Risperidone osmotic pump controlled release tablets and preparation method thereof

An osmotic pump controlled-release, risperidone technology, which is applied in the directions of pharmaceutical formulations, medical preparations containing active ingredients, and medical preparations with non-active ingredients, etc., can solve problems such as difficulties in industrial production and increase in production costs.

Inactive Publication Date: 2009-01-14
INST OF PHARMACOLOGY & TOXICOLOGY ACAD OF MILITARY MEDICAL SCI P L A
View PDF1 Cites 9 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It has a double-layer tablet core and a wrapped semi-permeable controlled-release coating film: the double-layer tablet core includes two parts: the drug-containing layer and the push layer. The corresponding special equipment increases the production cost and brings difficulties to industrial production

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Risperidone osmotic pump controlled release tablets and preparation method thereof
  • Risperidone osmotic pump controlled release tablets and preparation method thereof
  • Risperidone osmotic pump controlled release tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Prescription composition (1000 tablets)

[0039] Chip:

[0040] LPT 2.0g

[0041] Citric acid 2g

[0042] PVP K30 14g

[0043] HPMC 4g

[0044] Lactose 200g

[0045] Magnesium Stearate 1.5g

[0046] Coating solution:

[0047] Cellulose acetate 45mg / ml

[0048] PEG3350 5mg / ml

[0049] Acetone: water 95:5 (V / V)

[0050] Pass the risperidone and the auxiliary materials except the lubricant through a 60-mesh sieve, put them in a container and mix well. Add ethanol: water (70:30, volume ratio) to make a soft material, granulate with a 20-mesh sieve, and dry in a 45°C oven. Sieve through a 18-mesh sieve, add magnesium stearate, press into tablet cores, and place in a coating pan for coating. The coated tablet was dried in a drying oven at 50°C for 12 hours to solidify the coating film. Use a laser drilling machine to prepare a small hole with a diameter of 0.2-1.0 mm on one side of the core.

Embodiment 2

[0052] Prescription composition (1000 tablets)

[0053] Chip:

[0054] LPT 4.0g

[0055] Citric acid 4g

[0056] PVP K30 14g

[0057] HPMC 6g

[0058] Lactose 40g

[0059] Mannitol 160g

[0060] Magnesium Stearate 1.5g

[0061] Coating solution:

[0062] Cellulose acetate 45mg / ml

[0063] PEG4000 5mg / ml

[0064] Acetone: water 95:5 (V / V)

[0065] Pass the risperidone and the auxiliary materials except the lubricant through a 60-mesh sieve, put them in a container and mix well. Add ethanol: water (70:30, volume ratio) to make a soft material, granulate with a 20-mesh sieve, and dry in a 45°C oven. Sieve through a 18-mesh sieve, add magnesium stearate, press into tablet cores, and place in a coating pan for coating. The coated tablet was dried in a drying oven at 50°C for 12 hours to solidify the coating film. Use a laser drilling machine to prepare a small hole with a diameter of 0.2-1.0 mm on one side of the core.

Embodiment 3

[0067] Prescription composition (based on 1000 tablets)

[0068] Drug-containing layer:

[0069] Risperidone 2.0g

[0070] Polyoxyethylene (MW20,000) 80g

[0071] NaCl 29.3g

[0072] Magnesium Stearate Appropriate amount

[0073] 10% Povidone K30 Alcohol Liquid Appropriate amount

[0074] Boost layer:

[0075] Polyoxyethylene (MW5,000,000) 95.8g

[0076] NaCl 26g

[0077] Fe 2 o 3 1.3g

[0078] Magnesium Stearate Appropriate amount

[0079] 10% Povidone K30 Alcohol Liquid Appropriate amount

[0080] Coating solution:

[0081] Cellulose acetate 48mg / ml

[0082] PEG3350 2mg / ml

[0083] Acetone: water 97:3 (V / V)

[0084] The raw and auxiliary materials of the drug-containing layer and the booster layer are respectively passed through a 60-mesh sieve according to the above ratio, and placed in containers and fully mixed. Add 10% povidone K30 alcohol solution to make soft materials respectively, granulate with 20 mesh sieve, and dry in a 45°C dry...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more

PUM

PropertyMeasurementUnit
pore sizeaaaaaaaaaa
diameteraaaaaaaaaa
Login to view more

Abstract

The invention relates to a risperidone osmotic pump controlled release preparation, which is composed of semipermeable film coating and a solid tablet core. The semipermeable film coating comprises coating materials and plasticizers; the solid tablet core comprises main drug, cosolvent, osmotic pressure accelerants, filling agents and lubricants. The invention also relates to a preparation method of the risperidone osmotic pump controlled release preparation. The preparation has the characteristics of long efficacy, stable curative effect and few toxic and side effects, and the preparation process is simple and is easy for industrial production.

Description

technical field [0001] The invention relates to a novel pharmaceutical preparation in the category of non-classic antipsychotic drug preparations, in particular to risperidone osmotic pump tablets and a preparation method thereof. Background technique [0002] Risperidone, chemical name: 3-[2-[4-(6-fluoro-1,2)-benzisoxazol-3-yl-1-piperidine]ethyl]-6,7,8, 9-tetrahydro-hexa-methyl-4H-pyrido[1,2-α]pyrimidin-4-one, a nonclassical antischizophrenic drug that selectively inhibits the mesolimbic dopaminergic nervous system, thus While suppressing the symptoms of schizophrenia, it will not produce severe extrapyramidal reactions like traditional anti-schizophrenia drugs. Due to its relatively mild adverse reactions and low price, it is currently the most widely used anti-schizophrenia drug. One of the schizophrenia drugs. Risperidone is almost insoluble in water, easily soluble in dichloromethane, slightly soluble in ethanol, and soluble in dilute acid solution. [0003] The dosa...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more

Application Information

Patent Timeline
no application Login to view more
Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/30A61K31/519A61K47/30A61P25/18
Inventor 梅兴国吴小伟
Owner INST OF PHARMACOLOGY & TOXICOLOGY ACAD OF MILITARY MEDICAL SCI P L A
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Try Eureka
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap