Method for producing extended release tablet

A manufacturing method and sustained-release technology, which are applied in the field of sustained-release tablet manufacturing to achieve the effects of efficient manufacturing and improved fluidity

Active Publication Date: 2009-04-29
NIPPON SODA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] However, since the technology described in this document is to heat and melt the active substance, water-soluble polymer A and water-soluble polymer B, and then process and shape it into solid granular form, it is especially difficult to use thermally unstable (easy to change) When acting on substances, there is a problem

Method used

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  • Method for producing extended release tablet
  • Method for producing extended release tablet
  • Method for producing extended release tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0079] (Example 1, Comparative Example 1)

[0080] The following components (1) to (4) were mixed in the proportions (parts by weight) shown in Table 1.

[0081] (1) As an active ingredient, commercially available acetaminophen (manufactured by API Corporation) was used (the same applies hereinafter).

[0082] (2) As the excipient component of the additive, DCL (trade name: Pharmatose DCL-21, manufactured by DMV international) was used (the same applies hereinafter).

[0083] (3) As the hydroxyalkyl cellulose (A), use hydroxypropyl cellulose (trade name: HPC-L (fine powder), manufactured by Nippon Soda Co., Ltd.) with a viscosity of 8.1 mPa·s at 20° C. in a 2 mass % aqueous solution. More than 99% of the particles have a particle size of 150 μm or less. Hereinafter abbreviated as “HPC-1”) (the same below).

[0084] (4) In addition, as the hydroxyalkylcellulose (B) having a viscosity of 100 mPa·s or more at 20° C. in a 2 mass % aqueous solution, hydroxypropyl cellulose having...

Embodiment 2、3

[0090] (embodiment 2,3, comparative example 2,3)

[0091] The following components (1) to (4) were mixed in proportions (parts by weight) shown in Table 2.

[0092] (1) Active ingredient: Acetaminophen

[0093] (2) Excipient: DCL

[0094] (3) HPC-1

[0095] (4)HPC-2

[0096] Table 2

[0097] Table 2

[0098] Example 2 Example 3 Comparative example 2 Comparative example 3 Acetaminophen 3 3 3 3 DCL 47 27 67 47 HPC—1 40 50 — — HPC-2 10 20 30 50

[0099] Next, 300 mg of the mixture obtained above was directly compressed into tablets under a pressure of 10 kN using a hydraulic pressure forming machine (RIKENPOWER, manufactured by RIKEN POWER Co., Ltd.), to obtain flat-top tablets (about 3.2 mm in thickness) with a diameter of 10 mm, respectively. mm).

[0100] The lapse of time in water and the dissolution rate (%) of the active ingredient of the tablets obtained in Examples 2 and 3 and Comparative Examples 2 and 3 we...

Embodiment 4～6

[0103] The following components (1) to (4) were mixed in proportions (parts by weight) shown in Table 3.

[0104] (1) Active ingredient: Acetaminophen

[0105] (2) Excipient: DCL

[0106] (3) HPC-1

[0107] (4)HPC-2

[0108] table 3

[0109] table 3

[0110] Example 4 Example 5 Example 6 Acetaminophen 3 3 3 DCL 17 7 7 HPC—1 40 50 40 HPC-2 40 40 50

[0111] Next, 300 mg of the mixture obtained above was directly compressed into tablets using a hydraulic press molding machine (RIKENPOWER, manufactured by Riken Machine Co., Ltd.) under a pressure of 10 kN to obtain flat-topped tablets (about 3.5 mm thick) with a diameter of 10 mm. ).

[0112] The lapse of time in water and the dissolution rate (%) of the active ingredient of the tablets obtained in Examples 4 to 6 were measured. The measurement results are shown in image 3 middle. exist image 3 Among them, g is the measurement result of Example 4, h is the measuremen...

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PUM

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Abstract

Disclosed is a method for producing an extended release tablet, which enables to efficiently produce such an extended release tablet having excellent slow release property that is suppressed in initial release of a drug but capable of completing release of the drug after a predetermined time. Specifically disclosed is a method for producing an extended release tablet wherein a mixture, which is composed of a hydroxyalkyl cellulose (A) whose 2% by mass aqueous solution has a viscosity at 20 DEG C of 1-50 mPa s, a hydroxyalkyl cellulose (B) whose 2% by mass aqueous solution has a viscosity at 20 DEG C of not less than 100 mPa s, an active ingredient and an additive, is granulated by dry granulation and then the thus-obtained granules are formed into tablets, or alternatively the mixture is directly formed into tablets.

Description

technical field [0001] this application claims priority based on Japanese Patent Application No. 2006-109710 for which it applied on April 12, 2006, and uses the content here. [0002] The present invention relates to a method for producing a sustained-release tablet having excellent sustained-release properties. Background technique [0003] Sustained-release preparations containing pharmaceutically active ingredients are attracting attention as highly useful preparations capable of controlling the blood concentration of the medicinally active ingredient and sustaining the medicinal effect. Conventionally, as such a sustained-release preparation, a type of sustained-release preparation (matrix-type sustained-release preparation) using a water-soluble polymer that forms a gel upon contact with water to sustain the release of a drug from the preparation has been developed. A lot of research has been done. [0004] As such matrix-type sustained-release preparations, for exam...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K47/38
CPCA61K9/2054A61K9/2018A61K9/2095A61K47/38A61P29/00A61K9/20
Inventor 本间丈士古川研二
Owner NIPPON SODA CO LTD
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