DK2583668T3 - Sulfoalkylætercyclodextrinsammensætninger og fremgangsmåder til fremstilling deraf - Google Patents

Sulfoalkylætercyclodextrinsammensætninger og fremgangsmåder til fremstilling deraf Download PDF

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DK2583668T3
DK2583668T3 DK12189687T DK12189687T DK2583668T3 DK 2583668 T3 DK2583668 T3 DK 2583668T3 DK 12189687 T DK12189687 T DK 12189687T DK 12189687 T DK12189687 T DK 12189687T DK 2583668 T3 DK2583668 T3 DK 2583668T3
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Gerold L Mosher
Douglas B Hecker
James D Pipkin
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Cydex Pharmaceuticals Inc
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    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08B—POLYSACCHARIDES; DERIVATIVES THEREOF
    • C08B37/00—Preparation of polysaccharides not provided for in groups C08B1/00 - C08B35/00; Derivatives thereof
    • C08B37/0006—Homoglycans, i.e. polysaccharides having a main chain consisting of one single sugar, e.g. colominic acid
    • C08B37/0009—Homoglycans, i.e. polysaccharides having a main chain consisting of one single sugar, e.g. colominic acid alpha-D-Glucans, e.g. polydextrose, alternan, glycogen; (alpha-1,4)(alpha-1,6)-D-Glucans; (alpha-1,3)(alpha-1,4)-D-Glucans, e.g. isolichenan or nigeran; (alpha-1,4)-D-Glucans; (alpha-1,3)-D-Glucans, e.g. pseudonigeran; Derivatives thereof
    • C08B37/0012—Cyclodextrin [CD], e.g. cycle with 6 units (alpha), with 7 units (beta) and with 8 units (gamma), large-ring cyclodextrin or cycloamylose with 9 units or more; Derivatives thereof
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/53—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with three nitrogens as the only ring hetero atoms, e.g. chlorazanil, melamine
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
    • A61K31/5415—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame ortho- or peri-condensed with carbocyclic ring systems, e.g. phenothiazine, chlorpromazine, piroxicam
    • 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
    • A61K31/573—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 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/716—Glucans
    • A61K31/724—Cyclodextrins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40—Cyclodextrins; Derivatives thereof
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0075—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
    • 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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D1/00—Evaporating
    • B01D1/16—Evaporating by spraying
    • B01D1/18—Evaporating by spraying to obtain dry solids
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/29—Coated or structually defined flake, particle, cell, strand, strand portion, rod, filament, macroscopic fiber or mass thereof
    • Y10T428/2982—Particulate matter [e.g., sphere, flake, etc.]

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
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  • Bioinformatics & Cheminformatics (AREA)
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  • Chemical Kinetics & Catalysis (AREA)
  • Zoology (AREA)
  • Inorganic Chemistry (AREA)
  • Otolaryngology (AREA)
  • Pulmonology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Polymers & Plastics (AREA)
  • Organic Chemistry (AREA)
  • Materials Engineering (AREA)
  • Biochemistry (AREA)
  • Medicinal Preparation (AREA)
  • Polysaccharides And Polysaccharide Derivatives (AREA)

Claims (19)

1. Fluid-bed sprøjtetørringsfremgangsmåde til fremstilling af en sammensætning omfattende sulfoalkylætercyclodextrin (SAE-CD), hvori fremgangsmåden omfatter: (a) tilvejebringelse af en væsketilførsel omfattende en væskebærer og SAE-CD, (b) dannelse af en fluid-bed af partikler omfattende SAE-CD i et tørrekammer i et fluid-bed spraytørreapparat, (c) fjernelse af fine partikler fra denne fluid-bed og tilbageføring af dem til tørrekammeret, (d) forstøvning af væsketilførsel ind i tørrekammeret, (e) føring af større partikler til et andet kammer, der indeholder en fluid-bed af partikler, og (f) opsamling af partikelsammensætning for at tilvejebringe sammensætningen omfattende SAE-CD.
2. Fremgangsmåde ifølge krav 1, yderligere omfattende føring af de større partikler til et tredje kammer indeholdende en fluid-bed af partikler.
3. Fremgangsmåde ifølge krav 2, omfattende køling af de større partikler efterhånden som de føres til de andre og tredje kamre.
4. Fremgangsmåde ifølge krav 2 eller 3, omfattende opsamling af SAE-CD sammensætningen fra det tredje kammer.
5. Fremgangsmåde ifølge krav 2, 3 eller 4, omfattende tilvejebringelse af en gasstrøm til tørrekammer, andet kammer og tredje kammer, hvori gasstrømmen tilvejebragt i det tredje kammer er lavere i temperatur end gasstrømmen tilvejebragt i tørrekammeret, og gasstrømmen tilvejebragt i det tredje kammer er lavere i temperatur end gasstrømmen tilvejebragt i det andet kammer.
6. Fremgangsmåde ifølge krav 5, hvori temperaturen af den i tørrekammeret tilvejebragte gasstrøm er fra ca. 1 00° C til ca. 300° C, fra ca. 130° C til ca. 180° C, fra ca. 150° C til ca. 170° C eller fra ca. 210° C til ca. 250° C.
7. Fremgangsmåde ifølge ethvert af krav 3 til 6, omfattende fjernelse af fine partikler fra de andre og tredje kamre og tilbageføring af dem til tørrekammeret.
8. Fremgangsmåde ifølge ethvert af de foregående krav, hvori dannelse af denne fluid-bed af partikler i trin (a) omfatter forstøvning af en væsketilførsel i tørrekammeret i modstrøm mod en varm gasstrøm eller ved formaling, knusning, nedbrydning eller sigtning.
9. Fremgangsmåde ifølge ethvert af de foregående krav, omfattende sigtning af de fine partikler fjernet i trin (b) i en cyklon.
10. Fremgangsmåde ifølge ethvert af de foregående krav, hvori de fine partikler ført tilbage til tørrekammeret i trin (b) føres tilbage til et øvre parti af tørrekammeret på et sted tilstødende og i medstrøm med den i trin (c) forstøvede væsketilførsel.
11. Fremgangsmåde ifølge ethvert af de foregående krav, hvori tørrekammeret er cylindrisk eller konisk.
12. Fremgangsmåde ifølge ethvert af de foregående krav, hvori væsketilførslen omfatter en vandig væskebærer og et SAE-CD faststofindhold fra 0,1 til 80 vægt-%, 10 til 70 vægt-%, 30 til 70 vægt-% eller 40 til 60 vægt-%.
13. Fremgangsmåde ifølge ethvert af de foregående krav, hvori SAE-CD er en forbindelse eller en blanding deraf med strukturen i formlen I:
hvori: - n er 4, 5 eller 6; - R-!, R2, R3, R4, R5, Re, R7, Rs og Rg er hver uafhængigt -O- eller en -0-(C2. 6alkylen)-S03' gruppe, hvori mindst en af R! til Rg er uafhængigt en -0-(C2.6 alky-len)-S03' gruppe, en -0-(CFI2)mS03' gruppe, hvori m er 2 til 6, -0CFI2CFI2CFI2S03, eller -OCH2CH2CH2 CH2S03'; og - St, S2, S3, S4, S5, S6, S7, S8 og S9 er hver uafhængigt en farmaceutisk acceptabel kation.
14. Fremgangsmåde ifølge ethvert af de foregående krav, hvori sammensætningen omfatter: - et fugtindhold under SAE-CD sammensætningens henflydningspunkt, fortrinsvis ikke mere end 20 vægt-%, mere foretrukket mindre end 18 vægt-%, - en rumvægt på ca. 0,38 g/cm3 til ca. 0,66 g/cm3, fortrinsvis 0,55 g/cm3 til 0,66 g/cm3, og - en rystet massefylde (tapped density) på ca. 0,49 g/cm3 til ca. 0,75 g/cm3, fortrinsvis 0,66 g/cm3 til 0,75 g/cm3.
15. Fremgangsmåde ifølge krav 1, hvori sammensætningen har et CARR indeks på ca. 18% eller mindre.
16. Fremgangsmåde ifølge krav 1, hvori sammensætningen har et CARR indeks på ca. 16% eller mindre.
17. Fremgangsmåde ifølge krav 1, hvori sammensætningen har en minimum tyngdeudstrømningshuldiameter på 10 mm eller mindre.
18. Fremgangsmåde ifølge krav 1, hvori sammensætningen har en minimum tyngdeudstrømningshuldiameter på ca. 3 mm til 7 mm.
19. SAE-CD sammensætning fremstillet ved fremgangsmåden ifølge ethvert af krav 1 til 18.
DK12189687T 2005-10-26 2005-10-26 Sulfoalkylætercyclodextrinsammensætninger og fremgangsmåder til fremstilling deraf DK2583668T3 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
PCT/US2005/038933 WO2007050075A1 (en) 2005-10-26 2005-10-26 Sulfoalkyl ether cyclodextrin compositions and methods of preparation thereof
EP20120189687 EP2583668B1 (en) 2005-10-26 2005-10-26 Sulfoalkyl ether cyclodextrin compositions and methods of preparation thereof
EP20110161125 EP2335707B1 (en) 2005-10-26 2005-10-26 Sulfoalkyl ether cyclodextrin compositions and methods of preparation thereof

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DK2583668T3 true DK2583668T3 (da) 2015-01-19

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DK12189687T DK2583668T3 (da) 2005-10-26 2005-10-26 Sulfoalkylætercyclodextrinsammensætninger og fremgangsmåder til fremstilling deraf
DK05856927T DK1945228T4 (da) 2005-10-26 2005-10-26 Sulfoalkyl-ether-cyclodextrin-sammensætninger og fremgangsmåder til fremstilling deraf
DK12189690T DK2581078T3 (da) 2005-10-26 2005-10-26 Sulfoalkylætercyclodekstrinsammensætninger og fremgangsmåder til fremstilling deraf
DK15165737.6T DK2952197T3 (da) 2005-10-26 2005-10-26 Sulfoalkylætercyclodekstrin sammensætning og fremgangsmåde til fremstilling deraf
DK11161125.7T DK2335707T3 (da) 2005-10-26 2005-10-26 Sulfoalkylætercyclodekstrinsammensætninger og fremgangsmåder til fremstilling deraf

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DK05856927T DK1945228T4 (da) 2005-10-26 2005-10-26 Sulfoalkyl-ether-cyclodextrin-sammensætninger og fremgangsmåder til fremstilling deraf
DK12189690T DK2581078T3 (da) 2005-10-26 2005-10-26 Sulfoalkylætercyclodekstrinsammensætninger og fremgangsmåder til fremstilling deraf
DK15165737.6T DK2952197T3 (da) 2005-10-26 2005-10-26 Sulfoalkylætercyclodekstrin sammensætning og fremgangsmåde til fremstilling deraf
DK11161125.7T DK2335707T3 (da) 2005-10-26 2005-10-26 Sulfoalkylætercyclodekstrinsammensætninger og fremgangsmåder til fremstilling deraf

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US (1) US8049003B2 (da)
EP (5) EP2583668B1 (da)
JP (1) JP5465432B2 (da)
KR (1) KR101152886B1 (da)
CN (1) CN101365459B (da)
AT (1) ATE504305T1 (da)
AU (1) AU2005337613B2 (da)
BR (1) BRPI0520654B8 (da)
CA (2) CA2928065C (da)
CY (3) CY1116080T1 (da)
DE (1) DE602005027415D1 (da)
DK (5) DK2583668T3 (da)
ES (5) ES2634670T3 (da)
HU (2) HUE035181T2 (da)
IL (3) IL191081A (da)
LT (1) LT2952197T (da)
MX (2) MX348982B (da)
PL (4) PL2583668T3 (da)
PT (5) PT2583668E (da)
SI (2) SI2335707T1 (da)
WO (1) WO2007050075A1 (da)

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US7635773B2 (en) 2008-04-28 2009-12-22 Cydex Pharmaceuticals, Inc. Sulfoalkyl ether cyclodextrin compositions
US8492538B1 (en) 2009-06-04 2013-07-23 Jose R. Matos Cyclodextrin derivative salts
CA2807528C (en) 2010-08-05 2018-09-25 Siga Technologies, Inc. St-246 liquid formulations and methods
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WO2013123254A1 (en) 2012-02-15 2013-08-22 Cydex Pharmaceuticals, Inc. Manufacturing process for cyclodextrin derivatives
RU2615385C2 (ru) 2012-02-28 2017-04-04 Сидекс Фармасьютикалс, Инк. Композиции алкилированного циклодекстрина и способы их получения и применения
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