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Development of Hydrocortisone Mini-Tablets for Improved Paediatric Dosing

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Hydrocortisone, a steroid prescribed for replacement therapy in children with congenital adrenal hyperplasia, is commonly recommended in 3-4 doses of ≤2.5mg to meet the total daily requirement. To achieve the appropriate dose for pediatric patients, Hydrocortisone 10mg tablets are typically quartered. Previous research has exposed the inaccuracy associated with dosing through this method, underscoring the necessity for suitable pediatric formulations of hydrocortisone. Minitablets are compact dosage forms, typically 2-3mm in diameter, produced using traditional tableting methods such as direct compression or wet granulation on ordinary tablet machines. They allow for the production of defined sizes and strengths with minimal batch variability, and their small size aids in overcoming issues related to dysphagia. Recent studies have indicated that minitablets are a suitable dosage form for children aged between 2-6 years. Traditionally, compaction simulators have been operated in single-ended compaction mode, lacking realism in representing tablet production on a rotary tablet press. The Stylcam® 100 R, however, is a high-precision, single-station rotary press simulator capable of producing up to 2400 tablets per hour using an automatic feeder and employing a mechanical cam to generate a bi-axial compaction profile akin to that of a rotary tablet press. This study aimed to assess the feasibility of developing hydrocortisone minitablets for enhanced accuracy in pediatric dosing under simulated rotary press production conditions. The weight uniformity and dissolution behavior of minitablets were compared with quartered tablets.
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