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Ketoprofen osmotic pump type controlled release preparation and preparation method thereof

A technology of controlled-release preparations and osmotic pumps, applied in anti-inflammatory agents, pharmaceutical formulations, non-central analgesics, etc., can solve the problems of poor patient compliance, large fluctuations in blood concentration of ordinary oral preparations, and unfavorable clinical treatment. Stable curative effect, reduced medication frequency, and good drug release correlation

Inactive Publication Date: 2012-09-19
CHINA PHARM UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Ordinary oral preparations have large fluctuations in blood concentration and poor patient compliance, which is not conducive to clinical treatment; although the fluctuations in blood concentration of the sustained-release preparations have improved after taking them, they are non-zero-order releases, which are still not ideal
The existing dosage forms are far from meeting the clinical needs, and the development of once-a-day controlled-release preparations meets the needs of clinical development

Method used

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  • Ketoprofen osmotic pump type controlled release preparation and preparation method thereof
  • Ketoprofen osmotic pump type controlled release preparation and preparation method thereof
  • Ketoprofen osmotic pump type controlled release preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Tablet Core Prescription (1000 Tablets)

[0027]

[0028] Prescription of semi-permeable membrane coating solution:

[0029]

[0030] Preparation Process:

[0031] Pass the medicine and auxiliary materials except the lubricant through an 80-mesh sieve, fully mix, add magnesium stearate, talcum powder, micropowder silica gel, mix evenly, and directly compress into tablets to obtain tablet cores. Dissolve cellulose acetate, pore-forming agent PEG400, and plasticizer diethyl phthalate in acetone as a coating liquid, put the tablet core in a coating pan, and coat at a coating temperature of 40-50°C, and the coating is completed Afterwards, it was cured in a drying oven at 40°C for 12 hours. Then, a drug release hole with a diameter of 1.0 mm is prepared by laser drilling on one side of the coated tablet to obtain a ketoprofen monolayer osmotic pump controlled release tablet.

Embodiment 2

[0033] Tablet Core Prescription (1000 Tablets)

[0034]

[0035] Prescription of semi-permeable membrane coating solution:

[0036]

[0037] Preparation Process:

[0038] Pass the medicine and auxiliary materials except the lubricant through an 80-mesh sieve, fully mix, add magnesium stearate, talcum powder, micropowder silica gel, mix evenly, and directly compress into tablets to obtain tablet cores. Dissolve cellulose acetate, pore-forming agent PEG400, and plasticizer diethyl phthalate in acetone as a coating liquid, put the tablet core in a coating pan, and coat at a coating temperature of 40-50°C, and the coating is completed Afterwards, it was cured in a drying oven at 40°C for 12 hours. Then, a drug release hole with a diameter of 1.0 mm is prepared by laser drilling on one side of the coated tablet to obtain a ketoprofen monolayer osmotic pump controlled release tablet.

Embodiment 3

[0040] Tablet Core Prescription (1000 Tablets)

[0041]

[0042] Prescription of semi-permeable membrane coating solution:

[0043]

[0044] Preparation Process:

[0045] Pass the medicine and auxiliary materials except the lubricant through an 80-mesh sieve, fully mix, add magnesium stearate, talcum powder, micropowder silica gel, mix evenly, and directly compress into tablets to obtain tablet cores. Dissolve cellulose acetate, pore-forming agent PEG400, and plasticizer diethyl phthalate in acetone as a coating liquid, put the tablet core in a coating pan, and coat at a coating temperature of 40-50°C, and the coating is completed Afterwards, it was cured in a drying oven at 40°C for 12 hours. Then, a drug release hole with a diameter of 1.0 mm is prepared by laser drilling on one side of the coated tablet to obtain a ketoprofen monolayer osmotic pump controlled release tablet.

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Abstract

The invention relates to a ketoprofen osmotic pump type controlled release preparation and a preparation method thereof. The ketoprofen osmotic pump type controlled release preparation comprises an osmotic pump tablet core and a semipermeable controlled release coat film coated outside the tablet core, wherein the osmotic pump tablet core comprises a remedium cardinale, an osmotic active substance, a latent solvent, a retarding agent, a filling agent and a lubricating agent; and the semipermeable controlled release coat film comprises a coating material, a pore-foaming agent and a plasticizing agent. The invention also relates to the preparation method of the osmotic pump type controlled release preparation. The ketoprofen osmotic pump type controlled release preparation disclosed by the invention is prepared by a simple conventional preparation method of general tablets and is mainly characterized in that a single-layer osmotic pump tablet technology is applied to preparation of insoluble drug osmotic pump tablet; the tablet core is tabletted by adopting a conventional method without determining a punching surface; the drug release is safer, so that the toxic or side effects and the administration frequencies of the drug can be reduced; and the influence on the drug adsorption due to food intake and in vivo environment can be avoided, and thus the compliance of patients is improved.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to a ketoprofen osmotic pump type controlled-release preparation and a preparation method thereof. Background technique [0002] Ketoprofen (English name: Ketoprofen) is a kind of α-arylpropionic acid non-steroidal anti-inflammatory drugs (NSAIDs) listed by Rhdne-poulenc company in France in 1972. Mainly inhibit the synthesis of prostaglandins by inhibiting cyclooxygenase (COX-1, COX-2) from the periphery to play an analgesic and anti-inflammatory effect; at the same time, ketoprofen has the ability to stabilize lysosomal membranes, inhibit lipoxygen and enzymes thereby Inhibition of leukotriene synthesis, anti-bradykinin, scavenging hydroxyl and other mechanisms of action, all contribute to the peripheral analgesic function of ketoprofen. Ketoprofen has antipyretic and analgesic properties and is mainly used clinically to treat ankylosing spondylitis, rheumatoid ...

Claims

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Application Information

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IPC IPC(8): A61K31/192A61K9/22A61K9/32A61K9/36A61K9/44A61K47/32A61K47/34A61K47/36A61K47/38A61P19/02A61P29/00A61P29/02
Inventor 王柏陈灵楠
Owner CHINA PHARM UNIV
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