Claims for Patent: 11,154,521

Summary for Patent: 11,154,521

Title:	Palatable compositions including sodium phenylbutyrate and uses thereof
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.
Inventor(s):	Appel Leah E., Shockey Joshua R., Schelling D. Christopher
Assignee:	Acer Therapeutics Inc.
Application Number:	US17196416
Patent Claims:	2. The pharmaceutical composition of claim 1 , wherein the taste-mask coating is about 5 to 10% of the total weight.3. The pharmaceutical composition of claim 1 , wherein the sodium phenylbutyrate comprises about 65% of the total weight.4. The pharmaceutical composition of claim 1 , wherein the drug layer comprises sodium phenylbutyrate claim 1 , a binder claim 1 , and a plasticizer.5. The pharmaceutical composition of claim 4 , wherein the binder is hydroxypropyl methylcellulose.6. The pharmaceutical composition of claim 4 , wherein the plasticizer is polyethylene glycol having a molecular weight between 5 claim 4 ,000 and 7 claim 4 ,000.7. The pharmaceutical composition of claim 1 , wherein the drug layer comprises about 65% by total weight sodium phenylbutyrate; 5 to 7% by total weight hydroxypropyl methylcellulose; and 0.1 to 1% by total weight polyethylene glycol having a molecular weight between 5 claim 1 ,000 and 7 claim 1 ,000.8. The pharmaceutical composition of claim 1 , wherein the taste-mask coating further comprises a plasticizer and talc.9. The pharmaceutical composition of claim 8 , wherein the plasticizer is polyethylene glycol having a molecular weight between 5 claim 8 ,000 and 7 claim 8 ,000.10. The pharmaceutical composition of claim 1 , wherein the seed core comprises microcrystalline cellulose.11. The pharmaceutical composition of claim 1 , further comprising about 8 to 10% by total weight hydroxypropyl methylcellulose.12. The pharmaceutical composition of claim 1 , further comprising about 0.5 to 3% by total weight polyethylene glycol having a molecular weight between 5 claim 1 ,000 and 7 claim 1 ,000.13. The pharmaceutical composition of claim 1 , wherein the taste-mask coating further comprises talc claim 1 , and wherein the talc is less than about 4% by total weight.14. The pharmaceutical composition of claim 1 , further comprising a seal coating between the drug layer and taste-mask coating.15. The pharmaceutical composition of claim 14 , wherein the seal coating comprises about 1 to 5% by total weight of the composition.16. The pharmaceutical composition of claim 14 , wherein the seal coating comprises a water soluble polymer.17. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises about 65% by total weight sodium phenylbutyrate claim 1 , 8 to 10% by total weight hydroxypropyl methylcellulose claim 1 , 0.5 to 3% by total weight polyethylene glycol having a molecular weight between 5 claim 1 ,000 and 7 claim 1 ,000 claim 1 , 10 to 20% by total weight microcrystalline cellulose in the seed core claim 1 , less than 4% by total weight of talc in the taste-mask coating claim 1 , and 5 to 10% by total weight of the polymer formed from dimethylaminoethyl methacrylate claim 1 , butyl methacrylate claim 1 , and methyl methacrylate.18. The pharmaceutical composition of claim 1 , further comprising a glidant.19. The pharmaceutical composition of claim 18 , wherein the glidant is silica.20. The pharmaceutical composition of claim 1 , wherein claim 1 , upon administration to a subject claim 1 , the composition is bioequivalent to a sodium phenylbutyrate formulation that does not comprise a taste-mask coating.21. The pharmaceutical composition of claim 1 , wherein the plurality of layered particles has a volume-based particle size distribution in which at least 90% of the layered particles in the plurality of layered particles are smaller than about 400 μm.22. The pharmaceutical composition of claim 1 , formulated in unit dosage form.23. The pharmaceutical composition of claim 1 , wherein the composition scores favorably in a taste test in comparison to a sodium phenylbutyrate formation that does not comprise a taste-mask coating.24. The pharmaceutical composition of claim 1 , wherein claim 1 , upon administration to a subject claim 1 , the composition has greater sodium phenylbutyrate levels in the plasma at 30 minutes compared to a modified release formulation of sodium phenylbutyrate.25. The pharmaceutical composition of claim 1 , wherein less than 15% of the sodium phenylbutyrate in the composition dissolves in a neutral pH over a period of 10 minutes.26. The pharmaceutical composition of claim 1 , wherein at least 95% of the sodium phenylbutyrate in the composition dissolves at an acidic pH over a period of 60 minutes.27. The pharmaceutical composition of claim 1 , wherein the composition is a powder or granules.