Claims for Patent: RE47350

Summary for Patent: RE47350

Title:	Pharmaceutical formulations containing dopamine receptor ligands
Abstract:	The present invention relates to stable and bioavailable immediate release formulations comprising dopamine receptor ligands. Methods of treating various disorders by administering the formulations are also described.
Inventor(s):	Sarkar; Ranajoy (Skillman, NJ), Dedhiya; Mahendra G. (Pomona, NY), Chhettry; Anil (Holtsville, NY)
Assignee:	Richter Gedeon Nyrt. (Budapest, HU)
Application Number:	15/598,971
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent RE47350
Patent Claims:	1. A method of treating a condition selected from the group consisting of schizophrenia, bipolar disorder, acute mania, and depression, the method comprising administering to a patient in need thereof a solid oral pharmaceutical formulation comprising from about 0.05 to about 9 mg trans-1{4-[2-[4-(2,3-dichlorophenyl)-piperazin-1-yl]-ethyl]-cyclohexyl}-3- ,3-dimethyl-urea, or a pharmaceutically acceptable salt thereof, and .[.an excipient having low water activity selected from the group consisting of.]. .Iadd.a .Iaddend.pregelatinized starch.[., mannitol, anhydrous calcium hydrogen phosphate, and mixtures thereof.]., wherein the formulation provides an in vivo plasma profile comprising a mean C.sub.max of less than about 26.3 ng/mL, a mean AUC.sub.0-.infin. of more than about 2 nghr/mL and a mean T.sub.max of about 3 or more hours, wherein the formulation has a dissolution rate of more than about 80% within about the first 60 minutes following administration of the composition to the patient.[.; and wherein the formulation has a pH in the range of about 9.0 to about 12.0.].. 2. The method of claim 1, wherein the formulation comprises about 1.5 mg trans-1{4-[2-[4-(2,3-dichlorophenyl)-piperazin-1-yl]-ethyl]-cyclohexyl}-3- ,3-dimethyl-urea, or a pharmaceutically acceptable salt thereof, and provides an in vivo plasma profile comprising a mean C.sub.max of less than about 2.7 ng/mL and a mean T.sub.max of about 3 or more hours. 3. The method of claim 1, wherein the formulation comprises about 3 mg trans-1{4-[2-[4-(2,3-dichlorophenyl)-piperazin-1-yl]-ethyl]-cyclohexyl}-3- ,3-dimethyl-urea, or a pharmaceutically acceptable salt thereof, and provides an in vivo plasma profile comprising a mean C.sub.max of less than about 5.3 ng/mL and a mean T.sub.max of about 3 or more hours. 4. The method of claim 1, wherein the formulation comprises about 4.5 mg trans-1{4-[2-[4-(2,3-dichlorophenyl)-piperazin-1-yl]-ethyl]-cyclohexyl}-3- ,3-dimethyl-urea, or a pharmaceutically acceptable salt thereof, and provides an in vivo plasma profile comprising a mean C.sub.max of less than about 7.9 ng/mL and a mean T.sub.max of about 3 or more hours. 5. The method of claim 1, wherein the formulation comprises about 6 mg trans-I{4-[2-[4-(2,3-dichlorophenyl)-piperazin-I-yl]-ethyl]-cyclohexyl}-3- ,3-dimethyl-urea, or a pharmaceutically acceptable salt thereof, and provides an in vivo plasma profile comprising a mean C.sub.max of less than about 10.5 ng/mL and a mean T.sub.max of about 3 or more hours. 6. The method of claim 1, wherein the formulation comprises about 9 mg trans-I{4-[2-[4-(2,3-dichlorophenyl)-piperazin-I-yl]-ethyl]-cyclohexyl}-3- ,3-dimethyl-urea, or a pharmaceutically acceptable salt thereof, and provides an in vivo plasma profile comprising a mean AUC.sub.0-.infin. of more than about 180 nghr/mL and a mean T.sub.max of about 3 or more hours. 7. The method of claim 1, wherein the formulation comprises about 0.5 mg trans-I{4-[2-[4-(2,3-dichlorophenyl)-piperazin-I-yl]-ethyl]-cyclohexyl}-3- ,3-dimethyl-urea, or a pharmaceutically acceptable salt thereof, and provides an in vivo plasma profile comprising a mean C.sub.max of less than about 0.9 ng/mL and a mean T.sub.max of about 3 or more hours. .[.8. The method of claim 1, wherein the excipient comprises pregelatinized starch..]. .[.9. The method of claim 1, wherein the excipient comprises mannitol..]. .[.10. The method of claim 1, wherein the excipient comprises anhydrous calcium hydrogen phosphate..].