Development and characterization of a hydrocortisone gummy formulation for the treatment of corticotropic insufficiency in pediatric congenital adrenal hyperplasia

Chewable gels, also known as gummies, represent an emerging monolithic semi-solid oral dosage form, suitable for pediatric use due to their soft texture, ease of administration, and the possibility to optimize palatability. The aim of this study was to develop a gelatin-based gummy formulation containing 2 mg of hydrocortisone for use in the chronic treatment of congenital adrenal hyperplasia.
Gummies were obtained through a heat–molding–cooling process in blister molds and subsequently characterized. Mechanical properties by texture profile analysis, disintegration time, physical stability by mass-loss monitoring at room temperature, mass and content uniformity, and palatability in a group of healthy 15 adult volunteers were evaluated.
A robust formulation process, compatible with future adaptation in hospital pharmacy settings, was established. Preformulation studies defined suitable excipient ranges for the development of eight optimized formulations. A liquid chromatographic method with UV detection was developed and validated. Content uniformity met the acceptance criteria of 90–110%, with a mean dose of 1.96 mg. The measured pH was compatible with active substance stability. All eight formulations (F1–F8) exhibited disintegration times below 15 minutes. Texture profile analysis allowed the selection of three formulations (F2, F4, F7) with properties comparable to a commercial dietary supplement reference. Physical stability at room temperature was confirmed by < 5% unit mass loss and the absence of structural alteration after 42 days. A palatability study conducted on formulation F4 demonstrated overall satisfactory acceptability, particularly with red berry flavoring.
These results confirm the feasibility of preparing pediatric hydrocortisone gummies in hospital pharmacy practice and suggest potential transposability to other active pharmaceutical ingredients. Gummies represent an innovative approach that may improve adherence to chronic treatments in some patients and support their development in hospital pharmacies.