HomeWHYWhy Does Prednisone Taste So Bad

Why Does Prednisone Taste So Bad

Introduction

In 2007, the World Health Assembly underscored the importance of providing safe, effective and proven medicines for children.[1] The widespread lack of paediatric-specific drug products, however, forces medical providers and pharmacists to use alternative solutions to treat their paediatric patients. These alternatives are not backed by bioavailability, stability and safety studies.[2,3] Extemporaneously prepared oral drug formulations can also be plagued by poor palatability characteristics, which can compromise patient adherence.[4] This lack of child-friendly formulations affects 40% of the global population, subjecting paediatric patients to avoidable adverse drug events, reduced compliance with medication regimens, limited access to new medications and prolonged treatable illnesses.[5] The pressing need for child-friendly, palatable medications suitable for administration to both infants and young children has been stressed (through regulatory guidance) by both the European Medicines Agency and the United States Food and Drug Administration.

Prednisone is a bitter-tasting corticosteroid used for its anti-inflammatory and immunosuppressant effects to treat a wide variety of conditions in both adults and children. For paediatric patients, an alternative form of administration can be produced by crushing solid oral prednisone formulations to avoid swallowing difficulties or achieve weight-based dosing. This approach, however, creates extremely poor taste and mouth feel properties which are objectionable to paediatric patients. While these limitations can be somewhat mitigated by the use of proprietary oral liquid formulations of prednisone, such products still retain their profoundly bitter taste characteristics. It is estimated that approximately half of children refuse to take even a liquid form of prednisone, with the large majority of those reporting bad taste as the single major reason for non-compliance.[3] Efforts to mask flavours using sweetening agents, coatings, agglomeration or microencapsulation often result in poorly controlled, heterogeneous particle size distributions that result in a gritty or granular mouth feel and can provide ineffective taste masking, characteristics that may also compromise patient acceptance.[6]

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To address the challenge of palatable, paediatric-friendly drug formulations, Orbis Biosciences Inc. (Lenexa, KS, USA), has developed an innovative drug delivery platform that produces microspheres with specific physicochemical properties, which can be tailored to a wide variety of active pharmaceutical ingredients. This technology was used in the creation of a new taste-masked microsphere formulation containing prednisone. Herein, we report the results from the first human evaluation of this formulation, an effort to assess its palatability (both taste and mouth feel) and patient acceptance and provide ‘proof of concept’ regarding the potential utility of this formulation technology for children.

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