SI9300387B - Transdermalni terapevtski sistem z aktivno snovjo 17-beta-estradiolom (brezvodnim) - Google Patents
Transdermalni terapevtski sistem z aktivno snovjo 17-beta-estradiolom (brezvodnim) Download PDFInfo
- Publication number
- SI9300387B SI9300387B SI9300387A SI9300387A SI9300387B SI 9300387 B SI9300387 B SI 9300387B SI 9300387 A SI9300387 A SI 9300387A SI 9300387 A SI9300387 A SI 9300387A SI 9300387 B SI9300387 B SI 9300387B
- Authority
- SI
- Slovenia
- Prior art keywords
- estradiol
- therapeutic system
- transdermal therapeutic
- layer
- base material
- Prior art date
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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
- A61K9/70—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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
-
- 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
-
- 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
- A61K9/7061—Polyacrylates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
- A61P5/30—Oestrogens
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- Health & Medical Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Dermatology (AREA)
- Epidemiology (AREA)
- Diabetes (AREA)
- Endocrinology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Steroid Compounds (AREA)
Claims (9)
1 Patentni zahtevki 1. Transdermalni terapevtski sistem, ki vsebuje aktivno snov 17-ji?-estradiol in, po izbiri, nadaljnje aktivne snovi, s plastovito zgradbo nameščeno na eni, v bistvu aktivno snov in vlago neprepustni hrbtni plasti, eni ali večih matričnih plasteh in, po izbiri, lepilni plasti, označen s tem, da vsaj ena od matričnih plasti ali lepilna plast vsebuje brezvodni 17-/?-estradiol v kristalinični obliki in daje pri skladiščenju pred uporabo v za plin neprepustno zavarjenem embalimem sredstvu skupaj s sredstvom, ki odvzema vodo oz. sredstvom, ki navzema vodo.
2. Transdermalni terapevtski sistem po zahtevku 1, ki sestoji iz matrične plasti prijemalno-lepljive lepilne plasti na strani kože, označen s tem, da matrična plast vsebuje brezvodni 17-/i-estradiol v kristalni obliki, medtem ko je lepilna plast brez kristalnega 17-/i-estradiola.
3. Transdermalni terapevtski sistem po zahtevku 1 ali 2, označen s tem, daje osnovni material lepilne plasti kopolimer estrov akrilne kisline.
4. Transdermalni terapevtski sistem po zahtevku 1 ali 2, označen s tem, daje osnovni material vsaj ene od matričnih plasti poliizobutilen.
5. Transdermalni terapevtski sistem po zahtevku 1 ali 2, označen s tem, daje osnovni material vsaj ene od matričnih plasti kopolimer estrov akrilne kisline.
6. Transdermalni terapevtski sistem po zahtevku 3 ali 5, označen s tem, da ima kopolimer estrov akrilne kisline topnost za aktivno snov 17-^-estradiol (brezvodni) med 0,4 in 3,0 % (g/g).
7. Postopek za pripravo transdermalnega terapevtskega sistema po enem ali večih od zahtevkov 1 do 7, ki vsebuje aktivno snov 17-jS-estradiol v kristalni obliki, označen s tem, da najprej pripravimo suspenzijo 17-/-estradiol-semihidrata v raztopini, disperziji ali talini matričnega-osnovnega materiala in to v obliki plasti nanesemo na osnovni 2 material v obliki folije in plast posušimo, in takoj nato tako pridobljen substrat segrejemo na 90 do 175 °C in pri tem poteče pretvorba 17-^-estradiol-semihidrata v brezvodni 17-/?-estradiol v kristalni obliki.
8. Postopek za pripravo transdermalnega terapevtskega sistema po zahtevkih 1 do 6, označen s tem, da najprej pripravimo suspenzijo 17-^-estradiol-semihidrata v raztopini, disperziji ali talini matričnega oz. lepilnoplastnega-osnovnega materiala in to v obliki plasti nanesemo na, prednostno dehezivno opremljen, osnovni material, ki tvori folijo in plast v danem primeru posušimo, položimo na v bistvu aktivno snov- in vlago-neprepustno hrbtno stran in razsekamo s kontumim izsekanjem in razrezom folije, in embaliramo v za plin neprepustno zavarjeno embalimo sredstvo, pri čemer dodamo embalimemu sredstvu sredstvo, ki navzema vodo, in da s preko daljšega časovnega obdobja izvedenim odvzemanjem vode pride do pseudopolimorfne pretvorbe 17-^-estradiol-semihidrata v 17-/?-estradiol v kristalni, brezvodni obliki.
9. Postopek za pripravo transdermalnega terapevtskega sistema po zahtevku 8, označen s tem, da izvedemo pretvorbo 17-/?-estradiol-semihidrata v 17-/-estradiol v kristalni, brezvodni obliki znotraj največ enega meseca predskladiščenja.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE4223360A DE4223360C1 (sl) | 1992-07-16 | 1992-07-16 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| SI9300387A SI9300387A (en) | 1994-03-31 |
| SI9300387B true SI9300387B (sl) | 2002-02-28 |
Family
ID=6463319
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SI9300387A SI9300387B (sl) | 1992-07-16 | 1993-07-16 | Transdermalni terapevtski sistem z aktivno snovjo 17-beta-estradiolom (brezvodnim) |
Country Status (24)
| Country | Link |
|---|---|
| US (1) | US5997897A (sl) |
| EP (1) | EP0650359B1 (sl) |
| JP (1) | JP3227577B2 (sl) |
| KR (1) | KR100281235B1 (sl) |
| AT (1) | ATE179328T1 (sl) |
| AU (1) | AU679450B2 (sl) |
| CA (1) | CA2139929C (sl) |
| CZ (1) | CZ283501B6 (sl) |
| DE (2) | DE4223360C1 (sl) |
| DK (1) | DK0650359T3 (sl) |
| ES (1) | ES2133405T3 (sl) |
| FI (1) | FI950165A0 (sl) |
| GR (1) | GR3030807T3 (sl) |
| HR (1) | HRP930991B1 (sl) |
| HU (1) | HU221011B1 (sl) |
| IL (1) | IL106315A (sl) |
| MY (1) | MY111688A (sl) |
| NO (1) | NO306378B1 (sl) |
| NZ (1) | NZ254107A (sl) |
| PL (1) | PL172466B1 (sl) |
| SI (1) | SI9300387B (sl) |
| SK (1) | SK280081B6 (sl) |
| WO (1) | WO1994002151A1 (sl) |
| ZA (1) | ZA935107B (sl) |
Families Citing this family (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1043731C (zh) * | 1993-03-05 | 1999-06-23 | 中国人民解放军空军南京医院 | 治疗高血压的尼群地平贴片及其制备方法 |
| DE4336557C2 (de) * | 1993-05-06 | 1997-07-17 | Lohmann Therapie Syst Lts | Estradiolhaltiges transdermales therapeutisches System, Verfahren zu seiner Herstellung und seine Verwendung |
| DE4400770C1 (de) * | 1994-01-13 | 1995-02-02 | Lohmann Therapie Syst Lts | Wirkstoffhaltiges Pflaster zur Abgabe von Estradiol mit mindestens einem Penetrationsverstärker, Verfahren zu seiner Herstellung und seine Verwendung |
| DE4429664C2 (de) * | 1994-08-20 | 1997-09-11 | Lohmann Therapie Syst Lts | Estradiol-TTS mit wasserbindenden Zusätzen und Verfahren zu seiner Herstellung |
| US6238700B1 (en) | 1995-12-01 | 2001-05-29 | Alza Corporation | Method for preventing crystal formation in a dispersion of a liquid in a matrix |
| ATE207348T1 (de) * | 1995-12-01 | 2001-11-15 | Alza Corp | Verbessertes verfahren zur verhinderung der kristallbildung in einer dispersion eines flüssigen stoffes in einer matrix |
| DE19600347A1 (de) * | 1996-01-08 | 1997-07-10 | Lohmann Therapie Syst Lts | Hauthaftende pharmazeutische Zubereitung, insbesondere TTS zur Abgabe von 17-beta-Estradiol an den menschlichen Organismus |
| DE19738856C2 (de) * | 1997-09-05 | 2001-06-13 | Lohmann Therapie Syst Lts | Treibmittelfreies Verfahren zur Herstellung flächenförmiger Polymerschäume |
| DE19827732A1 (de) * | 1998-06-22 | 1999-12-23 | Rottapharm Bv | Transdermales System vom Matrix-Typ zur Abgabe von Wirkstoffen mit einer hohen Abgaberate von Steroid-Hormonen und die Verwendung eines derartigen Systems zur Hormonersatztherapie |
| AU760404B2 (en) * | 2000-07-14 | 2003-05-15 | Alchemia Oncology Pty Limited | Hyaluronan as a cytotoxic agent, drug pre-sensitizer and chemo-sensitizer in the treatment of disease |
| AR033748A1 (es) * | 2002-05-15 | 2004-01-07 | Thalas Group Inc | Un dispositivo para la administracion transdermica de sustancias farmacologicamente activas que comprende dos capas adhesivas superpuestas y un procedimiento para prepararlo |
| WO2006041907A2 (en) * | 2004-10-08 | 2006-04-20 | Noven Pharmaceuticals, Inc. | Transdermal delivery of estradiol |
| US20060127463A1 (en) * | 2004-12-15 | 2006-06-15 | Nugara Peter N | Composite structure including a low vinyl acetate layer |
| ES2684993T3 (es) | 2012-11-26 | 2018-10-05 | Ocv Intellectual Capital, Llc | Tejidos multiaxiales, estratificados polímero-fibra y cuerpos que incorporan los mismos para aplicaciones de conexión |
| PL236889B1 (pl) * | 2017-10-03 | 2021-02-22 | Univ Warszawski Medyczny | Nowa forma krystaliczna bezwodnego 17-β-estradiolu, sposób jej otrzymywania oraz kompozycja farmaceutyczna zawierająca nową formę krystaliczną bezwodnego 17-β-estradiolu i jej zastosowanie |
| HUP2200237A2 (hu) * | 2022-06-27 | 2023-12-28 | Pecsi Tudomanyegyetem | Alacsony dózisú, stabil hatóanyag-leadású transzdermális készítmény és tapasz, valamint eljárás ezek elõállítására |
Family Cites Families (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3854480A (en) * | 1969-04-01 | 1974-12-17 | Alza Corp | Drug-delivery system |
| US5145682A (en) * | 1986-05-30 | 1992-09-08 | Rutgers, The State University Of New Jersey | Transdermal absorption dosage unit for postmenopausal syndrome treatment and process for administration |
| US4832953A (en) * | 1987-08-13 | 1989-05-23 | Alza Corporation | Method for preventing the formation of a crystalline hydrate in a dispersion of a liquid in a monaqueous matrix |
| US4863738A (en) * | 1987-11-23 | 1989-09-05 | Alza Corporation | Skin permeation enhancer compositions using glycerol monooleate |
| JP2681365B2 (ja) * | 1988-04-11 | 1997-11-26 | 日東電工株式会社 | 経皮吸収性製剤及びその製法 |
| JPH0279792A (ja) * | 1988-09-12 | 1990-03-20 | Secoh Giken Inc | 高速３相直流電動機 |
| DE3933460A1 (de) * | 1989-10-06 | 1991-04-18 | Lohmann Therapie Syst Lts | Oestrogenhaltiges wirkstoffpflaster |
-
1992
- 1992-07-16 DE DE4223360A patent/DE4223360C1/de not_active Expired - Fee Related
-
1993
- 1993-05-21 MY MYPI93000967A patent/MY111688A/en unknown
- 1993-06-23 HR HRP4223360.7A patent/HRP930991B1/xx not_active IP Right Cessation
- 1993-07-07 DE DE59309549T patent/DE59309549D1/de not_active Expired - Lifetime
- 1993-07-07 CA CA002139929A patent/CA2139929C/en not_active Expired - Lifetime
- 1993-07-07 AU AU45650/93A patent/AU679450B2/en not_active Ceased
- 1993-07-07 CZ CZ95106A patent/CZ283501B6/cs not_active IP Right Cessation
- 1993-07-07 NZ NZ254107A patent/NZ254107A/en unknown
- 1993-07-07 EP EP93915819A patent/EP0650359B1/de not_active Expired - Lifetime
- 1993-07-07 JP JP50390894A patent/JP3227577B2/ja not_active Expired - Lifetime
- 1993-07-07 KR KR1019950700166A patent/KR100281235B1/ko not_active IP Right Cessation
- 1993-07-07 DK DK93915819T patent/DK0650359T3/da active
- 1993-07-07 SK SK1468-94A patent/SK280081B6/sk unknown
- 1993-07-07 PL PL93306557A patent/PL172466B1/pl unknown
- 1993-07-07 AT AT93915819T patent/ATE179328T1/de active
- 1993-07-07 WO PCT/EP1993/001754 patent/WO1994002151A1/de active IP Right Grant
- 1993-07-07 ES ES93915819T patent/ES2133405T3/es not_active Expired - Lifetime
- 1993-07-07 HU HU9403474A patent/HU221011B1/hu not_active IP Right Cessation
- 1993-07-12 IL IL10631593A patent/IL106315A/en not_active IP Right Cessation
- 1993-07-15 ZA ZA935107A patent/ZA935107B/xx unknown
- 1993-07-16 SI SI9300387A patent/SI9300387B/sl unknown
-
1995
- 1995-01-05 NO NO950047A patent/NO306378B1/no not_active IP Right Cessation
- 1995-01-13 FI FI950165A patent/FI950165A0/fi unknown
-
1998
- 1998-08-14 US US09/134,007 patent/US5997897A/en not_active Expired - Lifetime
-
1999
- 1999-07-20 GR GR990401895T patent/GR3030807T3/el unknown
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