US2018036363A1PendingUtilityA1

Process for manufacturing glatiramer acetate product

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Assignee: COHEN RAKEFETPriority: Jan 28, 2015Filed: Oct 19, 2017Published: Feb 8, 2018
Est. expiryJan 28, 2035(~8.5 yrs left)· nominal 20-yr term from priority
Inventors:Rakefet CohenSasson HabbahMuhammad Safadi
A61P 37/00A61P 25/14A61P 25/28A61P 25/00A61P 21/00A61K 9/08A61K 38/16A61K 9/0019A61K 38/03A61K 38/02A61K 47/26A61K 9/19A61M 5/178
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Claims

Abstract

The patent provides a process of preparing a pharmaceutical preparation of glatiramer acetate and mannitol in a suitable container comprising the steps of: (i) obtaining an aqueous pharmaceutical solution of glatiramer acetate and mannitol; (ii) filtering the aqueous pharmaceutical solution at a temperature of from above 0° C. up to 17.5° C. to produce a filtrate; and (iii) filling the suitable container with the filtrate obtained after performing step (ii), so as to thereby prepare the pharmaceutical preparation of glatiramer acetate and mannitol in the suitable container. This patent further provides an aqueous pharmaceutical solution comprising 40 mg/ml glatiramer acetate and 40 mg/ml mannitol, wherein the aqueous pharmaceutical solution a) has a viscosity in the range of 2.0-3.5 cPa; or b) has an osmolality in the range of 275-325 mosmol/Kg. This patent also provides a prefilled syringe, an automated injector and a method of treatment of a human patient.

Claims

exact text as granted — not AI-modified
What is claimed: 
     
         1 . A process of preparing a pharmaceutical preparation of 40 mg/ml glatiramer acetate and 40 mg/ml mannitol in a suitable container comprising the steps of:
 (i) obtaining an aqueous pharmaceutical solution of glatiramer acetate and mannitol;   (ii) cooling the aqueous pharmaceutical solution;   (iii) filtering the aqueous pharmaceutical solution of step (ii) to produce a filtrate; and   (iv) filling the suitable container with the filtrate obtained after performing step (iii), so as to thereby prepare the pharmaceutical preparation of 40 mg/ml glatiramer acetate and 40 mg/ml mannitol in the suitable container, wherein the pharmaceutical preparation in the suitable container is an aqueous pharmaceutical solution having a pH in the range of 5.5-7.0.   
     
     
         2 . The process of  claim 1 , wherein the filtering step (iii) comprises filtering the aqueous pharmaceutical solution through a first filter, or a first filter and a second filter. 
     
     
         3 . The process of  claim 2  comprising the step of cooling the aqueous pharmaceutical solution before filtration through the first filter. 
     
     
         4 . The process of  claim 2  comprising the step of cooling the aqueous pharmaceutical solution before filtration through the second filter. 
     
     
         5 . The process of  claim 3  further comprising the step of cooling the aqueous pharmaceutical solution before filtration through the second filter. 
     
     
         6 . The process of  claim 2 , wherein the filtering step (iii) further comprises the step of receiving the aqueous pharmaceutical solution filtered through the first filter in a receiving vessel. 
     
     
         7 . The process of  claim 1 , wherein the cooling step (ii) comprises passing the aqueous pharmaceutical solution through a heat exchanger and/or cooling of the whole bulk aqueous pharmaceutical solution. 
     
     
         8 . The process of  claim 2 , wherein the first filter, the second filter, or the first filter and the second filter, has a filter housing and the process comprises cooling the filter housing. 
     
     
         9 . The process of  claim 1 , wherein pressure during the filtering step and pressure during the filling step is maintained below 5.0 bar. 
     
     
         10 . The process of  claim 1 , wherein pressure during the filtering step and pressure during the filling step is maintained below 3.0 bar. 
     
     
         11 . The process of  claim 1 , wherein pressure during the filtering step and pressure during the filling step is maintained below 2.0 bar. 
     
     
         12 . The process of  claim 2 , wherein the filtering step comprises filtering the aqueous pharmaceutical solution through a first filter and a second filter, and wherein the aqueous pharmaceutical solution is passed through the second filter at a rate of 3-22 liters/hour. 
     
     
         13 . The process of  claim 12 , wherein pressure during the filtering step and pressure during the filling step is maintained below 5.0 bar. 
     
     
         14 . The process of  claim 12 , wherein pressure during the filtering step and pressure during the filling step is maintained below 3.0 bar. 
     
     
         15 . The process of  claim 12 , wherein pressure during the filtering step and pressure during the filling step is maintained below 2.0 bar. 
     
     
         16 . The process of  claim 1 , wherein the filtering is performed using a sterilizing filter having a pore size of 0.2 μm or less. 
     
     
         17 . The process of  claim 10 , wherein the filtering is performed using a sterilizing filter having a pore size of 0.2 μm or less. 
     
     
         18 . The process of  claim 11 , wherein the filtering is performed using a sterilizing filter having a pore size of 0.2 μm or less. 
     
     
         19 . The process of  claim 12 , wherein the first, the second or both filters are a sterilizing filter having a pore size of 0.2 μm or less. 
     
     
         20 . The process of  claim 14 , wherein the first, the second or both filters are a sterilizing filter having a pore size of 0.2 μm or less. 
     
     
         21 . The process of  claim 15 , wherein the first, the second or both filters are a sterilizing filter having a pore size of 0.2 μm or less. 
     
     
         22 . The process of  claim 1 , wherein the pharmaceutical preparation in the suitable container is an aqueous pharmaceutical solution which is a sterilized aqueous solution which has been sterilized by filtration and without subjecting the aqueous pharmaceutical solution to heat or radiation exposure, and wherein the suitable container is a syringe containing 1 ml of the aqueous pharmaceutical solution. 
     
     
         23 . The process of  claim 12 , wherein the pharmaceutical preparation in the suitable container is an aqueous pharmaceutical solution which is a sterilized aqueous solution which has been sterilized by filtration and without subjecting the aqueous pharmaceutical solution to heat or radiation exposure, and wherein the suitable container is a syringe containing 1 ml of the aqueous pharmaceutical solution. 
     
     
         24 . The process of  claim 14 , wherein the pharmaceutical preparation in the suitable container is an aqueous pharmaceutical solution which is a sterilized aqueous solution which has been sterilized by filtration and without subjecting the aqueous pharmaceutical solution to heat or radiation exposure, and wherein the suitable container is a syringe containing 1 ml of the aqueous pharmaceutical solution.

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