ORBIS BIOSCIENCES, INC. — Department of Health and Human Services SBIR Phase II: N

Description

DESCRIPTION provided by applicant New dosage forms are needed to address the shortcomings of current practice with regard to administration of medications to pediatric populations Specifically in the absence of pediatric specific products formulations that are both palatable to ensure compliance and titratable to meet the weight surface area appropriate dosage providers either utilize adult approved liquid formulations or manipulate available products to create extemporaneous formulations e g by crushing a tablet Liquid suspensions while titratable and largely preferred by children over tablets and capsules are often poorly palatable and thus suffer from poor compliance Ad hoc formulations can also alter the performance and risk the likelihood of under or over dosing Orbis Biosciencesandapos s has developed a free flowing drug loaded microcapsule based powder that will taste mask bitter pharmaceutical actives during ingestion and exhibit complete dosage form dissolution in the gastrointestinal tract This microcapsule platform is made possible by utilizing Precision Particle Fabrication PPF to place a pH responsive shell over a solid dispersed core of poorly water soluble drug in a water free single step process The first product to use Orbisandapos s microcapsule approach to taste masking will be ORB a prednisone loaded microcapsule formulation Upon successful FDA approval ORB will compete with oral liquid formulations or prednisone and prednisolone products that suffer from poor palatability Under the Phase I SBIR work Orbis successfully developed two formulations ORB and ORB containing prednisone and ritonavir respectively The microcapsule powders were able to reduce the presence of prednisone and ritonavir in neutral dissolution medium at minutes by and respectively compared to the RLD syrups for these two drugs and still exhibit dissolution by minutes when placed in acidic medium The objective of this Phase II proposal is to optimize the prednisone formulation ORB into a shelf stable powder in vitro Aim verify itandapos s superior palatability compared to the RLD in a human taste screening Aim and demonstrate its bioequivalence to the RLD in a human pharmacokinetic study Aim The completion of this Phase II SBIR program will facilitate the efficient and timely submission of an IND filing to the FDA Phase III SBIR and have an immediate and lasting impact on the best practices for treating prednisone responsive pediatric disorders by establishing the improved palatability or ORB in the first human trials while readying ORB and the PPF platform on which it is based for a co development agreement or venture capital funding PUBLIC HEALTH RELEVANCE Inadequate pediatric pharmaceutical formulations impair effective treatment of diseases in children due to poor compliance extemporaneous formulations and dangerous medication errors 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 prednisone as a model foul tasting API this project aims to develop pediatric specific formulations using Precision Particle Fabrication technology that are palatable age appropriate and allow for accurate dosing as a means to safer pediatric medications and better compliance