A kind of Empagliflozin dry suspension and preparation method thereof

A technology of empagliflozin and dry suspension, which is applied in the directions of pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc. preparations and other issues, to achieve the effect of being conducive to absorption, stable and controllable quality, and reducing dosage

Active Publication Date: 2022-06-14
QINGDAO HUANGHAI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For empagliflozin tablets, the inconvenience of taking medicines for special groups such as patients with dysphagia, children, and the elderly has affected the use of empagliflozin pharmaceutical preparations to a certain extent, especially for children For patients, it is even more difficult to conveniently use safe drugs that meet their own body weight

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] The empagliflozin dry suspension provided by the present embodiment, the content of each component is respectively:

[0045] Empagliflozin 20g, sorbitol 400g, polyvinylpyrrolidone 80g, micropowder silica gel 4g, cross-linked polyvinylpyrrolidone 60g, aspartame 0.5g; the raw material particle size of empagliflozin is D90=56um.

[0046] The preparation method of the empagliflozin dry suspension described in the present embodiment comprises the following steps:

[0047] 1) get 20g of empagliflozin and 120g of sorbitol and pulverize altogether, pass 80 mesh sieves after pulverizing, obtain the two mixture;

[0048] 2) Take the remaining 280g of sorbitol, 60g of cross-linked polyvinylpyrrolidone, and 4g of micropowder silica gel, pass through a 40-mesh sieve, add the mixture in step 1), mix well, and add 200g of purified water to make a soft material;

[0049] 3) Pass the soft material obtained in step 2) through a 40-mesh sieve to make granules, and after drying at 60° C.,...

Embodiment 2

[0052] The Enpagliflozin dry suspension provided by the present embodiment, its each raw material consumption is respectively:

[0053] Empagliflozin 20g, sorbitol 320g, polyvinylpyrrolidone 80g, micropowder silica gel 4g, cross-linked polyvinylpyrrolidone 60g, aspartame 0.5g; the raw material particle size of empagliflozin is D90=56um.

[0054]The preparation method of the empagliflozin dry suspension described in the present embodiment comprises the following steps:

[0055] 1) get 20g of empagliflozin and 96g of sorbitol and pulverize altogether, cross 80 mesh sieves after pulverizing, obtain the two mixture;

[0056] 2) Take the remaining 224g of sorbitol, 60g of cross-linked polyvinylpyrrolidone, and 4g of micropowder silica gel, pass through a 40-mesh sieve, add the mixture in step 1), mix well, and add 200g of purified water to make a soft material;

[0057] 3) Pass the soft material obtained in step 2) through a 40-mesh sieve to make granules, and after drying at 60° ...

Embodiment 3

[0060] The Enpagliflozin dry suspension provided by the present embodiment, its each raw material consumption is respectively:

[0061] Empagliflozin 20g, mannitol 400g, polyvinylpyrrolidone 70g, micropowder silica gel 4g, cross-linked polyvinylpyrrolidone 60g, aspartame 0.5g; the raw material particle size of empagliflozin is D90=22um.

[0062] The preparation method of the empagliflozin dry suspension described in the present embodiment comprises the following steps:

[0063] 1) get 20g of empagliflozin and 120g of sorbitol and pulverize altogether, pass 80 mesh sieves after pulverizing, obtain the two mixture;

[0064] 2) Take the remaining 280 g of sorbitol, 60 g of sodium carboxymethyl starch, and 4 g of micropowder silica gel, pass them through a 40-mesh sieve, add the mixture in 1), and after mixing evenly, add 200 g of an aqueous solution of 30% ethanol by volume to prepare into soft material;

[0065] 3) Pass the soft material through a 40-mesh sieve to make granule...

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Abstract

The invention relates to the technical field of medicine and medicine production, and relates to an empagliflozin dry suspension and a preparation method thereof. Empagliflozin dry suspension is calculated by weight percentage, empagliflozin 1-10%, filler 55-80%, suspending agent 10-20%, lubricant 0.1-2%, disintegrant 8 ‑15%, flavoring agent 0.05‑1%; the preparation method comprises the following steps: 1) take empagliflozin and filler to carry out co-crushing, and sieve after pulverization to obtain the mixture of the two; 2) weigh filler, disintegrating After sieving the solution and lubricant, add the mixture obtained in step 1), mix evenly, and add a wetting agent to make a soft material; 3) make the soft material obtained in step 2) into granules, sieve and granulate after drying; 4 ) mixing the granules obtained in step 2) with a suspending agent and a flavoring agent, and subpackaging to obtain empagliflozin dry suspension. When the empagliflozin dry suspension of the present invention is taken, it can be dispersed into a uniform suspension by adding water and shaking, so that its distribution area in the body is increased, and it can be quickly absorbed in the digestive tract and transformed into a structure with pharmacological effects.

Description

technical field [0001] The invention relates to the technical field of medicine and pharmaceutical production, in particular to an empagliflozin dry suspension and a preparation method thereof. Background technique [0002] The incidence of type II diabetes is increasing, and its complications (such as diabetic foot, blindness, renal failure, etc.) not only affect the quality of life of patients, but also may lead to shortening of lifespan. [0003] Empagliflozin, chemical name is (1S)-1,5-anhydrous-1-C-[4-chloro-3-[[4-[[((3S)-tetrahydro-3-furanyl ]oxy]benzyl]phenyl]-D-glucitol, is a sodium glucose co-transporter 2 (SGLT-2) inhibitor. SGLT-2 is the major transporter for the reabsorption of glucose from the glomerular filtrate into the blood circulation. Empagliflozin is used in the treatment of type 2 diabetes by reducing the renal glucose reabsorption, lowering the renal glucose threshold, and promoting the excretion of glucose from the urine. [0004] The raw material o...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K47/04A61K47/32A61K47/26A61K47/02A61K47/12A61K47/18A61K31/351A61P3/10
CPCA61K9/1682A61K9/1623A61K9/1611A61K9/1617A61K9/1635A61K31/351A61P3/10
Inventor 周小梅尤恒高丹丹赵月芳程芬李金凤代晓丽江云霞
Owner QINGDAO HUANGHAI PHARM CO LTD
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