Abstract
Owing to considerable differences observed in anatomy and physiology between paediatric subsets, it has been well established that children respond to drugs differently compared to adults. Furthermore, from a formulation perspective, there is a distinct challenge to develop a dosage form that is capable of safely, accurately, and reliably delivering the dose across the whole paediatric population. Orally disintegrating mini-tablets (ODMT) have widely been considered as an age-appropriate formulation option that possess the ability for adequate dose flexibility, avoids swallowing difficulties, and exhibits superior stability due to its solid state. Within this study, two strengths (0.5 mg and 2 mg) of carvedilol ODMT formulations were developed using an excipient composition and load that is appropriate for paediatric use. The formulations demonstrated adequate mechanical strength (>20 N) and fast disintegration times (<30 s). Dissolution profiles observed were robust and comparable to the marketed conventional tablet formulation across various parts of the gastrointestinal (GI) tract in both the fed and fasted state, signifying appropriate efficacy, quality, and performance. As such, the formulations developed in this study show potential to address the need of an ‘age-appropriate’ formulation of carvedilol, as highlighted by the European Medicines Agency (EMA) Inventory of the Needs for Paediatric Medicine.
Highlights
Published: 3 June 2021In Europe, a product licence (‘marketing authorisation’) is required to market a medicinal product that specifies the agreed terms of use, including medical indication, target age, dose, and route of administration [1]
The availability of multiple strengths ensures to cover a wide range of therapeutic doses and the novel Orally disintegrating mini-tablets (ODMT) formulation is aimed at birth up to the age of 12 years
Two strengths of carvedilol ODMT formulations were developed using an excipient composition and load that is appropriate for paediatric use
Summary
Published: 3 June 2021In Europe, a product licence (‘marketing authorisation’) is required to market a medicinal product that specifies the agreed terms of use, including medical indication, target age, dose, and route of administration [1]. Owing to insufficient age-appropriate formulations that enable paediatric dosing and administration, many medicines are manipulated prior to use (e.g., crushing of tablets, emptying content of capsules and sprinkling over food, or changing the dosage form type), with an aim to improve patient compliance and adherence [2] This serves as a vital option to deliver medicines to children when needed, many safety-related incidents have been reported, due to contamination, and purity and potency inconsistencies [3,4]. On account of such limitations and to limit the potential of unknown adverse effects of unlicensed and ‘off-label’ use, the primary expectation and preference with paediatric pharmacotherapy is to develop an age-appropriate and ready-to-administer dosage form that is licensed and commercially available [5]. This provides regulatory safeguards and ensures the formulation intended has thoroughly been evaluated in all aspects of safety and efficacy and is appropriate for paediatric use
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