Claims for Patent: 11,433,041

Summary for Patent: 11,433,041

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:	US16746186
Patent Claims:	2. The pharmaceutical composition of claim 1 , wherein the taste-mask coating is about 5-10% 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 comprises a polymer formed from dimethylaminoethyl methacrylate claim 1 , butyl methacrylate claim 1 , and methyl methacrylate.9. The pharmaceutical composition of claim 1 , wherein the taste-mask coating comprises a polymer formed from dimethylaminoethyl methacrylate claim 1 , butyl methacrylate claim 1 , and methyl methacrylate claim 1 , a plasticizer claim 1 , and talc.10. The pharmaceutical composition of claim 9 , wherein the plasticizer is polyethylene glycol having a molecular weight between 5 claim 9 ,000 and 7 claim 9 ,000.11. The pharmaceutical composition of claim 1 , wherein the seed core is about 10 to 20% of the total weight.12. The pharmaceutical composition of claim 11 , wherein the seed core comprises microcrystalline cellulose.13. The pharmaceutical composition of claim 1 , further comprising about 8 to 10% by total weight hydroxypropyl methylcellulose.14. 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 ,000.15. 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.16. The pharmaceutical composition of claim 1 , wherein the seal coating is about 1-5% of the total weight.17. The pharmaceutical composition of claim 16 , wherein the seal coating comprises a water soluble polymer.18. 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% talc in the taste-mask coating claim 1 , and 5 to 10% of a polymer formed from dimethylaminoethyl methacrylate claim 1 , butyl methacrylate claim 1 , and methyl methacrylate.19. The pharmaceutical composition of claim 1 , wherein claim 1 , upon administration to a subject claim 1 , said composition has equivalent distribution in plasma compared to a sodium phenylbutyrate formulation that does not comprise a taste-mask coating.20. The pharmaceutical composition of claim 1 , wherein claim 1 , upon administration to a subject claim 1 , said composition has greater sodium phenylbutyrate levels in the plasma at 30 minutes compared to a modified release formulation of sodium phenylbutyrate.21. The pharmaceutical composition of claim 1 , said composition scores favorably in a taste test in comparison to a sodium phenylbutyrate formulation that does not comprise a taste-mask coating.22. The pharmaceutical composition of claim 1 , wherein taste-masking coating is insoluble at pH 6.5-7.5.23. The pharmaceutical composition or claim 1 , wherein the taste-mask coating is soluble at a pH of less than 2.24. The pharmaceutical composition of claim 1 , taste-mask coasting is soluble at pH 1-2.