Pharmaceutical preparation containing benzimidazoles

A technology of benzimidazole and compound is applied in the field of pharmaceutical preparations containing benzimidazole compound solid dispersion, and can solve problems such as slow dissolution

Inactive Publication Date: 2009-08-26
SHANGHAI HUIDE MEDICINE SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This patent provides a large number of formulation examples of enteric-coated tablets or enteric-coated pellets containing omeprazole and omeprazole salt, but the formulations with better acid resistance are in the buffer solution of pH 6.0-7.5 Dissolution is slow, and a foreign prescription with good dissolution is found to have a certain amount of degradation in the acid solution

Method used

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  • Pharmaceutical preparation containing benzimidazoles
  • Pharmaceutical preparation containing benzimidazoles
  • Pharmaceutical preparation containing benzimidazoles

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0062] Embodiment 1 enteric-coated pellet preparation containing lansoprazole

[0063] drug layer coating

[0064] The drug layer was added by weight as shown in Table 1 below.

[0065] Table 1 Drug layer formulation of lansoprazole enteric-coated pellets

[0066] Raw materials

Recipe 1

Recipe 2

Recipe 3

Recipe 4

Comparing formula 1 *

Comparing formula 2 *

blank core

250g

250g

250g

250g

250g

250g

Lansoprazole

100g

100g

100g

100g

100g

100g

PVPK30

150g

100g

80g

50g

200g

100g

Sodium dodecyl sulfate

50g

100g

70g

50g

0g

0g

magnesium carbonate

15g

15g

15g

15g

15g

15g

[0067] * Note: the comparative formula is formulated according to the technical scheme disclosed in WO2006069159A2. According to the general knowledge of pharmacy, the ratio of medicine and hydrophilic carrier is less ...

Embodiment 2

[0107] Example 2 Enteric-coated pellet formulation containing esomeprazole

[0108] drug layer coating

[0109] Table 5 Drug layer formulation of esomeprazole enteric-coated pellets

[0110] Raw materials

Recipe 5

Recipe 6

Recipe 7

Recipe 8

blank core

250g

250g

250g

250g

Esomeprazole

80g

80g

80g

80g

PVP K30

160g

120g

100g

60g

Sodium dodecyl sulfate

0g

0g

20g

20g

magnesium carbonate

10g

10g

10g

10g

[0111] The specific preparation method is as follows:

[0112] Take 0.9 liter of 50% ethanol, dissolve magnesium carbonate, add esomeprazole, stir until dissolved, add the prescribed amount of PVP K30 under stirring, and add twelve Sodium Alkyl Sulfate, stir until a homogeneous solution is formed.

[0113] Drug layer coating is carried out in a fluidized bed coating machine, and the specific operating parameters are according to Ex...

Embodiment 3

[0138] Example 3 Enteric-coated pellet preparation containing pantoprazole sodium

[0139] Drug Layer Formulation

[0140] Blank ball core 250g

[0141] Pantoprazole Sodium 110g

[0142] PVPK30 120g

[0143] Poloxamer 188 40g

[0144] Sodium carbonate 50g

[0145] The specific preparation method is as follows:

[0146] Take 1 liter of 50% ethanol, dissolve sodium carbonate, add pantoprazole sodium, stir until dissolved, add PVP K30 and poloxamer under stirring, and stir until forming a uniform solution. The blank pellet core is fluidized in a fluidized spray coating machine (DPL type micro-experimental machine), and the above-mentioned material liquid is spray-coated by adopting the bottom spray method. Concrete operating parameters are according to embodiment 1.

[0147] Barrier Coating

[0148] The pellets coated with the drug layer remain in a fluidized state and continue to be coated with an isolation layer.

[0149] The formula is as follows:

[0150] PVP-S630 3...

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Abstract

The invention provides a solid dispersion of the benzimidazoles and a method for preparing the same. The solid dispersion comprises benzimidazole drugs, surfactant and a solid dispersion hydrophilic carrier material and can also contain an alkaline compound, wherein the solid dispersion hydrophilic carrier material is selected from or a mixture of polyvinylpyrrolidone, polyethylene glycol, poloxamer, hydroxypropyl methyl cellulose, hydroxypropyl cellulose and sugar alcohols. The invention also provides an enteric-coated micro granule containing the benzimidazoles of the solid dispersion and a method for preparing the same. The structure of the micro granule comprises a drug core and an enteric-coated layer from outside to inside, wherein the solid dispersion is arranged in the drug core, and an insolating layer can also be arranged between the drug core and the enteric-coated layer.

Description

technical field [0001] The invention relates to a class of pharmaceutical preparations containing benzimidazole compounds, in particular to a pharmaceutical preparation containing solid dispersions of benzimidazole compounds. Background technique [0002] Proton pump inhibitors (PPI) can strongly inhibit gastric acid secretion and are mainly used for diseases related to excessive gastric acid secretion, such as gastric and esophageal reflux disease and gastric and duodenal ulcers. Combined application with antibiotics can eradicate Helicobacter pylori infection, prevent and treat lesions caused by non-steroidal anti-inflammatory drugs, treat hypersecretory state of Zol-Ellison syndrome, upper gastrointestinal bleeding caused by non-esophageal varices and non-ulcerative Indigestion etc. PPIs are mainly weakly basic benzimidazole compounds, including Omeprazole, Lansoprazole, Pantoprazole, Rabeprazole, and Esomeprazole (Esomeprazole), Leminorazole (Leminorazole), etc. PPI i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4439A61K9/20A61K47/32A61K47/34A61K47/38A61P1/04A61K47/10A61K47/20A61K47/26
Inventor 吴伟张兴旺阙俐陈虎林
Owner SHANGHAI HUIDE MEDICINE SCI & TECH
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