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|Title:||Method of preparing comtrolled release fenofibrate|
|Abstract:||A process for preparing a controlled release medicine containing fenofibrate in an intermediate layer in the form of cyrstalline microparticles included within pores of an inert matrix prepared by a process involving the sequential steps of dampening said inert core with a solution based on said biner, then projecting said fenofibrate microparticles in a single layer onto said dampened core, and thereafter drying before said solution based on said binder dissolves said fenofibrate microparticles and repeating said three steps in sequence until said intermediate layer is formed.|
|Inventor(s):||Boyer; Jean-Francois (Houdan, FR)|
|Assignee:||Ethypharm (Houdan, FR)|
|Filing Date:||Oct 12, 1988|
|Claims:||1. A method for preparing a medicine involving a controlled release of fenofibrate in aqueous medium, said medicine being in the form of a granule that comprises an inert core in its center, a protective outer coating and an intermediate layer based on fenofibrate, said process comprising forming said intermediate layer on said inert core by performing in a time duration of the order of one or two minutes three sequential steps (i), (ii) and (iii) as follows: |
(i) dampening said inert core with a solution based on a binder comprising a solvent selected from the group consisting of water and alcohols,
(ii) then projecting onto said dampened core in a single layer fenofibrate crystalline microparticles that have diameters less than 30 microns,
(iii) and thereafter drying before said solution based on said binder dissolves said fenofibrate microparticles, and repeating said three steps in sequence until said intermediate layer is formed so that said fenofibrate microparticles therein are included in the pores of an inert matrix constituted by said binder.
2. A method according to claim 1 wherein said binder constituting said inert matrix is a substance selected from the group consisting of methacrylic polymers, polyvinylpyrolidone, mixtures of methacrylic polymers and polyvinylpyrolidone cellulose derivatives and polyethylene glycols.
3. A method according to claim 1 wherein said inert core is prepared by spraying an aqueous sugar solution containing a starch suspension at about 50.degree. C. onto sugar crystals having a diameter of about 0.3 mm until their diameter reaches about 0.6 mm.
4. A method according to claim 3 wherein said sugar in said crystals having a diameter of about 0.3 mm is selected from the sugar group consisting of glucose, sucrose, lactose and their equivalents.
5. A method according to claim 3 wherein said starch in said suspension is maize starch.
6. A method according to claim 3 wherein said inert core comprises about 25% by weight starch and about 75% by weight sugar.
7. A method according to claim 1 wherein said protective outer layer is made of a substance selected from the group consisting of methacrylic polymers, polyvinylpyrolidone, and mixtures of methacrylic polymers and polyvinylpyrolidone, and cellulose derivatives and polyethylene glycols.
8. A method according to claim 1 wherein said protective outer layer represents about 1% by weight of said granule.
9. A method according to claim 1 wherein said process is conducted in a turbine, and said drying operation is carried out with the help of an air flow.
10. A method according to claim 1 wherein said process is repeated until said intermediate layer contains a quantity of said binder such that the quantity of fenofibrate released in one hour in an aqueous medium is greater than 65%.
11. A method according to claim 3 wherein said sugar in said aqueous solution is selected from the sugar group consisting of glucose, sucrose, lactose and their equivalents.
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