Palatability of a Novel Oral Formulation of Prednsione

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.

Study Overview

• Status: Completed
• Conditions: Palatability

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 32 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• age 18 to 32 years, male and female who are healthy at the time of study
• can demonstrate holding 10 mL of apple juice in mouth for 5 seconds without swallowing and then expectorate contents into a cup
• demonstrate ability to complete study questionnaire

Exclusion Criteria:

• history of smoking or using any tobacco products
• previous history of taste disturbance
• any condition or dietary habit known to interfere with the sense of smell and taste
• any structural or functional abnormality of the upper gastrointestinal tract
• ingestion of any medication or nutritional supplement (with exception of acetaminophen tablets or capsules) in a 48 hour period prior to study
• history of any significant illness within the two weeks prior to study
• history of autonomic dysfunction, bronchospastic disease or atopic allergy
• known hypersensitivity (ie., allergic reaction) to any drug, food coloring agent or artificial sweetener
• any history of participating in a clinical trial of a drug or device within a 30 day period from the time of study
• brushing of the teeth, usage of mouthwash, and or oral ingestion of any substance within two hours of receipt of the initial test article and
• inability to speak and/or read English at a grade 10 level

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Healthy Adults

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	Immediately

Collaborators and Investigators

• Sponsor: Arkansas Children's Hospital Research Institute
• Collaborators: Orbis
• Investigators: Principal Investigator: Gregory L Kearns, Pharm D. PhD, Children's Mercy Hospital Kansas City

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: September 3, 2014
• First Submitted That Met QC Criteria: September 4, 2014
• First Posted (Estimate): September 9, 2014

Study Record Updates

• Last Update Posted (Estimate): February 18, 2016
• Last Update Submitted That Met QC Criteria: February 16, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: Orbis Palatability

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided