for salicylic acid, drinking water treatment ketoprofen approached calculated values, stirring. Active ingredient concentrations Received: January 12, 2012 indicating better homogeneity and stability were determined by high-performance liquid Accepted: May 29. 2012 chromatography on three samples collected in drinking water. Resumen - Homogeneidad y estabilidad de instrucciones de la etiqueta. Se determinó la traciones obtenidas en todos los tiempos y medicamentos antiinflamatorios no estero- concentración de ingrediente activo a través profundidades para ketoprofen se aproxima- idales orales en el agua de bebida autoriza- de la cromatografía líquida de alta resolución ron a los valores calculados, indicando una dos para cerdos en Europa en tres muestras recolectadas a tres profun- mejor homogeneidad y estabilidad en el agua didades estándares (alta, media, y baja) en el de bebida. Objetivos: Verificar, bajo condiciones de tanque a los 5 minutos, 12 horas, y 24 horas campo, la estabilidad y homogeneidad en el Implicaciones: Cuando los NSAIDs se post mezcla. agua de bebida de cinco medicamentos anti- utilizan para tratar animales de granja en inflamatorios no esteroidales (NSAIDs por Resultados: No se observaron diferencias los tanques de agua de bebida puede haber sus siglas en inglés) autorizados para cerdos estadísticamente significativas en las concen- variabilidad en la dosis si el agua no se agita en Europa, incluyendo soluciones orales de traciones de principio activo con relación adecuadamente después de la adición del ketoprofen (300 mg por mL) y paracetamol al tiempo de muestreo. Sin embargo, se producto. La falta de homogeneidad puede (200 mg por mL) y polvo soluble de silicato detectaron diferencias significativas a dife- producir una sobredosis o una dosis inferior, de sodio 100%, paracetamol (200 mg por g), rentes profundidades en las muestras de incrementando así el riesgo de reacciones y ácido acetilsalicílico 100%. solución y polvo de paracetamol y silicato de adversas y la presencia de residuos no per- sodio. Se observó variabilidad para el ácido mitidos en la canal o la posibilidad de falta Materiales y métodos: En un tanque de acetilsalicílico, pero las diferencias no fueron de eficacia, respectivamente. Esta situación granja de 300 L, se preparó sin agitar una estadísticamente significativas. Las concen- es más evidente cuando el producto se agrega solución de cada producto de acuerdo a las como polvo soluble y no en solución. IM, JH: Esteve Veterinaria, Laboratorios Dr Esteve SA, Barcelona, Spain. Résumé - Homogénéité et stabilité dans JB: Clinobs SL (Estudis Clínics Veterinaris), Banyoles (Girona), Spain. l’eau de boisson de médicaments anti- EF: Laboratorio de Diagnóstico General, Barcelona, Spain. inflammatoires non-stéroïdiens homo- Corresponding author: Dr Josep Homedes, Esteve Veterinaria, Laboratorios Dr Esteve SA, Avda logués pour les porcs en Europe Mare de Déu de Montserrat, 221, 08041 Barcelona, Spain; Tel: + 34 93 4466318; Fax: + 34 93 446 Objectifs: Vérifier, dans des conditions de 6201: E-mail: [email protected]. champs, la stabilité et l’homogénéité dans This article is available online at http://www.aasv.org/shap.html. l’eau de boisson de cinq médicaments anti- Mayós I, Bosch J, Fadurdo E, et al. Homogeneity and stability in drinking water of oral nonsteroidal inflammatoires non-stéroïdiens (AINS) anti-inflammatory drugs labelled for swine in Europe. J Swine Health Prod. 2012;20(6):270–275. homologués pour les porcs en Europe, 270 Journal of Swine Health and Production — November and December 2012 incluant des solutions orales de ketoprofène Résultats: Aucune différence statistique- Implications: Lorsque des AINS préparés (300 mg/mL) et de paracetamol (200 mg/ ment significative associée au temps n’a dans des réservoirs d’eau de boisson sont mL) et des poudres solubles de salicylate de été observée dans les concentrations des utilisés pour traiter des animaux de ferme, sodium 100%, de paracetamol (200mg/g) et principes actifs. Toutefois, des différences une variabilité dans la dose peut survenir d’acide acétylsalicilique 100%. significatives furent détectées dans les échan- si l’eau n’est pas brassée adéquatement tillons prélevés à des profondeurs différentes après l’ajout du médicament. Un manque Matériels et méthodes: Une solution de pour le salicylate de sodium et la poudre et d’homogénéité peut entraîner une surdose chaque produit a été préparée dans un réser- la solution de paracetamol. Une certaine ou une sous-dose, augmentant ainsi le risque, voir de ferme de 300 L selon les instructions variabilité fut également observée pour respectivement, de réactions adverses et sur l’étiquette, sans agitation. Les concentra- l’acide acétylsalicylique, mais les différences d’infractions pour résidus dans les carcasses tions d’ingrédient actif ont été déterminées n’étaient pas statistiquement significatives. ou la possibilité d’un manque d’efficacité. par chromatographie liquide à haute per- Les concentrations obtenues à tous les temps Cette situation est plus évidente lorsque le formance sur trois échantillons prélevés à et profondeurs d’échantillonnage pour le produit ajouté est une poudre soluble plutôt trois profondeurs standards dans le réservoir ketoprofène s’approchaient des valeurs cal- qu’une solution. (haute, moyenne, et basse) à des temps de culées, indiquant une meilleure homogénéité 5 minutes, 12 heures, et 24 heures suite à la et stabilité dans l’eau de boisson. préparation du mélange. rugs are often administered in administration route of drugs from both hours post mixing. All medicated water drinking water to treat large groups a pharmacokinetic and residue viewpoint, samples were frozen at -25°C ± 5.0°C until of various livestock species under which could lead to errors in withdrawal submitted to the analytical laboratory, suit- Dintensive farming conditions. This route of times. Dorr et al5 reported the influence of ably packaged in dry ice, for determination administration is less labor intensive and water flow when tetracycline hydrochloride of active-ingredient concentrations. less stressful for the animals than individual is administered by this route in pig farms, Firstly, in order to facilitate its dissolu- administration by the parenteral route, and its subsequent therapeutic effect. tion and following normal field practice, a which would also prove unfeasible in com- Toutain and Lees2 and Santos et al6 also predilution of each product was prepared mercial poultry facilities1 and many swine related the variability of this administration by adding the total dose to be administered finishing farms. However, when products route to the possible onset of resistance (in a final water volume of 300 L) to 10 L are administered in drinking water, the dose if antibiotic underdose were to occur. In of water in a plastic bucket. This predilution ingested by each animal may vary because addition to these factors, other sources of was poured directly into a previously cali- of differences in individual drinking pat- variability relate to use of dirty tanks and the 2 brated polyester and fiberglass tank (diam- terns. In addition, if the concentration of addition of pH-modifying substances.7 the active ingredient fails to be homogenous eter 65 cm, height 100 cm) filled with water at all times, both in the water tank and in Considering the risks described by these to 300 L. Neither predilutions nor final solu- the drinking troughs it supplies, individual authors in connection with orally adminis- tions were stirred after preparation during overdosing or underdosing can easily occur, tered products, this study attempts to verify, the entire experiment. The doses tested for depending on distance of troughs from the under field conditions,
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