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Pancretin microparticles

A microparticle, pancreas technology, applied in the field of medicine, can solve the problems of lack of stability of enzymes, unsafe patients, health threats, etc., and achieve the effects of high solubility, loss of storage stability, and high stability

Pending Publication Date: 2022-04-15
艾孚沃药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0015] Disadvantages of this manufacturing method are the presence of traces of acetone in the resulting pellets and the lack of stability of the enzyme at pH = 1 to 6
[0016] The presence of residual acetone in the composition obtained according to the method of pancreatic secretin pellets above makes this product unsafe for patients, since acetone has a toxicity degree of 3 and can cause damage to some organs (for example, skin and lungs)
Despite the fact that there is very little residual acetone in the composition of such micropellets, multiple doses (in a day) of such micropellets are used for long-term or even life-long use in the treatment of many diseases, especially cystic fibrosis. Pills Can Cause Other Health Threats

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Embodiment 1 (according to the present invention)

[0044] The examples illustrate the preparation of a pharmaceutical composition comprising pancreatin in the presence of an ethanol solvent, in which microparticle cores are obtained.

[0045] First, a solution of the binder is prepared.

[0046] According to one embodiment of the present invention, ethanol is injected at 40°C to 45°C into a fabrication vessel equipped with a stirrer and a heating jacket. Then, under stirring, cetyl alcohol (powder) and poloxamer 407 (powder) were added at a ratio of ethanol: cetyl alcohol: poloxamer 407 of 1:0.11:0.11. A ternary mixture of binders is thus obtained.

[0047] According to one embodiment of the present invention, ethanol is injected at 40°C to 45°C into a fabrication vessel equipped with a stirrer and a heating jacket. Then, under stirring, cetyl alcohol (powder) and poloxamer 407 (powder) were added at a ratio of ethanol: cetyl alcohol: poloxamer 407 of 1:0.12:0.12, r...

Embodiment 2

[0057] Example 2 (comparison by method of manufacturing particle cores)

[0058] The method for making the core of pancreatic insulin microparticles is similar to that of Example 1, except that, first, ethanol is charged into a mixing granulator, and pancreatin is added in batches, and then added in the ratio described in Example 1 adhesive. The mixture was mixed thoroughly for 15 minutes after each supply of one component.

Embodiment 3

[0059] Example 3 (comparison by method of manufacturing particle cores)

[0060] The method for manufacturing the core of pancreatic insulin microparticles is similar to that of Example 1, except that the prepared mixture of pancreatic insulin and binder is charged into the hopper of the molding machine. Using a mold with a hole diameter of 1.0 mm, the suspension was granulated under the condition that the drying temperature of the core was controlled at 28°C.

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Abstract

The present invention relates to a pharmaceutical composition in which a core is microparticles containing predetermined amounts of pancreatin, cetanol, and poloxamer 407, a method for producing the same, and production of water-based enteric-coated microparticles. In addition, the resulting oral dosage form does not contain residual acetone. The technical result is that the core and the enteric-coated microparticles each achieve high stability while maintaining good solubility of the enteric-coated microparticles, which makes it possible for the claimed pancreatin microparticles to be used in the preparation of safe and non-toxic medicaments for the treatment of digestive system disorders.

Description

technical field [0001] The present invention relates to the field of medicine and relates to a pancreatin-based enzyme preparation in oral dosage form of enteric-coated microparticles. [0002] Most specifically, the present invention describes a pharmaceutical composition manufactured to include a microparticle core, the pharmaceutical composition having a pharmaceutically effective amount of pancreatin, cetyl alcohol, and poloxamer 407 . [0003] The present invention relates to a manufacturing method of the pharmaceutical composition and the manufacturing of microparticles coated with water-based enteric coating based on the pharmaceutical composition. [0004] Enteric-coated microparticles are obtained by the method according to the invention and are used in replacement therapy for children and adults for the treatment of exocrine (enzymatic) pancreatic insufficiency due to decreased pancreatic enzyme activity drug. Decreased pancreatic enzyme activity due to disturbance...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/50A61K9/52A61K47/10A61K47/34A61K47/32A61K38/46A61P1/18A61P1/14A61P29/00A61P3/10A61P1/00
CPCA61P1/18A61K38/54A61K9/5026A61K35/39A61K38/465A61K38/47A61K38/48A61K9/16A61K9/2081A61K9/4858A61K9/4866A61K9/501A61K9/5031A61K9/5089
Inventor 阿尔乔姆·谢尔盖耶维奇·茨韦特科夫帕维尔·瓦列里耶维奇·塞沃丁
Owner 艾孚沃药业有限公司
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