Method for producing granules

专利摘要:
Pharmaceutical preparation containing an acid labile compound together with an alkaline reacting compound or an alkaline salt of an acid labile compound optionally together with an alkaline compound as the core material, one or more subcoating layers comprising inert reacting compounds which are soluble or rapidly disintegrating in water, or polymeric, water soluble filmforming compounds, optionally containing pH-buffering alkaline compounds and an enteric coating as well as a process for the preparation thereof and the use in the treatment of gastrointestinal diseases.
公开号:SU1709894A3
申请号:SU874202437
申请日:1987-04-29
公开日:1992-01-30
发明作者:Ингмар ЛЕВГРЕН Курт；Гуннар Пилбрант Оке；Ясумура Мицуру；Моригаки Сатоси；Ода Минору；Охиси Наохиро
申请人:Актиеболагет Хессле (Фирма)；
IPC主号:

专利说明:

This invention relates to the pharmaceutical and pharmaceutical industry and relates to a process for the production of granules.
The aim of the invention is to increase stability. Example1.
Uncoated granules lactose powder 253
at 7 Lactose is anhydrous 167
, I Oxypropylcellulose25
(Compound 1 (according to table) 50 / Sodium lauryl sulfate5
7i) Sour disodium phosphate 1.5
sodium dihydrophosphate 0.1
Distilled water125
The dry ingredients (1) are pre-mixed in a blender.
Granulation liquid (II) containing the suspended active substance was added and the mass was subjected to wet mixing to obtain an appropriate consistency. This wet mass was passed through an extruder and gave a spherical shape to the granules. The granules were dried and classified according to particle size. Intermediate Coated Granules Uncoated Granules 500
- Goxmpropylmethylcellulose2p
- Distilled water400
The polymer solution (III) was sprayed onto uncoated granules in fluidized bed devices. Sprays were placed above the fluidized bed.
Granules with soluble in the intestine coating,
Intermediate coated granules500
Goxypropylmethylcellulose phthalate 57 uCethyl alcohol3
/ Acetone 540
-l ethanol 231
J Olive solution (IV) was sprayed onto intermediate coated granules in fluidized bed devices using spray guns located above the bed. After dehydration to a water content of 0.5%, enteric-coated granules were classified and filled into hard gelatin capsules in an amount of 284 mg, which corresponds to 25 mg of active compound 1. 30 capsules were packed in rigid containers together with a desiccant.
EXAMPLE2. Composition with salt of compound 2 (according to the table).
Uncoated granules / Compound 2, sodium salt (as shown) 339
Mannitol (powder) 2422
Lactose is anhydrous 120
Oh xi propyl cellulose90
Microcrystalline Cellulose60
- / 1-1 sodium lauryl sulfate7
{.D styled water650
The drug was made as in example 1, except that, together with other
ingredients to mixture 1 were added to sodium salt of compound 2. Intermediately coated granules Uncoated granules 500 ScKPropylmethylcellulose 20 Aluminum hydroxide / carbo-1 sodium magnesium 4 I Distilled ibda 400 Granules, intermediate coating of composition III 500.- / xipropylmethylcellulose 20
The two layers of intermediate coating were applied to the uncoated granules in the fluidized bed apparatus in sequential order, as indicated.
Granules with soluble in the intestine coating, g;
Intermediate coated granules500
/ ixypropylmethylcellulose naphthalate57
Cetal alcohol3
 Acetone540
Ethanol
Obtaining granules with a soluble coating described in example 1.
PRI me R 3. Composition with compound 6 (according to the table).
This example is a single unit dosage composition according to the invention.
The core tablets mg Compound 6 (according to the table) 15
Lactose119
Hydroxypropylcellulose (low substituent) 5
Hydroxypropylcellulose1
Talc5
Md (OH) 215
Total160
The tablet cores, the indicated composition and the weight of each 160 mg, were first obtained by known methods.
Separating layer (inner), mg Oxypropylcellulose2
Synthetic hydro. talcite A20x6MdO CO2H12N20 0.3 Separating layer (outer), mg Hydroxypropylcellulose 2
These two separating layers were applied onto the cores using known coating methods.
Intestinal soluble coating layer, mg
Hydroxypropyl methylcellulose phthalate7
Cetyl alcohol0,5
A solution of intestinal coating sprayed A onto the cores, coated with two separating layers, using known methods of applying an enteric coating.
The stability of some of the indicated compounds of the general formula given is presented in the table, and the data on the half-life of the decomposition reaction are given (disgusted in a solution with a pH of 2m 7).
Compound 1: 5 - acetoxy-6-methyl-2 (3-methyl-2-pyridyl) methyl-sulfinyl-1N benzimidazole;
Compound 2: 2- (3,5-dimethyl-2-pyridyl) methyl sulfinyl-5-methyl-1H-benzimidazole;
Compound 3: 2 - {(4-methoxy-2-pyridyl) methyl sulfinyl-5-trifluoromethyl-1H-5-benzimidazole;
Compound 4: 2- (4-methoxy-3-methyl-2-pyridyl) -methyl sulfinyl-5-triftomethyl-1H-benzimidazole;
Compound 5: 2- (5-methyl-4-phenoxy-2-pyridyl) methyl sulfinyl-5-methoxy-1 Ibenzimidazole:
Compound 6: 5-methoxy-2- (4-phenoxy-2-pyridyl) methyl (sulfinyl) -1H-benzimidazole;
Compound 7; 5-ethyl-2 (1-methyl-2-benzimidazolyl) - methyl (supinip) -1H-benzimidazole.
The granules thus prepared in a preferred way differ in x-;
storage stability compared with granules obtained in a known manner.

权利要求:
Claims (1)
[1]
The invention of the method of producing granules by applying to the active substance a coating soluble in the intestine, characterized in that, in order to increase the stability, the compound 5-acetoxy-6-methyl-2 - {(3methyl-2-pyridyl) methyl-sulfinyl-1 N-benzimidazole, 2 - {(3,5-dimethyl-2-pyridyl) methyl-sulfinyl-5-methyl-1 N-benzimidazole, 2- (4-methyl-2-pyridyl) methyl; ulanyl-5-trifluoromethyl- 1H-benzimideSpeed degradation (conversion) of compounds of general structure
ash, 2- (4-methoxy-3-methyl-2-pyridyl) methyl sulfanyl -5-trifluoromethyl-, 1H-benzimidzol, 2 - {(5-ethyl-4-phenoxy-2-pyridyl) methyl sulfanyl -5- methoxy-1H-benzimidazole, 5-methoxy-2- (4-phenoxy-2-pyridyl) methyl (sulfanyl) -1H-benzimidazole, 5ethyl-2- {1-methyl-2-benzimidazolyl) methyl (sulfanyl) - N-benzimidazole with an alkaline compound of magnesium hydroxide, or phosphate, or aluminum hydroxide of magnesium of the formula A1203-6 MDO CO2 x 12H20 is coated with one or more layers that are inert to the interaction, including hydroxypropylmethylcellulose with a thickness of at least 2 microns.
A-SZ-8

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法律状态:

优先权:

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申请号 | 申请日 | 专利标题

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