Claims for Patent: 12,691,120

« Back to Dashboard

Summary for Patent: 12,691,120

Title:	Liquid oral formulations for PDE V inhibitors
Abstract:	The present disclosure is directed to pharmaceutical compositions comprising a PDE V inhibitor and one or more pharmaceutical excipients or additives wherein the pharmaceutical compositions are in the form of liquid pharmaceutical compositions. The pharmaceutical compositions of the present disclosure are useful for the treatment of diseases or conditions which are treatable by administration of PDE V inhibitor drug such as pulmonary arterial hypertension, erectile dysfunction, etc.
Inventor(s):	Jinal Pandya, Sandip P. Mehta, Manish Umrethia, Jayanta Kumar Mandal, Hiren Pansuriya
Assignee:	Liqmeds Worldwide Ltd
Application Number:	US19/556,116
Patent Claims:	1. A liquid oral pharmaceutical composition comprising: about 4 mg/mL tadalafil or a pharmaceutically acceptable salt thereof, wherein the tadalafil comprises particulate tadalafil having a d90 particulate size of from about 5 microns to about 200 microns; a pharmaceutically acceptable excipient comprising a wetting agent in an amount of from about 1 mg/mL to about 900 mg/mL; and at least one of (i) a preservative present in an amount of from about 0.1 mg/mL to about 100 mg/mL; (ii) a sweetener present in an amount of from about 0.1 mg/mL to about 50 mg/mL; and (iii) a flavorant present in an amount of from about 0.1 mg/mL to about 50 mg/mL; and a vehicle comprising water; wherein when the liquid oral pharmaceutical composition is administered to a human, the tadalafil exhibits a Tmax of from about 2 hours to about 8 hours. 2. The liquid oral pharmaceutical composition of claim 1, wherein the tadalafil comprises particulate tadalafil having a d90 particulate size of from about 5 microns to about 100 microns. 3. The liquid oral pharmaceutical composition of claim 1, wherein the tadalafil comprises particulate tadalafil having a d90 particulate size of from about 5 microns to about 50 microns. 4. The liquid oral pharmaceutical composition of claim 1, wherein the tadalafil comprises particulate tadalafil having a d90 particulate size of from about 8 microns to about 20 microns. 5. The liquid oral pharmaceutical composition of claim 1, wherein the Tmax is from about 3 hours to about 6 hours. 6. The liquid oral pharmaceutical composition of claim 1, wherein the Tmax is about 4 hours. 7. The liquid oral pharmaceutical composition of claim 4, wherein the Tmax is from about 3 hours to about 6 hours. 8. The liquid oral pharmaceutical composition of claim 4, wherein the Tmax is about 4 hours. 9. The liquid oral pharmaceutical composition of claim 1, wherein the liquid oral pharmaceutical composition has a pH of from about 4.5 to about 5.5. 10. The liquid oral pharmaceutical composition of claim 1, wherein the liquid oral pharmaceutical composition has a pH of about 5. 11. The liquid oral pharmaceutical composition of claim 1, wherein the pharmaceutically acceptable excipient further comprises a viscosity modifying agent. 12. The liquid oral pharmaceutical composition of claim 1, wherein the pharmaceutically acceptable excipient further comprises a buffering agent. 13. The liquid oral pharmaceutical composition of claim 1, wherein the pharmaceutically acceptable excipient further comprises a viscosity modifying agent and a buffering agent. 14. The liquid oral pharmaceutical composition of claim 1, wherein the liquid oral pharmaceutical composition exhibits a dissolution rate of at least about 90% in 10 minutes when measured in 0.5% sodium lauryl sulfate. 15. The liquid oral pharmaceutical composition of claim 1, wherein the liquid oral pharmaceutical composition exhibits a dissolution rate of at least about 95% in 15 minutes when measured in 0.5% sodium lauryl sulfate. 16. The liquid oral pharmaceutical composition of claim 1, wherein the liquid oral pharmaceutical composition retains at least about 95% of labeled tadalafil concentration after storage for at least 6 months at 25° C. and 60% relative humidity. 17. The liquid oral pharmaceutical composition of claim 1, wherein the liquid oral pharmaceutical composition contains no more than about 2% total tadalafil-related impurities. 18. A method for treating pulmonary arterial hypertension, which comprises administering to a human patient in need thereof a therapeutically effective amount of the liquid oral pharmaceutical composition of claim 1. 19. A method for treating erectile dysfunction, which comprises administering to a human patient in need thereof a therapeutically effective amount of the liquid oral pharmaceutical composition of claim 1. 20. A method for treating benign prostatic hyperplasia, which comprises administering to a human patient in need thereof a therapeutically effective amount of the liquid oral pharmaceutical composition of claim 1.