Processing

Please wait...

Settings

Settings

1. WO2007011139 - SUSTAINED-RELEASE TABLET CONTAINING PAROXETINE HYDROCHLORIDE AND MANUFACTURING METHOD THEREOF

Note: Text based on automatic Optical Character Recognition processes. Please use the PDF version for legal matters

Claims
[1] A paroxetine hydrochloride -containing sustained-release tablet, comprising
paroxetine hydrochloride, a highly viscous polymer, a low viscous hydrox- ypropylmethylcellulose and a pharmaceutically acceptable excipient.
[2] The paroxetine hydrochloride-containing sustained-release tablet of claim 1,
wherein the highly viscous polymer is at least one selected from the group
consisting of a highly viscous hydroxypropylmethylcellulose; an 8:2(w/w)
physical mixture of polyvinylacetate and povidone; and an ethylcellulose.
[3] The paroxetine hydrochloride-containing sustained-release tablet of claim 2,
wherein the viscosity of the highly viscous hydroxypropylmethylcellulose is
between 3,000 and 5,600 cP when its viscosity is measured at 2O0C as 2 wt% of aqueous solution.
[4] The paroxetine hydrochloride-containing sustained-release tablet of claim 2,
wherein the highly viscous polymer comprises both a highly viscous hydroxypropylmethylcellulose; and an 8:2(w/w) physical mixture of polyvinylacetate and povidone.
[5] The paroxetine hydrochloride-containing sustained-release tablet of claim 1,
wherein the viscosity of the low viscous hydroxypropylmethylcellulose is
between 80 and 120 cP when its viscosity is measured at 2O0C as 2 wt% of
aqueous solution.
[6] The paroxetine hydrochloride-containing sustained-release tablet of claim 1,
wherein the pharmaceutically acceptable excipient comprises mannitol and
lactose.
[7] A paroxetine hydrochloride-containing sustained-release tablet, comprising
between 6 and 14% by weight of paroxetine hydrochloride; between 6 and 20% by weight of a highly viscous polymer; between 20 and 40% by weight of a low viscous hydroxypropylmethylcellulose; and between 30 and 60% by weight of pharmaceutically acceptable excipient based on the total weight of the tablet.
[8] The paroxetine hydrochloride-containing sustained-release tablet of claim 7,
wherein the highly viscous polymer is at least one selected from the group
consisting of a highly viscous hydroxypropylmethylcellulose; an 8:2(w/w)
physical mixture of polyvinylacetate and povidone; and an ethylcellulose.
[9] The paroxetine hydrochloride-containing sustained-release tablet of claim 7,
wherein the highly viscous polymer comprises between 4 and 10% by weight of 8:2(w/w) physical mixture of polyvinylacetate and povidone and between 2 and 10% by weight of highly viscous hydroxypropylmethylcellulose based on the
total weight of the tablet.

[10] The paroxetine hydrochloride-containing sustained-release tablet of claim 7,
wherein the pharmaceutically acceptable excipient comprises mannitol and
lactose.
[11] A method for preparing a paroxetine hydrochloride-containing sustained-release tablet, comprising the acts of:
(51) mixing paroxetine hydrochloride and mannitol;
(52) dissolving 8:2(w/w) physical mixture of polyvinylacetate and povidone or ethylcellulose in lower alcohol to make a binding solution;
(53) making granules using the binding solution of the (S2) act and the mixture of the (Sl) act;
(54) mixing the granules of the (S3) act, a highly viscous hydroxypropylmethyl- cellulose, a low viscous hydroxypropylmethylcellulose and a pharmaceutically
acceptable excipient, and tabletting them; and
(55) enteric-coating the tablet prepared in the (S4) act.
[12] The method of claim 11, wherein at least one ingredient selected from the group consisting of a pharmaceutically acceptable excipient; an 8:2(w/w) physical
mixture of polyvinylacetate and povidone; and an ethylcellulose is further mixed with paroxetine hydrochloride and mannitol in the (Sl) act.