前苏联专利SU1706373A3 Method for obtaining a means with controlled release of active substance

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专利摘要:
Controlled release preparation containing a number of insoluble beads applied with one or more pharmaceutically active compounds, a method for the production thereof and the use in a treatment where a controlled release of a pharmaceutically active compound is needed.
公开号:SU1706373A3
申请号:SU884355516
申请日:1988-04-04
公开日:1992-01-15
发明作者:Давид Дахлиндер Ларс-Эрик；Андерс Сандберг Джон；Ове Йоханссон Матс；Альберт Шегрен Джон
申请人:Актиеболагет Хессле (Фирма)；
IPC主号:

专利说明:

The invention relates to the chemical and pharmaceutical industry, in particular to methods for producing an agent with controlled release of the active compound.
The purpose of the invention is to provide a more even separation of the target product.
Example 1. The cores contain. g:
Metoprololfumarate Methylene Chloride Ethanol (95%) Silicon Dioxide (0.15-0.25 mm) Polymer layer contains, ethylcellulose
1 hour 9618 3888
375
(10 сP) .265.6 D) xypropylmethylcellulose 58.4 Acetyltributyl citrate 36.0 Methylene Chloride 6X1 Isopropyl Alcohol 15HH Metoprolol fumarate is sprayed with a solution 95% using a 95% solution with a solution in a solution in a mixture of 95%. . On 400 g of balls prepared in this way (fractions O, -0.63 mm), coating is applied in the form of a polymer solution containing ethylcellulose (U cP), hydroxypropylmethylcellulose, and acetyltributyl citrate,
05
with
with

O4
by spraying a solution of these substances in methylene chloride and isopropyl alcohol. The coated gel pellets are then filled into hard gelatin capsules.
Examples 2, 3 and 1G (comparative).
The content of components in the cores, g, according to the examples given in table 1.
Polymer layer. On 00 g of granules (fractions Q, k - 0.5 mm), coatings are applied using a composition that includes:
Ethylcellulose (10 cp) 52.3 Acetyltributyl Citrate 8.6 Methylene Chloride 1111 Isopropyl Alcohol 218 Spray cores of silica, glass and sodium chloride with metoprolol succinate, using a solution in 95% alcohol and methylene chloride. Shaoiki molded in this way are coated using a polymer solution containing ethyl cellulose (U cP) and etstiltributiltitratitrat, dissolved in methylene chloride and isoprolyl alcohol, by spraying. An adjustable and permanently release of the active substance is achieved when this substance is applied to silicon dioxide or glass, whereas when using a core of soluble sodium chloride, the initial release rate is higher (see comparative example 2, as pot material, soluble potassium chloride is used as the core material).
Example 2 (comparative). The cores contain, g:
Metoprolol succinate 2000 Potassium chloride (0.1-0.2 mm) 00 Methylene chloride 13360
Ethanol (95%) 7900
Polymer layer.
On 00 g of granules in accordance with comparative example 2, the coating using a composition comprising, g:
Ethyl cellulose (10 cp) 135.3
Acrylic copolymer
and methacrylic acids with low content of quaternary ammonium GROUPS / hc Product Eudrap, 27, Detyltributyl citrate 27, Methylene chloride Y69 Isopropyl alcohol 661 Granules are prepared as described in the previous examples.
Examples b-6. The content of components in the cores, g, in this examples are given in table 2.
Polymer layer.
On 00 g of granules in accordance with Examples A-6, coating is applied using compositions whose content of components, g, is given in Table 8.
Preparations are prepared as described.
In tab. k presents data on the release of metoprolosuccinate for 20 hours. All drugs are characterized by controlled release of the drug over a long period of time.
Example 7. The cores contain, g:
Magnesium chloride
(hexahydrate) 1100
Stanol (99.5%) 6200
Silicon dioxide
(0.15-0.30 mm) AOO, the polymer layer contains, g:
Ethyl cellulose
(50 сП) 533
Methylene chloride107
Isopropyl alcohol5 81 Sprayed with magnesium chloride
(MgClg) silica cores using a solution in 99.5% ethanol. For 00 g of balls thus formed, a coating of ethyl cellulose (50 cP) is used using a solution in methylene chloride and isopropyl alcohol, resulting in granules containing mg / g MgCl. When tested in laboratory conditions, it was found that the amount of released medication was $ 38 after 1 hour, 58% after 2 hours and $ 82 after 6 hours.
Will V. Seltseviiii contain, g:
Ampicillin
(sodium salt) 600 Ethanol (95%) S31 Purified water 1020 Glass (0.5 mm) 500 Polymer layer contains, g: ethyl cellulose
(100 сП) 15 Methylene Chloride 600 Isopropyl alcohol 150 With the use of ampicillin sodium salt, glass cores are sprayed with a solution in a mixture of ethanol and water. Then, 500 g of beads with ampicillin (sodium salt) are coated using a polymer solution of ethyl cellulose (100 cP) in methylene chloride and isopropyl alcohol. When tested in laboratory conditions and solubility, it was found that the balls isolated 50% of the contained drug after 0 min.
P
9. Core soderr and meper, g:
Metoprolol succinate
Methylene chloride
Ethanol ()
Silicon dioxide
(0.15-0.25 mm
The polymer layer contains, g
Ethylcellulose N-10
Hydroxypropylmethyl Cellulose
Acetyltitrate Il-citrate
Methylene chloride
Isopropyl alcohol
Pills for tablets
Microcrystalline
cellulose
Corn starch
Powdered
lactose
Polyficone
Purified water
Magnet stearate
Coatings applied to tablets 12500 pcs.), G:
Okeipropilmetil cellulose (6 SP)
Polyethylene glycol 6000
Pigment dioxide
titanium
9678 3888
375
166.2
39.0
22,8
3889
978
29.3 67.1
0.3
55.5
ST, 7
1.2
259.6 39.9 39.9
0
five
0
five
0
five
0
five
0
five
Purified water 1356 Paravin 1.6 Metoprolol succinate is sprayed with silica cores in accordance with the method described in the previous examples. On 00 g of beads prepared in this way (fractions 0, -0.63 mm), coating is applied using the polymer solution described. Coated beads with metoprolol succinate are mixed with additives in equal proportions, and after the addition of magnesium stearate, 0.1%, the mixture is dried and pressed into tablets. These tablets are then coated in a coating reservoir using the polymer solution described.
Very small particles (0.15-0.25 mm) of dense silicon deuskie used as the core material cause a high content of the drug in small molded balls (0, -0.63 mm), which allows reducing the size of the finished product.
A uniform dose of 190 mg of metoprolol succinate (equivalent to 200 g of meto-prololtartrate) in a controlled release preparation according to the invention was administered to 10 healthy men. Plasma concentrations of metoprolol were compared to plasma concentrations after a single dose in a tablet with a constant release (Durules®), based on an insoluble matrix containing 200 mg of metoprolol tartrate. The preparation according to the invention provides an almost constant plasma concentration profile of metoprolol, while the matrix tablet has a high peak plasma concentration during the first hours after administration to the body.
Received by the proposed method, the compositions provide an adjustable and more even allocation in comparison with the means obtained in a known manner.

权利要求:
Claims (1)
[1]
Invention Formula
A method for producing an agent with controlled release of the active compound by depositing the active compound and the outer layer onto the core, characterized by
the fact that, in order to provide a more even release of the target product, metoprolol fumarate, or metoproluccinate, or ampicillin sodium salt, dissolved in a mixture of ethanol and methylene chloride, is applied on the silicon dioxide core as the active substance; 0.25 mm or from
0.2 mm glass, then the solvent is removed by drying, after applying the active substance, 0, -0.63 mm granules are applied to which the outer layer containing ethylcellulose, hydroxypropylmethylcellulose, acetyltributyl citrate or ethylcellulose and acetone is applied. tyltributyl citrate.
Table 1
Silicon dioxide (0.15 - 0.25 mm)
Glass (0.2 mm)
Sodium chloride (0.15-0.25 mm)
Methylene chloride
Ethanol ()
Silicon dioxide (0.15 - 0.2 mm)
Silicon dioxide (0.25 - 0.3 mm)
Silicon dioxide (O, 4 - 0.5 mm)
375
375
table 2
9613
9618
3888
3888
375
375
Isopropyl alcohol
Spreadsheets
In total, the isolation of laboratory conditions of metolrolol i phosphate buffer at hH 6.8. / Methods: device and US Pharmacopoeia, bristle with a scab rotated e) 00
Table 3
1114
858

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同族专利:

公开号 | 公开日

DK287687D0|1987-06-04|

AU6529686A|1987-05-05|

DK287687A|1987-06-04|

PL261801A1|1987-08-10|

FI881657A0|1988-04-08|

CN1025283C|1994-07-06|

JPS63501080A|1988-04-21|

CS729486A2|1989-08-14|

CY1764A|1994-07-15|

US4927640A|1990-05-22|

KR940000098B1|1994-01-05|

AU593038B2|1990-02-01|

PT83508A|1986-11-01|

HU199677B|1990-03-28|

NZ217697A|1989-04-26|

DD266734A5|1989-04-12|

JP2560019B2|1996-12-04|

ES2003139A6|1988-10-16|

HUT47843A|1989-04-28|

WO1987002240A1|1987-04-23|

GR862526B|1987-02-09|

EP0277127A1|1988-08-10|

IE58967B1|1993-12-01|

PT83508B|1989-05-31|

FI881657A|1988-04-08|

EP0277127B1|1991-04-10|

SE8504720L|1987-04-12|

KR870700344A|1987-12-28|

IE862493L|1987-04-11|

SE450087B|1987-06-09|

CN86106651A|1987-04-15|

DK175592B1|2004-12-13|

IS1530B|1993-02-23|

FI97686C|1997-02-10|

FI97686B|1996-10-31|

IS3152A7|1987-04-12|

SE8504720D0|1985-10-11|

PL148624B1|1989-11-30|

CS268819B2|1990-04-11|

ZA866861B|1987-05-27|

PH24739A|1990-10-01|

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法律状态:

优先权:

申请号 | 申请日 | 专利标题

SE8504720A|SE450087B|1985-10-11|1985-10-11|GRAINS WITH CONTROLLED RELEASE OF PHARMACIFICALLY ACTIVE SUBSTANCES APPLIED SIGNED ON A COMPACT INSULABLE NUCLEAR MATERIAL|LTRP1089A| LT2310B|1985-10-11|1993-09-22|MATERIALS FOR THE ADJUSTMENT OF THE REGULATORY ACTIVE COMPOUND|

LV930687A| LV5394A3|1985-10-11|1993-11-24|Sediment for obtaining a medicament with controlled release of the active substance|

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