WO2007049916A1 - Formulation a liberation controlee contenant de l'hydrochlorure de tamsulosine - Google Patents

Formulation a liberation controlee contenant de l'hydrochlorure de tamsulosine Download PDF

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Publication number
WO2007049916A1
WO2007049916A1 PCT/KR2006/004375 KR2006004375W WO2007049916A1 WO 2007049916 A1 WO2007049916 A1 WO 2007049916A1 KR 2006004375 W KR2006004375 W KR 2006004375W WO 2007049916 A1 WO2007049916 A1 WO 2007049916A1
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WO
WIPO (PCT)
Prior art keywords
weight
release
parts
preparation
tamsulosin hydrochloride
Prior art date
Application number
PCT/KR2006/004375
Other languages
English (en)
Inventor
Hong-Ryeol Jeon
Bong-Sang Lee
Se-Geun Yu
Do-Woo Kwon
Original Assignee
Ctc Bio, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ctc Bio, Inc. filed Critical Ctc Bio, Inc.
Publication of WO2007049916A1 publication Critical patent/WO2007049916A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating

Definitions

  • the present invention relates to a controlled-release formulation containing tamsulosin hydrochloride, and more particularly, a controlled release formulation that can release tamsulosin at zero-order rate regardless of ambient in vivo condition.
  • Tamsulosin hydrochloride is an alpha ( ⁇ ) 1 blocker that is selective to prostatic smooth muscle. Tamsulosin hydrochloride is a drug useful for the treatment of obstructive urinary tract disorders due to benign prostate enlargement. The usual daily dose of tamsulosin hydrochloride is 0.2-0.8 mg. Tamsulosin hydrochloride has a greater selectivity for prostatic smooth muscle and acts weakly on blood vessels, unlike other alphal blockers such as doxazosin and terazosin, thereby greatly decreasing occurrences of side effects such as orthostatic hypotension.
  • U.S. Patent No. 4,772,475 discloses a controlled release formulation containing tamsulosin hydrochloride.
  • tamsulosin hydrochloride is mixed with at least 50 % by weight of a unit-forming substance selected from the group consisting of crystalline cellulose, chitin and chitosan.
  • a release-controlling agent selected from the group consisting of acrylic acid polymers, acrylic acid copolymers and mixtures thereof is added, followed by granulation, to produce sustained-release granules containing tamsulosin hydrochloride.
  • the controlled-release formulation according to the above patent does not show enough controlled-release property.
  • 16.2 to 60.4 % of the drug is released from said formulation within one hour after start of release in a first acidic solution (about pH 1.2), and more than 90% of the drug is released within one hour after start of release in the second neutral solution when release is carried out in a second neutral solution (about pH 6.8) after the release in the first acid solution (See Korean patent application No. 10-2003-0015391).
  • Yamanouchi Co. Ltd.; and FlomaxTM Boehringer Ingelheim also exhibit distinct pH-dependent drug release property. It is reported that administration of these products into human before food intake results in 30% increase of bioavailability and 40-70% increase of maximum drug concentration in bloods (Cmax), as compared to after food intake (Physicians Desk Reference 2002). This report demonstrates that the above commercially available products are severely affected by the changes of the mobility of the gastric intestinal tract and the ambient pH of a drug-containing preparation caused by food intake. Disclosure of Invention Technical Problem
  • the object of the present invention is to provide a tamsulosin hy- drochloride-containing controlled-release preparation that releases constantly the drug irrespective of ambient in vivo pH, that is, releases the drug at regular rate (zero-order rate) from stomach to small intestine.
  • the object of the present invention is to provide a tamsulosin hydrochloride-containing preparation that maintains the effect of tamsulosin hydrochloride longer and reduces side effects such as orthostatic hypotension and abnormal ejaculation, which are caused by the large amount of absorption of tamsulosin hydrochloride during short time.
  • the present invention provides a tamsulosin hydrochloride- containing controlled-release preparation, wherein the preparation comprises:
  • a drug-coating layer surrounding the non-active core particle comprising tamsulosin hydrochloride, 15-35 parts by weight of high-viscosity hydroxypropyl- methylcellulose, 2-10 parts by weight of plasticizer, 12-25 parts by weight of nonaqueous and pH-independent polymer and 12-25 parts by weight of release-controlling assister, based on the weight of tamsulosin hydrochloride; and
  • a release-controlling layer surrounding the drug-coating layer comprising 0.03-0.13 parts by weight of non- aqueous polymer, 0.0005-0.01 parts by weight of plasticizer, 0.001-0.01 parts by weight of high-viscosity hydroxypropylmethylcellulose and 0.01-0.1 parts by weight of release-controlling assister, based on the total weight of the preparation including the non-active core particle and the drug-coating layer.
  • the present invention provides a tamsulosin hydrochloride- containing controlled-release preparation, wherein the preparation comprises:
  • a drug-coating layer surrounding the non-active core particle comprising tamsulosin hydrochloride, 20-30 parts by weight of high-viscosity hydroxypropylmethylcellulose, 4-9 parts by weight of plasticizer, 13-21 parts by weight of nonaqueous and pH-independent polymer and 13-21 parts by weight of release-controlling assister, based on the weight of tamsulosin hydrochloride; and
  • a release-controlling layer surrounding the drug-coating layer comprising 0.05-0.09 parts by weight of non- aqueous polymer, 0.001-0.008 parts by weight of plasticizer, 0.001-0.01 parts by weight of high-viscosity hydroxypropylmethylcellulose and 0.01-0.08 parts by weight of release-controlling assister, based on the total weight of the preparation including the non-active core particle and the drug-coating layer.
  • the present invention provides the tamsulosin hydrochloride- containing preparation, wherein the viscosity of the high- viscosity hydroxypropylmethylcellulose is 3,000-5,000 cP when measured as 2% aqueous solution at 2O 0 C.
  • the present invention provides the tamsulosin hydrochloride- containing preparation, wherein the non-aqueous and pH-independent polymer is ethylcellulose and the non-aqueous polymer is at least one selected from the group consisting of ethylcellulose; copolymer of ethylacrylate, methylmethacrylate and trimethylammonioethylmethacrylate chloride; and polyvinylacetate.
  • the present invention provides the tamsulosin hydrochloride - containing preparation, wherein the plasticizer is at least one selected from the group consisting of triethylcitrate, polyethylene glycol, glycerol, glycerol triacetate and propylene glycol.
  • the plasticizer is at least one selected from the group consisting of triethylcitrate, polyethylene glycol, glycerol, glycerol triacetate and propylene glycol.
  • the present invention provides the tamsulosin hydrochloride - containing preparation, wherein the release-controlling assister is at least one selected from the group consisting of talc, titanium oxide and colloidal silicon dioxide.
  • the present invention also provides the tamsulosin hydrochloride - containing preparation, wherein the preparation has an enteric coating layer surrounding the release-controlling layer. More preferably, the enteric coating layer is 0.04-0.2 parts by weight based on the total weight of the preparation including the non- active core particle; the drug-coating layer; and the release-controlling layer.
  • the tamsulosin hydrochloride-containing preparation of present invention releases tamsulosin hydrochloride at zero-order rate regardless of ambient in vivo condition of stomach and intestine by appropriately mixing a high-viscosity hydrox- ypropylmethylcellulose (a pH-independent release-controlling polymer), a nonaqueous and pH-independent polymer, a non-aqueous polymer and a release- controlling assister; adjusting the mixing ratio of the ingredients to make the preparation have a good drug-release pattern; and synergically controlling the release rate with two layers of the drug-coating layer and the release-controlling layer.
  • a high-viscosity hydrox- ypropylmethylcellulose a pH-independent release-controlling polymer
  • a nonaqueous and pH-independent polymer a non-aqueous polymer and a release- controlling assister
  • adjusting the mixing ratio of the ingredients to make the preparation have a good drug-release pattern
  • the present invention provides a tamsulosin hydrochloride-containing controlled- release preparation, wherein the preparation comprises:
  • a drug-coating layer surrounding the non-active core particle comprising tamsulosin hydrochloride, 15-35 parts by weight of high-viscosity hydroxypropyl- methylcellulose, 2-10 parts by weight of plasticizer, 12-25 parts by weight of nonaqueous and pH-independent polymer and 12-25 parts by weight of release-controlling assister, based on the weight of tamsulosin hydrochloride; and
  • a release-controlling layer surrounding the drug-coating layer comprising 0.03-0.13 parts by weight of non- aqueous polymer, 0.0005-0.01 parts by weight of plasticizer, 0.001-0.01 parts by weight of high-viscosity hydroxypropylmethylcellulose and 0.01-0.1 parts by weight of release-controlling assister, based on the total weight of the preparation including the non-active core particle and the drug-coating layer.
  • the present invention provides a tamsulosin hydrochloride- containing controlled-release preparation, comprising:
  • a drug-coating layer surrounding the non-active core particle comprising tamsulosin hydrochloride, 20-30 parts by weight of high-viscosity hydroxypropyl- methylcellulose, 4-9 parts by weight of plasticizer, 13-21 parts by weight of nonaqueous and pH-independent polymer and 13-21 parts by weight of release-controlling assister, based on the weight of tamsulosin hydrochloride; and
  • a release-controlling layer surrounding the drug-coating layer comprising 0.05-0.09 parts by weight of non- aqueous polymer, 0.001-0.008 parts by weight of plasticizer, 0.001-0.01 parts by weight of high-viscosity hydroxypropylmethylcellulose and 0.01-0.08 parts by weight of release-controlling assister, based on the total weight of the preparation including the non-active core particle and the drug-coating layer.
  • the more preferable controlled-release preparation shows better drug-release pattern.
  • the release of tamsulosin hydrochloride in the preparation according to the present invention is controlled complexly by two steps. Firstly, three ingredients of the high- viscosity hydroxypropylmethylcellulose, the non-aqueous and pH-independent polymer and the release-controlling assister, which are mixed uniformly with tamsulosin hydrochloride and then coated on the non-active core particle, harmoniously control the release of tamsulosin hydrochloride. Secondly, the release- controlling layer, which surrounds the drug-coating layer and comprises the nonaqueous polymer, the high- viscosity hydroxypropylmethylcellulose and the release- controlling assister, controls the release of tamsulosin hydrochloride.
  • high- viscosity in the high- viscosity hydroxypropylmethylcellulose of the present invention means that the viscosity of 2% water solution made with the hydroxypropylmethylcellulose is from 3,000 to 5,000 cP, more preferably from 3,500 to 4,500 cP when measured at 2O 0 C according to the viscosity-measuring method of the U.S. Pharmacopoeia.
  • a commercially available high- viscosity hydroxypropylmethylcellulose includes MetoloseTM 90SH 4000SR (Shin-Etsu Chemical Co., Ltd.).
  • a preferable non-aqueous and pH-independent polymer is ethylcellulose, which is comprised in the drug-coating layer and plays a role in controlling the release of tamsulosin hydrochloride with the high-viscosity hydroxypropylmethylcellulose and the release-controlling assister.
  • Ethylcellulose powder dissolved in organic solvent may be used, and a commercially available aqueous suspension (for example, Aquacoat ECDTM, FMC Co.) can be used in the present invention.
  • the non-aqueous polymer comprised in the release-controlling layer controls the release of tamsulosin hydrochloride with the high-viscosity hydroxypropylmethyl- cellulose and the release-controlling assister.
  • Preferable non-aqueous polymer is at least one selected from the group consisting of ethylcellulose; copolymer of ethy- lacrylate, methylmethacrylate and trimethylammonioethylmethacrylate chloride; and polyvinylacetate. Ethylcellulose is more preferable.
  • Preferable release-controlling assister is at least one selected from the group consisting of talc, titanium oxide and colloidal silicon dioxide, which controls the release of tamsulosin hydrochloride.
  • the release-controlling assister is not dissolved and extracted in vivo so that a pore is formed in the layer, which complexly controls the release of tamsulosin hydrochloride.
  • Preferable plasticizer according to the present invention includes, but is not limited to, triethylcitrate, polyethylene glycol, glycerol, glycerol triacetate, propylene glycol and their mixture. Any plasticizer can be used in the present invention if the plasticizer gives the release-controlling polymer plasticity so that the layer can be formed continuously without separation.
  • the plasticizer used in the present invention may also play a role as wetting agent, which affects the release pattern of tamsulosin hydrochloride.
  • the coating process of the present invention can be performed with a fluidized bed granulator, a granule coater, a C/F granulator, etc.
  • any machine can be used in the present invention if the machine can coat powder or granule.
  • the present invention also provides the tamsulosin hydrochloride - containing preparation, wherein the preparation has an enteric coating layer surrounding the release-controlling layer. More preferably, the enteric coating layer is 0.06-0.2 parts by weight based on the total weight of the preparation including the non- active core particle; the drug-coating layer; and the release-controlling layer.
  • Preferable polymer for enteric coating includes, but is not limited to, hydroxypropylmethyl- cellulose phthalate, methacrylic acid copolymer (for example, a series of EudragitTM L, Degussa), hydroxypropylmethylcellulose acetate succinate.
  • Figure 1 shows the results of dissolution tests for controlled-release preparations according to examples of the present invention and commercially-available products. Mode for the Invention
  • Examples 1 and 2 were prepared with ingredients and contents of the below table 1. More detailed preparing method is as follows: Sugar bead was fluidized in a chamber of a fluidized bed granulator (GX20, Freund, Japan).
  • Tamsulosin hydrochloride, plasticizer, high- viscosity HPMC, ethylcellulose and talc were dissolved or suspended in a mixture of acetone:ethanol:water (weight ratio 5:5:2, 1,500 g) to make a coating solution, and then the coating solution was coated on the sugar bead to make a drug- coating layer with conditions of about 55 0 C of inlet air temperature, about 35 0 C of fluidized granule temperature, about 35 0 C of outlet air temperature, and about 20 ml/ min of spraying rate.
  • HPMC means hydroxypropylmethylcellulose and Metolose 90SH 4000SRTM(Shin-Etsu) was used as the high-viscosity HPMC.
  • Dissolution tests were performed with the above manufactured examples 1-2 and commercially available products [TAMSNALTM (Yuhan Corp., South Korea), URONALTM (KyungDong Pharm. Co. Ltd., South Korea) and HARNALTM (Yamanouchi Korea Co. Ltd., South Korea)] according to the paddle method of the dissolution test method of the Korea Pharmacopoeia.
  • the paddle was rotated at a rate of 100 rpm and the temperature of dissolution medium was 37+0.5.
  • pH 1.2 solution 500 ml of pH 1.2 solution [2.0 g of NaCl was dissolved in 7.0 ml of hydrochloric acid, and then distilled water was added to make the volume 1 liter], to which 1 ml of polysorbate 80 solution (3 ⁇ 200) was added, was used as dissolution medium until 2 hours after the start of the test, and then the pH 1.2 solution was immediately replaced with 500 ml of pH 7.2 phosphate buffered solution.
  • Mobile phase 8.7 ml of perchloric acid and 3.0 g of NaOH were dissolved in 1,900 ml of water to make a solution. A pH of the solution was adjusted to 2.0 with NaOH solution and water was added to make the volume 2,000 ml. 1,400 ml of the solution and 600 ml of acetonitrile were mixed to make a mobile phase.
  • examples 1 and 2 according to the present invention showed near zero-order release pattern irrespective of pH change, and the adequate amount of the enteric coating layer located on the outside of the release- controlling layer could control overall release pattern.
  • the commercially available products released a large amount of tamsulosin hydrochloride between 120 minutes and 150 minutes when the dissolution medium was changed from pH 1.2 to pH 7.2 (that is, the preparation is passed on into small intestine from stomach), which may cause several side effects.
  • the examples of the present invention showed a constant release pattern (zero-order rate release) irrespective of ambient condition.
  • the present invention provides a tamsulosin hydrochloride-containing controlled- release preparation that can maintain the effect of the drug longer and reduce side effects such as orthostatic hypotension and abnormal ejaculation by releasing constantly the drug irrespective of ambient in vivo pH, that is, releasing the drug at regular rate (zero-order rate) from stomach to small intestine.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
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  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

Formulation à libération contrôlée contenant de l'hydrochlorure de tamsulosine. Il s'agit d'une préparation capable de libérer ledit hydrochlorure à un débit de l'ordre du zéro indépendamment des conditions ambiantes de l'estomac et de l'intestin grêle, ce qui permet de réduire plusieurs effets secondaires et de maintenir l'effet du médicament à un niveau constant.
PCT/KR2006/004375 2005-10-26 2006-10-25 Formulation a liberation controlee contenant de l'hydrochlorure de tamsulosine WO2007049916A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR10-2005-0101220 2005-10-26
KR1020050101220A KR20070044911A (ko) 2005-10-26 2005-10-26 염산 탐스로신 함유 방출조절 제제

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WO2007049916A1 true WO2007049916A1 (fr) 2007-05-03

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100092552A1 (en) * 2008-12-24 2010-04-15 Korinde Annemarie Jansen Low dose controlled release tablet
CN115873435A (zh) * 2022-12-15 2023-03-31 宏源防水科技集团有限公司 一种聚合物水泥防水涂料及其制备工艺

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20160100570A (ko) * 2015-02-16 2016-08-24 한미약품 주식회사 탐수로신 염산염 함유 서방성 과립을 포함하는 경구용 약제학적 제제
AU2017297117A1 (en) * 2016-07-15 2019-01-24 Hanmi Pharm. Co., Ltd. Oral pharmaceutical preparation having improved content uniformity, containing tamsulosin hydrochloride-containing extended release pellet
KR20200078146A (ko) * 2018-12-21 2020-07-01 한미약품 주식회사 내산성이 우수한 탐수로신 염산염 함유 제약 조성물 및 이의 제조방법

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003039531A1 (fr) * 2001-11-07 2003-05-15 Synthon B.V. Comprimes de tamsulosine a liberation modifiee
WO2004048711A1 (fr) * 2002-11-22 2004-06-10 Tec-Truss Holdings Pty Ltd Poutres composites
WO2005044235A1 (fr) * 2003-11-07 2005-05-19 Gl Pharmtech Corp. Forme galenique d'hydrochlorure de tamsulosine a liberation controlee et procede de preparation de ladite composition
WO2005053659A1 (fr) * 2003-12-03 2005-06-16 Natco Pharma Limited Preparation pharmaceutique amelioree contenant un sel de tamsulosine et procede de fabrication

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003039531A1 (fr) * 2001-11-07 2003-05-15 Synthon B.V. Comprimes de tamsulosine a liberation modifiee
WO2004048711A1 (fr) * 2002-11-22 2004-06-10 Tec-Truss Holdings Pty Ltd Poutres composites
WO2005044235A1 (fr) * 2003-11-07 2005-05-19 Gl Pharmtech Corp. Forme galenique d'hydrochlorure de tamsulosine a liberation controlee et procede de preparation de ladite composition
WO2005053659A1 (fr) * 2003-12-03 2005-06-16 Natco Pharma Limited Preparation pharmaceutique amelioree contenant un sel de tamsulosine et procede de fabrication

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100092552A1 (en) * 2008-12-24 2010-04-15 Korinde Annemarie Jansen Low dose controlled release tablet
US8465770B2 (en) * 2008-12-24 2013-06-18 Synthon Bv Low dose controlled release tablet
CN115873435A (zh) * 2022-12-15 2023-03-31 宏源防水科技集团有限公司 一种聚合物水泥防水涂料及其制备工艺
CN115873435B (zh) * 2022-12-15 2023-09-01 宏源防水科技集团有限公司 一种聚合物水泥防水涂料及其制备工艺

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