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Dividing the Tablets for Children – Good or Bad?

Article  in  Pharmaceutical Methods · January 2016

DOI: 10.5530/phm.2016.7.4

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Pharm Methods, 2016; 7(1): 23-27 Original Article
A multifaceted peer reviewed journal in the field of Pharm Analysis and Pharmaceutics
www.phmethods.net | www.journalonweb.com/phm

Dividing the Tablets for Children–Good or Bad?

Åsa C Andersson1*, Synnöve Lindemalm1,2, Staffan Eksborg1,3
1
Division of Paediatrics, Karolinska University Hospital, Astrid Lindgrens Children’s Hospital, Stockholm, Sweden, EUROPE.
2
Department of Clinical Sciences, Karolinska Institutet, Intervention and Technology (CLINTEC), Stockholm, Sweden, EUROPE.
3
Department of Women’s and Children’s Health, Karolinska University Hospital and Karolinska Institutet, Stockholm, Sweden, EUROPE.

ABSTRACT
Introduction: To investigate the dosing accuracy using split tablets in available age-appropriate formulations. Extemporaneously prepared formu-
paediatric patients. Methods: Five brands of tablets (Alvedon® (paracetamol), lations should be considered as an alternative to the use of split tablets.
Catapresan® (clonidine), Hydrocortone® (hydrocortisone), Prednisolon®
(prednisolon) and Tavegyl® (clemastine) were split into halves and quarters Key words: Dosing accuracy, Manipulation of drugs, Paediatric patients,
by hand or by using a tablet splitter. The resulting halves and quarters were Subdivision of tablets, Tablet splitting.
weighed. Results: Three out of the five tablet brands passed the test in the
Ph. Eur. (European Pharmacopoeia) for subdivision of tablets when split Correspondence:
once and when split twice to yield quarters only one of the tablets passed Åsa Andersson, Division of Paediatrics, H2:03, Karolinska University
the test. When also applying the limit for relative standard deviation (RSD) Hospital, Astrid Lindgrens Children’s Hospital, 171 76 Stockholm,
from the US Pharmacopoeia only one of the tablet halves passed and the Sweden, EUROPE.
other two was just outside the limit. None of the tablet quarters passed
the RSD limit. Conclusion: Our results indicate that tablets larger than Tel: +46 8 51 77 55 79; Mobile: +46 70 00 28 707
8 mm might be split once. Tablets should not be split more than once, due E-mail: [email protected]
to uncertainty in dose accuracy. There is a need for more commercially DOI : 10.5530/phm.2016.7.4

INTRODUCTION
Medicines for paediatric patients are often prescribed as dose per kilo divided in two equal parts, although that is not always the case.10,11 WHO
bodyweight or per meter square body surface area (BSA). Paediatric amongst others have stated that non-functional breakmarks should be
patients show a large variability in weight and BSA and hence there is avoided.12
a clinical need for a large variation of tablet strengths for proper drug Reasons for splitting tablets other than achieving a smaller dose are
treatment and also liquids or suspensions for oral or rectal use. Tablets to facilitate administration due to ease of swallowing and economical
are a practical solid dosage form with normally long shelf-life and a well reasons, when tablets with high strength cost the same as tablets with low
defined dose. Even in children as young as two years of age, tablets can be strength (mostly common for adults).13
used.1 Small tablets have recently been shown to be preferred by parents The aim of the present study was to investigate the dosing accuracy for
to children as young as 6 months when compared to powder, suspension, paediatric patients by weighing halves and quarters of tablets obtained
and syrup.2,3 Oro-dispersible mini-tablets is a recommended dosage from splitting intact tablets by hand or by the use of a tablet splitter. The
form, either to be administered as they are or to be used for preparation brands of tablets investigated were chosen because they were commonly
of oral liquids.4 split into halves and quarters in clinical practice at Astrid Lindgren
Only a few brands of tablets with strengths suitable for use in children Children’s Hospital (ALB), a large children’s hospital in Stockholm.
are available and consequently split tablets are often used in the clinical
practice to achieve the prescribed dose. In a nationwide study in MATERIALS AND METHODS
Sweden at paediatric hospital wards, approximately 20% of all medication Splitting of the following tablets was studied: Alvedon® (paracetamol)
orders were for tablets and capsules. More than half of them (56%) were GlaxoSmithKline, Consumer Healthcare A/S, Bröndby, Denmark,
prescribed for adolescents, a little more than 30% for children, and even Catapresan® (clonidine) Boehringer Ingelheim, Stockholm, Sweden,
infants and neonates were prescribed tablets or capsules.5 Hydrocortone® (hydrocortisone) MSD, Sollentuna, Sweden, Predniso-
Since 2002 the European Pharmacopoeia (Ph. Eur.) has guidelines how lon® (prednisolon) Pfizer, Sollentuna, Sweden and Tavegyl® (clemastine)
to measure the dosing accuracy of subdivided scored tablets6,7 and since Novartis, Täby, Sweden. All tablets studied had scores and one of them
2010 the European Commission has stated in their Guideline on (Hydrocortone®) had a crossed score. All manufacturers stated that the
Summary of Product Characteristics (SmPC) that for tablets designed active ingredient in their tablets is uniformly distributed. Earlier studies
with a score line, information on whether or not reproducible dividing have shown that weight of a split tablet correlates to drug content, a state-
of the tablets has been shown, according to the rules in Ph. Eur., one of ment we assume is correct.14
the following phrases should be used in the SmPC:8,9 Three of the tablets studied, Alvedon, Prednisolon and Tavegyl, are
• “The score line is only to facilitate breaking for ease of swallowing licensed in Sweden. Catapresan and Hydrocortone are not licensed for
and not to divide into equal doses” use but can be prescribed as unlicensed drugs. Details regarding intact
• “The tablet can be divided into equal halves” tablets are given in (Table 1).
• “The tablet must not be divided at all” The selection of tablets investigated in the present study was based on a
This information is vital to both health professionals and patients, since short survey to ten clinically active paediatric nurses at ALB in Stockholm.
many people believe that a score line is a sign that the tablet can be The nurses stated which tablets they regularly split or even quartered

Pharmaceutical Methods, Vol 7, Issue 1, Jan-Jun, 2016 23

 ANDERSSON et al.: Dividing the Tablets for Children-Good or Bad?

Table 1: Tablet characteristics

Original size (mm)
Trade name Active ingredient Mean weight (g) SD RSD (%) Score/cross
(ø * height)
16.2*7.7*5.8
Alvedon® paracetamol 500 mg 0.548 0.007 1.11 Score
(length*width* height)
Hydrocortone® hydrocortisone 10 mg 0.244 0.003 1.27 10.8*2.7 Cross score
Prednisolon® prednisolon 5 mg 0.178 0.002 0.90 8.0*2.7 Score
Tavegyl® clemastine 1 mg 0.131 0.001 0.93 7.0*2.4 Score
Catapresan® clonidine 75 microg 0.096 0.001 1.08 6.0*2.3 Score
SD = standard deviation.
RSD = relative standard deviation.

Table 2: Results (Tablets are given in increasing size, see Table 1)

Splitting test as per the EUP Adopted splitting
Mean Half or (Total No. of tablets=30) test as per the USP
Trade name Active ingredient
weight (g) quarter No. of tablets No. of tablets Test
Test result RSD%
outside 85-115% outside 75-125% result
Catapresan® clonidine 75 microg 0.096 ½ 5 2 Failed 16.7 Failed
Catapresan ®
clonidine 75 microg - ¼ 9 3 Failed 15.7 Failed
Tavegyl® clemastine 1 mg 0.131 ½ 2 0 Failed 7.3 Failed
Tavegyl ®
clemastine 1 mg - ¼ 1 0 Passed 8.2 Failed
Prednisolon® prednisolon 5 mg 0.178 ½ 0 0 Passed 6.1 Failed
Prednisolon ®
prednisolon 5 mg - ¼ 4 0 Failed 9.3 Failed
Hydrocortone® hydrocortisone 10 mg 0.244 ½ 0 0 Passed 4.7 Passed
Hydrocortone® hydrocortisone 10 mg - ¼ 5 0 Failed 9.4 Failed
Alvedon® paracetamol 500 mg 0.548 ½ 1 0 Passed 6.5 Failed
Alvedon ®
paracetamol 500 mg - ¼ 14 4 Failed 17.4 Failed

Figure 1: Tablet splitter from LGS Corp (USA).

24 Pharmaceutical Methods, Vol 7, Issue 1, Jan-Jun, 2016

 ANDERSSON et al.: Dividing the Tablets for Children-Good or Bad?

Figure 2: Results from splitting tablets

Filled figures=split manually
Non-filled figures=split by the use of a tablet splitter
The European Pharmacopoeia limits for uniformity of mass of subdivided scored tablets are presented with
dotted lines:
........ =85 and 115%
------ =75 and 125%.

to paediatric patients. The tablets chosen also represent a wide variety comparison of the variability of data in two populations.16 The Fisher’s
of sizes. To avoid inter-individual variability the data presented in this exact test was used for the comparison of classified data from two inde-
report are the results of one paediatric pharmacist (ÅA) splitting the pendent populations. Two-tailed p-value less than 0.05 was considered
tablets using a tablet splitter in the pharmacy and using a pair of thumb statistically significant.
forceps when lifting the halves or quarters onto the scale.
All tablets were weighed before splitting. All brands of tablets were split RESULTS
by the use of a tablet splitter (LGS Corp (USA)), (Figure 1). Four of the All intact tablets fulfilled the criteria for uniformity of mass according to
tablet brands were also halved manually. We were not able to split Taveg- Ph. Eur.17 The variability in weight, expressed as relative standard devia-
yl® manually probably due to a combination of size and hardness. The tion (RSD), was very low (0.90-1.27%), (Table 1).
tablet halves split by the tablet splitter were further split into quarters. Due to the design of the tablet splitter oval tablets must be placed in the
All intact tablets as well as all halves and quarters were weighed on a cutter so that the blade would cut along the scoring line. Round tablets
Mettler HK 160 scale (Mettler Instrumente AG, Zürich, Switzerland). can be put in the splitter either way.
The precision measured by controlled standard weights and expressed The variability of weight, expressed as relative standard deviation (RSD)
as relative standard deviation (RSD) at 20 mg, 200 mg, and 500 mg were of the halved tablets was within the range 4.7 to 16.7% RSD with a
0.67, 0.042, and 0.019%, respectively. We applied the European Pharma- tendency to a higher variability for smaller tablets, (Table 2). The variability
copoeia Test for subdivided scored tablets (European Pharmacopoeia of the weight of the tablet halves resulting from splitting by hand were
8.0) which states that thirty tablets are randomly selected from each higher for Catapresan® and Prednisolon® than after splitting by the tab-
batch of the chosen products. These thirty tablets were split and the let splitter (p=0.002 and 0.057, respectively). The accuracy of the tablet
tablets of a certain product were judged to have passed the test if no splitter was independent of whether the tablets were split within or apart
more than one individual mass was outside the range of 85-115% of the from the score (data not shown).
predicted average mass and if no individual mass was outside the range The variability in weight (RSD%) was within the range 8.2 to 17.4% for
of 75-125% of the predicted average mass.7 tablet quarters, (Table 2). The loss of tablet weight caused by splitting was
We also applied the limit for RSD from the United States Pharmacopoeia less than 1.2% for all tablet parts.
(USP), stating that the product passed the test if the RSD is less than 6%.15 After splitting into halves three of the tablet brands fulfilled the criteria
The USP has a somewhat different method for deciding what halves to for subdivision of scored tablets according to the Ph. Eur., Hydrocortone®
weigh and all of the weighed tablet parts must be within the 85-115% (hydrocortisone) and Prednisolon® had no tablet halves outside the
range of the target tablet weight, so in our study we used the criteria in the 85-115% range and Alvedon® (paracetamol) only had one tablet halve
European Ph guideline with the addition of the RSD limit from the USP. outside the 85-115% range. When we also applied the limit of 6% RSD
from the USP, Hydrocortone® still passed the test (4.7%) and Predniso-
Statistics lon® and Alvedon® were just outside the test limit (6.1 and 6.4% respec-
The statistical software used for statistical analysis is Graph PAD Instat tively). One of the tablet brands, Tavegyl® passed the Ph. Eur. guideline,
version 3.10 (LaJolla, CA, USA). The variance ratio test was used for the but did not pass the USP limit for standard deviation (8.2%), (Table 2).

Pharmaceutical Methods, Vol 7, Issue 1, Jan-Jun, 2016 25

 ANDERSSON et al.: Dividing the Tablets for Children-Good or Bad?

Our data demonstrate that splitting of tablets generally results in a very children in different age groups can take one or several small tablets.23
low dosing accuracy, (Figure 2), most pronounced for the tablet quarters. Mini-tablets are a valuable, or in some cases even superior, alternative to
syrup in children as young as six months.3
DISCUSSION From an earlier Swedish study we know that tablets and capsules are a
The results in the present study confirm previous findings that tablets common dosage form for paediatric patients. Approximately 20% of all
split more than once generally fail to meet expectations for uniformity medication orders were oral solid dosage forms. Unfortunately we do not
of weight. We do not recommend the general practice of splitting tablets have any information/numbers regarding how many of these medication
more than once for paediatric use. The fact that the dose administered orders that needed some drug manipulation to enable administration.5
may differ from the one prescribed when using subdivided tablets, must The use of a tablet splitter is, in our experience, an advantage, since
be taken into account when evaluating the effect of drug therapy. splitting by hand results in a higher, albeit not statistically significant,
Paediatric patients are at a higher risk of medication errors since a high percentage of accepted parts, also found by24 but not by.19
proportion of paediatric drug orders are off-label5 and alteration of avail- The European Pharmacopoeia 7.0 section 2.9.5 Uniformity of mass of
able dosage forms is often required.18 Uncertainty in dose administered, single-dose preparations is stricter than the Ph. Eur. test for subdivision
enhances the possible uncertainty from off-label prescribing, and must of scored tablets.17 It could be argued that when a tablet is split to give
be considered when evaluating drug therapy in paediatric patients. The a smaller dose the tablet half represents a new dosage form and there-
use of subdivision of tablets in paediatric drug treatment to ensure lower fore the stricter guideline should be applied, but since there are rules for
dosing is often necessary due to the fact that only a few brands of tab- subdivided tablets we applied them in this study. If we had applied the
lets with strengths suitable for use in children are available. It might be stricter rules only Hydrocortone would have fulfilled the criteria. It is
harder to swallow a broken tablet both because it normally has sharp also important to remember that the conditions in this study with one
ends and there is also a possible exposure of bitter taste not masked by pharmacist splitting the tablets and lifting the halves and quarters with
a coating. In our study we found that larger tablets split more correctly a thumb forceps, were optimized and probably giving better results than
than the smaller tablets. The results from our study also indicates that reality.
splitting can be made once if the tablet is larger than 8 mm in diameter/ Extemporaneously prepared formulations for paediatric use may have
length to achieve halves, but splitting twice to get quarter of tablets advantages over the use of split tablets. There is, however, still a lack
results in too high an uncertainty in dose administered. This finding is of information regarding the pharmacokinetics and bioequivalence of
supported in earlier studies.19,20 extemporaneous products, reformulated from the original products or
Only splitting of scored tablets were investigated in the present study. compounded from active substances.
The splitting of our tablets caused an almost negligible loss of weight Splitting tablets may also result in altered pharmacokinetics, since the
(less than 1.2%). surface of the tablet in relation to its weight becomes larger and it may
Approximately half of all tablets licensed for use in Sweden are made dissolve more rapidly further promoted by a not intact coating.
with a score or a crossed score21 and this may falsely lead the nurse and/
or patient/parent to believe that they are designed to be split safely and CONCLUSION
accurately.22 It has to be noticed that also tablets containing antibiotic, Our results indicate that tablets larger than 8 mm could be split once to
anti-neoplastic or antiviral substances in some cases are scored. Such achieve an approximate half dose for paediatric use. We do not recom-
tablets must not be split to avoid exposure of harmful compounds. mend tablets to be split more than once since the resulting parts deviate
Despite the fact that these tablets are scored their summary of product too much to fulfil the Ph. Eur. test for weight uniformity of tablet parts
characteristics clearly states that they should not be split or crushed.21 after splitting.
At least two anti-neoplastic drugs licensed for use in Sweden have a score Since paediatric patients are at higher risk for medication errors due
line, Puri-Nethol (mercaptopurine) 50 mg, and Metotrexathe Teva 2.5 to a number of reasons there is a great need for more age-appropriate
mg. Even slow release tablets can be found with a score and with contra­ dosage forms including small tablets which enables safe administration
dictory information in the SmPC, where the information in one section of medicines to children.
states that the tablet can be split, generating two equal parts and in
We also agree totally with WHO that non-functional score lines should be
another section it is stated that the tablet must not be chewed, crushed
avoided since most patients and health professionals falsely believe that a
or otherwise modified.21
score line indicates the possibility to divide the tablet in two equal parts.
In the Guideline on Summary of Product Characteristics (SmPC) it is
clearly stated that for scored tablets the SmPC must contain information ACKNOWLEDGEMENTS
regarding whether reproducible splitting of the tablet has been shown
or not.8 Financial support was provided through the regional agreement on
medical training and clinical research (ALF), project 20130324, between
Studies, including this, have shown that it is more difficult to split smaller
Stockholm County Council and Karolinska Institutet for all authors.
sized tablets and our results are in line with earlier findings stating that
scored tablets should be at least 8 mm in diameter to be easier to handle.13 CONFLICT OF INTEREST
In the Guideline on Pharmaceutical Development of Medicines for
Paediatric Use, it is stated that “the tablet size is fundamental to the ability The author declare no conflict of interst.
of a child to swallow a tablet”.23 Different sizes of tablets are considered
acceptable for different age groups, although there are inter-individual ABBREVIATIONS USED
differences in ability to swallow tablets of course, and also different Ph. Eur: European Pharmacopoeia, RSD: Relative Standard Deviation,
illnesses and/or conditions may interfere with the ability to swallow USP: United States Pharmacopoeia, BSA: Body Surface Area, SmPC:
solid dosage forms. To improve dosing accuracy and administration of Summary of Product Characteristics, WHO: World Health Organiza-
medicines to children the production and use of oro-dispersible mini- tion, ALB: Astrid Lindgren Children´s Hospital (“Barnsjukhus” in
tablets should be encouraged. Mini-tablets enable varied dosing because Swedish).

26 Pharmaceutical Methods, Vol 7, Issue 1, Jan-Jun, 2016

 ANDERSSON et al.: Dividing the Tablets for Children-Good or Bad?

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PICTORIAL ABSTRACT SUMMARY

•  Tablets larger than 8 mm could be split once to achieve an approximate half
dose for paediatric use.
•  There is a great need for more age-appropriate dosage forms including
small tablets which enables safe administration of medicines to children.
•  Non-functional score lines should be avoided since they falsely lead people
to believe that the tablet can be divided in two equal parts.

ABOUT AUTHORS
Åsa Andersson: Is a registered paediatric pharmacist working at Astrid Lindgren Children’s Hospital, Stockholm,
Sweden. She has a special interest in studying what happens when medicines for children are being manipulated and
how safe this behavior is in the paediatric population.

Synnöve Lindemalm: Is a Senior Consultant at Astrid Lindgren Children’s Hospital at Karolinska University Hospital
in Stockholm Sweden. She is a paediatrician and a clinical pharmacologist. She is an associate professor at Karolinska
Institute. Dr Lindemalm has her main interest in the area of patient safety and improving dosing in paediatrics.

Staffan Eksborg: Is a Senior Professor of paediatric pharmacokinetics at Karolinska Institutet and also an Adjunct
Professor of Paediatric Clinical Pharmacy at the Uppsala University. Professor Eksborg is working on various aspects of
optimisation of drug treatment of paediatric patients, including paediatric cancer patients. He is supervising a number
of PhD students, within clinical pharmacy as well as within paediatric intensive care and ECMO.

Pharmaceutical Methods, Vol 7, Issue 1, Jan-Jun, 2016 27

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