(12) Unlted States Patent
`Desai et a].
`
`(10) Patent N0.2
`(45) Date of Patent:
`
`US 8,138,229 B2
`*Mar. 20, 2012
`
`US00813 8229B2
`
`(54) COMPOSITIONS AND METHODS OF
`ZEIIEIBXFSRY 0F PHARMACOLOGICAL
`
`(75) Inventors: Neil P. Desai, Los Angeles, CA (US);
`-
`_
`-
`Patnck soon slnong’ LOS Angeles’ CA
`(Us); Vuong Tm“, Calabasas, CA (Us)
`
`(73) Assignee: AbraXis Bioscience, LLC, Los Angeles,
`CA 3
`(U )
`
`.
`( * ) Not1ce:
`
`.
`.
`.
`.
`Subject‘ to any d1scla1mer, the term ofth1s
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`This patent is subject to a terminal dis-
`C1aimer_
`
`_
`(21) Appl' No" 12/910’693
`(22) F1 d
`0 t 22 2010
`1e 3
`c -
`1
`
`Prior Publication Data
`
`US 2011/0301248 A1
`
`Dec. 8, 2011
`
`Related U_s_ Application Data
`
`.
`
`.
`
`.
`
`.
`
`(63) Continuation of application No. 11/553,339, ?led on
`Oct. 26, 2006, noW Pat. NO. 7,820,788, which is a
`cont1nuat1on of appl1cat1on No. 10/731,224, ?led on
`1360- 9, 2003, now abandoned
`(60) Provisional application No. 60/432,317, ?led on Dec.
`9, 2002, provisional application No. 60/526,544, ?led
`on Dec. 3, 2003, provisional application No.
`60/526,773, ?led on Dec. 4, 2003, provisional
`application No. 60/ 527,177, ?led on Dec. 5, 2003.
`
`51
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`I
`C]
`.
`nt.
`(2006.01)
`A61K 47/42
`(200691)
`A61K 9/14
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`C07K 14/76
`(52) us. Cl. ...... .. 514/776; 424/489; 424/499; 530/362;
`977/705; 977/773; 977/906; 977/911
`(58) Field of Classi?cation Search ...................... .. None
`See application ?le for complete search history.
`R f
`Ct d
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`C .
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`Non Flnal Of?ce Act1on mailed on Nov. 21, 2011, for US. Appl. No.
`12/422’192’?1edAPr' 10100930 Pages‘
`(Continued)
`
`Primary Examiner i Marsha Tsay
`(74) Attorney, Agent, or Firm * Morrison & Foerster LLP
`
`ABSTRACT
`(57)
`The present invention relates to a pharmaceutical composi
`tion comprising a pharmaceutical agent and a pharmaceuti
`cally acceptable carrier, Which carrier comprises a protein, for
`example, human serum albumin and/or deferoxamine. He
`human serum albumin is present in an amount effective to
`reduce one or more side effects associated With administra
`tion of the pharmaceutical composition. The inventor also
`provides methods for reducing on or more side effects of
`administration of the pharmaceutical composition, and meth
`ods for enhancing transport and binding of a pharmaceutical
`agent to a cell.
`
`48 Claims, N0 Drawings
`
`Actavis - IPR2017-01104, Ex. 1001, p. 1 of 25
`
`

`

`US 8,138,229 B2
`Page 2
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`US 8,138,229 B2
`
`1
`COMPOSITIONS AND METHODS OF
`DELIVERY OF PHARMACOLOGICAL
`AGENTS
`
`CROSS-REFERENCE TO RELATED PATENT
`APPLICATIONS
`
`This patent application is a continuation of US. applica
`tion Ser. No. 11/553,339, ?led Oct. 26, 2006; Which is a
`continuation of US. patent application Ser. No. 10/731,224,
`?led Dec. 9, 2003; Which claims the bene?t of US. Provi
`sional Patent Application Nos. 60/432,317, ?led Dec. 9,
`2002; 60/526,544, ?led Dec. 3, 2003; 60/526,773, ?led Dec.
`4, 2003 and 60/527,177, ?led Dec. 5, 2003, the contents of
`each of Which is hereby incorporated by reference in their
`entirety.
`
`FIELD OF THE INVENTION
`
`This invention pertains to pharmaceutical compositions
`comprising pharmaceutically active agents for parenteral or
`other internal use, Which have the effect of reducing certain
`undesirable side effects upon administration When compared
`With available formulations of similar drugs.
`
`BACKGROUND OF THE INVENTION
`
`It is Well recognized that many drugs for parenteral use,
`especially those administered intravenously, cause undesir
`able side effects such as venous irritation, phlebitis, burning
`and pain on injection, venous thrombosis, extravasation, and
`other administration related side effects. Many of these drugs
`are insoluble in Water, and are thus formulated With solubi
`liZing agents, surfactants, solvents, and/or emulsi?ers that are
`irritating, allergenic, or toxic When administered to patients
`(see, e.g., Briggs et al., Anesthesis 37, 1099 (1982), and
`Waugh et al., Am. J. Hosp. Pharmacists