Palatability of a novel oral formulation of prednisone in healthy young adults

Abstract

Objectives Prednisone is a widely used anti-inflammatory for a variety of conditions. While oral liquid formulations of prednisone enable weight-based dosing, children frequently find them to be objectionable due to bitter taste. This limitation of prednisone can adversely impact patient acceptance and may result in non-compliance. Efforts to mask flavors often result in poorly controlled, heterogeneous particle distributions and can provide ineffective taste masking. The present work utilized a novel drug delivery technology developed by Orbis Biosciences, Inc., to create an oral taste-masked formulation of prednisone. Methods The study examined the palatability of Orbis’ microsphere prednisone formulation in healthy young adults (n=24). Four test articles were used in the study including a reference formulation (Roxane Laboratories), a control, and the test formulation (Orbis) prepared in two different ways. Study participants were randomized in a crossover design. Key Findings Results indicated that the test prednisone formulation was indistinguishable from the control, and both were preferable to the reference formulation in every category of palatability assessed using a validated 9-point Hedonic Scale. The data also suggested that preparing the microsphere suspension immediately prior to administration results in the most ideal palatability properties. Conclusions In conclusion, the novel microsphere formulation technology was effective in taste-masking prednisone.

Extemporaneous Compounding: Selective Pharmacists with Separate Skill

“…Efforts to mask flavors 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. The design of an ideal paediatric formulation needs to consider the following factors: (i) producing minimal impact on the lifestyle of the child, manifesting as the lowest dosage frequency and a palatable product, (ii) provision of individualized dosing or dose banding appropriate for effective therapy, (iii) sufficient bioavailability, (iv) non-toxic excipients in the formulation, (v) convenient and reliable administration and (vi) robust production process at minimal cost [20], [36][37][38][39].  Health and safety risks: When handling hazardous products, units should be equipped with suitable containment devices and systems should be put in place to eliminate the risk of cross-contamination.…”

Randomised, blinded, cross-over evaluation of the palatability of and preference for different potassium binders in participants with chronic hyperkalaemia in the USA, Canada and Europe: the APPETIZE study

“…Palatability is an under-recognised factor in drug development that can have a significant impact on long-term treatment adherence among patients and prescribing patterns among physicians 34–38. Studies evaluating the palatability of K + binders12 or other medications35 38 are scarce. In one phase I study, three formulations of a calcium-containing polystyrene sulfonate (RDX7675) were evaluated versus SPS 12.…”

Extemporaneous compounding: Selective pharmacists with separate skill

“…The design of an ideal paediatric formulation needs to consider the following factors: (i) producing minimal impact on the lifestyle of the child, manifesting as the lowest dosage frequency and a palatable product, (ii) provision of individualized dosing or dose banding appropriate for effective therapy, (iii) sufficient bioavailability, (iv) non-toxic excipients in the formulation, (v) convenient and reliable administration and (vi) robust production process at minimal cost. 20,[36][37][38][39] Health and Safety Risks: When handling hazardous products, units should be equipped with suitable containment devices and systems should be put in place to eliminate the risk of cross-contamination. Therapeutic Risks and Clinical Consequences: Any inaccuracy of dosing associated with medicines that have a narrow therapeutic index can lead to significant morbidity, whether due to under-dosing leading to treatment failure or overdosing leading to toxicity.…”