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UCL SCHOOL OF PHARMACY BRUNSWICK SQUARE Liquid dosage form (e.g. Solutions, suspensions) Oral administration devices: Example :Measuring spoons, measuring cups, droppers, oral syringes Oral syringes are better than other devices but… Paediatrics Image source:
Citation preview
Accuracy of enteral syringes for liquid
medicines prescribed in
childrenKaruna Gurung, UCL School of Pharmacy
UCL SCHOOL OF PHARMACYBRUNSWICK SQUARE
Accuracy of enteral syringes for liquid medicines prescribed in children
Arenas-Lopez S, Gurung K , Wei Li , Tibby S, Tuleu C
UCL SCHOOL OF PHARMACYBRUNSWICK SQUARE
Liquid dosage form (e.g. Solutions, suspensions)
Oral administration devices: Example :Measuring spoons, measuring cups, droppers,
oral syringes
Oral syringes are better than other devices but…
Paediatrics
Image source: www.rxlist.com/onfi-drug
UCL SCHOOL OF PHARMACYBRUNSWICK SQUARE
Aims
A. To compare the dosing accuracy of oral syringes from different brands :
Baxa and Medicina Of different syringe sizes for each brands At different volumes size for each brands and each
sizes
B. To investigate the influence of physical characteristics of oral liquid drugs on the accuracy of oral syringes
UCL SCHOOL OF PHARMACYBRUNSWICK SQUARE
Materials & Methods
Aqueous
1) Calcium Carbonate BP suspension
2) Amoxicillin 125mg/5ml suspension
3) Peppermint water BP 1974
4)Nifedipine oral drops
Lipidic
9)Neoral oral solution
(ciclosporin)
10) Ciproxin (Ciprofloxacin)
suspension
Hydro-alcoholic
5) Lanoxin PG elixir (Digoxin)
6)Sytron elixir
7) One-alpha (alfacalcidol)
8) Epanutin(phenytoin) suspension
Liquid drugs were chosen according to their foreseeable differences in characteristics
Water = control
UCL SCHOOL OF PHARMACYBRUNSWICK SQUARE
Characterisation of Liquids
ViscosityAt shear rate of
100 s-1Rotational rheometer
(Gemini HR nano by Malvern)
DensityDensity=
mass/volume
Measuring cylinders/
Balance (Precisa 180A balance)
Surface Tension
Tensiometer (Delta-8
multichannel microtensiometer
by Kibron Inc.)
Conductivity
Conductivity meter (Primo 5
Hanna ®)
pHpH
pH meter (pH 209 Hanna®)
n=3
UCL SCHOOL OF PHARMACYBRUNSWICK SQUARE
Oral syringes’ brands and sizesBAXA
MEDICINA
1ml 2.5ml 5ml
5ml3ml1ml
widerTips
taperedTips
1ml 2.5ml 5ml
1ml 3ml 5ml
0.01ml 0.1ml 0.2ml
Oral Syringe sizes – smallest graduations
UCL SCHOOL OF PHARMACYBRUNSWICK SQUARE
6 Drugs : Lanoxin, Amoxicillin, Ciproxin, Peppermint water, Calcium Carbonate BP, Sytron
5 Drugs: Amoxicillin, Ciproxin, Peppermint water, Calcium Carbonate BP, Sytron
1ml Syringes
2.5ml/3ml syringes
5ml syringes
All 10 liquid drugs
Drugs used
Water = control
UCL SCHOOL OF PHARMACYBRUNSWICK SQUARE
Volume Measured
0.05ml 0.1ml 0.25ml 0.5ml 1ml
0.1ml 0.25ml 0.5ml 1ml 2ml
0.2ml 0.5ml 1ml 2ml 3ml 5ml
1ml Syringe
2.5ml/3ml syringe
5ml syringe
• 10 measurements were carried out with each volume of liquid
n=10New syringe at each measurement
UCL SCHOOL OF PHARMACYBRUNSWICK SQUARE
(measured) density d=m/V
Volume
mean +/- Standard deviation n= 10
Data analysed by ANCOVA (Stata)Significance: 0.05
Dead spacevolume
Dose volume
weight
Method
UCL SCHOOL OF PHARMACYBRUNSWICK SQUARE
Irrespective of syringe size, volume and liquid delivered, the dead space was fairly constant
• Baxa [0.07+/-0.05ml] • Medicina (wider tip) [0.13+/-0.08ml]
• However for the accuracy of volumes, all 2- and 3-way interactions (brand ± syringe size ± drug volume) were examined and all were very significant
Results
UCL SCHOOL OF PHARMACYBRUNSWICK SQUARE
Baseline model : brand, syringe size and drug volume
M
UCL SCHOOL OF PHARMACYBRUNSWICK SQUARE
Comparison between brands: 1ml syringe
INCREASING VISCOSITY
UCL SCHOOL OF PHARMACYBRUNSWICK SQUARE
Comparison between brands: 2.5ml/3ml syringe
UCL SCHOOL OF PHARMACYBRUNSWICK SQUARE
Comparison between brands: 5ml syringe
UCL SCHOOL OF PHARMACYBRUNSWICK SQUARE
Surface Tension
Viscosity
B
UCL SCHOOL OF PHARMACYBRUNSWICK SQUARE
• Dosing accuracy with enteral syringes commonly found in the HealthCare systems was heterogenous for different brands, sizes and liquid characteristics especially for small volumes (0.25ml and less) which are not uncommon doses in paediatrics
• To improve medication safety in paediatrics, carers should choose the right syringe size for the dose (for small volumes <0.5ml use 1ml size syringes or less if available)
• Manufacturers need to include as part of the pharmaceutical development plan the validation of the syringes to use with their products specially if dosing volumes are envisaged to be <0.5ml
Conclusion
0.5ml
UCL SCHOOL OF PHARMACYBRUNSWICK SQUARE
Future work
• Clinical significance of these variabilities?- Including possibility of rounding the dose volumes to
the next accurate volume (if the Therapeutic index of the drugs permits)
• What is the accuracy of devices supplied as part of the packaging of licensed products? Are they any better?– Neoral (1 and 4ml syringes)
UCL SCHOOL OF PHARMACYBRUNSWICK SQUARE
Thank you for listening
Any questions?
AcknowledgementsThe Evelina London Paediatric Pharmacy Team for their kind donations of Oral Liquid Medicines
UCL SCHOOL OF PHARMACYBRUNSWICK SQUARE
UCL SCHOOL OF PHARMACYBRUNSWICK SQUARE
Model Simulation 1 ml syringes
UCL SCHOOL OF PHARMACYBRUNSWICK SQUARE
2.5ml/3ml syringe
0.2ml 0.5ml 1ml 2ml 3ml 5ml
0.05ml 0.1ml 0.25ml 0.5ml 1ml
0.1ml 0.25ml 0.5ml 1ml 2ml
1ml Syringe
5ml syringe
Volume measurements
UCL SCHOOL OF PHARMACYBRUNSWICK SQUARE Comparison between sizes
MEDICINA
UCL SCHOOL OF PHARMACYBRUNSWICK SQUARE
Comparison between sizes: 1ml and 2.5ml/3ml syringe size
UCL SCHOOL OF PHARMACYBRUNSWICK SQUARE
Comparison between brands: 1ml syringe
UCL SCHOOL OF PHARMACYBRUNSWICK SQUARE
Comparison between brands: 1ml syringe
UCL SCHOOL OF PHARMACYBRUNSWICK SQUAREComparison between brands: 2.5ml/3ml syringe
UCL SCHOOL OF PHARMACYBRUNSWICK SQUAREComparison between brands: 2.5ml/3ml syringe
UCL SCHOOL OF PHARMACYBRUNSWICK SQUARE
Comparison between brands: 5ml syringe
UCL SCHOOL OF PHARMACYBRUNSWICK SQUARE
Comparison between brands: 5ml syringe
UCL SCHOOL OF PHARMACYBRUNSWICK SQUARE
1ml Syringe Volume measured Medicina Baxa
0.05ml ✖ ✖0.1ml ✖ ✖0.25ml ✖ ✔0.5ml ✔ ✔1ml ✔ ✔
2.5ml/3ml syringe
5ml syringe
Volume measured Medicina Baxa
0.1ml ✖ ✖0.25ml ✖ ✖0.5ml ✔ *Except Ciproxin ✔1ml ✔ ✔2ml ✔ ✔
Volume measured Medicina Baxa
0.2ml ✖ ✖
0.5ml ✔ ✖
1ml ✔ ✔
2ml ✔ ✔
3ml ✔ ✔
5ml ✔ ✔