Implant and preparation method thereof

A technology of implants and release regulators, which is applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., and can solve problems such as difficult application, high price, and complicated structure of twin-screw extruders question

Active Publication Date: 2017-04-26
AC PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the structure of the twin-screw extruder is complex, the price is high, the operation is relatively complicated, and the process control requirements are high.
[0011] The material mixing, dispersion and homogenization effect of conventional single-screw extruder is relatively poor, making it difficult to apply hot melt extrusion technology to prepare implants

Method used

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  • Implant and preparation method thereof
  • Implant and preparation method thereof
  • Implant and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0060] An embodiment of the implant of the present invention, the preparation raw material of the implant described in this embodiment contains the following components by weight: 26 parts of poorly water-soluble / slightly soluble drugs, 64 parts of poorly water-soluble polymers, release 10 parts of regulator; wherein the water-insoluble / slightly soluble drug is aripiprazole, and the water-insoluble polymer is PLA (the weight average molecular weight of the PLA is 25kDa, the viscosity is 0.22dL / g, and the The PLA has a terminal ester group), and the release regulator is lauric acid.

[0061] The preparation method of implant described in the present embodiment is:

[0062] (1) Pulverize the water-insoluble polymer with a feather-type pulverizer, and collect particles no larger than 40 meshes by sieving;

[0063] (2) dissolving the release modifier and the poorly water-soluble / slightly soluble drug in a mixture of tetrahydrofuran and absolute ethanol to obtain a solution;

[0...

Embodiment 2

[0068] An embodiment of the implant of the present invention, the preparation raw material of the implant described in this embodiment contains the following components by weight: 30 parts of poorly water-soluble / slightly soluble drugs, 62 parts of poorly water-soluble polymers, release 8 parts of regulators; wherein the water-insoluble / slightly soluble drug is entecavir, and the water-insoluble polymer is PLA (the PLA is a mixture of PLA with carboxyl-terminated PLA and PLA with ester-terminated PLA, and has carboxyl-terminated PLA) The mass ratio of PLA and PLA with terminal ester group is 295:300, and the weight average molecular weight of described PLA with carboxyl group and PLA with terminal ester group is 30kDa, and the viscosity is 0.28dL / g), and the release modifier is PEG600.

[0069] The preparation method of implant described in the present embodiment is:

[0070] (1) Pulverize the insoluble polymer with a blade mill, and collect particles no larger than 60 meshes...

Embodiment 3

[0076] An embodiment of the implant of the present invention, the preparation raw material of the implant described in this embodiment contains the following components by weight: 35 parts of poorly water-soluble / slightly soluble drugs, 59 parts of poorly water-soluble polymers, release 6 parts of regulators; wherein the insoluble / slightly soluble drug in water is Anastrozole, and the insoluble polymer in water is PLGA (the mol ratio of lactide and glycolide is 90:10, and the weight-average molecular weight is 35kDa , a viscosity of 0.36dL / g, with a terminal ester group), the release modifier is composed of palmitic acid and PEG800, and the mass ratio of palmitic acid to PEG800 is 42:18.

[0077] The preparation method of implant described in the present embodiment is:

[0078] (1) Pulverize the water-insoluble polymer with a feather-type pulverizer, and collect particles no larger than 80 meshes by sieving;

[0079] (2) dissolving the release regulator and the poorly water-s...

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Abstract

The invention relates to an implant and a preparation method thereof. The implant is prepared from components of raw materials in parts by weight as follows: 25-65 parts of a water-insoluble / micro-soluble medicine, 35-75 parts of a water-insoluble polymer and 0-10 parts of a release modifier. The preparation method of the implant comprises steps as follows: (1) the water-insoluble / micro-soluble medicine and the release modifier are dissolved in an organic solvent, and a water-insoluble / micro-soluble medicine solution is obtained; (2) the water-insoluble polymer and the water-insoluble / micro-soluble medicine solution obtained in the step (1) are mixed, the organic solvent is removed and a solid mixture is obtained; (3) the solid mixture obtained in the step (2) is put into a hot melt extruder to be extruded and cut, alternatively, the solid mixture in the step (2) is pressed and formed, and the implant is obtained. With the adoption of the preparation method of the implant, the phenomena of medicine crystallization or aggregation and degradation of the polymer can be effectively reduced or avoided, and long-term release of a medicine is facilitated.

Description

technical field [0001] The invention relates to an implant and a preparation method thereof, in particular to an implant of poorly water-soluble / slightly soluble drugs and a preparation method thereof. Background technique [0002] Drug BCS class II and IV chemical drugs are poorly water-soluble / slightly soluble drugs. Because these drugs have low water solubility or are insoluble in water, their application is usually limited, such as most antipsychotics, antidepressants and Chemical drugs such as mood stabilizers. Clinically, chronic diseases (such as mental illness, diabetes, cancer, etc.) require long-term maintenance treatment after acute treatment to achieve the purpose of consolidating curative effect and preventing recurrence. However, due to economic, time and other reasons, patients and their relatives are often difficult to persist for a long time, which will lead to worsening of symptoms, less than ideal treatment effect, frequent recurrence and return to hospit...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K45/00A61K47/34
CPCA61K9/0002A61K9/0024A61K45/00A61K47/34
Inventor 刘锋赖树挺郑阳曹付春连远发
Owner AC PHARMA CO LTD
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