Preparing method for controlled released type tablet tamsulosin hcl and the tablet thereof

A technology for sustained-release tablets and hydrochloric acid, which is applied in the field of tamsulosin hydrochloride sustained-release tablets and the preparation of tamsulosin hydrochloride sustained-release tablets, and achieves the effects of high economic factor, uniform distribution and high yield

Inactive Publication Date: 2006-09-20
KYUNG DONG PHARM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Contents of the invention

Method used

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  • Preparing method for controlled released type tablet tamsulosin hcl and the tablet thereof
  • Preparing method for controlled released type tablet tamsulosin hcl and the tablet thereof
  • Preparing method for controlled released type tablet tamsulosin hcl and the tablet thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] Sustained-release tablets containing the following ingredients were prepared as follows:

[0053] Tamsulosin Hydrochloride 0.2g

[0054] Hydroxypropylmethylcellulose phthalate (A) 10g

[0055] Hydroxypropylmethylcellulose phthalate (B) 65g

[0056] Lactose 99.8g

[0057] Glyceryl Dielmate 15g

[0058] Metolose 60SH-4000(A)15g

[0059] Metolose 60SH-4000(B)20g

[0060] Magnesium stearate 2g

[0061] A binder solution was prepared by completely dissolving tamsulosin hydrochloride in 60 ml of a mixed organic solvent (ethanol:water=8:2), followed by dissolving hydroxypropylmethylcellulose phthalate (A) therein. Meanwhile, lactose, hydroxypropylmethylcellulose phthalate (B), Metolose 60SH-4000 (A) and glyceryl dielmate were mixed with each other, and the resulting binder solution was added thereto and kneaded. The kneaded material is granulated and dried. The dried granules were sieved and mixed with Metolose 60SH-4000(B) as an excipient and magnesium stearate as a l...

Embodiment 2

[0063] Sustained-release tablets containing the following ingredients were prepared as follows:

[0064] Tamsulosin Hydrochloride 0.2g

[0065] Hydroxypropylmethylcellulose phthalate (A) 10g

[0066] Hydroxypropylmethylcellulose phthalate (B) 60g

[0067] Lactose 94.8g

[0068] Glyceryl Dielmate 15g

[0069] Cereal starch 20g

[0070] Magnesium stearate 2g

[0071]A binder solution was prepared by completely dissolving tamsulosin hydrochloride in 50 ml of a mixed organic solvent (ethanol:water=8:2), followed by dissolving hydroxypropylmethylcellulose phthalate (A) therein. At the same time, lactose, hydroxypropylmethylcellulose phthalate (B) and glyceryl diglycerin were mixed with each other, and the resulting binder solution was added thereto and kneaded. The kneaded material is granulated and dried. The dried granules are sieved and mixed with cereal starch as excipient and magnesium stearate as lubricant, followed by compression into tablets with a tablet machine. E...

Embodiment 3

[0073] Except adding the low-substituted hydroxypropyl cellulose 11, the sustained-release tablet containing the following components was prepared in the same manner as in Example 1:

[0074] Tamsulosin Hydrochloride 0.2g

[0075] Hydroxypropylmethylcellulose phthalate (A) 20g

[0076] Hydroxypropylmethylcellulose phthalate (B) 70g

[0077] Lactose 104.8g

[0078] Glyceryl Dielmate 15g

[0079] Low-Substituted Hydroxypropyl Cellulose 11 15g

[0080] Metolose 60SH-4000(B)30g

[0081] Magnesium stearate 2g

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Abstract

The present invention relates to a simple and effective method for preparing a tamsulosin HCl sustained-release tablet and a tamsulosin HCl sustained-release tablet produced thereby. The method comprises the steps of: dissolving tamsulosin HCl as an active ingredient in an organic solvent; dissolving the tamsulosin HCl solution in hydroxypropylmethylcellulose phthalate to prepare a binder solution; and kneading the binder solution with a hydroxypropylmethylcellulose phthalate / glyceryl dibehenate mixture as an excipient and allows tamsulosin HCl to be released at uniformly controlled amounts in a subtained-release manner in vivo by controlling drug release rate according to different pH environments in vivo, so that it shows improved bioavailability and minimized side effects.

Description

technical field [0001] The invention relates to a preparation method of a tamsulosin hydrochloride (HCl) sustained-release tablet and a tamsulosin hydrochloride sustained-release tablet prepared by using the same. More particularly, the present invention relates to the method for preparing tamsulosin hydrochloride slow-release tablet, and it comprises the steps: dissolving tamsulosin hydrochloride as an active ingredient in an organic solvent; dissolving gained tamsulosin hydrochloride solution in Preparation of binding agent (binder) solution in hydroxypropyl methylcellulose phthalate; dibehenate) mixture kneading (kneading). The tamsulosin hydrochloride sustained-release tablet prepared according to the present invention controls the drug release rate according to different pH environments in the body, so that a lower dose of tamsulosin hydrochloride as the active drug can be uniformly controlled in the body in a sustained-release manner. released in the same amount, thus ...

Claims

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Application Information

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IPC IPC(8): A61K31/18A61K31/137A61K47/14A61K9/22
CPCA61K9/2018A61K9/2054A61K9/2095A61K31/137A61K31/18
Inventor 李炳硕李安然朴钟植金银珠吉亨俊
Owner KYUNG DONG PHARM
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