Sio2 Medical Products, Inc.

Formycon Ag

Klinge Biopharma Gmbh

Dow Global Technolgoies LLC

Si02 Medical Products, Inc.

Christopher Weikart

John Thomas Felts

Adam Stevenson

Becky L Clark

Robert S Abrams

Thomas E Fisk

Peter J Sagona

John Ferguson

Jonathan R Freedman

Robert J Pangborn

Jean-Pierre Giraud

John Belfance

Thomas H Kalantar

Stéphane Costeux

Murray Stephen Bennett

Ahmad Taha

Carsten Brockmeyer

Thomas Strungmann

Brian R Maurer

Joseph A Jones

Adam Breeland

Martin Baltazar

Jacob N Israelachvili

Matthew Wills

David E Henton

Benjamin Hunt

Ralf Kibele

Steven J Martin

Kenneth Wade Kelly

Tadashi Yamamoto

Brian Fitzpatrick

Lingbo Zhu

Shawn Kinney

David Henton

John Berggren

Eugene Sadzewicz

Adrian Raiche

Thomas STRÜNGMANN

Disclosed are polymer vials () and injection stretch blow molding methods for making the same. A polymer vial has a base () having a base surface area and a sidewall () extending up from the base. The base and sidewall define an interior () configured to house product, the sidewall narrowing at an upper section of the vial to form a neck leading to an opening that provides access to the interior. The vial is optionally round and symmetrical about a central axis, a lower portion of the sidewall including a first surface that is outwardly curved along a first radius having an imaginary center positioned within the vial. The base is positioned below the first surface and is substantially flat such that at least 80% of the base surface area has a standing base surface occupying a single plane.

Polymer vials with substantially flat bottoms and injection stretch blow molding methods for making the same

A vessel including a thermoplastic wall enclosing a lumen is disclosed. The wall supports an SiOcomposite barrier coating or layer, for which x is from 1.8 to 2.4, between the wall and the lumen. High Resolution X-ray Photoelectron Spectroscopy (XPS) shows the presence of an interface between the composite barrier coating or layer and the wall or substrate. In one aspect, the interface has at least 1 mol. % O—Si—C covalent bonding, as a proportion of the O—Si—C covalent bonding plus SiObonding. In another aspect, the interface has an Si 2p chemical shift to lower binding energy (eV), compared to the binding energy of SiObonding. The result is a tightly adherent composite barrier coating or layer having a high degree of adhesion to the substrate under practical use conditions. Methods of applying the composite barrier coating or layer are also disclosed.

SiObarrier for pharmaceutical package and coating process

An article or vessel is described including a vessel surface and a coating set comprising at least one tie coating, at least one barrier coating, and at least one pH protective coating. For example, the coating set can comprise a tie coating, a barrier coating, a pH protective coating and a second barrier coating; and in the presence of a fluid composition, the fluid contacting surface is the barrier coating or layer. The respective coatings can be applied by PECVD of a polysiloxane precursor. Such vessels can have a coated interior portion containing a fluid with a pH of 4 to 8. The barrier coating prevents oxygen from penetrating into the thermoplastic vessel, and the tie coating and pH protective coating together protect the barrier layer from the contents of the vessel. The second barrier coating is comparable to glass surface if needed.

PECVD coated pharmaceutical packaging

A method for providing a passivation layer or pH protective coating on a substrate surface by PECVD is provided, the method comprising generating a plasma from a gaseous reactant comprising polymerizing gases. The lubricity, passivation, pH protective, hydrophobicity, and/or barrier properties of the passivation layer or pH protective coating are set by setting the ratio of the Oto the organosilicon precursor in the precursor feed, and/or by setting the electric power used for generating the plasma. In particular, a passivation layer or pH protective coating made by the method is provided. Pharmaceutical packages coated by the method and the use of such packages protecting composition contained in the vessel against mechanical and/or chemical effects of the surface of the package without a passivation layer or pH protective coating material are also provided.

Passivation, pH protective or lubricity coating for pharmaceutical package, coating process and apparatus

A pre-filled pharmaceutical package comprising a liquid formulation of a VEGF-antagonist, for example Ranibizumab, in a pre-filled pharmaceutical package, for example a syringe, cartridge, or vial, made in part or in whole of a thermoplastic polymer, coated on the interior with a tie coating or layer, a barrier coating or layer, a pH protective coating or layer, and optionally a lubricity coating or layer. Stability performance of the VEGF-antagonist packaged in the coated COP vessel comparable to or better than glass was obtained.

Pre-filled pharmaceutical package comprising a liquid formulation of a VEGF-antagonist

A liquid formulation of an ophthalmic drug in a pharmaceutical package, for example a syringe, cartridge, or vial, made in part or in whole of a thermoplastic polymer, coated on the interior with a tie coating or layer, a barrier coating or layer, a pH protective coating or layer, and optionally a lubricity coating or layer.

Pharmaceutical package for ophthalmic formulations

A method and apparatus for plasma modifying a workpiece such as a syringe barrel, cartridge barrel, vial, or blood tube is described. Plasma is provided within the lumen of the workpiece. The plasma is provided under conditions effective for plasma modification of a surface of the workpiece. A magnetic field is provided in at least a portion of the lumen. The magnetic field has an orientation and field strength effective to improve the uniformity of plasma modification of the interior surface of the generally cylindrical wall. A vessel made according to the process or using the apparatus described above. A pharmaceutical package comprising the syringe barrel or vial containing a pharmaceutical preparation, secured with a closure.

Controlling the uniformity of PECVD deposition

A vessel has an interior surface facing a lumen. The interior surface includes a tie coating or layer, a barrier coating or layer, and a pH protective coating or layer. The tie coating or layer can comprise SiOCor SiNC, where x is from about 0.5 to about 2.4 and y is from about 0.6 to about 3. The barrier coating or layer can comprise SiO, wherein x is from 1.5 to 2.9. The barrier coating or layer reduces the ingress of atmospheric gas into the lumen. The pH protective coating or layer can comprise SiOCor SiNC, as well. In an embodiment, in the presence of a fluid composition contained in the lumen and having a pH between 5 and 9, the calculated shelf life of the package can be more than six months at a storage temperature of 4&#xb0; C.

Coated packaging

A vessel has a lumen defined at least in part by a wall. The wall has an interior surface facing the lumen, an outer surface, and a plasma-enhanced chemical vapor deposition (PECVD) coating set supported by the wall. The PECVD coating set comprises a water barrier coating or layer having a water contact angle from 80 to 180 degrees, applied using a precursor comprising at least one of a saturated or unsaturated fluorocarbon precursor having from 1 to 6 carbon atoms and a saturated or unsaturated hydrocarbon having from 1 to 6 carbon atoms. Optionally, the coating set includes an SiOx gas barrier coating or layer from 2 to 1000 nm thick, in which x is from 1.5 to 2.9 as measured by x-ray photoelectron spectroscopy (XPS), and optionally other related coatings.

Vessels, containers, and surfaces coated with water barrier coatings

A blood sample collection tube and other vessels are described including an article surface and a coating set comprising a tie coating or layer of SiOxCy or SiNxCy applied to the article surface, a barrier coating or layer of SiOx, and a pH protective layer of SiOxCy or SiNxCy. The vessels optionally contain a fluid with a pH of 4 to 8, alternatively 5 to 9. The barrier coating or layer prevents oxygen from penetrating into the thermoplastic vessel, and the tie coating or layer and pH protective coating or layer together protect the barrier layer from the contents of the vessel.

Blood sample collection tube

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Auburn, AL, United States of America

Christopher Weikart