Teva has new drug composition for treating multiple sclerosis [MS]

Business-standard reports on a patent application from Teva related to a new MS drug:


The patent application, titled Stable Laquinimod Preparations, is for a pharmaceutical composition comprising laquinimod or a pharmaceutically acceptable salt of it and meglumine and a pharmaceutically acceptable carrier. The company claims that it has unexpectedly found that this pharmaceutical composition provides a superior stabilisation effect. It has also amended some of the claims to include the ratio range of the ingredients used in the composition, in order to address the objections raised by the examiner of Patent Office.



The report suggests allowance has been given:


srael-based Teva Pharmaceuticals has received patent approval for a product related to multiple sclerosis drug Laquinimod. According to reports, Laquinimod is developed by Teva Pharma in collaboration with Active Biotech AB, a Swedish biotechnology company which has focus on neurodegenerative/ inflammatory diseases and cancer.



link: http://www.business-standard.com/article/companies/teva-gets-patent-for-invention-related-to-multiple-sclerosis-drug-116041600202_1.html

See for example published US application 20140024678 [notice of allowance mailed 19 Jan 2016], with first published claim:


14. A process for the manufacture of a sealed package comprising a pharmaceutical composition of N-ethyl-N-phenyl-1,2,-dihydro-4-hydroxy-5-chloro-1-methyl-2-oxoquinoline-- 3-carboxamide or a pharmaceutically acceptable salt thereof comprising obtaining the pharmaceutical composition and packaging said pharmaceutical composition in a container under conditions containing less oxygen than standard atmospheric conditions.



Published example 1:


EXAMPLE 1

Laquinimod Sodium Capsules Comprising Sodium Carbonate

[0065] Capsules were made which corresponded to 0.3 mg of laquinimod acid (LA) per capsule and 0.6 mg of laquinimod acid per capsule using the following excipients as shown in Table 1:

TABLE-US-00001 TABLE 1 Component 0.3 mg LA/capsule 0.6 mg LA/capsule Laquinimod Sodium 0.32 0.64 Mannitol USP 151.08 302.16 Sodium carbonate 4.55 9.10 anhydrous USP Sodium Stearyl 1.6 3.2 fumarate NF Total Weight 157.55 315.1

[0066] The capsules were made using the following steps: [0067] 1. Mannitol and 99% of the total desired anhydrous sodium carbonate were placed into a high shear granulating mixer and were mixed for 30 seconds. [0068] 2. A solution of laquinimod sodium, 1% of the total desired anhydrous sodium carbonate and purified water was prepared in a mixer until dissolved. [0069] 3. The solution from step 2 was added to the contents of the high shear granulating mixer of step 1 and was mixed to form a suitable granulate. [0070] 4. The granulate was dried in a fluid bed dryer with the inlet air temperature of 50.degree. C. and outlet air temperature of 40.degree. C. [0071] 5. The dry granulate was milled using a 0.8 mm screen, and blended with sodium stearyl fumarate. [0072] 6. The mixture from step 5 was filled into size 1 hard gelatin capsules (0.5 mL volume) for the 0.6 mg laquinimod acid dose and into size 3 hard gelatin capsules (0.3 mL volume) for the 0.3 mg of laquinimod acid dose.




This is related to issued US patent 8,545,885 .