Method for reducing filtrate waste in a manufacturing process of a pharmaceutical product containing benzalkonium chloride

• US 5,550,163 A
• Filed: 08/03/1994
• Issued: 08/27/1996
• Est. Priority Date: 08/03/1994
• Status: Expired due to Fees

• Current Assignee: Allergan SPA (Abbvie Incorporated)
• Original Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Inventors: Tien, Walter L., Pallo, Robert J., Olejnik, Orest, Ding, Shulin
• Primary Examiner(s): O SULLIVAN, PETER G
• Application Number:
  US08/285,079
• Time in Patent Office: 755 Days
• Field of Search: 564/262, 564/288, 514/643
• US Class Current: 514/643
• CPC Class Codes: A61K 9/0048 Eye, e.g. artificial tears

Abstract

A method for reducing filtrate waste in a manufacturing process of a pharmaceutical product containing benzalkonium chloride as a preservative generally includes the steps of mixing the non-benzalkonium chloride components with benzalkonium chloride to formulate the product and thereafter sterilizing the product by passing same through a microfiltration membrane. In processes in which the product has a time dependent benzalkonium chloride content due to benzalkonium chloride adsorption on a microfiltration membrane, an amount of benzalkonium chloride wasted can be reduced by maintaining a selected temperature of the microfiltration membrane and the product therein.

Claims

1. A method for reducing filtrate waste in a manufacturing process of a pharmaceutical product containing benzalkonium chloride as a preservative, said manufacturing process including the steps of storing product components, mixing the product components and dispensing product to containers, said method comprising the steps of:

mixing the non-benzalkonium chloride components with benzalkonium chloride to formulate the product;

sterilizing the product by passing same through a microfiltration membrane, said product having a time dependent benzalkonium chloride content, the time dependence being dependent on benzalkonium chloride adsorption equilibration in the microfiltration membrane; and

reducing a benzalkonium chloride equilibration time in the microfiltration membrane by maintaining a selected temperature of the microfiltration membrane and the product therein.

2. The method according to claim 1 wherein the microfiltration membrane is maintained at room temperature.

3. The method according to claim 1 wherein the microfiltration membrane is maintained above room temperature.

4. The method according to claim 1 wherein the microfiltration membrane is maintained above about 23°

C.

5. The method according to claim 4 wherein the microfiltration membrane is maintained above about 38°

C.

6. The method according to claim 1 further comprising the step of prefiltering all the non-benzalkonium chloride product components to remove particulates.

7. The method according to claim 1 further comprising the step of post filtering the product.

8. The method according to claim 5 further comprising the step of prefiltering all the non-benzalkonium chloride product components to remove particulates.

9. A method for reducing loss of benzalkonium chloride in a manufacturing process of an ophthalmic product, said manufacturing process including the steps of storing product components, mixing the product components and dispensing product to containers, said method comprising the steps of:

prefiltering all non-benzalkonium chloride product components to remove particulates;

mixing the prefiltered non-benzalkonium chloride product components with benzalkonium chloride to formulate the product;

sterilizing the product by passing same through a microfiltration membrane; and

maintaining a microfiltration membrane temperature in order to control benzalkonium chloride adsorption on the microfiltration membrane.

10. The method according to claim 9 wherein the microfiltration membrane is maintained at room temperature.

11. The method according to claim 9 wherein the microfiltration membrane is maintained above room temperature.

12. The method according to claim 9 wherein the microfiltration membrane is maintained above about 23°

C.

13. The method according to claim 12 wherein the microfiltration membrane is maintained above about 38°

C.