SI20566B - Stabilne tekoče oblike botulinusovega toksina - Google Patents
Stabilne tekoče oblike botulinusovega toksina Download PDFInfo
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- SI20566B SI20566B SI9920081A SI9920081A SI20566B SI 20566 B SI20566 B SI 20566B SI 9920081 A SI9920081 A SI 9920081A SI 9920081 A SI9920081 A SI 9920081A SI 20566 B SI20566 B SI 20566B
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- botulinum toxin
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- 108030001720 Bontoxilysin Proteins 0.000 title claims abstract 14
- 229940053031 botulinum toxin Drugs 0.000 title claims abstract 14
- 239000012669 liquid formulation Substances 0.000 title abstract 2
- 239000003814 drug Substances 0.000 claims abstract 8
- 238000009472 formulation Methods 0.000 claims abstract 6
- 239000000203 mixture Substances 0.000 claims abstract 6
- 238000011282 treatment Methods 0.000 claims abstract 4
- 239000007788 liquid Substances 0.000 claims abstract 3
- 238000004519 manufacturing process Methods 0.000 claims abstract 2
- 210000003205 muscle Anatomy 0.000 claims 6
- 239000000872 buffer Substances 0.000 claims 5
- 208000014094 Dystonic disease Diseases 0.000 claims 4
- 108010057266 Type A Botulinum Toxins Proteins 0.000 claims 4
- 208000010118 dystonia Diseases 0.000 claims 4
- 108010074523 rimabotulinumtoxinB Proteins 0.000 claims 4
- 229940094657 botulinum toxin type a Drugs 0.000 claims 3
- 208000008238 Muscle Spasticity Diseases 0.000 claims 2
- 208000002193 Pain Diseases 0.000 claims 2
- 206010067672 Spasmodic dysphonia Diseases 0.000 claims 2
- 206010044074 Torticollis Diseases 0.000 claims 2
- 239000000546 pharmaceutical excipient Substances 0.000 claims 2
- 108090000623 proteins and genes Proteins 0.000 claims 2
- 102000004169 proteins and genes Human genes 0.000 claims 2
- 201000002849 spasmodic dystonia Diseases 0.000 claims 2
- 208000018198 spasticity Diseases 0.000 claims 2
- 208000008035 Back Pain Diseases 0.000 claims 1
- 208000018652 Closed Head injury Diseases 0.000 claims 1
- 206010063006 Facial spasm Diseases 0.000 claims 1
- 108010010803 Gelatin Proteins 0.000 claims 1
- 206010019233 Headaches Diseases 0.000 claims 1
- 208000004095 Hemifacial Spasm Diseases 0.000 claims 1
- 102000008100 Human Serum Albumin Human genes 0.000 claims 1
- 108091006905 Human Serum Albumin Proteins 0.000 claims 1
- 208000008454 Hyperhidrosis Diseases 0.000 claims 1
- 208000019695 Migraine disease Diseases 0.000 claims 1
- 206010033078 Otitis media Diseases 0.000 claims 1
- 208000018737 Parkinson disease Diseases 0.000 claims 1
- 208000036496 Pelvic floor dyssynergia Diseases 0.000 claims 1
- 206010039424 Salivary hypersecretion Diseases 0.000 claims 1
- 102000007562 Serum Albumin Human genes 0.000 claims 1
- 108010071390 Serum Albumin Proteins 0.000 claims 1
- 208000004350 Strabismus Diseases 0.000 claims 1
- 208000006011 Stroke Diseases 0.000 claims 1
- 201000002898 anismus Diseases 0.000 claims 1
- 230000002917 arthritic effect Effects 0.000 claims 1
- 208000006673 asthma Diseases 0.000 claims 1
- 206010005159 blepharospasm Diseases 0.000 claims 1
- 230000000744 blepharospasm Effects 0.000 claims 1
- 206010008129 cerebral palsy Diseases 0.000 claims 1
- 201000002866 cervical dystonia Diseases 0.000 claims 1
- 206010009887 colitis Diseases 0.000 claims 1
- 238000007906 compression Methods 0.000 claims 1
- 230000006835 compression Effects 0.000 claims 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 1
- 208000035475 disorder Diseases 0.000 claims 1
- 230000008030 elimination Effects 0.000 claims 1
- 238000003379 elimination reaction Methods 0.000 claims 1
- 239000012530 fluid Substances 0.000 claims 1
- 210000004211 gastric acid Anatomy 0.000 claims 1
- 229920000159 gelatin Polymers 0.000 claims 1
- 239000008273 gelatin Substances 0.000 claims 1
- 235000019322 gelatine Nutrition 0.000 claims 1
- 235000011852 gelatine desserts Nutrition 0.000 claims 1
- 210000004907 gland Anatomy 0.000 claims 1
- 231100000869 headache Toxicity 0.000 claims 1
- 230000037315 hyperhidrosis Effects 0.000 claims 1
- 230000002401 inhibitory effect Effects 0.000 claims 1
- 206010027599 migraine Diseases 0.000 claims 1
- 201000006417 multiple sclerosis Diseases 0.000 claims 1
- 208000004296 neuralgia Diseases 0.000 claims 1
- 201000001119 neuropathy Diseases 0.000 claims 1
- 230000007823 neuropathy Effects 0.000 claims 1
- 210000000056 organ Anatomy 0.000 claims 1
- 208000033808 peripheral neuropathy Diseases 0.000 claims 1
- 239000008363 phosphate buffer Substances 0.000 claims 1
- 239000007981 phosphate-citrate buffer Substances 0.000 claims 1
- 208000026451 salivation Diseases 0.000 claims 1
- 230000001148 spastic effect Effects 0.000 claims 1
- 208000020431 spinal cord injury Diseases 0.000 claims 1
- 239000008362 succinate buffer Substances 0.000 claims 1
- 230000016978 synaptic transmission, cholinergic Effects 0.000 claims 1
- 239000003053 toxin Substances 0.000 claims 1
- 231100000765 toxin Toxicity 0.000 claims 1
- 230000002485 urinary effect Effects 0.000 claims 1
- 208000019553 vascular disease Diseases 0.000 claims 1
- 230000037303 wrinkles Effects 0.000 claims 1
- 239000002537 cosmetic Substances 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 230000001225 therapeutic effect Effects 0.000 abstract 1
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Abstract
Izum se nanaša na tekoče oblike botulinusovega toksina, ki so stabilne pri shranjevanju v tekoči obliki pri standardni temperaturi hladilnika za najmanj 1-2 leti in pri shranjevanju pri višjih temperaturah za najmanj 6 mesecev. Izum se prav tako nanaša na metode zdravljenja z uporabo teh oblik in na uporabo teh oblik pri izdelavi zdravil za različne terapevtske in kozmetične postopke.
Claims (23)
1 SI 20566 STABILNE TEKOČE OBLIKE BOTULINUSOVEGA TOKSINA Patentni zahtevki 1. Stabilna tekoča farmacevtska oblika botulinusovega toksina, ki vsebuje farmacevtsko sprejemljiv pufer, ki je sposoben vzdrževati pufran pH v območju med približno pH 5 in pH 6, in izoliran botulinusov toksin; pri čemer je omenjena oblika stabilna kot tekočina za najmanj eno leto pri temperaturi med približno 0 in 10°C, ali vsaj 6 mesecev pri temperaturi med okoli 10 in 30°C.
2. Oblika po patentnem zahtevku 1, pri čemer ima omenjen pufer pK vrednost v območju odpH 4,5-6,5.
3. Oblika po patentnem zahtevku 1 ali zahtevku 2, pri čemer je omenjeno pufrano pH območje približno pH 5,6±0,2.
4. Oblika po kateremkoli patentnem zahtevku od 1-3, pri čemer je omenjeni pufer izbran iz skupine, ki sestoji iz fosfatnega pufra, fosfat-citratnega pufra in sukcinatnega pufra.
5. Oblika po kateremkoli patentnem zahtevku od 1-4, pri čemer je omenjen botulinusov toksin serotip botulinusovega toksina, izbran iz skupine, ki sestoji iz serotipov A, B, Cl5 C2, D, E, F in G.
6. Oblika po patentnem zahtevku 5, pri čemer je omenjen botulinusov toksin botulinusov toksin tipa B prisoten v koncentraciji v območju približno 100-20000 U/ml.
7. Oblika po patentnem zahtevku 6, pri čemer je omenjen botulinusov toksin tipa B prisoten v koncentraciji med približno 1000-5000 U/ml.
8. Oblika po patentnem zahtevku 6 ali patentnem zahtevku 7, pri čemer je omenjen botulinusov toksin tipa B prisoten v kompleksu z visoko molekulsko maso približno 700 kilodaltonov (kD).
9. Oblika po patentnem zahtevku 5, pri čemer je omenjen botulinusov toksin botulinusov toksin tipa A, prisoten v koncentraciji v območju približno 20-2000 U/ml. 2
10. Oblika po patentnem zahtevku 9, pri čemer je omenjen botulinusov toksin tipa A prisoten v koncentraciji v območju približno 100-1000 U/ml.
11. Oblika po kateremkoli patentnem zahtevku, ki nadalje vključuje ekscipientni protein.
12. Oblika po patentnem zahtevku 11, pri čemer je omenjen ekscipientni protein izbran iz skupine, ki sestoji iz serumskega albumina, rekombinantnega človeškega serumskega albumina in želatine.
13. Uporaba stabilne tekoče oblike botulinusovega toksina glede na katerikoli predhodni patentni zahtevek za proizvodnjo zdravil za inhibiranje holinergičnega prenosa do izbrane mišice, mišične skupine, žleze ali organa.
14. Uporaba glede na patentni zahtevek 13, pri čemer se zdravilo uporablja za zdravljenje motnje, izbrane iz skupine, ki sestoji iz spastičnosti, blefarospazma, strabizma, hemifacialnega spazma, distonije, otitis medie, spastičnega kolitisa, anizmusa, sečne detruzor-sfinkter dissinergije, stiskanja čeljusti in ukrivljenosti hrbtenice.
15. Uporaba glede na patentni zahtevek 14, pri čemer je zdravilo za zdravljenje spastičnosti zaradi ene ali več skupin, ki sestojijo iz udarca, poškodbe hrbtenjače, zaprte poškodbe glave, cerebralne paralize, multiple skleroze in Parkinsonove bolezni.
16. Uporaba glede na patentni zahtevek 14, pri čemer je zdravilo za zdravljenje distonije, izbrane iz skupine, ki sestoji iz spazmodičnega tortikolisa (cervikalna distonija), spazmodične disfonije, distonije uda, laringealne distonije, in oromandibulame (Meigeve) distonije.
17. Uporaba glede na patentni zahtevek 13, pri čemer omenjena izbrana mišica ali mišična skupina povzroča gubo ali zgrbančen obraz.
18. Uporaba glede na patentni zahtevek 13, pri čemer je omenjena izbrana mišica perinealna mišica, in pri čemer omenjen pacient rojeva.
19. Uporaba glede na patentni zahtevek 13, pri čemer je zdravilo za zdravljenje stanja, izbranega iz skupine, ki sestoji iz miofascialne bolečine, glavobola povezanega z migreno, vaskulamih motenj, nevralgije, nevropatije, artritisne bolečine, bolečine hrbta, hiperhidroze, rinoreje, astme, prekomernega slinjenja in prekomernega izločanja želodčne kisline. 3
20. Uporaba glede na katerikoli patentni zahtevek od 13-19, pri čemer je zdravilo za zdravljenje pacienta, ki je odporen na botulinusov toksin tipa A in ko je omenjen botulinusov toksin v omenjeni obliki izbran iz skupine, ki sestoji iz botulinusovega toksina serotipov B, C1} C2, D, E, F in G.
21. Uporaba glede na patentni zahtevek 20, pri čemer je omenjen botulinusov toksin v omenjeni obliki botulinusov toksin tipa B.
22. Uporaba glede na katerikoli patentni zahtevek od 13-19, pri čemer je zdravilo za zdravljenje pacienta, ki je odporen na botulinusov toksin tipa B in je omenjeni botulinusov toksin v omenjeni obliki izbran iz skupine, ki sestoji iz botulinusovega toksina serotipov A, Ci, C2, D, E, F in G.
23. Uporaba po patentnem zahtevku 22, pri čemer je omenjen botulinusov toksin v omenjeni obliki botulinusov toksin tipa A.
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- 1999-09-09 RS YUP-190/01A patent/RS50344B/sr unknown
- 1999-09-09 SI SI9920081A patent/SI20566B/sl not_active IP Right Cessation
- 1999-09-09 GE GEAP19995844A patent/GEP20032946B/en unknown
- 1999-09-09 SI SI9930126T patent/SI1112082T1/sl unknown
- 1999-09-09 HR HR20010259A patent/HRP20010259B1/xx not_active IP Right Cessation
- 1999-09-09 AU AU58214/99A patent/AU755556C/en not_active Ceased
- 1999-09-09 UA UA2001042366A patent/UA72477C2/uk unknown
- 1999-09-09 EP EP99945649A patent/EP1112082B2/en not_active Expired - Lifetime
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2001
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- 2001-02-21 IL IL141564A patent/IL141564A/en not_active IP Right Cessation
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- 2001-03-12 CU CU20010063A patent/CU23251A3/es not_active IP Right Cessation
- 2001-04-10 LV LV010056A patent/LV12684B/xx unknown
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- 2001-04-10 BG BG105435A patent/BG65555B1/bg unknown
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2007
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- 2007-03-27 JP JP2007083103A patent/JP2007169301A/ja not_active Withdrawn
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2010
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2013
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