Method of treating a disease condition susceptible to baclofen therapy

a disease condition and effective treatment technology, applied in the field of effective methods of treating a disease condition susceptible to baclofen therapy, can solve the problems of reduced bioavailability of release preparations, increased plasma concentrations, and increased blood plasma concentrations. , to achieve the effect of increasing plasma levels

US20110200671A1Inactive Publication Date: 2011-08-18SUN PHARMA INDS
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Patent Information

Authority / Receiving Office
US · United States
Patent Type
Applications(United States)
Current Assignee / Owner
Publication Date
2011-08-18
Estimated Expiration
Not applicable · inactive patent

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Abstract

The present invention discloses a method of treating a disease condition susceptible to baclofen therapy, said method comprising orally administering once-a-day in the evening a controlled release drug delivery system comprising baclofen or its pharmaceutically acceptable salt or its derivatives and pharmaceutically acceptable excipients.
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Description

FIELD OF INVENTION

[0001] The present invention relates to an effective method of treating a disease condition susceptible to baclofen therapy, said method comprising administering a controlled release drug delivery system of baclofen or its pharmaceutically acceptable salts or its derivatives.

[0002] The present invention also relates to an effective method of treating disease conditions susceptible to baclofen therapy, said method comprising administering a controlled release drug delivery system of baclofen or its pharmaceutically acceptable salts or its derivatives and to the use of baclofen for such treatment.BACKGROUND OF THE INVENTION

[0003] U.S. Pat. No. 3,471,548 disclosed 4-amino-3-(p-chlorophenyl)butyric acid). 4-amino-3-(p-chlorophenyl)butyric acid) designates the R-isomers, the S-isomer and mixtures of R and S isomers including the racemate. Baclofen is indicated in many disease conditions such as for alleviating signs and symptoms of spasticity resulting from multiple sclero...

Examples

example 1

[0076]This example represents an embodiment of the controlled release drug delivery system which is gastric retention drug delivery system comprising baclofen. It is prepared according to formulae given Table 1 below.

TABLE 1first region of second compositionS.Qty in% by weight of theNo.Ingredientsmgdrug delivery system1Baclofen353.252Mannitol32430.123Hydroxypropyl Cellulose -mw807.431150; apparent viscosity1500-3000 at 1% w / v4Colloidal silicon dioxide50.465Talc12.51.666Magnesium stearate12.51.167Hydrogenated Vegetable oil20.01.868Mannitol46.04.279Water soluble protective20.01.85film coating based on lowviscosity hydroxypropyl-methyl cellulose

[0077]First Region of Second Composition

[0078]Table 1 gives the formula for the preparation of the first region of the second composition. The first region is the formulation that is filled into gelatin capsules. The polymer hydroxypropylmethyl cellulose, low viscosity that does not function as a rate controlling polymer but only serve as a aid ...

example 2

[0088]A gastric retention drug delivery system comprising baclofen was prepared as mentioned in Table 8 below.

TABLE 8Composition detailsmg per weightof drug% by weight of theIngredientsdelivery systemdrug delivery systemFirst region of the second compositionBaclofen22.55.49Fumaric acid10.02.44Mannitol264.564.5Hydroxypropyl cellulose68.016.59Sodium bicarbonate30.07.32Colloidal silicon dioxide5.01.22Talc5.01.22Magnesium stearate5.01.22Second region of the second compositionAlginic acid54.35Coated to aSodium bicarbonate10.87weight gain ofSodium starch glycolate27.17about 25% byMannitol13.59weight of the corePolyvinylpyrrolidone16.30Talc3.26Polysorbate1.09Third compositionPolycarbophil4.41Coated to aSodium bicarbonate8.82weight gain ofMethacrylic acid copolymer35.29about 18% byEudragit S-1008.82weightMannitol35.29Sodium starch glycolate10.29Polysorbate0.59Polyethylene glycol1.47Talc2.35Diethyl phthalate6.62First compositionBaclofen7.5Coated to aPolyvinylpyrrolidone1.50weight gain ofTalc...

example 3

[0090]A gastric retention drug delivery system comprising baclofen was prepared as mentioned in Table 9 below.

TABLE 9Quantity(% w / w of the drugIngredients(mg / capsule)delivery systemFirst region of the second compositionBaclofen22.55.49Fumaric acid10.02.44Mannitol200.548.90Polycarbophil108.026.34Sodium bicarbonate54.013.17Colloidal silicon dioxide5.01.22Talc5.01.22Magnesium stearate5.01.22

[0091]The first region of the second composition was obtained by blending the excipients listed in Table 10 with baclofen and filling it in a hard gelatin capsule. The capsule was then coated with a second region of the second composition and third composition similar to example 2 described above.