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Flurbiprofen sustained release capsules and preparation method thereof

A flurbiprofen and sustained-release capsule technology, applied in the field of flurbiprofen sustained-release preparations, can solve problems such as poor safety, and achieve the effects of small differences in bioavailability, good fluidity, and reduced drug toxicity and side effects

Inactive Publication Date: 2012-07-25
广州科的信医药技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Controlled-release flurbiprofen and muscle relaxant combination drug (Patent No.: EP2074990, US20090175938, SANOVEL ILAC SANAYIVE TICARET), which describes the controlled-release of flurbiprofen and muscle relaxant tizanidine released once a day for 24 hours Double-layer tablet and its preparation process, the drug is mixed with non-functional excipients and sustained-release materials to form granules, which are pressed into double-layer tablets, which are skeleton-type sustained-release tablets. Local damage and defects during production of sustained-release tablets will cause Burst release of the entire formulation occurs and therefore less safe

Method used

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  • Flurbiprofen sustained release capsules and preparation method thereof
  • Flurbiprofen sustained release capsules and preparation method thereof
  • Flurbiprofen sustained release capsules and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] 1. Preparation of drug-containing pill core:

[0035]

[0036] Preparation process: mix flurbiprofen and microcrystalline cellulose uniformly in an equal increasing method, add sodium lauryl sulfate to 35% ethanol solution and dissolve to prepare sodium lauryl sulfate ethanol solution, mix the above The powder is made into a soft material, and pellets are extruded and spheronized. The particle size of the sieve plate is 0.8mm, oven-dried at 60°C, sieved, and 20-40 meshes containing pill cores are selected for coating.

[0037] 2. Package slow-release layer:

[0038]

[0039] Add the prescribed amount of Surelease into purified water, make it fully dispersed, stir for 45 minutes, place the drug-containing pellet core in a fluidized bed, adjust various process parameters to ensure a fluidized state, and increase the weight of the coating to 12%.

[0040] Process parameters of fluidized bed: Inlet air volume: 20~30HZ, Inlet air temperature: 45~55℃, Material temperat...

Embodiment 2

[0046] 1. Preparation of drug-containing pill core:

[0047]

[0048] Preparation process: Mix flurbiprofen, lactose, and microcrystalline cellulose uniformly in equal increments, add Tween into 35% ethanol solution, make the above mixed powder into a soft material, and use extrusion spheronization mechanism pellets , the particle size of the sieve plate is 0.8mm, oven-dried at 60°C, sieved, and 20-40 mesh-containing pill cores are selected for coating.

[0049] 2. Package slow-release layer:

[0050]

[0051] Add the prescribed amount of talc powder into purified water and stir for 45 minutes, add Eudragit NE30D water dispersion to make it fully dispersed, continue stirring for 45 minutes, and set aside. The pill core containing the drug is placed in a fluidized bed, and various process parameters are adjusted to ensure a fluidized state, and the weight of the coating is increased to 4%.

[0052] Process parameters of fluidized bed: air intake: 20-30HZ, air intake tem...

Embodiment 3

[0058] 1. Preparation of drug-containing pill core:

[0059]

[0060] Preparation process: Mix flurbiprofen, microcrystalline cellulose, and mannitol uniformly by increasing the method in equal amounts, add PVP-K30 and Tween to 35% ethanol solution, make the above mixed powder into a soft material, and extrude The spheronization mechanism pellets are produced, the particle size of the sieve plate is 0.8mm, oven-dried at 60°C, sieved, and 20-40 mesh-containing pellet cores are selected for coating.

[0061] 2. Package slow-release layer:

[0062]

[0063] Add the prescribed amount of talc powder into purified water and stir for 45 minutes, add triethyl citrate, Eudragit RS30D and RL30D water dispersion to make it fully dispersed, continue stirring for 45 minutes, and set aside. The pill core containing the drug is placed in a fluidized bed, and various process parameters are adjusted to ensure a fluidized state, and the weight of the coating is increased to 8%.

[0064]...

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Abstract

The invention discloses flurbiprofen sustained release capsules and a preparation method of the flurbiprofen sustained release capsules. The flurbiprofen sustained release capsules consist of sustained release pellets and hollow capsules; and each sustained release pellet consists of the following raw materials by weight: 75-97% of drug-containing core and 3-25% of a sustained release coating layer. The flurbiprofen sustained release capsules consist of hundreds of sustained release pellets with uniform particle sizes, and errors or defects appearing in the preparation method of some pellets are unlikely to have serious influence on drug release of the whole preparation, so that the flurbiprofen sustained release capsules are safer than that of the sustained release tablets, have little irritation to gastrointestinal tract, have more stable plasma concentration and higher bioavailability and can continuously release drug to relieve inflammation and pain for 24 hours by administration once in a day. The preparation method provided by the invention adopts a extrusion-spheronization method to prepare the drug-containing cores and adopts a fluidized bed to wrap the sustained release coat layers; and the flurbiprofen sustained release capsules have simple process and are easy for industrial production.

Description

technical field [0001] The invention relates to the technical field of flurbiprofen sustained-release preparations, in particular to a flurbiprofen sustained-release capsule and a preparation method thereof. It belongs to a sustained-release preparation of non-steroidal anti-inflammatory analgesics. Background technique [0002] Rheumatoid arthritis (rheumatoid arthritis, RA) is a chronic heterogeneous systemic disease of unknown etiology, which is an autoimmune disease. It may be related to various factors such as infection, genetic and immune mechanism disorders. Mainly manifested as peripheral symmetrical polyarticular chronic non-specific inflammation, which may be accompanied by extra-articular systemic damage, such as subcutaneous rheumatoid nodules, pericarditis, myocarditis, pulmonary fibrosis, pleurisy, splenomegaly, renal amyloid Changes, peripheral neuritis, arteritis and other pathological changes, sometimes may invade the eyes, scleritis and iritis occur. The...

Claims

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Application Information

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IPC IPC(8): A61K9/52A61K31/192A61K47/32A61K47/34A61K47/36A61K47/38A61P29/00
Inventor 黎炜烘
Owner 广州科的信医药技术有限公司
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