ES2570205T3 - Sistema terapéutico transdérmico con pequeña tendencia a la cristalización espontánea - Google Patents
Sistema terapéutico transdérmico con pequeña tendencia a la cristalización espontáneaInfo
- Publication number
- ES2570205T3 ES2570205T3 ES12810316T ES12810316T ES2570205T3 ES 2570205 T3 ES2570205 T3 ES 2570205T3 ES 12810316 T ES12810316 T ES 12810316T ES 12810316 T ES12810316 T ES 12810316T ES 2570205 T3 ES2570205 T3 ES 2570205T3
- Authority
- ES
- Spain
- Prior art keywords
- transdermal therapeutic
- layers
- matrix
- melting point
- therapeutic system
- Prior art date
- Legal status (The legal status 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 status listed.)
- Active
Links
- 230000001225 therapeutic effect Effects 0.000 title abstract 3
- 238000002425 crystallisation Methods 0.000 title 1
- 230000008025 crystallization Effects 0.000 title 1
- 230000002269 spontaneous effect Effects 0.000 title 1
- 239000003814 drug Substances 0.000 abstract 4
- 239000011159 matrix material Substances 0.000 abstract 4
- 230000008018 melting Effects 0.000 abstract 4
- 238000002844 melting Methods 0.000 abstract 4
- 239000003292 glue Substances 0.000 abstract 3
- 239000013543 active substance Substances 0.000 abstract 2
- 239000000853 adhesive Substances 0.000 abstract 2
- 230000004048 modification Effects 0.000 abstract 2
- 238000012986 modification Methods 0.000 abstract 2
- 239000011248 coating agent Substances 0.000 abstract 1
- 238000000576 coating method Methods 0.000 abstract 1
- 229940079593 drug Drugs 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 239000002245 particle Substances 0.000 abstract 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 abstract 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 abstract 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 abstract 1
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
- A61K9/70—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
- A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
-
- 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
- A61K31/325—Carbamic acids; Thiocarbamic acids; Anhydrides or salts thereof
-
- 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
-
- 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
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/439—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom the ring forming part of a bridged ring system, e.g. quinuclidine
-
- 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
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/47—Quinolines; Isoquinolines
- A61K31/485—Morphinan derivatives, e.g. morphine, codeine
-
- 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
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
-
- 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
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
- A61K31/5375—1,4-Oxazines, e.g. morpholine
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Dermatology (AREA)
- Emergency Medicine (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Sistema terapéutico transdérmico (TTS) que comprende una capa posterior impermeable a la sustancia activa, una matriz constituida por una, dos o más capas y una capa de protección desprendible, caracterizado por que la capa o capas de matriz o al menos una de las capas de matriz comprenden al menos un pegamento autoadhesivo, al menos un medicamento y partículas de polivinilpirrolidona transversalmente reticulada, y durante la fabricación de la capa o capas de matriz que contienen medicamento y/o el revestimiento de la capa posterior impermeable a la sustancia activa del sistema terapéutico transdérmico se ha realizado un tratamiento a temperatura en el que la temperatura estaba por encima del punto de fusión o el intervalo de punto de fusión de la modificación estable del medicamento o medicamentos, preferiblemente al menos 10ºC por encima del punto de fusión o del intervalo de fusión de dicha modificación estable, consistiendo el pegamento autoadhesivo en un pegamento autoadhesivo fusible.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE102011090178A DE102011090178A1 (de) | 2011-12-30 | 2011-12-30 | Transdermales therapeutisches System mit geringer Neigung zur Spontankristallisation |
| PCT/EP2012/077046 WO2013098390A1 (de) | 2011-12-30 | 2012-12-28 | Transdermales therapeutisches system mit geringer neigung zur spontankristallisation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ES2570205T3 true ES2570205T3 (es) | 2016-05-17 |
Family
ID=47505017
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES12810316T Active ES2570205T3 (es) | 2011-12-30 | 2012-12-28 | Sistema terapéutico transdérmico con pequeña tendencia a la cristalización espontánea |
Country Status (9)
| Country | Link |
|---|---|
| US (2) | US20140378917A1 (es) |
| EP (1) | EP2797588B1 (es) |
| JP (1) | JP6335790B2 (es) |
| CN (2) | CN104144683A (es) |
| BR (1) | BR112014016176B1 (es) |
| CA (1) | CA2861782C (es) |
| DE (1) | DE102011090178A1 (es) |
| ES (1) | ES2570205T3 (es) |
| WO (1) | WO2013098390A1 (es) |
Families Citing this family (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP3730129B1 (en) | 2017-12-19 | 2024-08-07 | Hisamitsu Pharmaceutical Co., Inc. | Rotigotine-containing patch |
| CN108358911A (zh) * | 2018-04-19 | 2018-08-03 | 安徽德信佳生物医药有限公司 | 一种磁性诱导结晶分离东莨菪碱的方法 |
| EP3925606B1 (en) | 2019-02-15 | 2026-03-11 | Hisamitsu Pharmaceutical Co., Inc. | Rotigotine stabilization method |
| CN112891324A (zh) * | 2021-01-19 | 2021-06-04 | 北京亚宝生物药业有限公司 | 一种透皮贴剂 |
| CN116829131B (zh) * | 2022-01-12 | 2024-05-07 | 新领医药技术(深圳)有限公司 | 奥氮平透皮给药系统及其制备方法和用途 |
| WO2023134618A1 (zh) * | 2022-01-12 | 2023-07-20 | 新领医药技术(深圳)有限公司 | 抑制药物结晶的透皮贴剂及其制备方法 |
| KR102844541B1 (ko) | 2022-02-21 | 2025-08-08 | 히사미쓰 세이야꾸 가부시키가이샤 | 로티고틴 함유 첩부제 |
| WO2024040860A1 (zh) * | 2022-08-24 | 2024-02-29 | 新领医药技术(深圳)有限公司 | 抑制结晶的罗替高汀透皮给药系统及其制备方法和用途 |
| AU2023406609A1 (en) | 2022-12-01 | 2025-06-05 | Hisamitsu Pharmaceutical Co., Inc. | Rotigotine-containing patch and method for improving stability of rotigotine |
| WO2024145845A1 (zh) * | 2023-01-04 | 2024-07-11 | 新领医药技术(深圳)有限公司 | 稳定的罗替高汀透皮给药试剂盒及其制备方法和用途 |
Family Cites Families (26)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5656286A (en) | 1988-03-04 | 1997-08-12 | Noven Pharmaceuticals, Inc. | Solubility parameter based drug delivery system and method for altering drug saturation concentration |
| DE3910543A1 (de) | 1989-04-01 | 1990-10-11 | Lohmann Therapie Syst Lts | Transdermales therapeutisches system mit erhoehtem wirkstofffluss und verfahren zu seiner herstellung |
| IT1243745B (it) | 1990-10-17 | 1994-06-21 | Vectorpharma Int | Composizioni terapeutiche transdermali contenenti farmaco e/o agente promotore dell'assorbimento cutaneo supportato su particelle microporose e microsfere polimeriche e loro preparazione. |
| US5906830A (en) * | 1995-09-08 | 1999-05-25 | Cygnus, Inc. | Supersaturated transdermal drug delivery systems, and methods for manufacturing the same |
| WO1997020550A2 (en) * | 1995-12-01 | 1997-06-12 | Alza Corporation | Improved method for preventing crystal formation in a dispersion of a liquid in a matrix |
| US5663258A (en) * | 1996-02-20 | 1997-09-02 | Isp Investments Inc. | Strongly swellable, moderately crosslinked copolymers of vinylpyrrolidone and vinyl acetate |
| JPH1045571A (ja) * | 1996-07-29 | 1998-02-17 | Sekisui Chem Co Ltd | 貼付剤 |
| JPH10306023A (ja) * | 1997-05-06 | 1998-11-17 | Sekisui Chem Co Ltd | 経皮吸収製剤及びその製造方法 |
| JP2001514213A (ja) * | 1997-09-02 | 2001-09-11 | ノバルティス アクチエンゲゼルシャフト | スコポラミン経皮剤における結晶形成防止の改善法 |
| 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 |
| AU3478200A (en) | 1999-02-02 | 2000-08-25 | Ortho-Mcneil Pharmaceutical, Inc. | Method of manufacture for transdermal matrices |
| CA2374930C (en) | 1999-07-02 | 2008-08-05 | Lts Lohmann Therapie-Systeme Ag | Microreservoir system based on polysiloxanes and ambiphilic solvents |
| DE10012908B4 (de) | 2000-03-16 | 2005-03-17 | Lts Lohmann Therapie-Systeme Ag | Stabilisierte übersättigte transdermale therapeutische Matrixsysteme und Verfahren zu ihrer Herstellung |
| US6824874B1 (en) * | 2000-08-23 | 2004-11-30 | Dana Corporation | Insulator and seal for fuel cell assemblies |
| EP1386604A1 (en) | 2002-07-30 | 2004-02-04 | Schwarz Pharma Ag | Improved transdermal delivery system |
| 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 |
| EP1386605A1 (en) | 2002-07-30 | 2004-02-04 | Schwarz Pharma Ag | Improved 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 |
| DE102006026578B4 (de) * | 2006-06-08 | 2009-01-08 | Lts Lohmann Therapie-Systeme Ag | Wirkstoffpartikelhaltiges Transdermales Therapeutisches System mit erhöhtem Wirkstofffluss und Verfahren zu seiner Herstellung sowie Verwendung |
| DE102006054732B4 (de) * | 2006-11-21 | 2010-12-30 | Lts Lohmann Therapie-Systeme Ag | Transdermales therapeutisches System mit Ionenpaar-Mikroreservoiren |
| US20080226698A1 (en) * | 2007-03-16 | 2008-09-18 | Mylan Technologies, Inc. | Amorphous drug transdermal systems, manufacturing methods, and stabilization |
| CA2739380C (en) * | 2008-10-06 | 2014-12-09 | Mylan Technologies, Inc. | Amorphous rotigotine transdermal system |
| DE102009052972A1 (de) * | 2009-11-12 | 2011-09-15 | Lts Lohmann Therapie-Systeme Ag | Verfahren zur Verhinderung der Kristallisation von Arzneistoffen in einem Polymerfilm |
| WO2011076879A1 (en) | 2009-12-22 | 2011-06-30 | Ucb Pharma Gmbh | Polyvinylpyrrolidone for the stabilization of a solid dispersion of the non-crystalline form of rotigotine |
| JP5766475B2 (ja) * | 2010-03-30 | 2015-08-19 | 日東電工株式会社 | 貼付製剤およびその製造方法 |
| CN103108648A (zh) * | 2010-07-12 | 2013-05-15 | 细胞基因公司 | 罗米地辛固体形式及其用途 |
-
2011
- 2011-12-30 DE DE102011090178A patent/DE102011090178A1/de active Pending
-
2012
- 2012-12-28 CN CN201280068937.1A patent/CN104144683A/zh active Pending
- 2012-12-28 CN CN201910674434.2A patent/CN110251490A/zh active Pending
- 2012-12-28 ES ES12810316T patent/ES2570205T3/es active Active
- 2012-12-28 EP EP12810316.5A patent/EP2797588B1/de not_active Revoked
- 2012-12-28 US US14/368,864 patent/US20140378917A1/en not_active Abandoned
- 2012-12-28 JP JP2014549486A patent/JP6335790B2/ja active Active
- 2012-12-28 CA CA2861782A patent/CA2861782C/en active Active
- 2012-12-28 BR BR112014016176-3A patent/BR112014016176B1/pt active IP Right Grant
- 2012-12-28 WO PCT/EP2012/077046 patent/WO2013098390A1/de not_active Ceased
-
2019
- 2019-07-08 US US16/504,604 patent/US20190328680A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| WO2013098390A1 (de) | 2013-07-04 |
| JP6335790B2 (ja) | 2018-05-30 |
| EP2797588B1 (de) | 2016-04-27 |
| CA2861782A1 (en) | 2013-07-04 |
| CA2861782C (en) | 2020-04-14 |
| US20140378917A1 (en) | 2014-12-25 |
| HK1202430A1 (zh) | 2015-10-02 |
| BR112014016176A2 (pt) | 2017-06-13 |
| CN104144683A (zh) | 2014-11-12 |
| JP2015503541A (ja) | 2015-02-02 |
| BR112014016176A8 (pt) | 2017-07-04 |
| BR112014016176B1 (pt) | 2022-01-04 |
| DE102011090178A1 (de) | 2013-07-04 |
| US20190328680A1 (en) | 2019-10-31 |
| CN110251490A (zh) | 2019-09-20 |
| EP2797588A1 (de) | 2014-11-05 |
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