Warsaw Orthopedic, Inc.

Other

Jerbrena C Jacobs

Roger E Harrington

David S Scher

Benjamin T Reves

Susan J Drapeau

Damodaragounder Gopal

Ke-Qing Ling

Marco Burello

Steven Marquis Peckham

Robert Doyle

Daniel A Shimko

Ian Dunkley

Jason A Rister

Dawin A Rodriguez Santiago

Provided is a compression resistant implant configured to fit at or near a bone defect to promote bone growth, the compression resistant implant comprising porous ceramic particles in a biodegradable polymer, and an oxysterol disposed in or on the compression resistant implant. Methods of making and use are further provided.

Compression resistant implants including an oxysterol and methods of use

Provided is a compression resistant implant configured to fit at or near a bone defect to promote bone growth. The compression resistant implant comprises a biodegradable polymer in an amount of about 0.1 wt % to about 20 wt % of the implant and a freeze-dried oxysterol in an amount of about 5 wt % to about 90 wt % of the implant. Methods of making and use are further provided.

Implants having a drug load of an oxysterol and methods of use

A spinal implant for insertion into and positioning in an intervertebral space is provided. The insert comprises a compressible support configured to change the height of the insert, wherein the insert comprises a first portion having a first surface and a compressible support adjacent to the first surface; and a second portion having a second surface and a second compressible support adjacent to the second surface. A method for fusing two adjacent vertebrae utilizing the spinal implant including the bone insert is also provided.

Spinal implant having a compressible insert

A method of making a hydroxyl-terminated thioketal diol is provided, the method comprising reacting a thioketal ester with a non-pyrophoric reducing agent to form a hydroxyl-terminated thioketal diol. The hydroxyl-terminated thioketal diol can be 2,2-(propane-2,2-diylbis(sulfanediyl)) diethanol. The non-pyrophoric reducing agent can be a sodium aluminum hydride, for example, sodium bis (2-methoxyethoxy)aluminum hydride. The thioketal ester can be dimethyl 2,2-(propane-2,2-diylbis(sulfanediyl)) diacetate. A biodegradable matrix prepared by reacting a hydroxyl-terminated thioketal diol with an isocyanate is provided. A method of making a biodegradable polyurethane composite is also provided.

Methods of synthesis for a thioketal diol

Provided is an implant configured to fit at or near a bone defect to promote bone growth. The implant comprises an oxysterol uniformly disposed in an acellular tissue matrix (ATM). The acellular tissue matrix can be porcine collagen, which in some cases is crosslinked. The implant can contain an acellular porcine crosslinked collagen in an amount of about 5 wt. % to about 25 wt. % of the implant and an oxysterol in an amount of about 5 wt. % to about 90 wt. % of the implant. The oxysterol can be Oxy133 monohydrate or an Oxy133 polymorph. Methods of making and using the implant are further provided.

Moldable formulations containing an oxysterol in an acellular tissue matrix

Compositions and methods for preparing OXY133 polymorphs Form C to Form I are provided. The methods include subjecting a slurry of OXY133 to conditions sufficient to convert OXY133 to the OXY133 polymorph Form C, polymorph Form D, polymorph Form E, polymorph Form F, polymorph Form G, polymorph Form H, polymorph Form I or a mixture thereof. A polymorph of OXY133 is also provided and that polymorph can be polymorph Form C, polymorph Form D, polymorph Form E, polymorph Form F, polymorph Form G, polymorph Form H, polymorph Form I or a mixture thereof. Pharmaceutical compositions including OXY133 polymorphs are also provided.

Polymorphic forms of an oxysterol and methods of making them

Oxysterol-statin compounds and methods of synthesizing the same are provided for use in promoting osteogenesis, osteoinduction and/or osteoconduction. Methods of synthesizing in a single container OXY133-statin compounds having high yields and improved process safety are also provided. Methods for synthesizing OXY133-statin compounds that are stereoselective are also provided.

Oxysterol-statin compounds for bone growth

Assay methods for determining purity of a sample of a sterol are provided. These methods include providing an HPLC eluent including a sterol, other compounds related to the sterol and a mobile volatile phase; generating an aerosol of liquid droplets from the HPLC eluent; drying the liquid droplets to obtain residue particles of the sterol; contacting the residue particles of the sterol with an ion stream which applies a size-dependent electrical charge to each of the residue particles to generate an electrical signal and measuring the electrical signal to determine the purity of the sterol in the sample. The sterol can be OXY133 or OXY133 monohydrate.

Methods for the separation and detection of an oxysterol

A method of making a hydroxyl-terminated thioketal diol is provided, the method comprising reacting a thioketal ester with a non-pyrophoric reducing agent to form a hydroxyl-terminated thioketal diol. The hydroxyl-terminated thioketal diol can be 2,2-(propane-2,2-diylbis(sulfanediyl)) diethanol. The non-pyrophoric reducing agent can be a sodium aluminum hydride, for example, sodium bis(2-methoxyethoxy)aluminum hydride. The thioketal ester can be dimethyl 2,2-(propane-2,2-diylbis(sulfanediyl)) diacetate. A biodegradable matrix prepared by reacting a hydroxyl-terminated thioketal diol with an isocyanate is provided. A method of making a biodegradable polyurethane composite is also provided.

Compounds and methods of synthesizing oxysterols are provided. The compounds and methods provided allow the oxysterol to be safely produced at a high yield. The compounds and methods provided can produce the oxysterol in a stereoselective manner. The oxysterols of the current application can be used in effective amounts to grow bone.

Compounds and methods of making sterols using diols

Provided is a slow release composition to promote bone growth, the slow release composition comprising: an oxysterol encapsulated in a biodegradable polymer to control the release of the oxysterol. Methods of making and use are further provided.

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Hernando, MS, United States of America

Jerbrena C Jacobs