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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 preparing tamsulosin hydrochloride sustained-release tablets and tamsulosin hydrochloride sustained-release tablets, and achieves the effects of high yield, high economic factor and uniform distribution

Inactive Publication Date: 2009-07-01
KYUNG DONG PHARM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] Therefore, the researchers considered it difficult to formulate tamsulosin hydrochloride into tablets with satisfactory drug sustained release properties
For this reason, tamsulosin hydrochloride extended-release tablets have not been developed

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), and then 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. Each...

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 1115g

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

[0081] Magnesium stearate 2g

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Abstract

PURPOSE: A preparing method of sustained release type tamsulosin tablets and the tablet prepared thereby are provided, thereby resolving problems of conventional method such as organic solvent remaining and high density at the end of drying process, and evenly distributing drugs into the tablets. CONSTITUTION: The preparing method of sustained release type tamsulosin tablets comprises the steps of: (a) dissolving tamslosin chloride in solvent, dissolving first phthalic acid hydroxypropylmethylcellulose into the tamslosin chloride dissolved solution to prepare a conjugate solution; (b) adding the conjugate solution into a diluent solution comprising second phthalic acid hydroxypropylmethylcellulose and glyceryldibehenate and assembling them; and (c) optionally drying the assembled mixture, wherein the solvent is at least one selected from ethanol, methylene chloride and water.

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 method. 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, thu...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/18A61K31/137A61K47/14A61K9/22A61P13/08
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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