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Sacubitril and valsartan sodium single-layer osmotic pump controlled release tablet and preparation method thereof

A technology of sacubitrilvaler and single-layer osmotic pump, which is applied in coatings, pharmaceutical formulations, medical preparations of non-active ingredients, etc., can solve the problems of slow release rate and susceptibility to external environment, and reduce the Toxic and side effects, the effect of reducing the total dose of medication and reducing the frequency of medication

Active Publication Date: 2021-10-01
南京康川济医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] CN105935358 discloses a sacubitril-valsartan slow-release agent and its preparation method, selects hydrophilic gel skeleton material and moisture-proof film coating, releases The rate will gradually slow down and is easily affected by the external environment

Method used

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  • Sacubitril and valsartan sodium single-layer osmotic pump controlled release tablet and preparation method thereof
  • Sacubitril and valsartan sodium single-layer osmotic pump controlled release tablet and preparation method thereof
  • Sacubitril and valsartan sodium single-layer osmotic pump controlled release tablet and preparation method thereof

Examples

Experimental program
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Effect test

preparation example Construction

[0034]Examples 1 to Example 15 Preparation method: Weighing a variety of drugs and excipients (except for magnesium stearate), mix uniformly in an equal amount. Add appropriate amount of wetting agent anhydrous ethanol soft material, over 20 mesh sieves, 40 ° C for 0.5 hours, and 20 mesh sieve dry. Magnesium stearate is mixed. A circular shallow dimming die or 14 * 9 mm diamond shallow dimming die or 18.4 * 7.2mm, a shallow concave mold, and a hardness of 6-8 kg. According to the calculation of cellulose and polyethylene glycol 3350, 35 ° C, the heating water bath is added, and the magnetic stirring is added to the acetone - aqueous solution (94.525: 0.75), and the coating liquid is clear and transparent. The core is placed in the coating pot, and the temperature of the bed temperature is 22 to 29 ° C, and the coating is 3 to 10%. After the coating was completed, the aging was placed in an oven at 40 ° C for 12 hours to remove acetone. An interpretation hole having a diameter of 0...

Embodiment 1

[0037] Core prescription

[0038] composition Dosage (per piece) Sandaki vals 452mg Polyethylene pyrrolidone K90F 36mg Lactose G200 40mg Magnesium stearate 12mg

[0039] Coated film prescription

[0040] composition Dosage (per 100 pieces) Cellulose acetate 1.87g Polyethylene glycol 3350 0.47g acetone 44.24g water 0.22g

Embodiment 2

[0042] Core prescription

[0043] composition Dosage (per piece) Sandaki vals 452mg Polyethylene pyrrolidone K90F 24mg Lactose G200 52mg Magnesium stearate 12mg

[0044] Coated film prescription

[0045] composition Dosage (per 100 pieces) Cellulose acetate 2.71g Polyethylene glycol 3350 0.68g acetone 64.09g water 0.32g

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Abstract

The invention belongs to the field of pharmaceutical preparations, and particularly relates to a sacubitril and valsartan sodium single-layer osmotic pump controlled release tablet and a preparation method thereof. The single-layer osmotic pump controlled release tablet comprises a tablet core, a semi-permeable coating membrane and small drug release holes; the tablet core comprises the following components in percentage by weight: 53-92% of sacubitril valsartan sodium, 2-33% of suspending aid, 0-33% of penetration enhancer and 0.5-3% of lubricant; the semi-permeable coating membrane comprises 60-99% of a semi-permeable membrane forming material and 1-40% of a pore-foaming agent, and the weight of the coating is 3-10% of the weight of the tablet core; and the aperture of the small drug release holes is 0.6mm-1.5 mm. The sacubitril and valsartan sodium single-layer osmotic pump controlled release tablet is orally taken once a day, has stable blood concentration, and is not easily influenced by gastrointestinal tract environment.

Description

Technical field [0001] The present invention belongs to the field of pharmaceutical preparations, and specifically, the present invention relates to a monolayer penetration pump controlled release tablet and its preparation method thereof. Background technique [0002] Heart failure is a common disease in the clinic, the incidence rate is high, and has a continuous increase in trend, the disease is complex clinical syndrome caused by factors such as cardiac structure, functional abnormalities, divided into acute heart failure and chronic heart effort Failure. Among them, chronic heart failure is the end stage of the clinical center of vascular disease, which seriously affects the health of the patient, and reduces the quality of life. The main method of treating chronic congestive heart failure in the clinic is the drug, and common drugs are angiotensin II receptor antagonists. [0003] Shatak Bamquaisa is a clinical angiotensin II receptor antagonist, which is a clinical first a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/44A61K9/22A61K9/36A61K47/32A61K47/36A61K47/38A61K31/41A61K31/216A61P9/04
CPCA61K9/2072A61K9/2095A61K9/2027A61K9/205A61K9/2054A61K9/2866A61K31/41A61K31/216A61P9/04A61K2300/00
Inventor 王孝伟朱春莉冯婧劼
Owner 南京康川济医药科技有限公司
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