Engineering Microparticles for Taste-Masking and Controlled Release of Pediatric

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$216,020.00
Award Year:
2012
Program:
SBIR
Phase:
Phase I
Contract:
1R43HD074326-01
Award Id:
n/a
Agency Tracking Number:
R43HD074326
Solicitation Year:
2012
Solicitation Topic Code:
NICHD
Solicitation Number:
PAR11-304
Small Business Information
2002 W 39th Ave, KANSAS CITY, KS, -
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
828536438
Principal Investigator:
MILIND SINGH
(785) 691-8693
milind@orbisbio.com
Business Contact:
MARIA FLYNN
(816) 223-2662
maria@orbisbio.com
Research Institute:
Stub




Abstract
DESCRIPTION (provided by applicant): Pediatric drug development presents many unique challenges in the effective treatment of diseases in children, from adequate dosing information and pediatric-specific testing to palatable flavor profiles and effective delivery formats. A novel technology that masks bitter drug flavors while providing flexibility in dose design and format would enable formulation of existing adult pharmaceutical products into medications specially designed for pediatric patients. Our proposed strategy uses Precision Particle Fabrication (PPF) to develop pediatric drug-loaded microparticles that mask bitter flavors and allow for flexible dosing and formats. The central advantage of PPF technology lies in its precise control of particle size, shape, material, and release rates. Our long-term goal is to adapt this flexible, user-friendly, inexpensive technology to create a platform for microencapsulating unpalatable pediatric active pharmaceutical ingredients (API's). We hypothesize that theuniform, precisely engineered microparticles produced by PPF will create effectively taste- masked formulations for pediatric drugs while also allowing for the swift and controlled release of the active agents under digestive conditions. We further hypothesize that this robust microparticle strategy will allow for accurate, flexible dosing and adaptation to multiple drug delivery formats. Our research team will develop and characterize model bitter API-containing microparticles with precisely controlled physicochemical features that are designed to meet palatability standards (Aim 1). We will then optimize the release characteristics and taste-masking performance of these model microparticles (Aim 2). The result will be model drug-loaded microparticles thatmeet palatability standards based on particle size, homogeneity, and drug surface concentration and that can be tailored for desired release profiles under digestive conditions. After establishing the feasibility of precisely engineering these microparticles, Phase II will focus on the clinical evaluation of organoleptic properties of taste and mouth feel as well as demonstration of dosing accuracy, titration, and format flexibility. This PPF-based encapsulation strategy addresses issues of palatability, dosage accuracy, and format flexibility in pediatric drugs, while improving upon existing encapsulation techniques that are costly and time-consuming and produce poorly controlled, heterogeneous batches of microparticles. In adition, this PF technology is highly adaptable to multiple drugs and matrix/coating materials as well as large-scale production. The result will be an inexpensive, highly flexible pediatric platform for creating palatable, age-appropriate, and accurate dosage forms, leading to safer pediatric formulations and improved patient compliance. PUBLIC HEALTH RELEVANCE: Inadequate pediatric pharmaceutical formulations impair effective treatment of diseases in children due to poor compliance, ad hoc formulations, and dangerous medicationerrors. At the foundation of the problem are palatability, accurate dosing, and age-appropriate dosage format challenges. Development of a user-friendly, inexpensive development platform for pediatric reformulation of existing adult drug products to administer taste-masked active pharmaceutical ingredients (APIs) with controlled release rates is needed. Using model bitter APIs, this project aims to test the feasibility of Precision Particle Fabricatio technology to produce palatable, age-appropriate, and accurate doses as a means to safer pediatric medications and better compliance.

* information listed above is at the time of submission.

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