Dapagliflozin microencapsulated sustained-release tablet and preparation method thereof

A technology for sustained-release tablets and microcapsules, applied in the field of dapagliflozin microencapsulated sustained-release tablets and their preparation, can solve the problems of short action time, failure to achieve long-term blood sugar control, fast absorption, etc. Long-acting release, prolonging the intestinal action time, reducing the effect of toxic and side effects

Inactive Publication Date: 2020-08-04
乐普制药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Invention patent CN105853386B discloses a preparation process of tablets containing dapagliflozin, which is characterized in that firstly dissolving dapagliflozin propylene glycol hydrate in a solvent to make a drug solution, and then mixing the drug solution with diluent, viscose Mixtures, disintegrating agents, and lubricants are wet granulated and compressed into tablets to obtain tablets containing dapagliflozin, but this tablet absorbs faster in the body and has a short action time, which cannot achieve ideal long-term blood sugar control Effect

Method used

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  • Dapagliflozin microencapsulated sustained-release tablet and preparation method thereof
  • Dapagliflozin microencapsulated sustained-release tablet and preparation method thereof
  • Dapagliflozin microencapsulated sustained-release tablet and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031]

[0032]

[0033] Its preparation method is

[0034] (1) Microencapsulation:

[0035] Mix the formulated amount of dapagliflozin and ethyl cellulose ethanol solution evenly, and spray-dry the above suspension. Working conditions: inlet temperature: 130-160°C, outlet temperature: 70-90°C, feeding speed: 20mL / min to obtain dry particles with a particle size of 600 μm.

[0036] (2) mixing:

[0037] Add the prepared microcapsules, microcrystalline cellulose, anhydrous lactose, silicon dioxide, crospovidone, and magnesium stearate into a hopper mixer and mix evenly;

[0038] (3) Tablets:

[0039] The uniformly mixed intermediate product in (2) is selected from a circular shallow concave die and pressed into tablets, the weight of the tablet is controlled to be about 191 mg, and the hardness range is 6-12 kg, and finally a microencapsulated sustained-release tablet containing dapagliflozin is obtained.

[0040] It should be noted that, as an alternative implementat...

Embodiment 2

[0043]

[0044]

[0045] Its preparation method is

[0046] (2) Microencapsulation:

[0047] Mix the formula amount of dapagliflozin and ethyl cellulose ethanol solution evenly, and spray the above suspension to dry. Working conditions: inlet temperature: 130-160°C, outlet temperature: 70-90°C, feeding speed: 20ml / min to obtain dry particles with a particle size of 600 μm.

[0048] (2) mixing:

[0049] Add the prepared microcapsules, cornstarch, silicon dioxide, low-substituted cellulose, and stearic acid into a hopper mixer and mix evenly;

[0050] (3) Tablets:

[0051] The uniformly mixed intermediate product in (2) is selected from a circular shallow concave die and pressed into tablets, the weight of the tablet is controlled to be about 332 mg, and the hardness range is 6-12 kg, and finally a microencapsulated sustained-release tablet containing dapagliflozin is obtained.

Embodiment 3

[0053]

[0054] Its preparation method is

[0055] (3) Microencapsulation:

[0056] Mix the formula amount of dapagliflozin and ethyl cellulose ethanol solution evenly, and spray the above suspension to dry. Working conditions: inlet temperature: 130-160°C, outlet temperature: 70-90°C, feeding speed: 20ml / min to obtain dry particles with a particle size of 600 μm.

[0057] (2) mixing:

[0058] Add the prepared microcapsules, microcrystalline cellulose, anhydrous lactose, low-substituted cellulose, and stearic acid into a hopper mixer and mix evenly;

[0059] (3) Tablets:

[0060] The uniformly mixed intermediate product in (2) is selected from a circular shallow concave die and pressed into tablets. The weight of the tablet is controlled to be about 181mg, and the hardness range is 6-12kg. Finally, a microencapsulated sustained-release tablet containing dapagliflozin is obtained.

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Abstract

The invention discloses a dapagliflozin microencapsulated sustained-release tablet and a preparation method thereof, and the dapagliflozin microencapsulated sustained-release tablet is prepared by thefollowing steps: preparing active components dapagliflozin and ethyl cellulose into microcapsules, uniformly mixing the microcapsules with other additional auxiliary materials, and tabletting. According to the dapagliflozin microencapsulated sustained-release tablet, a microencapsulation slow-release technology is adopted to control the drug delivery speed so as to prolong the curative effect ofthe drug, and the microencapsulated dapagliflozin raw material is prevented from being contacted with air, so that the interference of air moisture in the tabletting process is solved. Each micro-capsule is an independently controlled drug release unit, and drug release is uniform and stable. The microencapsulated sustained-release tablet can ensure the dissolution of the drug and the stability ofthe drug, and is simple in process and suitable for large-scale production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a dapagliflozin microencapsulated sustained-release tablet and a preparation method thereof. Background technique [0002] Diabetes is a group of metabolic diseases characterized by hyperglycemia. Hyperglycemia is caused by defects in insulin secretion or its biological effects, or both. Long-term hyperglycemia in diabetes leads to chronic damage and dysfunction of various tissues, especially the eyes, kidneys, heart, blood vessels, and nerves. Diabetes has become the third largest non-communicable disease after cardiovascular disease and cancer. [0003] Dapagliflozin works by inhibiting sodium-glucose transporter 2 (SGLT2), a protein in the kidney that allows glucose to be reabsorbed into the blood. This allows excess glucose to be excreted from the body through the urine, improving blood sugar control without increasing insulin secretion. Dapa...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/26A61K31/351A61P3/10A61K9/50A61K47/38
CPCA61K9/2081A61K9/5042A61K31/351A61P3/10
Inventor 陈岑波陈盈潘裕生愉悦王海翔
Owner 乐普制药科技有限公司
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