Comparative study of the administration of capsules, oral suspension and 3D prints of amiodarone by nursing staff in a neonatal unit.

S. Cailleaux1, S. Roulon3,M. Warembourg1, F. Maillard1, J. Alié3 I. Soulairol1,2
1 Pharmacie, Centre Hospitalier Universitaire de Nîmes, Nîmes, France
2 ICGM, Université de Montpellier, CNRS, ENSCM, Montpellier, France
3 Sanofi R&D, Service de caractérisation de l’état solide et impression 3D, Montpellier, France

Context and Objective
Administration of drugs to children is still today a problem for which Hospital Pharmacies (HP) respond with the manufacture of pharmaceutical preparations such as capsules (Ca) or liquid forms. 3D printing is a technology that could take a place in the production tools for dry oral forms of HPs to address this issue. The objective of the present study is (i) to evaluate the use of oral 3D prints of amiodarone (3Dp) produced in an HP neonatal unit (NNU), (ii) to compare them with 2 other classical Pharmaceutical Forms (PF).

Methods
Within a HP, 3 doses of 3Dp (25, 140 and 200 mg), 5 doses of Ca (5, 20, 70 and 100 mg) and a Drinkable Suspension (DS) (C = 50 mg / ml) of amiodarone have been manufactured. All the batches produced complied with the Pharm. Eur. requirements. The simulation of the administration of three doses of amiodarone (25, 140 and 200 mg) with the 3 PFs was carried out by 3 nurses of the NNU’s department. Doses were prepared in service according to an established protocol. For Ca, the combination of several Ca with the appropriate dosages was carried out to obtain the desired dose. The contents of the Ca were placed in a mini-bottle with either 5 ml (25 mg, 140 mg) or 10 ml (200 mg) of water and then withdrawn into a 20 ml Oral Syringe (OS). The prints were directly introduced into a 20 ml OS then 5 or 10 ml of water were taken depending on the dose. Finally, a volume of DS corresponding to the desired dose was taken from a 5 ml OS suitable for packaging the DS. The prepared OSs were sent to the HP’s control laboratory to be assayed within 3 hours of their preparation. Each manipulator performed 3 manipulations for each form and each dose.

Results
The main result observed is the difference between the target dose and the prepared dose (ED). The means of ED observed are respectively for Ca, 3Dp and DS for 25 mg: - 23.3, -18.0 and -1.82%; for 140 mg: -22.69, -2.0, -0.1%; for 200 mg: -16.7, -0.7, -0.6%. The average times observed to prepare the doses are respectively for Ca, 3Dp and DS for 25mg: 161, 260, 42 s; for 140 mg 216, 311 and 40 s; for 200 mg 253, 377 and 40 s.

Discussion / conclusion
The results obtained for the 25 mg dose could be explained by a phenomenon of absorption of amiodarone on the OS, absent with the oral suspension which is ten times more concentrated. For doses at 140 and 200 mg, the ED observed for 3Dp and DS are very low, unlike those of Ca for which manipulation generates a loss of content. Furthermore, an improvement of the disintegration time of 3Dp would be necessary. In conclusion, the 3Dps present the advantages of a single-dose dry oral form while ensure the precision of administration of a DS.

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