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Aceclofenac bi-layer osmotic pump controlled release tablets and preparation method thereof

A technology of osmotic pump controlled release and aceclofenac, which is applied in the direction of pharmaceutical formulations, medical preparations containing no active ingredients, and medical preparations containing active ingredients, etc. clinical treatment and other issues

Inactive Publication Date: 2013-07-31
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Common oral preparations have large fluctuations in blood concentration and poor patient compliance, which is not conducive to clinical treatment. The development of its once-a-day controlled-release preparations meets the needs of clinical development

Method used

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  • Aceclofenac bi-layer osmotic pump controlled release tablets and preparation method thereof
  • Aceclofenac bi-layer osmotic pump controlled release tablets and preparation method thereof
  • Aceclofenac bi-layer osmotic pump controlled release tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Tablet prescription:

[0024] Drug-containing layer

[0025] Aceclofenac 200mg

[0026] Polyoxyethylene 250mg

[0027] Sucrose 50mg

[0028] Magnesium Stearate 1mg

[0029] booster layer

[0030] Polyoxyethylene 70mg

[0031] Lactose 15mg

[0032] Semi-permeable coating film prescription:

[0033] Cellulose acetate 20g

[0034] Polyethylene glycol 4g

[0035] Solvent prescription for dissolving film coating material:

[0036] Acetone 500mL

[0037] Distilled water 20mL

[0038] Preparation Process:

[0039] Pass the prescribed amount of medicine, polyoxyethylene with a molecular weight of 300,000, sucrose, and magnesium stearate through an 80-mesh sieve, and mix evenly; Punch No. 11 twice and pressurize to get the tablet core. Dissolve cellulose acetate and polyethylene glycol with an average molecular weight of 2000 in acetone and water and mi...

Embodiment 2

[0041] Tablet prescription:

[0042] Drug-containing layer

[0043] Aceclofenac 200mg

[0044] Sodium Alginate 200mg

[0045] Sodium chloride 40mg

[0046] Magnesium Stearate 1mg

[0047] booster layer

[0048] Polyoxyethylene 90mg

[0049] Sodium chloride 10mg

[0050] Semi-permeable coating film prescription:

[0051] Ethyl cellulose 20g

[0052] Polyethylene glycol 4g

[0053] Solvent prescription for dissolving film coating material:

[0054] Acetone 500mL

[0055] Distilled water 20mL

[0056] Preparation Process:

[0057]Pass the prescribed amount of medicine, sodium alginate, sodium chloride, and magnesium stearate through an 80-mesh sieve, and mix evenly; pass the prescribed amount of polyoxyethylene and sodium chloride with a molecular weight of 4,000,000 through an 80-mesh sieve, mix evenly, and use 11 No. punch twice and pressurize to get the ta...

Embodiment 3

[0058] Tablet prescription:

[0059] Drug-containing layer

[0060] Aceclofenac 200mg

[0061] Gum Arabic 150mg

[0062] Mannitol 10mg

[0063] Micronized silica gel 2mg

[0064] booster layer

[0065] Polyoxyethylene 140mg

[0066] Lactose 25mg

[0067] Semi-permeable coating film prescription:

[0068] Cellulose acetate 12g

[0069] Acrylic 6

[0070] Polyethylene glycol 4g

[0071] Solvent prescription for dissolving film coating material:

[0072] Acetone 500mL

[0073] Distilled water 20mL

[0074] Preparation Process:

[0075] Pass the prescribed amount of medicine, gum arabic, mannitol, and micropowdered silica gel through 80 mesh sieves, and mix evenly; pass the prescribed amount of polyoxyethylene and lactose with a molecular weight of 5,000,000 through 80 mesh sieves, mix evenly, and pressurize twice with No. 12 That is the tablet core. Dissolve cellulose...

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Abstract

The invention provides an aceclofenac bi-layer osmotic pump controlled release tablet and a preparation method thereof, belongs to the technical field of medicinal preparation. The osmotic pump preparation comprises a tablet core containing aceclofenac and a semipermeable coating membrane which is coated outside the tablet core and provided with orifices, the tablet core comprises a drug layer containing aceclofenac and a boosting layer; wherein, the drug layer comprises the following components: 200mg of aceclofenac, 100mg-300mg of suspension, 10mg-50mg of osmotic stress active substance and0.5 mg-2mg of lubricant; the boosting layer comprises 50mg-150mg of sweller and 5mg-30mg of osmotic stress active substance; the semipermeable coating membrane comprises the following components: 10g-20g of semipermeable high polymer material dissolved in 500ml of acetone and 2g-5g of water soluble pore former dissolved in 20ml of distilled water and the weight of the coating membrane is 5%-10% of the tablet core weight; laser or a power drill is used to drill the orifices on the drug-containing side of the coating tablet. The invention is characterized of less dosing frequency, convenient taking way, long lasting and stable curative effect and can be used to cure pains and inflammations caused by osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and the like.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to a double-layer osmotic pump controlled-release tablet of aceclofenac and a preparation method thereof. Background technique [0002] Aceclofenac (aceclofenac) is a new oral potent non-steroidal anti-inflammatory drug, the chemical name is 2-[(2,6-dichlorophenyl) amino] phenylacetoxyacetic acid, used for the treatment of bone and joint Pain and inflammation caused by inflammation, rheumatoid arthritis, ankylosing spondylitis, rheumatoid arthritis, chronic polyarthritis, concurrent osteoarthritis, etc. Aceclofenac is a derivative of diclofenac sodium, which can reduce the biosynthesis of prostaglandins in the pain site by inhibiting cyclooxygenase and reduce the exudation of inflammatory mediators such as leukotrienes and bradykinin by inhibiting lipoxygenase, so as to reduce the local inflammatory response , Congestion and swelling of tissues, reduce the sensiti...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/30A61K9/22A61K31/222A61K47/32A61K47/34A61K47/36A61K47/38A61P19/02A61P19/04A61P19/08A61P29/00A61K47/10
Inventor 潘卫三张世忠关津杨星钢孙光美
Owner SHENYANG PHARMA UNIVERSITY
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