http://rdf.ncbi.nlm.nih.gov/pubchem/patent/WO-2014153145-A2
Outgoing Links
| Predicate | Object |
|---|---|
| assignee | http://rdf.ncbi.nlm.nih.gov/pubchem/patentassignee/MD5_280113c7567c4fb402adb6afaadf5d6b http://rdf.ncbi.nlm.nih.gov/pubchem/patentassignee/MD5_951c28c409151ff801c0fa73c54fa9b1 http://rdf.ncbi.nlm.nih.gov/pubchem/patentassignee/MD5_10e4b1416c6e66e0ade5429212414964 http://rdf.ncbi.nlm.nih.gov/pubchem/patentassignee/MD5_ff01c11a03eeabb07a002e50e63ea312 http://rdf.ncbi.nlm.nih.gov/pubchem/patentassignee/MD5_6f52aa3dae10f8b4bf8a6e3bc1e27b99 http://rdf.ncbi.nlm.nih.gov/pubchem/patentassignee/MD5_4ef36b14d6b6a7928598413b964927da |
| classificationCPCAdditional | http://rdf.ncbi.nlm.nih.gov/pubchem/patentcpc/C07B2200-13 |
| classificationCPCInventive | http://rdf.ncbi.nlm.nih.gov/pubchem/patentcpc/G01N30-06 http://rdf.ncbi.nlm.nih.gov/pubchem/patentcpc/C07C235-16 http://rdf.ncbi.nlm.nih.gov/pubchem/patentcpc/A61P19-02 http://rdf.ncbi.nlm.nih.gov/pubchem/patentcpc/A61P13-12 http://rdf.ncbi.nlm.nih.gov/pubchem/patentcpc/A61P1-04 http://rdf.ncbi.nlm.nih.gov/pubchem/patentcpc/G01N33-15 http://rdf.ncbi.nlm.nih.gov/pubchem/patentcpc/C07D215-56 http://rdf.ncbi.nlm.nih.gov/pubchem/patentcpc/A61P29-00 http://rdf.ncbi.nlm.nih.gov/pubchem/patentcpc/A61P25-24 http://rdf.ncbi.nlm.nih.gov/pubchem/patentcpc/A61P27-02 http://rdf.ncbi.nlm.nih.gov/pubchem/patentcpc/A61P25-00 http://rdf.ncbi.nlm.nih.gov/pubchem/patentcpc/A61P37-06 http://rdf.ncbi.nlm.nih.gov/pubchem/patentcpc/A61K31-47 |
| filingDate | 2014-03-14^^<http://www.w3.org/2001/XMLSchema#date> |
| inventor | http://rdf.ncbi.nlm.nih.gov/pubchem/patentinventor/MD5_0cf1943e6a69f1a7b2672727b2821583 http://rdf.ncbi.nlm.nih.gov/pubchem/patentinventor/MD5_b2d1f11c28f7cca6fc91923d58e6fecd http://rdf.ncbi.nlm.nih.gov/pubchem/patentinventor/MD5_d770ec373e7f7f2359cffc81a9f3894a http://rdf.ncbi.nlm.nih.gov/pubchem/patentinventor/MD5_58d3f470c5c34c309aed201e14a99f4b http://rdf.ncbi.nlm.nih.gov/pubchem/patentinventor/MD5_d8ed6a619db645c29a79a0ae701382fe |
| publicationDate | 2014-09-25^^<http://www.w3.org/2001/XMLSchema#date> |
| publicationNumber | WO-2014153145-A2 |
| titleOfInvention | Crystals of laquinimod sodium and improved process for the manufacture thereof |
| abstract | The subject invention provides a mixture of crystalline laquinimod sodium particles, wherein (i) ≥ 90% of the total amount by volume of the laquinimod sodium particles have a size of ≤ 40 μm or (ii) ≥ 50% of the total amount by volume of the laquinimod sodium particles have a size of ≤ 15 μm, and wherein: a) the mixture has a bulk density of 0.2-0.4 g/mL; b) the mixture has a tapped density of 0.40-0.7 g/mL; c) an amount of heavy metal in the mixture is no more than 20ppm relative to the amount by weight of laquinimod sodium; d) an amount of MCQ in the mixture is no more than 0.15% relative to the amount of laquinimod sodium as measured by HPLC; e) an amount of MCQCA in the mixture is no more than 0.15% relative to the amount of laquinimod sodium as measured by HPLC; or f) an amount of MCQME in the mixture is no more than 0.12% relative to the amount of laquinimod sodium as measured by HPLC. The subject invention also provides a pharmaceutical composition comprising an amount of laquinimod and at least one of BH-3-HLAQ, MCQ, MCQCA, MCQME, NEA, and MCQEE. The subject invention also provides processes for preparing BH-3-HLAQ, MCQ, MCQCA, MCQME, MCQEE, and compounds prepared by said processes. Further provided is a process for testing whether a sample of laquinimod contains an undesirable impurity. Further provided isp a process for preparing a validated pharmaceutical composition comprising laquinimod, for preparing a pharmaceutical composition comprising laquinimod, or for distributing a validated batch of a pharmaceutical composition comprising laquinimod, for validating a batch of a pharmaceutical product containing laquinimod and a pharmaceutically acceptable carrier for distribution, and for preparing a packaged pharmaceutical composition comprising laquinimod, each comprising determining the amount of at least one of BH-3-HLAQ, MCQ, MCQCA, MCQME, NEA, and MCQEE in a sample or batch. The subject invention further provides use of BH-3-HLAQ, MCQ, MCQCA, MCQME, MCQEE as a reference standard to detect trace amounts of the impurity in a pharmaceutical composition comprising laquinimod. Finally, the subject invention provides methods of ddenrrining the concentration of BH-3- HLAQ, MCQ, MCQCA, MCQME, MCQEE, 5-HLAQ, SPIRO-LAQ or 3 H-LAQ in a pharmaceutical composition comprising laquinimod. |
| priorityDate | 2013-03-14^^<http://www.w3.org/2001/XMLSchema#date> |
| type | http://data.epo.org/linked-data/def/patent/Publication |
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