Claims for Patent: RE49110

Summary for Patent: RE49110

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. (N/A)
Application Number:	16/372,031
Patent Claims:	1. A method of treating a condition selected from the group consisting of schizophrenia, bipolar disorder, acute mania, and depression comprising administering to a patient in need thereof a solid oral dosage form comprising between about 0.5% and about 15% of cariprazine or a pharmaceutically acceptable salt thereof, .[.an excipient having low water activity selected from the group consisting of.]. pregelatinized starch.[., mannitol, anhydrous calcium hydrogen phosphate, and mixtures thereof.]., and .[.between about 0.1% and about 0.5%.]. .Iadd.less than 0.5% .Iaddend.of trans-4-[2-[4-(2,3-dichlorophenyl)-piperazin-1-yl]-ethyl]-cyclohexyl-amin- e or a pharmaceutically acceptable salt thereof.[.; 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 solid oral dosage form comprises cariprazine or a pharmaceutically acceptable salt thereof in an amount from about 0.5 mg to about 15 mg. 3. The method of claim 1, wherein the solid oral dosage form comprises cariprazine or a pharmaceutically acceptable salt thereof in an amount from about 1 mg to about 12 mg. 4. The method of claim 1, wherein the solid oral dosage form comprises magnesium stearate. 5. The method of claim 1, wherein the .[.excipient having a low water activity.]. .Iadd.pregelatinized starch .Iaddend.is present in an amount greater than 80% by weight of the solid oral dosage form. .[.6. The method of claim 1, wherein the solid oral dosage form comprises a compound that modulates the pH environment of the composition solid oral dosage form in an amount between about 1% by weight and 15% by weight of the composition solid oral dosage form..]. 7. The method of claim 1, wherein the solid oral dosage form has a dissolution rate of more than about 80% within about the first 60 minutes following administration of the solid oral dosage form to the patient. .[.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..]. .Iadd.11. The method of claim 1, wherein the solid oral dosage form comprises less than 0.1% of trans-4-[2-[4-(2,3-dichlorophenyl)-piperazin-1-yl]-ethyl]-cyclohexyl-amin- e or a pharmaceutically acceptable salt thereof..Iaddend.