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Method for producing granulated matter

A manufacturing method and technology of granule preparations, which are applied in the field of granule preparation manufacturing and can solve problems such as instability and loss of stability of unstable substances

Inactive Publication Date: 2010-11-03
OHARA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it is undesirable for an unstable substance to be unstable in water because if it dissolves in water, the substance continues to lose stability

Method used

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  • Method for producing granulated matter
  • Method for producing granulated matter

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] 356.0 g of magnesium oxide was charged into a jet fluidized bed granulator (Model MP-01-SPC, manufactured by Powrex Corporation), followed by fluidization. The granules were produced by spraying a liquid prepared by dissolving 80.0 g of rabeprazole sodium in a solution of 20.0 g of sodium hydroxide in 220.0 g of pure water on a fluidized bed, followed by drying. The granules were made into a uniform size (stable uniform granules) by passing through a JIS 24-mesh sieve. 114.0 g of the obtained stable uniform granules were fed into a jet fluidized bed granulator, and the granules were coated by spraying a liquid by dissolving and suspending 11.0 g of polyvinyl alcohol copolymer and 11.0 g of talc in 253.0 g of pure water was prepared and then dried. The granules were then coated by spraying a liquid prepared by dissolving and suspending 62.0 g of methacrylic acid copolymer LD (30% by weight liquid), 9.6 g of talc and 1.8 g of triethyl citrate in purified water , then dr...

Embodiment 2

[0049] Into the same jet fluidized bed granulator as used in Example 1, 406.0 g of D-mannitol was added, followed by fluidization. The particles were then produced by spraying a liquid prepared by dissolving 40.0 g of rabeprazole sodium having an average particle diameter of 5 μm in a solution of 10.0 g of sodium hydroxide dissolved in 110.0 g of pure water, followed by drying. The granules were made into a uniform size (stable uniform granules) by passing through a JIS 24-mesh sieve. Add 228.0 g of the obtained stable and uniform granules into a jet fluidized bed granulator, and coat the granules by spraying a liquid that dissolves and suspends 22.0 g of polyvinyl alcohol and 22.0 g of talc in 506.0 g of pure Water is prepared and then dried. The granules were then coated by using a liquid by dissolving and suspending 124.0 g of methacrylic acid copolymer LD (30 W / W% liquid), 19.2 g of talc and 3.6 g of triethyl citrate in purified water prepared, then dried. The obtained ...

Embodiment 3

[0061] To the same jet fluidized bed granulator as used in Example 1 was added 414.0 g of D-mannitol. Particles were then produced by using a liquid prepared by dissolving 40.0 g of rabeprazole sodium having an average particle diameter of 5 μm in a solution of 2.0 g of sodium hydroxide dissolved in 110.0 g of pure water, followed by drying. The granules were made into a uniform size (stable uniform granules) by passing through a JIS 24-mesh sieve. As a result of operating in the same manner as in Example 1, an enteric granule preparation having the composition given below was obtained.

[0062] [Ingredient] [Weight (mg) based on 500mg granule preparation]

[0063] Rabeprazole Sodium 10.0

[0064] D-mannitol 103.5

[0065] Sodium hydroxide 0.5

[0066] Polyvinyl alcohol copolymer 11.0

[0067] Talc 20.6

[0068] Methacrylic acid copolymer LD 18.6

[0069] Triethyl citrate 1.8

[0070] D-mannitol 314.0

[0071] Hydroxypropyl Cellulose 20.0

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Abstract

It has been demanded to provide a method for producing a granulated matter capable of maintaining a stability of a chemically unstable substance in a neutral or acidic region for a long period of time with a simple and safe method in a preparation procedure, and a tablet produced by using the method. The invention provides a granulation method in which an unstable substance is successively subjected to aqueous stabilization treatment and granulation procedure. Further, it became possible to provide a tablet which is absorbed in the intestine without losing the potency in a gastric region by forming an intermediate layer on a surface of the thus obtained granule and subsequently subjecting the granule to enteric coating.

Description

technical field [0001] The present invention relates to a process for the manufacture of granule formulations, in particular to a process for the manufacture of granule formulations containing unstable substances. Background technique [0002] Some substances become chemically unstable as a result of moisture, solution pH, heat, or incorporation or contact with other substances, and as a result, decomposition, inactivation, etc., may occur, wherein such substances are hereinafter referred to as "unstable substance". Thus, in granule processing (such as granulation-coating and tabletting) of a substance that becomes unstable under some conditions, selection of conditions that have no effect on the stability of the substance requires a lot of time, labor and cost. In addition, keeping the quality of such processed granules stable requires more complex granule processing methods, and meeting this demand significantly reduces the manufacturing efficiency of granule formulations...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/02A61K9/14A61K9/32A61K9/50A61K31/4433A61K31/4439A61K47/26A61K47/32A61K47/36A61K47/38A61P1/04A61P43/00
CPCA61K9/2013A61K9/1694A61K31/4439A61K9/1652A61K9/1611A61K9/2027A61K9/2095A61K9/2009A61K9/2054A61K9/2018A61K31/4433A61K9/1623A61K9/1635A61P1/04A61P43/00
Inventor 坂本浩谷口俊哉
Owner OHARA PHARMA
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