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Oral pharmaceutical preparation having improved content uniformity, containing tamsulosin hydrochloride-containing extended release pellet

A technology of tamsulosin hydrochloride and pharmaceutical preparations, which is applied in the field of oral pharmaceutical preparations, can solve the problems of poor content uniformity of tamsulosin hydrochloride and reduction of tamsulosin hydrochloride content, and achieve the effect of ensuring quality and high reproducibility

Active Publication Date: 2019-03-15
HANMI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, this preparation method of Patent Document 2 may result in a decrease in the content of tamsulosin hydrochloride because tamsulosin hydrochloride dissolved in distilled water may still adhere when added to a mixed solution of other ingredients to form granules on the walls of equipment or containers
In addition, uneven distribution of tamsulosin hydrochloride aqueous solution dissolved in distilled water in the mixture may lead to poor content uniformity of tamsulosin hydrochloride

Method used

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  • Oral pharmaceutical preparation having improved content uniformity, containing tamsulosin hydrochloride-containing extended release pellet
  • Oral pharmaceutical preparation having improved content uniformity, containing tamsulosin hydrochloride-containing extended release pellet
  • Oral pharmaceutical preparation having improved content uniformity, containing tamsulosin hydrochloride-containing extended release pellet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-3 and comparative example 1-3

[0068] Embodiment 1-3 and Comparative Example 1-3: Preparation of sustained-release pellets containing tamsulosin hydrochloride

[0069] Put tamsulosin hydrochloride, polyvinyl acetate (PVAc) (Kollicoat SR30D, obtained from BASF), hydroxypropyl methylcellulose (HPMC) (METOLOSE 90SH) and diluent in the amounts shown in Table 1. In a high-speed mixer, and distilled water in the amount shown in Table 1 was added thereto, mixed for 5 minutes to about 10 minutes, and then wet pulverized. Put the obtained wet pulverized product into an extruder equipped with a sieve with a mesh size of about 0.8mm, extrude at a screw speed of about 35rpm, and then use a spheroidizer to spheroidize at a speed of about 750rpm for about 26 minutes to obtain Core pellets.

[0070]For the sustained-release pellets containing tamsulosin hydrochloride prepared above of 150.0 parts by weight, use NQ-160 fluidized bed system (available from Japan DALTON) to spray from its bottom by 5.5 parts by weight (1....

Embodiment 4-14 and comparative example 4-8

[0079] Examples 4-14 and Comparative Examples 4-8: Preparation of Sustained Release Pellets Containing Tamsulosin Hydrochloride

[0080] The sustained-release pellets of Example 1 were sieved through a sieve with a sieve size of 0.85 mm and a sieve with a sieve size of 0.5 mm to collect the particles remaining on the 0.85 mm sieve and the particles remaining on the 0.5 mm sieve respectively. Granules and granules passing through a 0.5 mm sieve. Then, use a Turbula mixer (T2F, Switzerland, 75rpm, 15 minutes) to mix the granules with different particle sizes in the ratio shown in Table 3, and then use the capsule filler to fill in capsules, thereby preparing capsule preparations (Example 4 -14 and Comparative Examples 4-8).

[0081] [Table 3] Particle size ratio of each pellet (unit: weight %)

[0082]

[0083]

Embodiment 15

[0111] Example 15: Preparation of composite formulation comprising sustained-release pellets containing tamsulosin hydrochloride

[0112] According to the method and composition shown in Table 6, sustained-release pellets containing tamsulosin hydrochloride were prepared in the same manner as in Example 1.

[0113] [Table 6]

[0114]

[0115] According to the method and composition shown in Table 7, tadalafil tablets were prepared as follows. First, the ingredients for wet granulation shown in Table 7 were mixed using a high-speed mixer, and a binder solution was added thereto, and wet pulverized together. The mixture was then dried using a fluid bed drier and then sieved to prepare wet granules. The wet granulation is mixed with the excipients (post-blended) and then finally with the magnesium stearate. The final blend was compressed with a circular punch having a diameter of 5.5 mm using a rotary tablet press (GRC-18, available from SejongPharmatech Co., Ltd., Korea)...

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Abstract

The present invention relates to an oral pharmaceutical preparation containing a tamsulosin hydrochloride-containing extended release pellet containing tamsulosin hydrochloride and a pharmaceuticallyacceptable additive, wherein the extended release pellet comprises particles having a particle size of approximately 0.50-0.85 mm in an amount of approximately 50-100 wt% and particles of approximately 0.50 mm or less in an amount of less than approximately 15 wt%. The oral pharmaceutical preparation of the present invention exhibits low tamsulosin hydrochloride dissolution deviation and a constant amount in products, thereby having high production reproducibility for products so as to facilitate quality assurance for the preparation.

Description

technical field [0001] The present disclosure relates to oral pharmaceutical preparations comprising sustained-release pellets containing tamsulosin hydrochloride, more particularly, to oral pharmaceutical preparations comprising sustained-release pellets containing tamsulosin hydrochloride and a preparation method thereof, the oral pharmaceutical preparations With improved sample-to-sample content uniformity and dissolution rate bias and consistent efficacy. Background technique [0002] Tamsulosin hydrochloride can selectively inhibit α-adrenergic receptors to selectively act on urogenital organs, thereby causing relaxation of smooth muscle around the bladder and prostate and improving urination rate, and is known to improve benign prostatic hyperplasia ( BPH) symptoms of good efficacy and less side effects. [0003] Tamsulosin hydrochloride has a relatively good bioavailability of 90% or higher, and has a half-life of about 9 hours to 13 hours in normal adults, and a rel...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K47/38A61K9/50A61K31/18A61K9/00
CPCA61K9/00A61K9/16A61K9/50A61K31/18A61K47/38A61K9/5073A61K9/5026A61K9/1652A61K9/1635A61K9/5084A61P13/08A61K9/1611A61K9/5021A61K9/0053A61K9/1682
Inventor 金炯序赵正贤金唇哲金用镒朴宰贤禹钟守
Owner HANMI PHARMA
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