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Linaclotide enteric controlled-release pellet capsule preparation and preparing method and application thereof

A technology of linaclotide enteric and sustained-release pellets, which can be applied to pharmaceutical formulations, peptide/protein components, and medical preparations containing active ingredients, etc., and can solve problems such as easy missed doses and ineffective treatment

Inactive Publication Date: 2016-03-23
HYBIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Commercially available linaclotide capsules are taken orally once a day. For middle-aged and elderly people who often need to take medicine, it is easy to miss the dose and cannot achieve therapeutic effect

Method used

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  • Linaclotide enteric controlled-release pellet capsule preparation and preparing method and application thereof
  • Linaclotide enteric controlled-release pellet capsule preparation and preparing method and application thereof
  • Linaclotide enteric controlled-release pellet capsule preparation and preparing method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] 1. Prescription

[0035]

[0036]

[0037] 2. Preparation process

[0038] Drug-containing pill core: Mix linaclotide, mannitol and microcrystalline cellulose evenly in an equal increasing method, add carboxymethyl cellulose solution dissolved in water to make a soft material, and put it in a multifunctional pill coating machine ( Purchased from Shenzhen Xinyite Technology Co., Ltd., the model is Mini250), extruded into a cylindrical strip, and then added to a multi-functional pellet coating machine and rolled into a 15-35-mesh drug-containing pellet core;

[0039] Isolation layer: Dissolve hydroxypropyl methylcellulose in water to prepare a 12% coating solution, then place the pill core in a multifunctional pill coating machine for coating, and then place the micropills wrapped in the isolation layer Dry in an electric blast drying oven (purchased from Shanghai Yiheng Scientific Instrument Co., Ltd., model DHG-9245A) at 45°C for 4 hours;

[0040] Sustained-rele...

Embodiment 2

[0045] 1. Prescription

[0046]

[0047] 2. Preparation process

[0048] Pill core with medicine: Mix linaclotide, starch and calcium chloride uniformly in equal increments, add hydroxypropyl methylcellulose solution dissolved in water to make a soft material, and put it in a multi-functional pill-making coating machine Extruded into cylindrical strips, then added to a multi-functional pellet coating machine and rounded to form a 15-35-mesh drug-containing pellet core;

[0049] Isolation layer: Dissolve polyvinylpyrrolidone in water to prepare a 12% coating solution, then place the pill core in a multifunctional pellet coating machine for coating, and then place the micropills wrapped in the isolation layer at 45°C Dry in an electric blast drying oven for 4 hours;

[0050] Sustained-release coating layer: gelatin, polyethylene glycol and silicon dioxide are dissolved in absolute ethanol to prepare a 10% coating solution, and the above-mentioned pellets are coated in a mul...

Embodiment 3

[0054] 1. Prescription

[0055]

[0056] 2. Preparation process

[0057] Drug-containing pill core: Mix linaclotide, dextrin and calcium hydrogen phosphate uniformly in an equal increasing method, add carboxymethyl cellulose solution dissolved in water to make a soft material, and put it in a multi-functional pill-making coating machine Extruded into cylindrical strips, then added to a multi-functional pellet coating machine and rounded to form a 15-35-mesh drug-containing pellet core;

[0058] Isolation layer: Dissolve ethyl cellulose in water, prepare 12% coating liquid, then place the pill core containing the pills in a multifunctional pellet coating machine for coating, then place the micropills wrapped by the isolation layer at 45 ℃ drying in an electric blast drying oven for 4 hours;

[0059] Sustained-release coating layer: Sodium alginate, citric acid and starch were dissolved in absolute ethanol to prepare a 10% coating solution, and the above-mentioned pellets w...

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Abstract

The invention relates to a linaclotide enteric controlled-release pellet capsule preparation. The linaclotide enteric controlled-release pellet capsule preparation is composed of linaclotide enteric controlled-release pellets and a hollow capsule, wherein the linaclotide enteric controlled-release pellets comprise pellet cores, isolation layers, controlled-release layers and enteric layers. The invention further relates to a method for preparing the linaclotide enteric controlled-release pellet capsule preparation and application of the linaclotide enteric controlled-release pellet capsule preparation in preparing medicine for treating a constipation type irritable bowel syndrome.

Description

technical field [0001] The application relates to the field of pharmaceutical preparations, in particular to a linaclotide enteric-coated sustained-release pellet capsule preparation and its preparation method and application. Background technique [0002] Irritable bowel syndrome with constipation (IBS-C) is a functional bowel disorder characterized by abdominal pain or discomfort associated with defecation and altered bowel habits characterized by bowel disturbances. According to statistics, in the European population, the estimated incidence rate of IBS is more than 10%, and about 1 / 3 of IBS patients are IBS-C patients of different severity. Symptoms associated with IBS-C include abdominal pain and / or discomfort, abdominal distension, and constipation. IBS can negatively impact patients' daily lives, causing enormous socio-economic stress and poor psychological outcomes. In the primary medical system and the secondary medical system, the disease accounts for the vast ma...

Claims

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Application Information

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IPC IPC(8): A61K38/10A61K9/62A61K9/64A61P1/00A61P1/10
Inventor 徐春莲郑春莲陶安进袁建成
Owner HYBIO PHARMA
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