Palatable compositions including sodium phenylbutyrate and uses thereof
AssigneeAcer Therapeutics Inc.
InventorsLeah E. Appel, Joshua R. Shockey, D. Christopher Schelling
Life of this patent
Estimating the term…
Abstract
The present invention features palatable pharmaceutical compositions including sodium phenylbutyrate and methods for the treatment of inborn errors of metabolism (e.g., Maple Syrup Urine Disease or Urea Cycle Disorders), neurodegenerative disorders such as Parkinson's disease, spinal muscular atrophy, dystonia, or inclusion-body myositis with such compositions.
Claims24
A pharmaceutical composition for oral administration of sodium phenylbutyrate comprising a plurality of layered particles having a volume-based particle size distribution in which at least 90% of the layered particles in the plurality of layered particles are smaller than 500 μm, wherein each layered particle comprises (i) a seed core;
- (ii) a drug layer comprising the sodium phenylbutyrate;
- (iii) a seal coating;
- and (iv) a taste-mask coating, wherein the pharmaceutical composition comprises greater than 60% by total weight sodium phenylbutyrate, wherein the taste-mask coating is insoluble at a neutral pH of greater than 5 and soluble at an acidic pH of less than 2, and wherein the pharmaceutical composition comprises about 5% to 25% by total weight taste-mask coating.
Dependencies are inferred from the claim text.