`
`(12) United States Patent
`Brunner-Schwarz et al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 7,713,930 B2
`*May 11, 2010
`
`ACIDIC INSULIN PREPARATIONS HAVING
`IMPROVED STABILITY
`
`Inventors: Anette Brunner-Schwarz, Frankfurt
`(DE); Norbert Lill, Kronberg (DE)
`
`Assignee: Sanofi-Aventis Deutschland GmbH,
`Frankfurt am Main (DE)
`
`Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`This patent is subject to a terminal dis-
`claimer.
`
`(21) Appl. No.: 12/328,208
`
`(22) Filed:
`
`Dec. 4, 2008
`
`(65)
`
`Prior Publication Data
`
`US 2009/0082255 Al
`
`Mar. 26, 2009
`
`Related U.S. Application Data
`
`(63) Continuation of application No. 11/089,777, filed on
`Mar. 25, 2005, now Pat. No. 7,476,652, which is a
`continuation of application No. 10/461,740, filed on
`Jun. 13, 2003, now abandoned.
`
`(60) Provisional application No. 60/409,338, filed on Sep.
`9, 2002.
`
`(30)
`
`Foreign Application Priority Data
`
`Jun. 18, 2002
`
`(DE)
`
`
`
` 10227232
`
`(51) Int. Cl.
`A61K 38/28
` 514/3
`(52) U.S. Cl.
` None
`(58) Field of Classification Search
`See application file for complete search history.
`
`(2006.01)
`
`AU
`AU
`CA
`CA
`CA
`CA
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`
`530/303
`
`5,474,978 A
`5,496,924 A
`5,506,203 A
`5,514,656 A
`5,534,488 A
`5,547,929 A
`5,559,094 A
`5,597,796 A
`5,614,219 A
`5,656,722 A *
`5,663,291 A
`5,693,608 A
`5,700,662 A
`5,707,641 A
`5,783,556 A
`5,824,638 A
`5,948,751 A
`5,985,309 A
`6,034,054 A
`6,043,214 A
`6,051,551 A
`6,100,376 A
`6,174,856 B1
`6,211,144 B1
`6,248,363 B1
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`
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`
`(56)
`
`References Cited
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`
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`
`(Continued)
`
`Primary Examiner Christopher R. Tate
`Assistant Examiner Roy Teller
`(74) Attorney, Agent, or Firm Balaram Gupta
`
`(57)
`
`ABSTRACT
`
`The invention relates to a pharmaceutical formulation com-
`prising a polypeptide selected from the group consisting of
`insulin, an insulin metabolite, an insulin analog, an insulin
`derivative and combinations thereof; a surfactant or combi-
`nations of two or more surfactants; optionally a preservative
`or combinations of two or more preservatives; and optionally
`an isotonicizing agent, buffers or further excipients or com-
`binations thereof, the pharmaceutical formulation having a
`pH in the acidic range.
`
`20 Claims, No Drawings
`
`Mylan Ex.1093
`Mylan v. Sanofi - IPR2018-01676
`
`
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