Claims for Patent: 9,724,657

Summary for Patent: 9,724,657

Title:	High-speed centrifugal mixing devices and methods of use
Abstract:	A centrifugal mixing device can include a shaft assembly that is operably coupled to a motor such that the motor rotates the shaft assembly about a first axis. The devices can further include a turret that is rotatably coupled to the shaft assembly such that the turret rotates about the first axis relative to the shaft assembly. The turret can include a first support, a first canister rotatably coupled to the first support such that the first canister rotates about a second axis, and a second canister rotatably coupled to the first support such that the second canister rotates about a third axis. The turret is configured to rotate about the first axis in a first rotational direction and each of the first and second canisters is configured to rotate about the second and third axes, respectively, in a second rotational direction that is opposite the first rotational direction.
Inventor(s):	Hoffman; Steven (Mahwah, NJ)
Assignee:	Tyme, Inc. (Wilmington, DE)
Application Number:	14/059,837
Patent Claims:	1. A centrifugal mixing device comprising: a shaft assembly that is elongate along a first axis and is configured to be operably coupled to a motor such that the motor rotates the shaft assembly about the first axis; and a turret that is rotatably coupled to the shaft assembly such that the turret is configured to rotate about the first axis relative to the shaft assembly, the turret including a first support, a first canister rotatably coupled to the first support on a first side of the shaft assembly such that first canister rotates about a second axis, and a second canister rotatably coupled to the first support on a second side of the shaft assembly such that the second canister rotates about a third axis, wherein the turret is configured to rotate about the first axis in a first rotational direction and each of the first and second canisters are configured to rotate about the second and third axes, respectively, in a second rotational direction that is opposite the first rotational direction. 2. The centrifugal mixing device of claim 1, wherein: the first canister includes a first canister pulley, the second canister includes a second canister pulley, and the shaft assembly includes a shaft body that is elongate along the first axis and a first shaft pulley fixed to the shaft body between the first and second canister pulleys; and the mixing device further comprises a first drive belt that is in communication with the first shaft pulley and the first and second canister pulleys such that the first drive belt drives the first and second canister pulleys to rotate the first and second canisters about the second and third axes, respectively, when the motor causes the first shaft pulley to rotate about the first axis. 3. The centrifugal mixing device of claim 2, wherein the turret further includes a second support spaced from the first support along the first axis, the first and second canisters being rotatably coupled to both the first support and the second support. 4. The centrifugal mixing device of claim 3, wherein (i) the first canister includes a first canister shaft that is rotatably coupled to the first support, (ii) the second canister includes a second canister shaft that is rotatably coupled to the first support, and (iii) the first canister pulley is rigidly fixed to the first canister shaft and the second canister pulley is rigidly fixed to the second canister shaft. 5. The centrifugal mixing device of claim 4, wherein (i) the first canister includes a first removable vessel, (ii) the second canister includes a second removable vessel, and (iii) the first and second vessels are each configured to retain the at least two materials. 6. The centrifugal mixing device of claim 4, wherein: the turret further includes a first tension pulley and a second tension pulley, the first tension pulley is supported by the first support between the first shaft pulley and the first canister pulley, the second tension pulley is supported by the first support between the first shaft pulley and the second canister pulley, and the first and second tension pulleys are configured to maintain the first drive belt in tension. 7. The centrifugal mixing device of claim 2, wherein the shaft assembly includes a second shaft pulley fixed to the shaft body, and the device further comprises a transition member configured to transfer rotational motion of the shaft assembly to the turret. 8. The centrifugal mixing device of claim 7, wherein: the transition member includes a first transition pulley and a second transition pulley, and the device further comprises a second drive belt that is in communication with the second shaft pulley and the first transition pulley such that the second drive belt drives the transition member to rotate the first and second transition pulleys about a fourth axis when the motor causes the second shaft pulley to rotate about the first axis. 9. The centrifugal mixing device of claim 8, wherein the turret includes a turret pulley rotatably coupled to the shaft assembly about the first axis. 10. The centrifugal mixing device of claim 9, further comprising a third drive belt that is in communication with the second transition pulley and the turret pulley such that the third drive belt drives the turret pulley to rotate the turret about the first axis when the motor causes the first and second transition pulleys to rotate about the fourth axis. 11. The centrifugal mixing device of claim 10, wherein the turret pulley, the first and second transition pulleys, the first and second shaft pulleys and the first and second canister pulleys each has a respective diameter such that an acceleration of at least 600 g is imposed on material retained in the first and second canisters when the motor rotates the shaft assembly. 12. The centrifugal mixing device of claim 10, wherein the turret pulley, the first and second transition pulleys, the first and second shaft pulleys and the first and second canister pulleys each has a respective diameter such that an acceleration of about 691 g is imposed on material retained in the first and second canisters when the motor rotates the shaft assembly. 13. The centrifugal mixing device of claim 1, further comprising the motor. 14. The centrifugal mixing device of claim 1, wherein each canister comprises at least three substantially spherical members. 15. The centrifugal mixing device of claim 14, wherein the at least three members are made of ceramic. 16. The centrifugal mixing device of claim 1, wherein rotation of the shaft assembly (i) causes the turret to rotate about the first axis at a first rotational speed and (ii) causes each of the first and second canisters to rotate about the second and third axes, respectively, at a second rotational speed. 17. The centrifugal mixing device of claim 1, wherein one or both of said canisters comprises at least two different particulate materials. 18. The centrifugal mixing device of claim 17, wherein at least one of said particulate materials comprises an active pharmaceutical ingredient. 19. The centrifugal mixing device of claim 18, wherein at least one of said particulate materials comprises methyl (2R)-2-amino-3-(2-chloro-4 hydroxyphenyl) propanoate, D-tyrosine ethyl ester hydrochloride, methyl (2R)-2- amino-3-(2,6-dichloro-3,4-dimethoxyphenyl) propanoate H-D-Tyr(TBU)-allyl ester HCl, methyl (2R)-2-amino-3-(3-chloro-4,5-dimethoxyphenyl) propanoate, methyl (2R)-2-amino-3-(2-chloro-3-hydroxy-4-methoxyphenyl) propanoate, methyl (2R)-2-amino-3-(4-[(2-chloro-6-fluorophenyl) methoxy] phenyl) propanoate, methyl (2R)-2- amino-3-(2-chloro-3,4-dimethoxyphenyl) propanoate, methyl (2R)-2-amino-3-(3-chloro-5-fluoro-4-hydroxyphenyl) propanoate, diethyl 2-(acetylamino)-2-(4-[(2-chloro-6-fluorobenzyl) oxy] benzyl malonate, methyl (2R)-2-amino-3-(3-chloro-4-methoxyphenyl) propanoate, methyl (2R)-2-amino-3-(3-chloro-4-hydroxy-5-methoxyphenyl) propanoate, methyl (2R)-2-amino-3-(2,6-dichloro-3-hydroxy-4-methoxyphenyl) propanoate, methyl (2R)-2-amino-3-(3-chloro-4-hydroxyphenyl) propanoate, H-DL-tyr-OME HCl, H-3,5-diiodo-tyr-OME HCl, H-D-3,5-diiodo-tyr-OME HCl, H-D-tyr-OME HCl, D-tyrosine methyl ester hydrochloride, D-tyrosine-ome HCl, methyl D-tyrosinate hydrochloride, H-D-tyr-OMeHCl, D-tyrosine methyl ester HCl, H-D-Tyr-OMe-HCl, (2R)-2-amino -3-(4-hydroxyphenyl) propionic acid, (2R)-2-amino-3-(4-hydroxyphenyl) methyl ester hydrochloride, methyl (2R)-2-amino-3-(4-hydroxyphenyl) propanoate hydrochloride, methyl (2R)-2-azanyl-3-(4-hydroxyphenyl) propanoate hydrochloride, 3-chloro-L-tyrosine, 3-nitro-L -tyrosine, 3-nitro-L-tyrosine ethyl ester hydrochloride, DL-m-tyrosine, DL-o-tyrosine, Boc-Tyr (3,5-I.sub.2)-OSu, Fmoc-tyr(3-NO.sub.2)-OH, .alpha.-methyl-L-tyrosine, .alpha.-methyl-D-tyrosine, or .alpha.-methyl-DL-tyrosine. 20. The centrifugal mixing device of claim 19, wherein at least one of said particulate materials comprises melanin, a melanin promoter, or a combination thereof. 21. The centrifugal mixing device of claim 20, wherein at least one of said particulate materials comprises melanin. 22. The centrifugal mixing device of claim 21, wherein the melanin promoter is methoxsalen, melanotan II, or a combination thereof. 23. The centrifugal mixing device of claim 18, wherein at least one of said particulate materials comprises .alpha.-methyl-DL-tyrosine. 24. The centrifugal mixing device of claim 23, wherein at least one of said particulate materials comprises tamoxifen, toremifene, fulvestrant, anastrozole, exemestane, letrozole, imatinib mesylate, dasatinib, nilotinib, bosutinib, lapatinib, gefitinib, erlotinib, temsirolimus, everolimus, vandetanib, vemurafenib, crizotinib, vorinostat, romidepsin, bexarotene, alitretinoin, tretinoin, bortezomib, carfilzomib, pralatrexate, sorafenib, sunitinib, pazopanib, regorafenib, cabozantinib, denileukin diftitox, ziv-aflibercept, cisplatin, cisplatinum, (cis-diamminedichloroplatinum(II)), carboplatin, oxaliplatin, benzyl isothiocyanate, acetylcholine, or dihydrotestosterone (DHT). 25. The centrifugal mixing device of claim 1, wherein one or both of said canisters comprises a particulate material having particles that individually comprises two or more active pharmaceutical ingredients.

Details for Patent 9,724,657

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Eisai, Incorporated	ONTAK	denileukin diftitox	Injection	103767	02/05/1999		2039-02-26
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387	11/18/2011		2039-02-26
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387	08/16/2018		2039-02-26
Sanofi-aventis U.s. Llc	ZALTRAP	ziv-aflibercept	Injection	125418	08/03/2012		2039-02-26