111111
`
`1111111111111111111111111111111111111111111111111111111111111
`US008394405B2
`
`c12) United States Patent
`Chang et al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 8,394,405 B2
`*Mar. 12, 2013
`
`(54) ONCE DAILY FORMULATIONS OF
`TETRACYCLINES
`
`(75)
`
`Inventors: Rong-Kun Chang, Rockville, MD (US);
`Arash Raoufinia, Springfield, VA (US);
`Niraj Shah, Owings Mills, MD (US)
`
`(73) Assignee: Supernus Pharmaceuticals, Inc.,
`Rockville, MD (US)
`
`( *) 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(cid:173)
`claimer.
`
`(21) Appl. No.: 12/926,932
`
`(22) Filed:
`
`Dec.17, 2010
`
`(65)
`
`Prior Publication Data
`
`US 2011/0294759 Al
`
`Dec. 1, 2011
`
`EP
`EP
`
`(56)
`
`References Cited
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`Related U.S. Application Data
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`(63) Continuation of application No. 12/155,676, filed on
`Jun. 6, 2008, which is acontinuationofapplicationNo.
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`
`(Continued)
`Primary Examiner- Paul Dickinson
`(74) Attorney, Agent, or Firm- Foley & Lardner LLP;
`Stephen B. Maebius; Sunit Talapatra
`ABSTRACT
`(57)
`Disclosed are once-daily formulations containing tetracy(cid:173)
`clines, especially doxycycline. Such formulations are useful,
`for instance, for the treatment of collagenase destructive
`enzyme-dependent diseases, such as periodontal disease and
`acne, and acute and chronic inflammatory disease states, such
`as rosacea and arthritis.
`20 Claims, 6 Drawing Sheets
`
`Ooxycy.;:line Monohydrate IRPellets, 40 mg
`
`Report#: AR03A16
`Lot#: 801027(CTM)
`110 - - - - - - - - - - - - - - - - - - - - ·
`
`100
`
`~Vessel1
`--a- Vessel 2
`---it--Vesse-13
`---4E- Vessel4
`____.__Vessel 5
`
`-------G---Vessel6
`
`10
`
`Time (Minutes)
`
`20
`
`30
`
`Dissolution profile for doxycycline monohydrate IR beads
`
`1
`
`

`

`US 8,394,405 B2
`Page 2
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