SiOx BARRIER FOR PHARMACEUTICAL PACKAGE AND COATING PROCESS

Abstract

A vessel including a thermoplastic wall enclosing a lumen is disclosed. The wall supports an SiOx composite 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.% O3—Si—C covalent bonding, as a proportion of the O3—Si—C covalent bonding plus SiO4 bonding. In another aspect, the interface has an Si 2p chemical shift to lower binding energy (eV), compared to the binding energy of SiO4 bonding. 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.

Description

[0001]Priority is claimed from U.S. Ser. Nos. 61 / 667,871, filed Jul. 3, 2012, and 61 / 800,746, filed Mar. 15, 2013, and this application is a continuation-in-part of U.S. Ser. No. 13 / 169,811, filed Jun. 27, 2011, now pending, which is a divisional of U.S. Ser. No. 12 / 779,007, filed May 12, 2010, now U.S. Pat. No. 7,985,188, which claims priority to U.S. Provisional Ser. Nos. 61 / 222,727, filed Jul. 2, 2009; 61 / 213,904, filed Jul. 24, 2009; 61 / 234,505, filed Aug. 17, 2009; 61 / 261,321, filed Nov. 14, 2009; 61 / 263,289, filed Nov. 20, 2009; 61 / 285,813, filed Dec. 11, 2009; 61 / 298,159, filed Jan. 25, 2010; 61 / 299,888, filed Jan. 29, 2010; 61 / 318,197, filed Mar. 26, 2010, and 61 / 333,625, filed May 11, 2010. The above patent and applications are incorporated here by reference in their entirety.[0002]U.S. Pat. No. 7,985,188; International Application PCT / US11 / 36097, filed May 11, 2011; U.S. Ser. No. 61 / 558,885, filed Nov. 11, 2011; and U.S. Ser. No. 61 / 636,377, filed Apr. 20, 2012, are all in...

AI Technical Summary

Benefits of technology

The patent describes a combination of layers that can be applied to a vessel to improve its ability to prevent the ingress of gas and extend its shelf life. A barrier coating of silicon dioxide (SiOx) is applied to the vessel, which reduces the amount of gas that can enter the vessel. Additionally, a pH protective coating of silicon dioxide (SiOxCy) is applied over the barrier coating to further prevent the barrier coating from dissolving in the fluid inside the vessel. This combination of layers helps to keep the vessel and its contents fresher for longer.

Problems solved by technology

However, the recent advent of costly, complex and sensitive biologies as well as such advanced delivery systems as auto injectors has exposed the physical and chemical shortcomings of glass pharmaceutical packages or other vessels, including possible contamination from metals, flaking, and breakage, among other problems.

Moreover, glass contains several components which can leach out during storage and cause damage to the stored material.

The heterogeneous nature of borosilicate glass creates a non-uniform surface chemistry at the molecular level.

Many proteins and other biologies must be lyophilized (freeze dried), because they are not sufficiently stable in solution in glass vials or syringes.

Glass pharmaceutical packages or other vessels are prone to breakage or degradation during manufacture, filling operations, shipping and use, which means that glass particulates may enter the drug.

Glass-forming processes do not yield the tight dimensional tolerances required for some of the newer auto-injectors and delivery systems.

As a result, some companies have turned to plastic pharmaceutical packages or other vessels, which provide greater dimensional tolerance and less breakage than glass but lack its impermeability.

Although plastic is superior to glass with respect to breakage, dimensional tolerances and surface uniformity, its use for primary pharmaceutical packaging remains limited due to the following shortcomings:Gas (oxygen) permeability: Plastic allows small molecule gases to permeate into (or out of) the device.

The permeability of plastics to gases is significantly greater than that of glass and, in many cases (as with oxygen-sensitive drugs such as epinephrine), plastics have been unacceptable for that reason.Water vapor transmission: Plastics allow water vapors to pass through devices to a greater degree than glass.

This can be detrimental to the shelf life of a solid (lyophilized) drug.

These compounds can contaminate the drug and / or negatively impact the drug's stability.

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