Details

Autor(en) / Beteiligte

• Gavrus Ion, D
• Bossacoma Busquets, F
• Romo Murillo, MA
• Catala Foguet, JM
• Diaz Cambron, A
• Sánchez Celma, M
• Villaronga Flaqué, M
• Cuartero Lozano, JA
• Vinent Genestar, J
• Farre Riba, R

Titel

5PSQ-094 Use of excipients in oral liquid commercial medicines in a children’s hospital

Ist Teil von

• European journal of hospital pharmacy. Science and practice, 2019-03, Vol.26 (Suppl 1), p.A245-A245

Ort / Verlag

London: BMJ Publishing Group LTD

Erscheinungsjahr

2019

Quelle

Free E-Journal (出版社公開部分のみ）

Beschreibungen/Notizen

• BackgroundOral liquid medicines, such as solutions and suspensions, are commonly given to young children, because they are easy to swallow and allow weight-based dosage. The development of oral medicines for paediatric patients often requires age-appropriate formulations which can be more complex and may involve a broader range of excipients than adult dosage forms.PurposeIdentify excipients having a potential risk of safety concerns in the paediatric population of commercial oral liquid medicines of our hospital formulary.Material and methodsAll oral liquid medicines included in the hospital’s drug formulary were reviewed, using components information from the summary product characteristics obtained from the Spanish Medicament Agency (AEMPS1), and compared with the oral excipients from the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’.2ResultsWe reviewed 96 SPC oral liquid medicines, 16 oral drops and 80 suspensions or solutions, only 12 of which were non-indicated excipients-free.Abstract 5PSQ-094 Table 1 Excipient Percentage (%) Aspartame4Azo colouring agents4Benzoic acid (E210) and benzoates25 Benzyl alcohol3Cyclodextrins1 Ethanol19 Fructose5Glucose6Glycerol (E422)27Gluten2Sulphites including metabisulphites1Sucrose31Soya oil/hydrogenated soya oil3 Sorbitol (E420)21 Propylene glycol (E1520) and esters of propylene glycol25 Phenylalanine1Parahydroxybenzoates and their esters33Mannitol (E421)5Maltitol (E965)3Macrogolglycerol ricinoleate1None13Boldexcipients contraindicated in neonates/children less than 6 years. Italic: contraindicated in patients with metabolic disorders.3ConclusionA high percentage (87%) of liquid medicines in our formulary commonly used to treat children contain potentially harmful excipients. So, specific criteria have to be implemented in the drug procurement process. The use of excipients in paediatric medicines is driven by functional requirements and should be justified through a risk-based assessment, considering, among others, the paediatric age group, frequency of dosing and duration of treatment and excipient concentration. Clinicians should be aware of this in prescribing appropriate treatment in this population. When a commercial medicine contains an excipient that can cause problems in paediatrics, compounding may be an appropriated solution.References and/or acknowledgements1. AEMPS https://www.aemps.gob.es/cima/publico/home.html2. https://www.ema.europa.eu/documents/scientific-guideline/annex-european-commission-guideline-excipients-labelling-package-leaflet-medicinal-products-human_en.pdf3. Breikreutz J, Boos J. Expert Opin Drug Deliv2007;4:37–45.No conflict of interest.