LV13303B - Pharmaceutical composition - Google Patents

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LV13303B
LV13303B LVP-04-127A LV040127A LV13303B LV 13303 B LV13303 B LV 13303B LV 040127 A LV040127 A LV 040127A LV 13303 B LV13303 B LV 13303B
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testosterone
compound
composition
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weight
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Robert Gyurik
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Auxilium Pharmaceuticals Inc
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    • 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
    • A61K31/568—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 substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
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    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
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Claims (49)

  1. LV 13303 Izgudrojuma formula 1. Farmaceitisks savienojums, kas ietver: (A) androgēnu; (B) Hsieh pastiprinātāju un (C) iebiezināšanas vielu.
  2. 2. Vienības dozas sastāvs, kurš ir efektīvs testosterona piegādē transdermāli vīriešu dzimuma pacienta asinīm tā, ka pēc vienas vienības dozas ievadīšanas pacientam cirkulējošā testosterona daudzums (AUC0-24) pacienta asins serumā, sasniegts 24 stundu periodā pēc ievadīšanas, ir par apmēram 100 līdz aptuveni 35 000 ng.h/dL lielāks nekā cirkulējošā testosterona daudzums (AUC0-24) pacienta asins serumā, kuram vajadzētu būt sasniegtam tajā pašā 24 stundu periodā, ja doza nebūtu tikusi iedota, minētā vienības doza ietver līdz apmēram 1 svara % testosterona, apmēram 0,01 līdz apmēram 25 svara % Hsieh pastiprinātāja un apmēram 0,1 līdz apmēram 10 svara % sabiezināšanas vielas, testosterons minētajā vienības dozā ir apmēram 1 līdz apmēram 300 mg apjomā.
  3. 3. Vienības dozas sastāvs, kurš ir efektīvs testosterona piegādē transdermāli sieviešu dzimuma pacienta asinīm tā, ka pēc vienas vienības dozas ievadīšanas pacientam cirkulējošā testosterona daudzums (AUC0-24) pacienta asins serumā, sasniegts 24 stundu periodā pēc ievadīšanas, ir par apmēram 0,10 līdz aptuveni 11 700 ng.h/dL lielāks nekā cirkulējošā testosterona daudzums (AUC0-24) pacienta asins serumā, kuram vajadzētu būt sasniegtam tajā pašā 24 stundu periodā, ja doza nebūtu tikusi iedota, minētā vienības doza ietver līdz apmēram 1 svara % testosterona, apmēram 0,01 līdz apmēram 25 svara % Hsieh pastiprinātāja un apmēram 0,1 līdz apmēram 10 svara % sabiezināšanas vielas, testosterons minētajā vienības dozā ir apmēram 0,01 līdz apmēram 100 mg apjomā.
  4. 4. Vienības dozas sastāvs, kurš ir efektīvs dihidrotestosterona piegādē transdermāli vīriešu dzimuma pacienta asinīm tā, ka pēc vienas vienības dozas ievadīšanas pacientam cirkulējošā dihidrotestosterona daudzums (AUC0-24) pacienta asins serumā, sasniegts 24 stundu periodā pēc ievadīšanas, ir par apmēram 11 625 līdz aptuveni 465 000 pg.h/mL lielāks nekā cirkulējošā dihidrotestosterona daudzums (ĀUC0-24) pacienta asins serumā, kuram vajadzētu būt sasniegtam tajā pašā 24 stundu periodā, ja doza nebūtu tikusi iedota, minētā vienības doza ietver līdz apmēram 1 svara % dihidrotestosterona, apmēram 0,01 līdz apmēram 25 svara % Hsieh pastiprinātāja un apmēram 0,1 līdz apmēram 10 svara % sabiezināšanas vielas, dihidrotestosterons minētajā vienības dozā ir apmēram 5 līdz apmēram 200 mg apjomā.
  5. 5. Vienības dozas sastāvs, kurš ir efektīvs dihidrotestosterona piegādē transdermāli sieviešu dzimuma pacienta asinīm tā, ka pēc vienas vienības dozas ievadīšanas pacientam vidējā dihidrotestosterona koncentrācija (AUC0-24) pacienta asins serumā, sasniegta 24 stundu periodā pēc ievadīšanas, ir par apmēram 11,6 līdz aptuveni 232 500 pg.h/mL lielāka nekā vidējā dihidrotestosterona koncentrācija (AUC0.24) pacienta asins serumā, kurai vajadzētu būt sasniegtai tajā pašā 24 stundu periodā, ja doza nebūtu tikusi iedota, minētā vienības doza ietver līdz apmēram 1 svara % dihidrotestosterona, apmēram 0,01 līdz aptuveni 25 svara % Hsieh pastiprinātāja un apmēram 0,1 līdz aptuveni 10 svara % sabiezināšanas vielas, dihidrotestosterons minētajā vienības dozā ir apmēram no 0,005 līdz apmēram 100 mg apjomā.
  6. 6. Savienojums saskaņā ar 1. punktu, kur minētais androgēns ir testosterons.
  7. 7. Savienojums saskaņā ar 1. punktu, kur minētais androgēns ir dihidrotestosterons.
  8. 8. Savienojums saskaņā ar 1. punktu, kur minētais androgēns ir testosterona esteris.
  9. 9. Savienojums saskaņā ar 1. punktu, kur minētais androgēns ir vienkāršs testosterona alkil esteris.
  10. 10. Savienojums saskaņā ar 1. punktu, kur minētais androgēns ir testosterona cikloalifatisks esteris.
  11. 11. Savienojums saskaņā ar 1. punktu, kur minētais androgēns ir izvēlēts no grupas, kura sastāv no: testosterona enanthāta; testosterona propionāta; testosterona undekanoāta un testosterona heptilāta.
  12. 12. Savienojums saskaņā ar 1. punktu, kur minētais androgēns ir izvēlēts no grupas, kura sastāv no: testosterona cipionāta; testosterona ciklopentil alkil estera un testosterona cikloheksil alkil estera.
  13. 13. Savienojums saskaņā ar 1. punktu, kur minētais pastiprinātājs ir makrociklisks pastiprinātājs.
  14. 14. Savienojums saskaņā ar 1. punktu, kur minētais pastiprinātājs ir ciklisks ketons vai ciklisks esteris.
  15. 15. Savienojums saskaņā ar 1. punktu, kur minētais pastiprinātājs ir pentadekalaktons.
  16. 16. Savienojums saskaņā ar 1. punktu, kur minētais pastiprinātājs ir oksacikloheksadekan-2-ons.
  17. 17. Savienojums saskaņā ar 1. punktu, kur minētā iebiezinošā viela rāda zemu kairināmības līmeni vai nerada nekādu kairināmību mērķa membrānai.
  18. 18. Savienojums saskaņā ar 1. punktu, kur minētā iebiezinošā viela ir izvēlēta no grupas, kura sastāv no celulozes sabiezinošām vielām un akrīla iebiezinošām vielām.
  19. 19. Savienojums saskaņā ar 1. punktu, kur minētā sabiezinošā viela ir izvēlēta no grupas, kura sastāv no celulozes; karboksimetilcelulozes; hidroksietilcelulozēm un hidroksipropilmetilcelulozes.
  20. 20. Savienojums saskaņā ar 1. punktu, kur minētā iebiezinošā viela ir akrīla sabiezinātājs.
  21. 21. Savienojums saskaņā ar 1. punktu, kur minētā sabiezinošā viela ir karbomērs.
  22. 22. Savienojums saskaņā ar 1. punktu, kur minētā sabiezinošā viela ir izvēlēta no grupas, kura sastāv no karboksipolimetilēna; karboksivinil polimēra un alkil akrīlata. LV 13303
  23. 23. Savienojums saskaņā ar 1. punktu, kur minētā sabiezinošā viela ir karboksipolimetilēns.
  24. 24. Savienojums saskaņā ar 1. punktu ir lokālas lietošanas gēla formā.
  25. 25. Savienojums saskaņā ar 1. punktu, kur minētajai sabiezinošajai vielai ir lipīgas bio īpašības.
  26. 26. Savienojums, kas ietver: (A) androgēnu; (B) Hsieh pastiprinātāju, kurš ir ciklisks ketons vai ciklisks esteris, un (C) karbomēru.
  27. 27. Savienojums, kas ietver: (A) testosteronu; (B) oksacikloheksadekan-2-onu un (C) karboksipolimetilēnu.
  28. 28. Savienojums saskaņā ar 1. punktu, kurš ietver ari šķīdinātāju.
  29. 29. Savienojums saskaņā ar 1. punktu, kurš ietver ari kristalizāciju bremzējošu vielu.
  30. 30. Savienojums saskaņā ar 1. punktu, kurš ietver ari neitralizējošu vielu.
  31. 31. Savienojums saskaņā ar 1. punktu, kurš ietver neitralizējošu vielu, kura ir trometamīns.
  32. 32. Farmaceitisks savienojums homogēnas lokālas lietošanas gēla formā, kura pH ir apmēram 3 līdz apmēram 9 un viskozitāte apmēram 2 800 cps līdz apmēram 4 600 cps un kurš ietver: (A) apmēram 0,01 līdz apmēram 15 svara % testosterona; (B) apmēram 1 līdz 15 svara % oksacikloheksadekan-2-ona; (C) apmēram 1 līdz apmēram 6 svara % karboksipolimetilēna un akrīla skābes/ metakrilāta kopolimēra iebiezinošās vielas; (D) apmēram 40 līdz 98 svara % pildvielas, kas ietver metanolu un ūdeni; un (E) apmēram 0,001 līdz apmēram 5 svara % kristalizāciju bremzējošas vielas.
  33. 33. Savienojums saskaņā ar 1. punktu, kurš ietver ari pildvielu, kurā minētais androgēns un/vai minētais pastiprinātājs ir viegli samaisāms vienā šķidrumā un mazāk viegli samaisāms vai nesamaisāms citā šķidrumā.
  34. 34. Savienojums saskaņā ar 1. punktu, kurš ietver ari metanolu un ūdeni.
  35. 35. Savienojums, kurš ietver: (A) dihidrotestosteronu; (B) Hsieh pastiprinātāju un (C) karbomēru.
  36. 36. Savienojums, kurš ietver: (A) dihidrotestosteronu; (B) oksacikloheksadekan-2-onu un (C) karbomēru.
  37. 37. Savienojums saskaņā ar 1. punktu, kur minētā sastāva viskozitāte ir apmēram 2 800 cps līdz apmēram 4 600 cps.
  38. 38. Farmaceitisks sastāvs, kas ietver: (A) apmēram 0,01 līdz apmēram 15 svara % androgēnu; (B) apmēram 1 līdz apmēram 15 svara % Hsieh pastiprinātāju un (C) apmēram 1 līdz apmēram 6 svara % sabiezinošo vielu.
  39. 39. Sastāvs saskaņā ar 1. punktu, kurš rada zemu kairināmlbas līmeni vai nerada nekādu kairināmību mērķa membrānai.
  40. 40. Sastāva lietošana, kas ietver androgēnu, Hsieh pastiprinātāju un sabiezināšanas vielu kā solis slimīga stāvokļa ārstēšanā pacientam.
  41. 41. Sastāva lietošana saskaņā ar 40. punktu, kurā minētais sastāvs tiek pielietots lokāli.
  42. 42. Sastāva lietošana saskaņā ar 40. punktu, kurā minētais sastāvs tiek turēts uz pacienta membrānas laika periodā, kas ir pietiekams testosterona piegādei organismam caur šo membrānu.
  43. 43. Vienības doza saskaņā ar 2. punktu, kas ir uzliekama uz pacienta pleca vai augšdelma slimīga stāvokļa ārstēšanai pacientam.
  44. 44. Vienības doza saskaņā ar 43. punktu, kuras saturs tiek ierīvēts, līdz paliek sauss.
  45. 45. Metode savienojuma izgatavošanai, kurš ir derīgs slimīga stāvokļa ārstēšanai pacientam, ietver androhēna, Hsieh pastiprinātāja un sabiezinošās vielas sajaukšanas soli.
  46. 46. Savienojums saskaņā ar 1. punktu, kurš ietver arī zemāku alkanolu, kas ietver vismaz 40 svara % savienojuma.
  47. 47. Savienojums saskaņā ar 46. punktu, kur minētais zemākais alkanols ietver no apmēram 40 līdz apmēram 80 svara % savienojuma.
  48. 48. Savienojums saskaņā ar 46. punktu, kur minētais zemākais alkanols ietver no apmēram 50 līdz apmēram 75 svara % savienojuma.
  49. 49. Savienojums saskaņā ar 46. punktu, kur minētais zemākais alkanols ietver no apmēram 60 līdz apmēram 75 svara % savienojuma.
LVP-04-127A 2002-04-19 2004-10-27 Pharmaceutical composition LV13303B (en)

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