Purpose

The objective of the present work was to screen whether a novel pediatric hydrocortisone granule formulation can be co-administered with common food matrices and liquids.

Methods

Pediatric hydrocortisone granules were studied using a biopredictive in vitro approach. Experiments included an in situ chemical compatibility study of active ingredient and drug product with liquid dosing vehicles and soft foods commonly ingested by infants, pre-school- and school children. Drug solubility and stability experiments in the different vehicle types and, drug release/dissolution experiments mimicking age-related pediatric gastric conditions after administering the hydrocortisone granules together with the dosing vehicles and after different exposure/mixing times were performed.

Results

In the simulated dosing scenarios applied in dissolution experiments, in vitro dissolution in gastric conditions was rapid and complete. Results of the chemical compatibility/stability studies indicated that mixing with the different dosing vehicles studied should not be an issue regarding drug degradation products.

Conclusions

A novel in vitro approach ensuring a proper risk assessment of the use of dosing vehicles in the administration of pediatric dosage forms was established and applied to a novel pediatric hydrocortisone drug product. The studied dosing vehicles were shown to not alter performance of the drug product and are thus considered suitable for administration with hydrocortisone granules.

中文翻译：

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评估新型儿科氢化可的松药物产品在普通儿科给药工具中的相容性的生物体外预测方法。

目的

本研究的目的是筛选一种新型的儿科氢化可的松颗粒制剂是否可以与常见的食物基质和液体一起服用。

方法

使用生物预测性体外方法研究了小儿氢化可的松颗粒。实验包括活性成分和药物与婴儿，学龄前和学龄儿童通常摄入的液体计量载体和软食品的原位化学相容性研究。在将氢化可的松颗粒与给药媒介物一起给药之后以及在不同的暴露/混合时间之后，进行了在不同媒介物类型中的药物溶解度和稳定性实验，以及模拟与年龄相关的小儿胃病的药物释放/溶解实验。

结果

在用于溶出度试验的模拟给药方案中，在胃部条件下的体外溶出迅速而完整。化学相容性/稳定性研究的结果表明，与研究的不同剂量载体混合不应成为药物降解产物的问题。

结论

建立了一种新型的体外方法，该方法可确保对儿科剂型给药中使用赋形剂进行适当的风险评估，并将其应用于新型的儿科氢化可的松药物产品。已显示所研究的给药媒介物不会改变药物产品的性能，因此被认为适合与氢化可的松颗粒一起给药。