Sulfoalkyl ether cyclodextrin compositions and methods of preparation thereof
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
A61K-031/724
A61K-031/716
C07H-015/04
C07H-015/00
출원번호
UP-0363719
(2009-01-31)
등록번호
US-7629331
(2009-12-16)
발명자
/ 주소
Pipkin, James D.
Mosher, Gerold L.
Hecker, Douglas B.
출원인 / 주소
CyDex Pharmaceuticals, Inc.
대리인 / 주소
Sterne, Kessler, Goldstein & Fox P.L.L.C.
인용정보
피인용 횟수 :
32인용 특허 :
13
초록▼
A particulate SAE-CD composition is provided. The SAE-CD composition has an advantageous combination of physical properties not found in known solid forms of SAECD. In particular, the SAE-CD composition possesses an advantageous physicochemical and morphological property profile such that it can be
A particulate SAE-CD composition is provided. The SAE-CD composition has an advantageous combination of physical properties not found in known solid forms of SAECD. In particular, the SAE-CD composition possesses an advantageous physicochemical and morphological property profile such that it can be tailored to particular uses. The SAE-CD composition of the invention has improved flow and dissolution performance as compared to known compositions of SAE-CD.
대표청구항▼
What is claimed is: 1. A composition comprising an excipient and a sulfoalkyl ether cyclodextrin composition, wherein the sulfoalkyl ether cyclodextrin composition comprises: (a) sulfoalkyl ether cyclodextrin; (b) no more than about 20% by weight moisture; (c) a bulk density of about 0.38 g/cm3 to
What is claimed is: 1. A composition comprising an excipient and a sulfoalkyl ether cyclodextrin composition, wherein the sulfoalkyl ether cyclodextrin composition comprises: (a) sulfoalkyl ether cyclodextrin; (b) no more than about 20% by weight moisture; (c) a bulk density of about 0.38 g/cm3 to about 0.66 g/cm3; (d) a tapped density of about 0.49 g/cm3 to about 0.75 g/cm3, wherein the tapped density of the sulfoalkyl ether cyclodextrin composition is higher than the bulk density; and (e) a gravitational-flow minimum orifice diameter of about 3 mm to about 12 mm; and wherein the sulfoalkyl ether cyclodextrin composition comprises agglomerated particles, wherein the agglomerated particles are produced by a process comprising: (i) forming a fluidized bed of SAE-CD particles in a drying chamber of a fluidized bed spray dryer apparatus with an attached 3-chamber fluidization bed; (ii) recycling fine particles from the fluidized bed back into the drying chamber at a location adjacent to a liquid feed atomizer; and (iii) collecting agglomerated particles from the third chamber of the 3-chamber fluidization bed. 2. The composition of claim 1, wherein the sulfoalkyl ether cyclodextrin is a compound, or a mixture of compounds, of the Formula 1: wherein: n is 4, 5, or 6; R1, R2, R3, R4, R5, R6, R7, R8, and R9 are each, independently, O- or a O--(C2-6 alkylene)--SO3-group, wherein at least one of R1 and R2 is, independently, the O--(C2-C6 alkylene)--SO3-group; and S1, S2, S3, S4, S5, S6, S7, S8, and S9, are each, independently, a pharmaceutically acceptable cation. 3. The composition of claim 1, wherein the sulfoalkyl ether cyclodextrin composition comprises a bulk density of about 0.55 g/cm3 to about 0.66 g/cm3 and a tapped density of about 0.66 g/cm3 to about 0.75 g/cm3. 4. The composition of claim 1, wherein the sulfoalkyl ether cyclodextrin composition comprises a bulk density of about 0.38 g/cm3 to about 0.55 g/cm3 and a tapped density of about 0.49 g/cm3 to about 0.66 g/cm3. 5. The composition of claim 1, wherein the sulfoalkyl ether cyclodextrin composition comprises a gravitational-flow minimum orifice diameter of about 10 mm or less. 6. The composition of claim 1, wherein the sulfoalkyl ether cyclodextrin composition comprises a true density of about 1.1 g/cm3 to about 1.5 g/cm3. 7. The composition of claim 1, wherein the sulfoalkyl ether cyclodextrin composition comprises a CARR's index of about 12% to about 24%. 8. The composition of claim 1, wherein the sulfoalkyl ether cyclodextrin composition comprises particles with a mean particle diameter of about 75 microns to about 200 microns. 9. The composition of claim 8, wherein at least 90% of the particle volume of the sulfoalkyl ether cyclodextrin composition comprises particles having calculated diameters greater than or equal to about 25 microns. 10. The composition of claim 1, wherein the sulfoalkyl ether cyclodextrin composition comprises a moisture content of about 2% to about 3% by weight and a compression crushing strength of about 1.0 kP to about 20 kP when compressed into a tablet using a Pmax of about 30 MPa to about 275 MPa. 11. The composition of claim 1, wherein the sulfoalkyl ether cyclodextrin composition comprises a moisture content of about 5% to about 6% by weight and a compression crushing strength of about 0.5 to about 11 kP when compressed into a tablet using a Pmax of about 15 MPa to about 70 MPa. 12. The composition of claim 1, wherein 2.5 g of the sulfoalkyl ether cyclodextrin composition has an average dissolution time of about 2 mm to about 4.5 mm when placed in water. 13. The composition of claim 1, wherein the composition is a pharmaceutical composition further comprising an active agent. 14. A pharmaceutical dosage form comprising a sulfoalkyl ether cyclodextrin composition and an excipient, wherein the sulfoalkyl ether cyclodextrin composition comprises: (a) sulfoalkyl ether cyclodextrin; (b) no more than about 20% by weight moisture; (c) a bulk density of about 0.38 g/cm3 to about 0.66 g/cm3; (d) a tapped density of about 0.49 g/cm3 to about 0.75 g/cm3, wherein the tapped density of the sulfoalkyl ether cyclodextrin composition is higher than the bulk density; and (e) a gravitational-flow minimum orifice diameter of about 3 mm to about 12 mm; wherein the sulfoalkyl ether cyclodextrin composition comprises agglomerated particles, wherein the agglomerated particles are produced by a process comprising: (i) forming a fluidized bed of SALE-CD particles in a drying chamber of a fluidized bed spray dryer apparatus with an attached 3-chamber fluidization bed; (ii) recycling fine particles from the fluidized bed back into the drying chamber at a location adjacent to a liquid feed atomizer; and (iii) collecting agglomerated particles from the third chamber of the 3-chamber fluidization bed, and wherein the dosage form is selected from the group consisting of a tablet, liquid, suspension, emulsion, film, laminate, pellet, powder, bead, granule, suppository, ointment, cream, capsule, constitutable powder, dry powder inhaler, saché, troche, and lozenge. 15. The dosage form of claim 14, wherein the dosage form is a powder. 16. The dosage form of claim 14, wherein the dosage form is a tablet. 17. The dosage form of claim 16, wherein the tablet is selected from the group consisting of a controlled release tablet, an extended release tablet, a compressed tablet, a compressed rapid release tablet, and an orodispersable immediate release tablet. 18. A pharmaceutical dosage form comprising a sulfoalkyl ether cyclodextrin composition, an excipient, and an active agent, wherein the sulfoalkyl ether cyclodextrin composition comprises: (a) sulfoalkyl ether cyclodextrin; (b) no more than about 20% by weight moisture; (c) a bulk density of about 0.38 g/cm3 to about 0.66 g/cm3; (d) a tapped density of about 0.49 g/cm3 to about 0.75 g/cm3, wherein the tapped density of the sulfoalkyl ether cyclodextrin composition is higher than the bulk density; and (e) a gravitational-flow minimum orifice diameter of about 3 mm to about 12 mm; wherein the sulfoalkyl ether cyclodextrin composition comprises agglomerated particles, wherein the agglomerated particles are produced by a process comprising: (i) forming a fluidized bed of SAE-CD particles in a drying chamber of a fluidized bed spray dryer apparatus with an attached 3-chamber fluidization bed; (ii) recycling fine particles from the fluidized bed back into the drying chamber at a location adjacent to a liquid feed atomizer; and (iii) collecting agglomerated particles from the third chamber of the 3-chamber fluidization bed, and wherein the dosage form is selected from the group consisting of a tablet, liquid, suspension, emulsion, film, laminate, pellet, powder, bead, granule, suppository, ointment, cream, capsule, constitutable powder, dry powder inhaler, saché, troche, and lozenge.
연구과제 타임라인
LOADING...
LOADING...
LOADING...
LOADING...
LOADING...
이 특허에 인용된 특허 (13)
Pitha Josef, Alkylations of cyclodextrins leading to derivatives which have a ridgidly extended cavity.
Stella Valentino J. (Lawrence KS) Rajewski Roger (Lawrence KS), Derivatives of cyclodextrins exhibiting enhanced aqueous solubility and the use thereof.
Bodley Mark David (Port Elizabeth ZAX) Caira Mino Rodolfo (Cape Town ZAX) Glintenkamp Lueta Ann (Port Elizabeth ZAX) Griffith Vivienne Jean (Cape Town ZAX) Nassimbeni Luigi Renzo (Cape Town ZAX) Nich, Inclusion complex of beta-cyclodextrin and diclofenac, its preparation and use.
Fuertes Patrick,FRX ; Vappereau Bruno,FRX ; Serpelloni Michel,FRX ; Lis Jose,FRX, Pulverulent hydroxypropyl-.beta.-cyclodextrin composition and process for its preparation.
Stella Valentino J. ; Rajewski Roger A. ; Rao Venkatramana M. ; McGinity James W. ; Mosher Gerold L., Sulfoalkyl ether cyclodextrin based controlled release solid pharmaceutical formulations.
Mosher, Gerold L.; Wedel, Rebecca L.; Johnson, Karen T.; Machatha, Stephen G.; Cowee, Jane A.; Cushing, Daniel J., Formulations containing clopidogrel and sulfoalkyl ether cyclodextrin and methods of use.
Mosher, Gerold L.; Wedel, Rebecca L.; Johnson, Karen T.; Machatha, Stephen G.; Cowee, Jane A.; Cushing, Daniel J., Formulations containing clopidogrel and sulfoalkyl ether cyclodextrin and methods of use.
Mosher, Gerold L.; Wedel, Rebecca L.; Johnson, Karen T.; Machatha, Stephen G.; Cowee, Jane A.; Cushing, Daniel J., Formulations containing clopidogrel and sulfoalkyl ether cyclodextrin and methods of use.
Mosher, Gerold L.; Wedel, Rebecca L.; Johnson, Karen T.; Machatha, Stephen G.; Cowee, Jane A.; Cushing, Daniel J., Formulations containing clopidogrel and sulfoalkyl ether cyclodextrin and methods of use.
Gutstein, Howard, Methods of treatment of opioid tolerance, physical dependence, pain and addiction with inhibitors of certain growth factor receptors.
Mosher, Gerold L.; Machatha, Stephen G.; Cushing, Daniel J., Pharmaceutical compositions comprising prasugrel and cyclodextrin derivatives and methods of making and using the same.
Mosher, Gerold L.; Machatha, Stephen G.; Cushing, Daniel J., Pharmaceutical compositions comprising prasugrel and cyclodextrin derivatives and methods of making and using the same.
Mosher, Gerold L.; Machatha, Stephen G.; Cushing, Daniel J., Pharmaceutical compositions comprising prasugrel and cyclodextrin derivatives and methods of making and using the same.
Mosher, Gerold L; Machatha, Stephen G.; Cushing, Daniel J., Pharmaceutical compositions comprising prasugrel and cyclodextrin derivatives and methods of making and using the same.
※ AI-Helper는 부적절한 답변을 할 수 있습니다.