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Abstract
Despite the steadily improving medical care situation in pediatrics, some drugs are still not available in a suitable dose or dosage form and thus need to be prepared extemporaneously. Capsules can be easily compounded at the hospital and public pharmacies, offering an alternative to liquid formulations. This study aims at testing a mass-based approach for the extemporaneous preparation of low-dose pediatric capsules and investigating systematically the API loss during this procedure. A total of 54 capsule batches were prepared with baclofen and spironolactone as pediatric-relevant drugs. The hard capsules were prepared using three different bulking agents consisting of either mannitol, lactose-monohydrate and microcrystalline cellulose mixed with 0.5% colloidal silica. Capsules were tested according to Ph. Eur. method “2.9.40 Content Uniformity” as well as for occurring powder loss and mass uniformity. The results reveal that the mass-based approach, in general, allows the preparation of low-dose pediatric capsules of appropriate quality. However, absolute quality is highly dependent on the homogeneity of the powder mixture and the use of defined parameters for capsule preparation.
Highlights
In 1968, Shirkey labelled children as therapeutic orphans [1]
This study aims at testing a mass-based approach for the extemporaneous preparation of low-dose pediatric capsules and investigating systematically the API loss during this procedure
Inspired by the measures undertaken with the Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act (PREA) in the United States, the legislative approach obliges pharmaceutical companies to involve children in the earlier stages of medicine development by the means of a Paediatric Investigation Plan (PIP) [6]
Summary
In 1968, Shirkey labelled children as therapeutic orphans [1]. For the last few decades, this term has still been accurate, mostly owing to a lack of paediatric drugs and limited research conducted on this topic [2,3,4]. The endeavours of the European Union to overcome this problem and the long-time occurring lack of medicines for children resulted in the Paediatric Regulation, enacted in 2006 [5]. The report for the 10th anniversary of the Paediatric Regulation revealed that, from 2007 to 2016, more than 260 new paediatrics had been approved by the European Medicines Agency, underlining the success of the taken measures. Despite those pleasant achievements, the Paediatric Use Marketing Authorization (PUMA) concept, which is included in the same regulation, sadly failed to meet its expectations [8]. Until 2019, only six PUMAs had been granted by the European Medicines Agency (EMA) [11]
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