ME02874B - Obloženi dozni oblici sa kontrolisanim oslobađanjem otporni na zloupotrebu - Google Patents

Obloženi dozni oblici sa kontrolisanim oslobađanjem otporni na zloupotrebu

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ME02874B
ME02874B MEP-2017-220A MEP22017A ME02874B ME 02874 B ME02874 B ME 02874B ME P22017 A MEP22017 A ME P22017A ME 02874 B ME02874 B ME 02874B
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font
dosage form
mso
solid dosage
opioid analgesic
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Haiyong Hugh Huang
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Purdue Pharma Lp
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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
    • A61K9/20—Pills, tablets, discs, rods
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
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    • 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
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
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    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • 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
    • A61P25/04—Centrally acting analgesics, e.g. opioids

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  • Animal Behavior & Ethology (AREA)
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  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Pain & Pain Management (AREA)
  • Medicinal Preparation (AREA)
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Claims (37)

1. Čvrsti dozni oblik sa kontrolisanim oslobađanjem koji sadrži: jezgro koje sadrži prvi deo opioidnog analgetika raspršen u prvom matriksnom materijalu koji sadrži polietilen oksid prosečne molekulske težine od oko 300 000 do oko 3 000 000; i omotač koji oblaže jezgro i koji sadrži drugi deo opioidnog analgetika raspršen u drugom matriksnom materijalu koji sadrži polietilen oksid prosečne molekulske težine od oko 4 000 000 do oko 10 000 000; naznačen time što je težinski odnos jezgra prema omotaču od oko 1:1.2 do oko 1:1.5, i naznačen time što je opioidni analgetik u prvom i drugom delu hidrokodon bitartarat.
2. Čvrsti dozni oblik sa kontrolisanim oslobađanjem prema patentnom zahtevu 1, naznačen time što je količina opioidnog analgetika oslobođena iz doznog oblika, mereno in vitro rastvaranjem u aparaturi 1 (korpa), prema USP, na 100 o/min u 900 ml simuliranog želudačnog fluida bez enzima (SGF) na 37°C, u saglasnosti sa jednačinama (1a) i (1b):<!--[if gte msEquation 12]><m:oMath><i style='mso-bidi-font-style:normal'><span lang=SR-LATN-RS style='font-size: 12.0pt;line-height:115%;font-family:"Cambria Math","serif";mso-fareast-font-family: SimSun;mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:Arial; mso-bidi-theme-font:minor-bidi;mso-ansi-language:SR-LATN-RS;mso-fareast-language: EN-US;mso-bidi-language:AR-SA'><m:r>koli</m:r><m:r>č</m:r><m:r>ina</m:r><m:r> </m:r><m:r>oslobo</m:r><m:r>đ</m:r><m:r>ena</m:r><m:r> </m:r><m:r>za</m:r><m:r> 24 č</m:r><m:r>asa</m:r><m:r> ≤ </m:r></span></i><m:d><m:dPr><span style='font-size:12.0pt;mso-ansi-font-size:12.0pt;mso-bidi-font-size:12.0pt; font-family:"Cambria Math","serif";mso-ascii-font-family:"Cambria Math"; mso-hansi-font-family:"Cambria Math";font-style:italic;mso-bidi-font-style: normal'><m:ctrlPr></m:ctrlPr></span></m:dPr><m:e><m:f><m:fPr><span style='font-size:12.0pt;mso-ansi-font-size:12.0pt;mso-bidi-font-size:12.0pt; font-family:"Cambria Math","serif";mso-ascii-font-family:"Cambria Math"; mso-hansi-font-family:"Cambria Math";font-style:italic;mso-bidi-font-style: normal'><m:ctrlPr></m:ctrlPr></span></m:fPr><m:num><i style='mso-bidi-font-style: normal'><span lang=SR-LATN-RS style='font-size:12.0pt;line-height:115%; font-family:"Cambria Math","serif";mso-fareast-font-family:SimSun; mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:Arial; mso-bidi-theme-font:minor-bidi;mso-ansi-language:SR-LATN-RS;mso-fareast-language: EN-US;mso-bidi-language:AR-SA'><m:r>24</m:r></span></i></m:num><m:den><i style='mso-bidi-font-style:normal'><span lang=SR-LATN-RS style='font-size: 12.0pt;line-height:115%;font-family:"Cambria Math","serif";mso-fareast-font-family: SimSun;mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:Arial; mso-bidi-theme-font:minor-bidi;mso-ansi-language:SR-LATN-RS;mso-fareast-language: EN-US;mso-bidi-language:AR-SA'><m:r>8</m:r></span></i></m:den></m:f><i style='mso-bidi-font-style:normal'><span lang=SR-LATN-RS style='font-size: 12.0pt;line-height:115%;font-family:"Cambria Math","serif";mso-fareast-font-family: SimSun;mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:Arial; mso-bidi-theme-font:minor-bidi;mso-ansi-language:SR-LATN-RS;mso-fareast-language: EN-US;mso-bidi-language:AR-SA'><m:r> </m:r><m:r>x</m:r><m:r> </m:r><m:r>koli</m:r><m:r>č</m:r><m:r>ina</m:r><m:r> </m:r><m:r>oslobo</m:r><m:r>đ</m:r><m:r>ena</m:r><m:r> </m:r><m:r>za</m:r><m:r> 8 č</m:r><m:r>asova</m:r></span></i></m:e></m:d><i style='mso-bidi-font-style: normal'><span lang=SR-LATN-RS style='font-size:12.0pt;line-height:115%; font-family:"Cambria Math","serif";mso-fareast-font-family:SimSun;mso-fareast-theme-font: minor-fareast;mso-bidi-font-family:Arial;mso-bidi-theme-font:minor-bidi; mso-ansi-language:SR-LATN-RS;mso-fareast-language:EN-US;mso-bidi-language: AR-SA'><m:r>x</m:r><m:r> 1.2</m:r></span></i></m:oMath><![endif]--><!--[if !msEquation]--> <!--[endif]--> (1a) (1b)
3. Čvrsti dozni oblik sa kontrolisanim oslobađanjem prema patentnom zahtevu 1 ili 2, naznačen time što jezgro predstavlja komprimovanu tabletu.
4. Čvrsti dozni oblik sa kontrolisanim oslobađanjem prema bilo kom od patentnih zahteva 1 do 3, naznačen time što omotač predstavlja kompresionu prevlaku.
5. Čvrsti dozni oblik sa kontrolisanim oslobađanjem prema bilo kom od patentnih zahteva 1 do 4, naznačen time što polietilen oksid u drugom matriksnom materijalu ima prosečnu molekulsku težinu od oko 6 000 000 do oko 8 000 000 i polietilen oksid u prvom matriksnom materijalu ima prosečnu molekulsku težinu od oko 500 000 do oko 1 000 000.
6. Čvrsti dozni oblik sa kontrolisanim oslobađanjem prema bilo kom od patentnih zahteva 1 do 5, naznačen time što težinski odnos prvog dela opioidnog analgetika prema polietilen oksidu u prvom matriksnom materijalu iznosi od oko 1:0.5 do oko 1:100, poželjno od oko 1:1 do oko 1:10, poželjnije od oko 1:1.5 do oko 1:4.
7. Čvrsti dozni oblik sa kontrolisanim oslobađanjem prema bilo kom od patentnih zahteva 1 do 6, naznačen time što težinski odnos drugog dela opioidnog analgetika prema polietilen oksidu u drugom matriksnom materijalu iznosi od oko 1:2 do oko 1:200, poželjno od oko 1:5 do oko 1:50, poželjnije od oko 1:12 do oko 1:25.
8. Čvrsti dozni oblik sa kontrolisanim oslobađanjem prema patentnom zahtevu 1, naznačen time što je ukupna količina hidrokodon bitartarata u doznom obliku od oko 0.5 mg do oko 1250 mg, ili od oko 2 mg do oko 200 mg, ili od oko 16 mg do oko 120 mg.
9. Čvrsti dozni oblik sa kontrolisanim oslobađanjem prema bilo kom od patentnih zahteva 1 do 8, naznačen time što je količina oslobođenog opioidnog analgetika u saglasnosti sa jednačinama (1a`) i (1b`): i poželjno u saglasnosti sa jednačinama (la") i (l b"):
10. Čvrsti dozni oblik sa kontrolisanim oslobađanjem prema bilo kom od patentnih zahteva 1 do 8, naznačen time što je količina oslobođenog opioidnog analgetika u saglasnosti sa jednačinama (2a) i (2b): pri čemu je količina oslobođenog opioidnog analgetika poželjno u saglasnosti sa jednačinama (2a`) i (2b`): ili u saglasnosti sa jednačinama (2a``) i (2b``):
11. Čvrsti dozni oblik sa kontrolisanim oslobađanjem prema bilo kom od patentnih zahteva 1 do 8, naznačen time što je količina oslobođenog opioidnog analgetika u saglasnosti sa jednačinama (3a) i (3b): pri čemu je količina oslobođenog opioidnog analgetika poželjno u saglasnosti sa jednačinama (3a`) i (3b`): ili u saglasnosti sa jednačinama (3a``) i (3b``):
12. Čvrsti dozni oblik sa kontrolisanim oslobađanjem prema bilo kom od patentnih zahteva 1 do 8, naznačen time što je količina oslobođenog opioidnog analgetika u saglasnosti sa jednačinama (4a) i (4b): pri čemu je količina oslobođenog opioidnog analgetika poželjno u saglasnosti sa jednačinama (4a`) i (4b`): ili u saglasnosti sa jednačinama (4a``) i (4b``):
13. Čvrsti dozni oblik sa kontrolisanim oslobađanjem prema bilo kom od patentnih zahteva 1 do 8, naznačen time što je količina oslobođenog opioidnog analgetika u saglasnosti sa jednačinama (5a) i (5b): pri čemu je količina oslobođenog opioidnog analgetika poželjno u saglasnosti sa jednačinama (5a`) i (5b`): ili u saglasnosti sa jednačinama (5a``) i (5b``):
14. Čvrsti dozni oblik sa kontrolisanim oslobađanjem prema bilo kom od patentnih zahteva 1 do 13, naznačen time što je količina opioidnog analgetika oslobođena za 2 časa manja od oko 25%, i/ilinaznačen time što je količina opioidnog analgetika oslobođena za 4 časa od oko 10% do oko 30%, i/ilinaznačen time što je količina opioidnog analgetika oslobođena za 8 časova od oko 20% do oko 60%, i/ilinaznačen time što je količina opioidnog analgetika oslobođena za 12 časova od oko 40% do oko 90%, i/ilinaznačen time što je količina opioidnog analgetika oslobođena za 18 časova veća od oko 70%.
15. Čvrsti dozni oblik sa kontrolisanim oslobađanjem prema bilo kom od patentnih zahteva 1 do 14, naznačen time što je količina opioidnog analgetika oslobođena za 2 časa manja od oko 20%, i/ili naznačen time što je količina opioidnog analgetika oslobođena za 4 časa od oko 10% do oko 20%, i/ilinaznačen time što je količina opioidnog analgetika oslobođena za 8 časova od oko 20% do oko 40%, i/ilinaznačen time što je količina opioidnog analgetika oslobođena za 12 časova od oko 40% do oko 65%, i/ilinaznačen time što je količina opioidnog analgetika oslobođena za 18 časova veća od oko 80%.
16. Čvrsti dozni oblik sa kontrolisanim oslobađanjem prema bilo kom od patentnih zahteva 1 do 15, naznačen time što je količina opioidnog analgetika oslobođena za 2 časa manja od oko 15%, i/ilinaznačen time što je količina opioidnog analgetika oslobođena za 4 časa od oko 20% do oko 30%, i/ilinaznačen time što je količina opioidnog analgetika oslobođena za 8 časova od oko 45% do oko 60%, i/ilinaznačen time što je količina opioidnog analgetika oslobođena za 12 časova od oko 70% do oko 90%, i/ilinaznačen time što je količina opioidnog analgetika oslobođena za 18 časova veća od oko 90%.
17. Čvrsti dozni oblik sa kontrolisanim oslobađanjem prema patentnom zahtevu 1, koji može da se dobije očvršćavanjem doznog oblika na temperaturi najmanje jednakoj tački omekšavanja polietilen oksida u trajanju od najmanje 1 minuta, najmanje 5 minuta, ili najmanje 15 minuta.
18. Čvrsti dozni oblik sa kontrolisanim oslobađanjem prema patentnom zahtevu 1, koji može da se dobije očvršćavanjem doznog oblika na temperaturi najmanje jednakoj tački omekšavanja polietilen oksida u trajanju od oko 1 minut do oko 48 časova, ili od oko 5 minuta do oko 24 časa, ili od oko 15 minuta do oko 1 čas.
19. Čvrsti dozni oblik sa kontrolisanim oslobađanjem prema patentnom zahtevu 17 ili 18, koji može da se dobije očvršćavanjem doznog oblika na temperaturi od najmanje oko 60°C, najmanje oko 65°C, najmanje oko 70°C, najmanje oko 75°C, ili oko 72°C.
20. Čvrsti dozni oblik sa kontrolisanim oslobađanjem prema patentnom zahtevu 17 ili 18, koji može da se dobije očvršćavanjem doznog oblika na temperaturi od oko 60°C do oko 90°C, ili od oko 65°C do oko 85°C, ili od oko 70°C do oko 80°C, ili od oko 75°C do oko 80°C, ili od oko 70°C do oko 75°C.
21. Čvrsti dozni oblik sa kontrolisanim oslobađanjem prema bilo kom od patentnih zahteva 1 do 20, naznačen time što su jezgro i omotač vizuelno neodvojivi, ili naznačen time što jezgro i omotač imaju vrednosti CIE L*A*B* u okviru 10% jedan od drugog.
22. Čvrsti dozni oblik sa kontrolisanim oslobađanjem prema bilo kom od patentnih zahteva 1 do 21, naznačen time što dozni oblik može da bude spljošten bez lomljenja, pri čemu debljina doznog oblika posle spljoštavanja predstavlja ne više od oko 60% debljine doznog oblika pre spljoštavanja,poželjno debljina doznog oblika posle spljoštavanja predstavlja ne više od oko 50%, ili ne više od oko 40%, ili ne više od oko 30%, ili ne više od oko 20% debljine doznog oblika pre spljoštavanja.
23. Čvrsti dozni oblik sa kontrolisanim oslobađanjem prema patentnom zahtevu 22, naznačen time što količina opioidnog analgetika oslobođena za 0.5 časova iz spljoštenog doznog oblika ne odstupa za više od oko 20%-nih poena, ili za više od oko 15%-nih poena, ili za više od oko 10%-nih poena, od doznog oblika koji nije spljošten, mereno in vitro rastvaranjem u aparaturi 1 (korpa), prema USP, na 100 o/min u 900 ml simuliranog želudačnog fluida bez enzima (SGF) na 37°C.
24. Čvrsti dozni oblik sa kontrolisanim oslobađanjem prema patentnom zahtevu 1, koji obezbeđuje odnos C24/Cmax hidrokodona od oko 0.55 do oko 1.0 nakon primene,poželjno odnos C24/Cmax je oko 0.55 do oko 0.85, ili oko 0.55 do oko 0.75, ili oko 0.60 do oko 0.70.
25. Čvrsti dozni oblik sa kontrolisanim oslobađanjem prema patentnom zahtevu 1, koji obezbeđuje Tmax (h) hidrokodona od oko 4 do oko 20 časova nakon primene,poželjno Tmax (h) je oko 6 do oko 12 časova, ili oko 8 do oko 10 časova, ili oko 4 do oko 10 časova, ili oko 8 do oko 14 časova, ili oko 14 do oko 20 časova nakon primene doznog oblika.
26. Čvrsti dozni oblik sa kontrolisanim oslobađanjem prema patentnom zahtevu 24 ili 25, naznačen time što primena predstavlja prvu primenu kod zdravog subjekta ili kod populacije zdravih subjekata, ilinaznačen time što primena predstavlja primenu u stabilnom stanju kod zdravog subjekta ili kod populacije zdravih subjekata.
27. Čvrsti dozni oblik sa kontrolisanim oslobađanjem prema patentnom zahtevu 1, koji sadrži oko 20 mg hidrokodon bitartarata.
28. Čvrsti dozni oblik sa kontrolisanim oslobađanjem prema patentnom zahtevu 1, koji sadrži oko 120 mg hidrokodon bitartarata.
29. Čvrsti dozni oblik sa kontrolisanim oslobađanjem prema patentnom zahtevu 1, koji obezbeđuje srednju vrednost AUC (ng*h/mL) nakon primene od oko 250 do 400 na svakih 20 mg hidrokodona uključenog u dozni oblik, i/ili koji obezbeđuje srednju vrednost Cmax (ng/mL) nakon primene od oko 10 do oko 30 na svakih 20 mg hidrokodona uključenog u dozni oblik.
30. Čvrsti dozni oblik sa kontrolisanim oslobađanjem prema patentnom zahtevu 27, koji obezbeđuje srednju vrednost AUC (ng*h/mL) nakon primene od oko 250 do oko 400, oko 275 do oko 350, oko 300 do 330 ili oko 280 do oko 320, i/ili koji obezbeđuje srednju vrednost Cmax (ng/mL) nakon primene od oko 10 do oko 30, oko 12 do oko 25, oko 14 do oko 18, ili oko 12 do oko 17.
31. Čvrsti dozni oblik sa kontrolisanim oslobađanjem prema patentnom zahtevu 28, koji obezbeđuje srednju vrednost AUC (ng*h/mL) nakon primene od oko 1500 do oko 2400, oko 1700 do oko 2200, oko 1800 do oko 2100 ili oko 1900 do oko 2100, i/ili koji obezbeđuje srednju vrednost Cmax (ng/mL) nakon primene od oko 60 do oko 180, oko 100 do oko 160, oko 110 do oko 150, ili oko 100 do oko 140.
32. Čvrsti dozni oblik sa kontrolisanim oslobađanjem prema patentnom zahtevu 1, koji obezbeđuje srednju vrednost Tmax (h) nakon primene od oko 10 do oko 20, oko 12 do oko 18, oko 13 do oko 17 ili oko 14 do oko 16, i/ili koji obezbeđuje srednju vrednost T1/2 (h) nakon primene od oko 5 do oko 10, oko 6 do oko 9, oko 7 ili oko 8, i/ili koji obezbeđuje srednju vrednost Tlag (h) nakon primene od oko 0.01 do oko 0.2, oko 0.1 do oko 0.18, oko 0.3 do oko 0.17 ili oko 0.06 do oko 0.15, i/ili naznačen time što je srednja vrednost odnosa C24/Cmax oko 0.2 do oko 0.8, oko 0.3 do oko 0.7, ili oko 0.4 do oko 0.6.
33. Čvrsti dozni oblik sa kontrolisanim oslobađanjem prema bilo kom od patentnih zahteva 29-32, naznačen time što se primena obavlja u uslovima gladovanja.
34. Čvrsti dozni oblik sa kontrolisanim oslobađanjem prema patentnom zahtevu 1, naznačen time što je srednja vrednost AUC (ng*h/mL), nakon primene po uzimanju obroka, manje od 20% viša, manje od 16% viša, ili manje od 12% viša od AUC (ng*h/mL) nakon primene u uslovima gladovanja, i/ili naznačen time što je srednja vrednost Cmax (ng/mL), nakon primene po uzimanju obroka, manje od 80% viša, manje od 70% viša, ili manje od 60% viša od Cmax nakon primene u uslovima gladovanja.
35. Čvrsti dozni oblik sa kontrolisanim oslobađanjem prema patentnom zahtevu 1, naznačen time što je srednja vrednost Tmax (h), nakon primene po uzimanju obroka, u okviru 25%, u okviru 20%, ili u okviru 15% od Tmax (h) nakon primene u uslovima gladovanja, i/ili naznačen time što je srednja vrednost T1/2 (h), nakon primene po uzimanju obroka, u okviru 8%, u okviru 5%, ili u okviru 2% od T1/2 nakon primene u uslovima gladovanja, i/ili naznačen time što je srednja vrednost Tlag (h), nakon primene po uzimanju obroka, manje od 150% viša, manje od 125% viša, ili manje od 100% viša nego T1/2 nakon primene u uslovima gladovanja.
36. Čvrsti dozni oblik sa kontrolisanim oslobađanjem prema bilo kom od patentnih zahteva 1-35 za upotrebu u metodi za lečenje bola kod subjekta kome je to potrebno.
37. Metod za pripremu čvrstog doznog oblika sa kontrolisanim oslobađanjem koji obuhvata:pripremu jezgra koje sadrži prvi deo opioidnog analgetika raspršen u prvom matriksnom materijalu koji sadrži polietilen oksid srednje molekulske težine od oko 300 000 do oko 3 000 000; ioblaganje jezgra omotačem koji sadrži drugi deo opioidnog analgetika raspršen u drugom matriksnom materijalu koji sadrži polietilen oksid srednje molekulske težine od oko 4 000 000 do oko 10 000 000;naznačen time što je težinski odnos jezgra prema omotaču od oko 1:1.2 do oko 1:1.5,i nazančen time što je opioidni analgetik u prvom i drugom delu hidrokodon bitartarat.
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