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Empagliflozin dry suspension and preparation method thereof

A dry suspension, empagliflozin technology, applied in the directions of pharmaceutical formulations, medical preparations with inactive ingredients, medical preparations containing active ingredients, etc. preparations and other issues, to achieve the effect of favorable absorption, stable and controllable quality, and low risk

Active Publication Date: 2021-04-09
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 in this embodiment has the contents of each component as follows:

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

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

[0047] 1) Take 20g of Empagliflozin and 120g of sorbitol for co-grinding, and pass through an 80-mesh sieve after grinding to obtain a mixture of the two;

[0048] 2) Take the remaining 280g of sorbitol, 60g of cross-linked polyvinylpyrrolidone, and 4g of micropowdered 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, after drying at 60°C, t...

Embodiment 2

[0052] The Empagliflozin dry suspension provided in the present embodiment, the consumption of each raw material is respectively:

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

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

[0055] 1) Take 20g of Empagliflozin and 96g of sorbitol and carry out co-crushing, and pass through an 80-mesh sieve after crushing to obtain a mixture of the two;

[0056] 2) Take the remaining 224g of sorbitol, 60g of cross-linked polyvinylpyrrolidone, and 4g of micropowdered 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, ...

Embodiment 3

[0060] The Empagliflozin dry suspension provided in the present embodiment, the consumption of each raw material is respectively:

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

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

[0063] 1) Take 20g of Empagliflozin and 120g of sorbitol for co-grinding, and pass through an 80-mesh sieve after grinding to obtain a mixture of the two;

[0064] 2) Get remaining 280g sorbitol, 60g sodium carboxymethyl starch, 4g of micropowder silica gel, all cross 40 mesh sieves, add the mixture in 1), after mixing evenly, add 200g volume fraction after being the aqueous solution of 30% ethanol, prepare into soft material;

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

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Abstract

The invention relates to the technical field of medicines and medicine production, in particular to an empagliflozin dry suspension and a preparation method thereof. The empagliflozin dry suspension is prepared from the components in percentage by weight: 1-10% of empagliflozin, 55-80% of filler, 10-20% of a suspending aid, 0.1-2% of a lubricant, 8-15% of a disintegrating agent and 0.05-1% of a flavoring agent. The preparation method comprises the following steps that (1), the empagliflozin and the filler are co-crushed, and sieving is carried out after crushing to obtain a mixture of empagliflozin and the filler; (2), the filling agent, the disintegrating agent and the lubricating agent are weighed and sieved, the mixture obtained in the step (1) is added, uniform mixing is carried out, and a wetting agent is added to prepare a soft material; (3), the soft material obtained in the step (2) is prepared into particles, dried, sieved and granulated; and (4), the particles obtained in the step (2) is uniformly mixed with a suspending aid and a flavoring agent, and sub-packaging is carried out to obtain the empagliflozin dry suspension. When the empagliflozin dry suspension is taken, the empagliflozin dry suspension can be dispersed into a uniform suspension by adding water and shaking, so that the distribution area of the empagliflozin dry suspension in vivo is increased, and the empagliflozin dry suspension is rapidly absorbed and converted into a structure with pharmacological action in digestive tracts.

Description

technical field [0001] The invention relates to the technical field of medicine and medicine 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 shortened life span. [0003] Empagliflozin, the chemical name is (1S)-1,5-anhydrous-1-C-[4-chloro-3-[[4-[[(3S)-tetrahydro-3-furyl ]oxy]benzyl]phenyl]-D-glucitol, a sodium glucose cotransporter 2 (SGLT-2) inhibitor. SGLT-2 is the main transporter for the reabsorption of glucose from the glomerular filtrate into the blood circulation. Empagliflozin is used for the treatment of type 2 diabetes by reducing the reabsorption of glucose by the kidney, lowering the renal glucose threshold, and promoting the excretion of glucose from the urine. [0004] The raw material of...

Claims

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Application Information

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Patent Type & Authority Applications(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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