TH14009C3 - Risperidone aqueous solution formula - Google Patents

Abstract

------ 05/10/2017 ------ (OCR) page 1 of number 1 page Invention summary. The invention involved a chemically stable risperidone aqueous solution formula. Physics in a weakly acidic solution suitable for oral administration and injection. Contains the drug It is important that risperidone base or risperidone hydrochloride salts in solutions containing pH in the range 6.1-7.2 can be added with parabens or BHT. And sweetener sucralose or saccharin To be suitable for oral administration without impairing the stability of the vital drug. Risperidone aqueous solutions for oral administration contain risperidone bases in the range 0.02% (or 0.2 mg / mL) to 0.1% (or 1.0 mg / mL). Risperidone hydrochloride content ranges from 0.0218% (or 0.218 mg / mL) to 0.109% (or 1.09 mg / mL) as a weight by volume. Total solution The parenteral solution contained rispericone hydrochlor content. Rides range from 0.109% (or 1.09 mg / ml) to 0.654% (or 6.54 mg / ml), equivalent to weight. Total volume of solution ------------ The invention involved a chemically stable risperidone aqueous solution formula. Physics in a weakly acidic solution suitable for oral administration and injection. Contains the drug The important thing is risperidone base or risperidone hydrochloride salts in solutions containing pH in the range 6.1-7.2. Parabens, sodium benzoate or BH can be added. Sweetener, sucralose saccharin, to be suitable for oral administration without impairing the stability of the active substance. Risperidone aqueous solutions for oral administration have risperidone bases ranging from 0.02% (or 0.2 mg / mL) to 0.1% (or 1.0 mg / mL). Accounted for weight / volume Total solution The parenteral solution contained risperidone hydrochlor content. Rides range from 0.109% (or 1.09 mg / ml) to 1.09% (or 10.9 mg / ml), equivalent to weight. Total volume of solution

Claims (4)

Disclaimer (all) which will not appear on the advertisement page. : ------ 05/10/2017 ------ (OCR) page 1 of number 1 disclaimer 1. Risperidone aqueous solution formulation suitable for injection or Gives by mouth containing water and risperidone bases or risperidone hydrochloride salts. With characteristics that the solution Risperidone's aqueous solution was maintained in the range 6.1 to 7.2. 2. Risperidone's aqueous solution formulation according to claim 1, where the appropriate formula for Oral there The risperidone content ranges from 0.02% (or 0.2 mg / mL) to 0.1% (or 1.0 mg / mL), representing the total volume of the solution. Risperidone water according to claim 1 where the appropriate oral formulation contains The risperidone hydrochloride content ranges from 0.0218% (or 0.218 mg / mL) to 0.109% (or 1.09 mg / mL), representing the total volume of solution 4. Risperidone aqueous solution according to claim 1, where the appropriate injection formula contains the Risperidone hydrochloride ranges from 0.109% (or 1.09 mg / ml) to 0.654% (or 6.54 mg / ml) as the weight of the total volume of the solution --- --------- Revised 27/03/2017 (13/03/2017) 1. Risperidone aqueous solution formulation suitable for injection or oral administration containing water and rye. Speridone Base or Risperidone Hydrochloride Salt With characteristics that the solution Risperidone's aqueous solution was treated in the range 6.1 to 7.2. 2. Risperidone's aqueous solution formulation according to claim 1, where the appropriate oral formulation is available. The risperidone content ranges from 0.02% (or 0.2 mg / mL) to 0.1% (or 1.0 mg / mL), representing the total volume of the solution. Risperidone water according to claim 1 where the appropriate oral formulation contains The risperidone hydrochloride content ranges from 0.0218% (or 0.218 mg / mL) to 0.109% (or 1.09 mg / mL), representing the total volume of solution 4. Risperidone's aqueous solution formula according to claim 1, where the suitable injection formula contains the amount of Risperidone hydrochloride ranges from 0.109% (or 1.09 mg / mL) to 0.654% (or 6.54 mg / mL), representing the total volume of the solution. ------------------------------ 1. Risperidone's water-soluble formula suitable for injection or oral administration containing risperidone water and risperidone hydrochloride or salts. With characteristics that the solution The appropriate treatment for pH was in the range of 6.1 to 7.2. 2. Risperidone aqueous solution formulation according to claim 1, where the appropriate oral formulation has The risperidone content ranges from 0.02% (or 0.2 mg / mL) to 0.1% (or 1.0 mg / mL), representing the total volume of the solution. 3. Risperidone aqueous solution according to claim 1, where the appropriate oral formulation has The risperidone hydrochloride content ranges from 0.0218% (or 0.218 mg / mL) to 0.218% (or 2.18 mg / mL), representing the total volume of the solution. 4. Risperidone aqueous solution according to claim 1, where the suitable injection formula contains the Risperidone hydrochloride ranges from 0.109% (or 1.09 mg / mL) to 1.09% (or 10.9 mg / mL), representing the total volume of the solution.