CN1671364A - 用于d2促进素给药的热熔-经皮治疗系统 - Google Patents
用于d2促进素给药的热熔-经皮治疗系统 Download PDFInfo
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- CN1671364A CN1671364A CNA038183781A CN03818378A CN1671364A CN 1671364 A CN1671364 A CN 1671364A CN A038183781 A CNA038183781 A CN A038183781A CN 03818378 A CN03818378 A CN 03818378A CN 1671364 A CN1671364 A CN 1671364A
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- 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
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
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- 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
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
- A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
- A61K9/7069—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained otherwise than by reactions only involving carbon to carbon unsaturated bonds, e.g. polysiloxane, polyesters, polyurethane, polyethylene oxide
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/38—Heterocyclic compounds having sulfur as a ring hetero atom
- A61K31/381—Heterocyclic compounds having sulfur as a ring hetero atom having five-membered rings
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
- A61P25/16—Anti-Parkinson drugs
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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- Psychology (AREA)
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
- Heterocyclic Compounds That Contain Two Or More Ring Oxygen Atoms (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicines Containing Plant Substances (AREA)
- External Artificial Organs (AREA)
- Heterocyclic Compounds Containing Sulfur Atoms (AREA)
- Adhesives Or Adhesive Processes (AREA)
Abstract
Description
贴剂尺寸cm2 | 最少的D2促进素含量mg/cm2 |
10 | 7.0-8.4 |
15 | 4.7-5.6 |
20 | 3.5-4.2 |
25 | 2.8-3.4 |
30 | 2.3-2.8 |
批号(Ch.B.) | 白地蜡含量[%w/w] | 地蜡含量[%w/w] | 内相-型/含量[%w/w] | 理论D2促进素含量[%w/w] | 测得的D2促进素含量(n=5)[%w/w] | 粘结基质的重量(n=10)[g/m2] |
20011031 | 15 | - | PVP/10 | 9 | 8.51 | 108 |
20010132 | 15 | - | PVP/2 | 9 | 9.23 | 83 |
20011035 | 15 | - | PVP/2 | 15 | 15.81 | 66 |
20011036 | 15 | - | PVP/10 | 15 | 15.56 | 100 |
20012038 | 15 | - | PVP/2 | 9 | n.d. | 123 |
20012040 | 15 | - | PVP/2 | 15 | n.d. | 118 |
20012042 | 15 | - | PVP/2 | 25 | n.d. | 114 |
20103042 | 15 | - | 0 | 15 | 15.25 | 57 |
20103043 | 15 | - | PVP/25 | 15 | 14.04 | 127 |
20105038 | 15 | - | 0 | 9 | 8.75 | 91 |
20105039 | 15 | - | PVP/2 | 9 | 9.07 | 88 |
20105040 | 15 | - | PVP/10 | 9 | 9.14 | 91 |
20105041 | 5 | - | 0 | 9 | 8.08 | 106 |
20105043 | - | 5 | 0 | 9 | 8.03 | 105 |
20105044 | 15 | - | 0 | 15 | 14.50 | 78 |
20105045 | 15 | - | 0 | 25 | 25.20 | 77 |
20106016 | - | 15 | 0 | 9 | 8.12 | 88 |
20107040 | - | 5 | 0 | 15 | 13.71 | 99 |
20107041 | - | 5 | 0 | 25 | 24.71 | 84 |
20109009 | - | 15 | 0 | 15 | 13.28 | 89 |
20109010 | 5 | - | 0 | 15 | 14.09 | 107 |
20111059 | - | 5 | 0 | 25 | 23.95 | 54 |
20111058 | - | 5 | 0 | 15 | 14.57 | 54 |
20111057 | - | 5 | 0 | 9 | 8.64 | 56 |
20109043 | - | 5 | 0 | 25 | 22.69 | 117 |
20105044 | - | 15 | 0 | 15 | 14.49 | 57 |
20103043 | - | 15 | 0 | 15 | 14.04 | 78 |
WE11682*) | - | - | PVP/2 | 9 | 8.83 | 50 |
20107011*) | - | - | PVP/2 | 9 | 9.90 | 110 |
批号(Ch.B.) | 粘结剂 | 内相/含量[%w/w] | 理论活性成分含量[%w/w] | 测得活性成分含量[%w/w] | 重量(n=10)[g/m2] | 纯度%(220nm/272nm) |
20103041 | SXS | - | 15 | 14.96 | 85 | 94.9/94.3 |
20103048 | EVA | - | 16.2 | 18.24 | 58 | 98.1/99.7 |
20103047 | EVA | - | 16.2 | 15.96 | 127 | 98.8/99.9 |
号 | 批号(Ch.B.) | 规模 | 静态混合 | 白地蜡含量[%w/w] | 内相种装/含量[%w/w] | 理论D2促进素含量[%w/w] | 测得的D2促进素含量(n=5)[%w/w] | 基质重量(n=10)[g/m2] | D2促进素纯度[%](220nm/272nm) |
1 | 20105025 | 大型 | - | 15 | PVA/10 | 9 | 8.88 | 117 | 99.3/99.7 |
2 | 20105025 | 大型 | + | 15 | PVA/10 | 9 | 7.16 | 117 | 99.3/99.9 |
3 | 20105018 | 大型 | - | 15 | PVA/10 | 9 | 9.16 | 92 | 99.4/100 |
4 | 20105018 | 大型 | + | 15 | PVA/10 | 9 | 8.36 | 86 | 99.5/100 |
5 | 20109006 | 小型 | - | 15 | PVA/10 | 9 | 8.80 | 82 | 99.6 |
6 | 20109007 | 小型 | - | 15 | PVPVA/10 | 9 | 8.96 | 98 | 98.3 |
7 | 20109008 | 小型 | - | 15 | PEO/10 | 9 | 7.28 | 88 | 99.1 |
8 | 20108030 | 大型 | + | 15 | - | 25 | 22.43 | 187 | 99.2/n.d. |
9 | 20105045 | 小型 | - | 15 | - | 25 | 25.2 | 77 | 98.7/96.9 |
批号(Ch.B.) | 规模 | 内相/含量[%w/w] | 理论活性成分量[%w/w] | 测得的活性成分含量(n=5)[%w/w] | 重量(n=10)[g/m2] | D2促进素纯度[%](220nm/272nm) |
20103048 | 小型 | - | 16.2 | 18.24 | 58 | 98.1/99.7 |
20103047 | 小型 | - | 16.2 | 15.96 | 127 | 98.8/99.9 |
20109019 | 大型 | - | 9 | 8.62 | 93 | 98.9/99.9 |
20109045 | 大型 | - | 15 | 15.08 | 104 | 99.4/n.d. |
20109020 | 大型 | - | 20 | 18.57 | 89 | 96.1/n.d. |
Claims (26)
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE10234673A DE10234673B4 (de) | 2002-07-30 | 2002-07-30 | Heißschmelz-TTS zur Verabreichung von Rotigotin und Verfahren zu seiner Herstellung sowie Verwendung von Rotigotin bei der Herstellung eines TTS im Heißschmelzverfahren |
DE10234673.9 | 2002-07-30 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN1671364A true CN1671364A (zh) | 2005-09-21 |
CN100574755C CN100574755C (zh) | 2009-12-30 |
Family
ID=30469194
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN03818378A Expired - Fee Related CN100574755C (zh) | 2002-07-30 | 2003-07-29 | 用于d2促进素给药的热熔-经皮治疗系统 |
Country Status (22)
Country | Link |
---|---|
US (1) | US9186335B2 (zh) |
EP (2) | EP1669063A1 (zh) |
JP (1) | JP4514608B2 (zh) |
KR (1) | KR101041512B1 (zh) |
CN (1) | CN100574755C (zh) |
AT (1) | ATE324875T1 (zh) |
AU (1) | AU2003269859B2 (zh) |
BR (1) | BR0311437A (zh) |
CA (1) | CA2494361C (zh) |
CY (1) | CY1105138T1 (zh) |
DE (2) | DE10234673B4 (zh) |
DK (1) | DK1492517T3 (zh) |
ES (1) | ES2263999T3 (zh) |
HK (1) | HK1081436A1 (zh) |
IL (1) | IL166070A0 (zh) |
MX (1) | MXPA04012150A (zh) |
NO (1) | NO20050835L (zh) |
PL (1) | PL221308B1 (zh) |
PT (1) | PT1492517E (zh) |
RU (1) | RU2304434C2 (zh) |
WO (1) | WO2004012721A2 (zh) |
ZA (1) | ZA200500457B (zh) |
Cited By (3)
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CN102665699A (zh) * | 2009-12-22 | 2012-09-12 | 优时比制药有限公司 | 用于使非结晶形式的罗替戈汀的固体分散体稳定化的聚乙烯吡咯烷酮 |
CN102770128A (zh) * | 2009-11-12 | 2012-11-07 | Lts勒曼治疗系统股份公司 | 防止药物在聚合物薄膜中结晶的方法 |
CN106604748A (zh) * | 2014-05-21 | 2017-04-26 | Sk化学株式会社 | 具有改进的稳定性的含有罗替戈汀的经皮吸收制剂 |
Families Citing this family (52)
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DE19814084B4 (de) | 1998-03-30 | 2005-12-22 | Lts Lohmann Therapie-Systeme Ag | D2-Agonist enthaltendes transdermales therapeutisches System zur Behandlung des Parkinson-Syndroms und Verfahren zu seiner Herstellung |
DE10041479A1 (de) * | 2000-08-24 | 2002-03-14 | Sanol Arznei Schwarz Gmbh | Neue pharmazeutische Zusammensetzung zur Verabreichung von N-0923 |
US20040048779A1 (en) * | 2002-05-06 | 2004-03-11 | Erwin Schollmayer | Use of rotigotine for treating the restless leg syndrome |
DE10234673B4 (de) | 2002-07-30 | 2007-08-16 | Schwarz Pharma Ag | Heißschmelz-TTS zur Verabreichung von Rotigotin und Verfahren zu seiner Herstellung sowie Verwendung von Rotigotin bei der Herstellung eines TTS im Heißschmelzverfahren |
US8211462B2 (en) * | 2002-07-30 | 2012-07-03 | Ucb Pharma Gmbh | Hot-melt TTS for administering rotigotine |
US8246980B2 (en) * | 2002-07-30 | 2012-08-21 | Ucb Pharma Gmbh | Transdermal delivery system |
US8246979B2 (en) * | 2002-07-30 | 2012-08-21 | Ucb Pharma Gmbh | Transdermal delivery system for the administration of rotigotine |
DE10261696A1 (de) | 2002-12-30 | 2004-07-15 | Schwarz Pharma Ag | Vorrichtung zur transdermalen Verabreichung von Rotigotin-Base |
DE10334188B4 (de) * | 2003-07-26 | 2007-07-05 | Schwarz Pharma Ag | Verwendung von Rotigotin zur Behandlung von Depressionen |
DE10359528A1 (de) | 2003-12-18 | 2005-07-28 | Schwarz Pharma Ag | (S)-2-N-Propylamino-5-hydroxytetralin als D3-agonistisches Therapeutikum |
DE10361258A1 (de) * | 2003-12-24 | 2005-07-28 | Schwarz Pharma Ag | Verwendung von substituierten 2-Aminotetralinen zur vorbeugenden Behandlung von Morbus Parkinson |
US20050197385A1 (en) * | 2004-02-20 | 2005-09-08 | Schwarz Pharma Ag | Use of rotigotine for treatment or prevention of dopaminergic neuron loss |
DE102004014841B4 (de) * | 2004-03-24 | 2006-07-06 | Schwarz Pharma Ag | Verwendung von Rotigotin zur Behandlung und Prävention des Parkinson-Plus-Syndroms |
JP4986411B2 (ja) * | 2004-06-01 | 2012-07-25 | 久光製薬株式会社 | 貼付剤 |
EP1611882B1 (en) | 2004-06-01 | 2010-04-07 | Hisamitsu Pharmaceutical Co., Inc. | Adhesive patch |
JP2008514376A (ja) * | 2004-09-29 | 2008-05-08 | シュウォーツ ファーマ インコーポレイテッド | パーキンソン病のための経皮治療システム |
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CN102770128A (zh) * | 2009-11-12 | 2012-11-07 | Lts勒曼治疗系统股份公司 | 防止药物在聚合物薄膜中结晶的方法 |
US8932665B2 (en) | 2009-11-12 | 2015-01-13 | Lts Lohmann Therapie-Systeme Ag | Method for preventing the crystallisation of pharmaceuticals in a polymer film |
TWI489998B (zh) * | 2009-11-12 | 2015-07-01 | Lohmann Therapie Syst Lts | 防止聚合物薄膜中活性藥劑成分結晶化的方法 |
US9408809B2 (en) | 2009-11-12 | 2016-08-09 | Lts Lohmann Therapie-Systeme Ag | Method for preventing the crystallization of pharmaceuticals in a polymer film |
CN106619578A (zh) * | 2009-11-12 | 2017-05-10 | Lts勒曼治疗系统股份公司 | 防止药物在聚合物薄膜中结晶的方法 |
CN106619578B (zh) * | 2009-11-12 | 2021-10-01 | Lts勒曼治疗系统股份公司 | 防止药物在聚合物薄膜中结晶的方法 |
CN102665699A (zh) * | 2009-12-22 | 2012-09-12 | 优时比制药有限公司 | 用于使非结晶形式的罗替戈汀的固体分散体稳定化的聚乙烯吡咯烷酮 |
CN104189912A (zh) * | 2009-12-22 | 2014-12-10 | 优时比制药有限公司 | 用于使非结晶形式的罗替戈汀的固体分散体稳定化的聚乙烯吡咯烷酮 |
CN105997952A (zh) * | 2009-12-22 | 2016-10-12 | 优时比制药有限公司 | 用于使非结晶形式的罗替戈汀的固体分散体稳定化的聚乙烯吡咯烷酮 |
CN106604748A (zh) * | 2014-05-21 | 2017-04-26 | Sk化学株式会社 | 具有改进的稳定性的含有罗替戈汀的经皮吸收制剂 |
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