| Title of Invention | "A METHOD FOR PREPARING A PHARMACEUTICAL COMPOSITION" |
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| Abstract | A method for preparing a pharmaceutical composition comprising : (a) an inert hydrosoluble carrier covered with at least one layer containing fenofibrate in a micronized form having a size less than 20 jam, a hydrophilic polymer and, optionally, a surfactant; in which, based on the weight of (a), said inert hydrosoluble carrier makes up from 10 to 80% by weight, said fenofibrate makes up from 5 to 50% by weight, said hydrophilic polymer makes up from 20 to 60% by weight weight, and said surfactant makes up from 0 to 10% by weight; and (b) optionally one or several outer phase(s) or layer(s) of the kind as herein described provided that the percentage of all the ingredients selected does not exceed 100;comprising the steps of: (a) preparing a fenofibrate suspension in micronized form with a particle size below 20 urn, in a solution of hydrophilic polymer and, optionally surfactant; (b) appliying the suspension from step (a) to an inert hydrosoluble carrier; |
| Full Text | DESCRIPTION (COMPLETE) OCR NOT PREPARE DUE TO PRINT PROBLEM WE CLAIM-: 1. A method for preparing a pharmaceutical composition comprising: (a) an inert hydrosoluble carrier covered with at least one layer containing fenofibrate in a micronized form having a size less than 20 pm, a hydrophilic polymer and, optionally, a surfactant; in which, based on the weight of (a), said inert hydrosoluble carrier makes up from 10 to 80% by weight, said fenofibrate makes up from 5 to 50% by weight, said hydrophilic polymer makes up from 20 to 60% by weight, and said surfactant makes up from 0 to 10% by weight; and (b) optionally one or several outer phase(s) or layer(s) of the kind as herein described provided that the percentage of all the ingredients selected does not exceed 100; comprising the steps of: (a) preparing a fenofibrate suspension in micronized form with a particle size below 20 jim, in a solution of hydrophilic polymer and, optionally surfactant; (b) applying the suspension from step (a) to an inert hydrosoluble carrier; (c) optionally, coating granules thus obtained with one or several phase(s) or layer(s). 2. The method as claimed in claim 1, wherein a surfactant is present with fenofibrate and the hydrophilic polymer. 3. The method as claimed in claim 1 or 2, wherein the hydrophilic polymer is polyvinylpyrrolidone. 4. The method as claimed in claim 2 or 3, wherein fenofibrate and the surfactant are co-micronized. 5. The method as claimed in any one of claims 2 to 4, wherein said surfactant is sodium laurylsulfate. 6. The method according to any one of the preceding claims, in which the hydrophilic polymer makes up at least 25% by weight. 7. The method as claimed in any one of the preceding claims wherein the weight ratio of fenofibrate/hydrophilic polymer is comprised between 1/10 and 4/1. 8. The method as claimed in any one of the preceding claims, wherein the weight ratio of fenofibrate/hydrophilic polymer is comprised between 1/2 and 2/1. 9. The method as claimed in any one of the preceding claims, wherein based on the weight of (a), said inert hydrosoluble carrier makes up from 20 to 50% by weight, said fenofibrate makes up from 20 to 45% by weight, said hydrophilic polymer makes up from 25 to 45% by weight, and said surfactant makes up from 0.1 to 3% by weight. 10. The method as claimed in any one of the preceding claims, wherein the individual particle size of said inert hydrosoluble carrier is comprised between 50 and 500 microns. 11. A method as claimed in any one of the preceding claims, wherein the composition has a dissolution of at least 10% in 5 minutes, 20% in 10 minutes, 50% in 20 minutes and 75% in 30 minutes, as measured using the rotating blade method at 75 rpm according to the European Pharmacopoeia, in a dissolution medium constituted by water with 2% by weight polysorbate 80 or with 0.025M sodium lauryl sulfate. 12. The method as claimed in any one of the preceding claims, wherein step (b) is carried out in a fluidized-bed granulator. 13. The method as claimed in anyone of claims 1 to 12, comprising a step in which products obtained from step (b) are compressed. 14. The method as claimed in anyone of claims 1 to 13, comprising a step in which products obtained from step (c) are compressed. 15. A method for preparing a pharmaceutical composition substantially as hereinbefore described with reference to the accompanying drawings. |
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40-del-1998-complete specification (granted).pdf
40-del-1998-Correspondence Others-(27-04-2012).pdf
40-DEL-1998-Correspondence Others-(30-01-2012).pdf
40-del-1998-correspondence-others.pdf
40-del-1998-correspondence-po.pdf
40-del-1998-description (complete).pdf
40-del-1998-Form-27-(27-04-2012).pdf
40-del-1998-Petition-137-(27-04-2012).pdf
40-del-1998-petition-others.pdf
| Patent Number | 187906 | |||||||||
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| Indian Patent Application Number | 40/DEL/1998 | |||||||||
| PG Journal Number | 15/2010 | |||||||||
| Publication Date | 09-Apr-2010 | |||||||||
| Grant Date | 28-Feb-2003 | |||||||||
| Date of Filing | 08-Jan-1998 | |||||||||
| Name of Patentee | LABORATOIRES FOURNIER S.A. | |||||||||
| Applicant Address | 9 RUE PETITOT, 21000 DIJON,FRANCE. | |||||||||
Inventors:
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| PCT International Classification Number | A61K 45/01 | |||||||||
| PCT International Application Number | N/A | |||||||||
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PCT Conventions:
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