Method of producing solid drug form methoprolol having controlled releasing

专利摘要:
Controlled release preparation containing a number of beads comprising a salt of metoprolol as the main soluble component, a method for the production thereof and the use in the treatment of cardiovascular disorders.
公开号:SU1760969A3
申请号:SU864028342
申请日:1986-10-10
公开日:1992-09-07
发明作者:Эрик Йенссон Улф；Альберт Сьегрен Йен
申请人:Актиеболагет Хессле (Фирма)；
IPC主号:

专利说明:

cl
with
The invention relates to the chemical and pharmacological industry and concerns a method for producing a solid dosage form of metoprolol with controlled release.
The aim of the invention is to increase the time period for the release of the target product.
The method is carried out as follows.
The method of obtaining.
The method of making a controlled release formulation is another aspect of this invention. After the initial formation of metoprolol containing beads, the obtained beads are coated with the polymer layer described in the examples. The polymer mixture is dissolved
in an organic solvent such as ethanol, isopropyl alcohol and / or methylene chloride. The spraying can be carried out in a coating bath, but preferably this process is carried out in an upper-liquefied layer. Ethylcellulose may also be applied from an aqueous dispersion (latex).
The preparation obtained in accordance with this invention is particularly effective in treating disorders of the cardiovascular system, and the method for treating such conditions is another aspect of this invention.
The invention is illustrated by the following examples.
Example
Fumarat Metopropol 1440 g
Methylene chloride 9618 g
NJ ON Oh Yu Oh Oh
 SLE
Ethanol 95% 3888 g
02 (0.15-0.25 mm),; -, - 375 g
Polymer layer ethyl cellulose with a viscosity of 10 centipauz265.6 g
Hydroxypropyl methylcellulose58, 4 g
Acetyltributylcitrate36.0 g
Methylene chloride 6141 g
Isopropyl alcohol 1544 g
In a fluidized bed granulator, metoprolol fumarate is sprayed onto silica cores from a solution of 95% methanol, 40 g of the balls (granules) thus obtained (fractions 0.4-0.63 mm) are coated with a polymer layer containing ethyl cellulose. with a viscosity of 10 centipause, hydroxypropyl methylcellulose and acetyl tributyl citrate, by spraying a solution of these substances in methylene chloride and isopropyl alcohol. The coated balls are then placed in hard gelatin capsules. PRI me R 2.
Metoprolol succinate1440 g
Methylene chloride 9618 g
Ethanol 95% 3888 g
02 (0.15-0.25 mm) 375
Ethyl cellulose polymer layer with a viscosity of 50 centipauz 168.1 g
Hydroxypropyl methylcellulose 36, 9 g
Acetyltributylcitrate22.8 g
Methylene chloride 4167 g
Isopropyl alcohol815 g
Supplements for tablets. Microcrystalline cellulose470.3 g
Corn
starch117.6 g
Potato starch10.6 g
Purified water 342.2 g
Magnesium stearate 1.2 g
Metoprolol succinate is sprayed onto silica silica cores in accordance with the method described in Example 1. 400 g of the granules thus formed are coated with a polymer film containing ethyl cellulose with a viscosity of 50 centipoise, hydroxypropyl methyl cellulose, and acetyl tributyl citrate. Additional weight for the tablets was obtained by wet granulation of the dry mixture of macrocrystalline cellulose and corn starch with an aqueous solution of potato starch in a planetary mixer. Equal amounts (600 g) of active and additional granules were eventually mixed with magnesium stearate 0.1% and pressed into tablets.
PRI me R 3.
Metoprolol 100% succinate in the form of dense spherical granules with an average particle size of 0.42 mm.
400 g of succinate pellets
metoprolol with particles less than 0.63 mm was coated with a mixture of the following substances: ethyl cellulose with a viscosity of 10 centipauses 177.1 g
Hydroxypropyl methylcellulose 38, 9 g
Acetyltributyl citrate24.0 g
Methylene chloride 4094 g
Isopropyl alcohol 1029 g
From the obtained beads, pharmaceutical preparations were molded in accordance with the methods described above. Example 4. Metoprolol succinate 1440 g
Methylene chloride 9618 g
Ethanol 95% 3888 g
5102 (0.15-025 mm) 375 g
Polymer layer. Ethyl cellulose-10166,2
Hydroxypropyl methylcellulose39, 0
Acetyltributylcitrate22.8 g
Methylene chloride 3888 g
Isopropyl alcohol978 g
Supplements for tablets. Microcrystalline cellulose 429.3 g
Corn starch67.1 g
Powdered
lactose 40.3 g
Polyvidone55.5 g
Purified water314.7 g
Magnesium stearate 1.2 g
Coating for tablets (12,500 tablets)
Hydroxypropyl methylcellulose159, 6 g
Polyethylene glycol 600039,9 g
Colored titanium dioxide39.9 g
Purified water1356 g
Special paraffin1,6g.
Metoprolol succinate was sprayed onto the silica cores in accordance with the method described above.
Examples 1 and 2. 400 g of the balls thus obtained (fraction 0.4-0.63 mm) are coated with a polymer mixture, also described by yours. The resulting beads with metoprolol succinate coating are mixed with the additives in equal parts and, after adding 0.1% magnesium stearate, the dry mixture is pressed into tablets. Finally, these tablets are coated in a coating bath using the method described above.
PRI me R 5.
S-Enantiomeric sorbate of metoprolol in the form of dense spherical granules fraction of 0.4-0.63 mm.
40 g of the above sorbate metorpol granules with a particle size of less than 0.63 mm along with 360 g of ideal granules with a particle size in the range of 0.75-1.0 mm were coated with a mixture of the following substances:
Ethylcellulose with viscosity
Yusantipauz51,7
Hydroxypropyl methylcellulose 11 .3 g
Acetyltributyl citrate 7.0 g
Methylene chloride 1194 g
Isopropyl alcohol300 g.
From the obtained beads, pharmaceutical preparations are molded in accordance with the methods described above.
Biopharmaceutical research. Plasma concentrations of metoprolol after administration of a single dose of a controlled release preparation containing 190 mg of metoprolol succinate in accordance with Example 4 of the invention, and plasma concentrations after administration of a single dose of drug durules R containing 200 mg of metoprolol tartrate are shown in the attached Figure 2. -190 mg of succinic acid salt equivalent to 200 ml of metoprolol tartrate. The comparison was made in 10 people. Each result represents the average data obtained from 10 subjects. As can be seen, the drug in accordance with this isotophenia allows to obtain an almost constant concentration of metoprolol for more than 20 chus, while an insoluble metric preparation creates an undesirably high concentration in lpesm during the first hours after the administration of the drug.
Reducing the frequency of heartbeats during physical exertion,
12 subjects were given a usual pill containing 100 mg of meuprolol tartrate once a day, after which the frequency of heartbeats during exercise on the fifth day of treatment was measured and compared with a decrease in the frequency of heartbeats during exercise on the fifth day of treatment in subjects which were given a controlled release formulation according to Example 4 of this invention, containing 95 mg metoprolol succinate (equivalent to 100 mg metoprolol tartrate). A decrease in the frequency of heartbeats is illustrated in Figure 3. As can be seen, the preparation of the present invention provides uniform pharmacodynamic action for 24 hours.
The best embodiment of this invention is currently considered to be Example 1.

权利要求:
Claims (1)
[1]
Invention Formula
The method of obtaining a solid dosage form of metoprolol with controlled release by applying a membrane-forming solution on the core, and in order to increase the time period for the release of the target product, on the core of silicon 0.15-2 mm in size are applied to salts of metoprolol selected from the group consisting of succinate or fumarate or sorbate 1-enanteomer from ethanol solution, spray coated with membrane-forming solution containing ethyl cellulose and hydroxypropylmethyl cellulose obtained e granules with a size of 0.25-2 mm are placed in gelatin capsules or compressed into tablets with excipients.

类似技术:

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同族专利:

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公开号 | 公开日

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FI864108A0|1986-10-10|

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FI864108A|1987-04-12|

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LV10914A|1995-12-20|

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GB2181348B|1989-09-13|

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DE3680450D1|1991-08-29|

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EP0220143A1|1987-04-29|

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UA39162C2|2001-06-15|

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GB2181348A|1987-04-23|

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IE862492L|1987-04-11|

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IE59053B1|1993-12-15|

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CN1023293C|1993-12-29|

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PT83509B|1989-05-31|

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IS1529B|1993-02-23|

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UA26211A|1999-07-19|

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DK165939B|1993-02-15|

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US4957745A|1990-09-18|

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NO863997L|1987-04-13|

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LV5751B4|1997-06-20|

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SE8504721D0|1985-10-11|

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GR3002571T3|1993-01-25|

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HUT42324A|1987-07-28|

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PL261802A1|1987-08-10|

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NZ217696A|1989-05-29|

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JPS6296420A|1987-05-02|

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DD259789A5|1988-09-07|

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DE220143T1|1989-01-26|

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SE8504721L|1987-04-12|

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DK165939C|1993-07-05|

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CY1616A|1992-07-10|

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JPH0759506B2|1995-06-28|

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PH22277A|1988-07-14|

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EP0220143B1|1991-07-24|

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SE455836B|1988-08-15|

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DK478186D0|1986-10-07|

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AT65391T|1991-08-15|

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LTIP1679A|1995-07-25|

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HU197839B|1989-06-28|

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ES2003863A4|1988-12-01|

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FI88579C|1993-06-10|

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IS3151A7|1987-04-12|

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SG95291G|1992-01-17|

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LV5751A4|1996-12-20|

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AU588630B2|1989-09-21|

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DZ994A1|2004-09-13|

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KR940000100B1|1994-01-05|

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LTIP1680A|1995-07-25|

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GB8623048D0|1986-10-29|

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ZA869860B|1987-05-27|

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HK101791A|1991-12-20|

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CN86106588A|1987-04-08|

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LV10913B|1996-08-20|

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LT3951B|1996-05-27|

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PT83509A|1986-11-01|

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NO172276B|1993-03-22|

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LV10913A|1995-12-20|

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KR870003778A|1987-05-04|

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FI88579B|1993-02-26|

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CA2904155A1|2013-03-15|2014-09-18|David Barnes|Compositions and methods for administration to subjects with dysphagia|

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申请号 | 申请日 | 专利标题

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SE8504721A|SE455836B|1985-10-11|1985-10-11|PREPARATION WITH CONTROLLED RELEASE CONTAINING A SALT OF METOPROLOL AND METHOD FOR PREPARING THIS PREPARATION|

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