LV10929B - A styrene-isoprene-styrene copolymer-based transdermal matrix system for the administration of an oestrogen and/or a progestogen - Google Patents

A styrene-isoprene-styrene copolymer-based transdermal matrix system for the administration of an oestrogen and/or a progestogen Download PDF

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Publication number
LV10929B
LV10929B LVP-95-76A LV950076A LV10929B LV 10929 B LV10929 B LV 10929B LV 950076 A LV950076 A LV 950076A LV 10929 B LV10929 B LV 10929B
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LV
Latvia
Prior art keywords
weight
styrene
parts
oestradiol
mixture
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LVP-95-76A
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English (en)
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LV10929A (lv
Inventor
Claude Mikler
Laurent Liorzou
Daniel Dhuique-Mayer
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Lhd Lab Hygiene Dietetique
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Application filed by Lhd Lab Hygiene Dietetique filed Critical Lhd Lab Hygiene Dietetique
Publication of LV10929A publication Critical patent/LV10929A/lv
Publication of LV10929B publication Critical patent/LV10929B/en

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Classifications

    • 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
    • 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
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • 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
    • A61K9/7076—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising ingredients of undetermined constitution or reaction products thereof, e.g. rosin or other plant resins
    • 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

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Dermatology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Botany (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)
  • Steroid Compounds (AREA)
  • Adhesives Or Adhesive Processes (AREA)

Claims (2)

  1. LV 10929 Ο 'j LĪL) UiuJL * OiĪi.t ŪXjA. I. Pašmieliuoša transdermāla matricu sistēma Iiormona ievadīšanai caur ādu, minētā matricu sistēma, sastāvoša no pamatnes un paš^ielīposas matricas, satur matricu, kurā ietilpst: 5 (a) poli(stirola-izoprēna-stirola) trīsbloku-kopolimērs -ar 20 līdz 42 svara daļām, (b) lipīgie sveķi - ar 35 līdz 55 svara daļām, (c) plastifikators - ar 5 līdz 25 svara daļām, izvēlēts 10 no grupas, sastāvošas no oleīnspirta, peglikola 5-ole-āta, propilēnglikola laurāta vai polipropoksilcetil-spirta ētera, (d) vismaz viens komponents, sastādošs 5 līdz 15 svara daļas, izvēlēts no grupas, sastāvošas no: - krotamitona, un 15 - formulas I 17-aizvietota 2-pirolidona, E
    20 kur E apzīmē (C~-C^) - alkila, cikloheksila vai 2-oksistila grupu, (e) stabilizators - ar 0,01 līdz I svara maļu un, (f) hormons, sastādošs 0,1 līdz 5 svara daļas, izvēlēts no grupas, sastāvošas no estrogena komponenta, pro-gestogēna komponenta un to maisījuma. 25
  2. 2. Sistēma, atbilstoša formulas punktam I, kā plas- tifikators p. distema tifikators 4. Sistēma tifikators ietilpst oleīnspirts. atbilstoša formulas punktam I, kurā kā plas-ietilpst peglikola 5-oleāts. atbilstoša formulas punktam I, kurā kā plas-ietilost jropilēnglikola iaurāts. BAD ORlG’^Ai. 30 2 Γ* b ΙΟ 15 20 25 50 5· Sistēma, atbilstoša fonaulas punktam I, kurā kā plas-tifikators ietilpst poliproksilcetilspirta ēteris, it īpaši, kurš satur 10 molus propilēna oksīda uz I molu cetilspirta. 6. Sistēma, atbilstoša formulas punktam I, kurā komponents, kurš veicina ādas caurlaidību, ir izvēlēts no grupas, sastāvošas no krotamitona un formulas I N-aizvietota 2-pirolidona savienojuma, kurā B grupa pārstāv (C.T-C^.-)-alkila, cikloheksila vai 2-oksietila grupu· 7. Sistēma, atbilstoša formulas punktam I, kurā poli(stirola-izoprēna-stirola) trīsbloku-kopolimērs satur stirolu, sastādošu pēc svara 14- līdz 50% no minētā kopolimēra svara, un, galvenokārt, robežās starp I? un 4-7% no tā svara. 8. Sistēma, atbilstoša formulas punktam I, kurā kā estro-gēns ietilpst 17-β> -estradiols. 9. Sistēma, atbilstoša formulas punktam I, kurā kā pro-gestogēns ietilpst noretisterona acetāts. 10. Sistēma, atbilstoša formulas punktam I, kurā matrica satur, - uz kopējām 100 svara daļām: (a) 37>5 svara daļas poli(stirola-izoprēna-stirola) trīs-bloku-kopolimēra, (b) 38 svara daļas lipīgo sveķu, (c) 15 svara daļas propilēnglikola laurāta, (d) 7 svara daļas l\T-oktil-2-pirolidona, (e) 0,2 svara daļas stabilizatora, (f) 0,5 svara daļas Ί-Ί- β -estradiola, un (g) 2 svara daļas noretisterona acetāta. 11. Transdermālas matricu sistēmas, atbilstošas jebkuram no formulas punktiem no I līdz 10, pagatavošanas metode, minētā metode ietver secīgas darbības, sastāvošas no: (oi.) SIS (stirola-izoprēna-stirola) polimēra, stabilizatora un lipīgo sveķu sajaukšanas pie temperatūras augstākas par II0°G, pēc tam iegūtā maisījuma homo-geniz ācijas; (β) aktivatora(u) un jjlastifikatora ievadīšanas iegūtajā homogēnaj ā maisījumā pie temperatūras robežās starp BAD ORIGINAL 55 - 3 -5 10 15 20 25 LV 10929 80 un II0°G, pēc tam iegūtā maisījuma homogenizāci-jas; Qf) hormona, kurš izvēlēts no grupas, sastāvošas no estro-gēna komponenta, progestogēna komponenta un to sajaukuma, ievadīšanas iegūtajā homogēnaj ā maisījumā, pēc tam iegūtā maisījuma homogenizācijas; (6) iegūtā homogēnā maisījuma uzklāšanas uz pagaidu nepie-līpošas pamatnes tādā veidā, lai iegūtu uz pamatnes p pārklājumu ar 50 līdz 300 g/m ; un, (£ ) minētā pārklājuma pārnešanas uz pastāvīgu pamatni. 12. Transdermālas matricu sistēmas, atbilstošas jebkuram no formulas punktiem no I līdz 10, pagatavošanas metode, minētā metode ietver secīgas darbības, sastāvošas no: (pc) SIS (stirola-izoprēna-stirola) polimēra, stabilizatora, pēc tam lipīgo sveķu iejaukšanas SIS polimēra šķīdinātājā pie temperatūras, kura ir zemāka par šī šķīdinātāja vārīšanās punkta temperatūru, pēc tam iegūtā maisījuma homogenizācijas ļ (yg) aktivatora(u) un plastifikatora ievadīšanas iegūtajā maisījumā, pēc tam iegūtā maisījuma homogenizācijas·, (ļfO hormona, izvēlēta no grupas, sastāvošas no estrogēna komponenta, progestogēna komponenta un to sajaukuma, ievadīšanas iegūtajā homogēnajā maisījumā, pēc tam iegūtā maisījuma homogenizicijas; (<$) iegūtā homogēnā maisījuma uzklāšanas pie istabas temperatūras uz pagaidu nepielīpošas pamatnes tādā veidā, lai iegūtu uz pamatnes pārklājumu ar 50 līdz 300 g/m^, un, (5) šķīdinātāja iztvaicēšanas, karsējot pārklājumu pie temperatūras, kura ir augstāka par šķīdinātāja vārīšanās punkta temperatūru, pēc tam šī pārklājuma pārnešanas uz pastāvīgu pamatni. 30
LVP-95-76A 1994-03-28 1995-03-21 A styrene-isoprene-styrene copolymer-based transdermal matrix system for the administration of an oestrogen and/or a progestogen LV10929B (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
FR9403599A FR2717689B1 (fr) 1994-03-28 1994-03-28 Système matriciel transdermique d'administration d'un oestrogène et/ou un progestatif à base de copolymère styrène-isoprène-styrène.

Publications (2)

Publication Number Publication Date
LV10929A LV10929A (lv) 1995-12-20
LV10929B true LV10929B (en) 1996-08-20

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LVP-95-76A LV10929B (en) 1994-03-28 1995-03-21 A styrene-isoprene-styrene copolymer-based transdermal matrix system for the administration of an oestrogen and/or a progestogen

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Country Link
US (1) US5580572A (lv)
EP (1) EP0674901B1 (lv)
JP (1) JPH07330609A (lv)
KR (1) KR950031057A (lv)
CN (1) CN1114903A (lv)
AT (1) ATE173618T1 (lv)
AU (1) AU691558B2 (lv)
CA (1) CA2145584A1 (lv)
CZ (1) CZ76795A3 (lv)
DE (1) DE69506157T2 (lv)
DK (1) DK0674901T3 (lv)
ES (1) ES2128673T3 (lv)
FI (1) FI951424A (lv)
FR (1) FR2717689B1 (lv)
GR (1) GR3029401T3 (lv)
HU (1) HU219465B (lv)
LV (1) LV10929B (lv)
NO (1) NO951126L (lv)
NZ (1) NZ270811A (lv)
PL (1) PL178896B1 (lv)
RU (1) RU2110282C1 (lv)
SK (1) SK39095A3 (lv)
ZA (1) ZA952469B (lv)

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Also Published As

Publication number Publication date
KR950031057A (ko) 1995-12-18
DK0674901T3 (da) 1999-08-09
EP0674901A1 (fr) 1995-10-04
ATE173618T1 (de) 1998-12-15
FR2717689B1 (fr) 1996-07-05
FI951424A0 (fi) 1995-03-24
PL307891A1 (en) 1995-10-02
FI951424A (fi) 1995-09-29
HUT75238A (en) 1997-05-28
RU2110282C1 (ru) 1998-05-10
SK39095A3 (en) 1995-10-11
AU691558B2 (en) 1998-05-21
LV10929A (lv) 1995-12-20
DE69506157T2 (de) 1999-07-01
DE69506157D1 (de) 1999-01-07
PL178896B1 (pl) 2000-06-30
NZ270811A (en) 1995-12-21
US5580572A (en) 1996-12-03
CA2145584A1 (en) 1995-09-29
CZ76795A3 (en) 1995-10-18
HU219465B (hu) 2001-04-28
HU9500880D0 (en) 1995-05-29
ES2128673T3 (es) 1999-05-16
NO951126L (no) 1995-09-29
JPH07330609A (ja) 1995-12-19
AU1497895A (en) 1995-10-05
ZA952469B (en) 1995-12-19
FR2717689A1 (fr) 1995-09-29
EP0674901B1 (fr) 1998-11-25
GR3029401T3 (en) 1999-05-28
CN1114903A (zh) 1996-01-17
NO951126D0 (no) 1995-03-24

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