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| Name | Class |
|---|---|
| Orbis | OTHER |
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Prednisone solution USP (5mg/5mL), is the most commonly prescribed formulation of prednisone to pediatric and adult patients. The rationale for this study is that palatability is the most important determinant of pediatric patient compliance, and therefore, it is critical that the Orbis formulation be perceived as significantly more palatable compared to today's commercially available products in order to warrant further development of the TP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Adults |
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| Measure | Description | Time Frame |
|---|---|---|
| Palatability of a new oral formulation of prednisone | We will create optimized shelf-stable prednisone microcapsules designed for complete taste-masking followed by immediate release in the stomach. Release characteristics of the TP will be compared to a pharmaceutical grade formulation of prednisone. Milestone: Microencapsulated prednisone that: (i) shows less than 10% coefficient of variance (CV) in the in vitro release profile between fresh and 4-week, 40°C stability-exposed samples while maintaining (ii) maximum of 5% total drug release during the initial 2 minutes and (iii) >90% release within 30 minutes. N.B. This Specific Aim will be accomplished in the laboratories of Orbis Biosciences, Inc. Upon meeting all milestones associated with this SA, Orbis Biosciences will produce, in accordance with Good Laboratory and Manufacturing Principles, a single batch of TP suitable for use in accomplish SA2. | Immediately |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the TP for the organoleptic properties of taste, mouth-feel and aroma in healthy adults compared to the reference product (RP). | We will use a randomized cross-over design and a 9-Point Hedonic bipolar scale of scoring to compare the product appearance, smell, taste, mouth feel and after taste for three treatment groups: (i) Orbis's prednisone-loaded microcapsules (TP), developed in SA1, (ii) TP placebo microcapsules (i.e., delivery system not containing any active pharmaceutical ingredient or API), and (iii) the RP (Prednisone oral liquid, USP). We will suspend the microcapsules in a non-flavored suspension medium immediately before administration to healthy adults. The hypothesis associated with this SA is that microencapsulated prednisone (TP) will demonstrate significant improvement in organoleptic properties as compared to the RP. |
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Inclusion Criteria:
Exclusion Criteria:
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A total of 24 healthy young adults (12 males and 12 females), ranging in age from 18 to 32 years of age comprised of a convenience sample who meet study eligibility criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Gregory L Kearns, Pharm D. PhD | Children's Mercy Hospital Kansas City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
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Whole Blood
| Immediately |