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A new reconstitutable oral paediatric hydrocortisone solution containing hydroxypropyl-β-cyclodextrin.

Mine Orlu-Gul¹, Giacomo Fisco, Dipesh Parmar

¹UCL School of Pharmacy, Department of Pharmaceutics & Centre for Paediatric Pharmacy Research, London, UK. mine.orlu.gul@pharmacy.ac.uk

Drug Development and Industrial Pharmacy

|June 26, 2012

Summary

This summary is machine-generated.

A new taste-masked hydrocortisone (HC) oral solution for pediatric use was developed. This reconstitutable formulation improves palatability and stability, enhancing medication adherence and accessibility for children.

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Area of Science:

Pharmaceutical Sciences
Paediatric Medicine
Drug Formulation

Background:

Hydrocortisone (HC) is frequently used off-label in pediatric practice despite poor palatability and low aqueous solubility.
Extemporaneous preparation of pediatric HC formulations presents challenges in taste masking and solubility.

Purpose of the Study:

To develop a reconstitutable, taste-masked hydrocortisone oral solution suitable for extemporaneous preparation in pediatric practice.
To ensure chemical and microbiological stability of the reconstituted solution for a defined period.

Main Methods:

Selection of excipients based on solubility, safety, compatibility, and stability at optimal pH for HC.
Formulation development involving taste masking with Neotame, flavoring, preservation, and complexation with hydroxypropyl-β-cyclodextrin (HP-β-CyD).
Assessment of visual appearance, pH, chemical stability (HPLC), microbiological quality (European Pharmacopeia tests), and taste acceptability in adults.

Main Results:

A 5 mg/mL reconstituted oral palatable pediatric HC solution was successfully developed.
Neotame (0.075%) was identified as the optimal sweetener for masking HC's taste.
The reconstituted solution demonstrated chemical stability with >95% HC recovery for 1 month.
The preservative system ensured microbiological quality after reconstitution with repetitive sampling.

Conclusions:

The developed taste-masked hydrocortisone oral solution is stable for 1 month post-reconstitution.
This formulation has the potential to improve dosing, acceptability, availability, and affordability of hydrocortisone in pediatric care.