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Accuracy and Stability of Enteral Paediatric Nifedipine Doses. Roshni Kankali Dr Daniel Kirby Astrid Gerrard. What We Already Know. Lack of suitable paediatric dosage formulations Manipulation of solid and liquid dosage forms – unlicensed use
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Accuracy and Stability of Enteral Paediatric Nifedipine Doses RoshniKankali Dr Daniel Kirby Astrid Gerrard
What We Already Know • Lack of suitable paediatric dosage formulations • Manipulation of solid and liquid dosage forms – unlicensed use • Nifedipine susceptible to photodegradation and hydrolysis • Variation in clinical response to administered doses
Aim To determine the reproducibility and accuracy of methods used by nursing staff to prepare fractional doses of enteral nifedipine in liquid form in clinical practice and make recommendations to standardise this procedure.
Even simple manipulation leads to significant variation in dose.
Tablet and liquid suspensions destabilise to less than 90% of intended concentration within 30-40 minutes.
Tablet Manipulation Split 10mg tablet in half (guillotine tablet splitter) Crush 10mg tablet (screw top tablet crusher)
5 mg dose Dispersion of halved tablet in syringe (technique 2) achieved reproducible results with 93-95% of intended dose for 5 mg and 1 mg doses but marked overdoses for 0.5 mg doses (143 – 144%) 1 mg dose 0.5 mg dose
Drop Manipulation Measure required nifedipine liquid using oral syringe Instil required number of nifedipine drops
5 mg dose No single technique currently used by nursing staff achieved accurate reproducible results for all doses. 1 mg dose 0.5 mg dose
Limitations • Small project • Single operator • Laboratory-based
Conclusions • Wide variation of intended doses ? Impact on clinical outcomes • Need child-friendly formulations • Review drug choice – round doses • Standardise manipulation methods ? monographs