SiOx BARRIER FOR PHARMACEUTICAL PACKAGE AND COATING PROCESS

A barrier coating, coating technology, applied in the field of drug packaging or other containers, processing drug packaging or other containers, medical devices, coating the inner surface or inner surface of drug packaging or other containers, and can solve the problem of affecting drug stability. , contaminated drugs, not optimal, etc.

Inactive Publication Date: 2016-11-30
SI02 MEDICAL PRODS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

These compounds can contaminate the drug and / or negatively affect the stability of the drug
[0017] Clearly, while plastic and glass drug packaging or other containers each offer certain advantages in primary drug packaging, neither is optimal for all drugs, biologics, or other therapeutics

Method used

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  • SiOx BARRIER FOR PHARMACEUTICAL PACKAGE AND COATING PROCESS
  • SiOx BARRIER FOR PHARMACEUTICAL PACKAGE AND COATING PROCESS
  • SiOx BARRIER FOR PHARMACEUTICAL PACKAGE AND COATING PROCESS

Examples

Experimental program
Comparison scheme
Effect test

example 1-4

[2303] Syringe samples were generated as follows. A COC8007 extended barrel syringe was produced according to the protocol used to form the COC syringe barrel. According to the use of SiO x A solution to coating the interior of a COC syringe barrel would be a SiO x Barrier coatings or layers are applied to some syringes. A lubricious and / or pH protective coating or layer was applied to the SiO x coated syringe. OMCTS is supplied by a vaporizer due to its low volatility. Argon carrier gas was used. The process conditions are set as follows:

[2304] ·OMCTS-3sccm

[2305] ·Argon-65sccm

[2306] Power - 6 watts

[2307] · Time - 10 seconds

[2308] A Genesis packaged plunger force tester (Model SFT-01 Syringe Force Tester, manufactured by Genesis Machinery, Lionville, PA) was then used according to the specifications for the lubricity test. The protocol tests the lubricity of several syringes. Both the starting force and the sustaining force (in Newtons) were noted re...

example 5-8

[2312] Syringe samples were generated as follows. A COC8007 extended barrel syringe was produced according to the protocol used to form the COC syringe barrel. According to the use of SiO x A solution to coating the interior of a COC syringe barrel would be a SiO x A pH protective coating or layer is applied to the syringe barrel. A lubricious and / or pH protective coating or layer was applied to the SiO x coated syringe. Argon carrier gas and oxygen were used where indicated in Table 6. Process conditions were set as follows, or as indicated in Table 6:

[2313] · OMCTS-3sccm (when used)

[2314] Argon - 7.8 sccm (when used)

[2315] Oxygen 0.38sccm (when used)

[2316] Power - 3 watts

[2317] · Power supply time - 10 seconds

[2318] Syringes of Examples 5 and 6 were prepared under these conditions. Syringes of Example 7 prepared under these conditions without a lubricity and / or pH protective coating or layer were then tested using a Genesis packaging plunger for...

example 10

[2341] Use coated SiO x Coating + OMCTS Lubricity Layer Container An experiment was performed to test the functionality of the lubricity layer as a pH protective coating. These containers are made of cyclic olefin copolymer (COC, 6013M-07) (these vials are typically filled to 5 mL with product; when capped they have a capacity of about 7.5 mL without headspace).

[2342] According to the above list for the use of SiO x To coat the interior of the tube (in addition to using equipment suitable for coating a vial), the interior surfaces of sixty vessels were coated using an HMDSO precursor gas in a plasma-enhanced chemical vapor deposition (PECVD) A SiO produced by the method x coating. Use the following conditions.

[2343] ·HMDSO flow rate: 0.47sccm

[2344] Oxygen flow rate: 7.5sccm

[2345] ·RF power: 70 watts

[2346] Coating time: 12 seconds (including 2 seconds of RF power ramp time)

[2347] Next, use the protocol listed above for coating the interior of COC syr...

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Abstract

Disclosed is a container comprising a thermoplastic wall defining an inner cavity. The wall supports a SiOx composite barrier coating or layer arranged between the wall and the inner cavity, wherein x is 1.8-2.4. High-resolution X-ray photoelectron spectroscopy (XPS) shows that one interface exists between the composite barrier coating or layer and the wall or a substrate. In one aspect, the interface has O3-Si-C covalent bonds accounting for at least 1 mol% of the proportion of O3-Si-C covalent bonds and SiO4 bonds. In another respect, the interface has chemical shift of Si 2p with the bond energy (eV) lower than the bond energy of SiO4 bonds. The result is a closely attached composite barrier coating or layer having high degree of adhesion with the substrate. The invention also provides a method of applying the composite barrier coating or layer.

Description

[0001] Priority is claimed to U.S. Serial No. 61 / 667,871, filed July 3, 2012, and 61 / 800,746, filed March 15, 2013, and this application is U.S. Serial No. filed June 27, 2011 A continuation-in-part (now pending) of 13 / 169,811, which is a divisional application of U.S. Serial No. 12 / 779,007 (now U.S. Patent No. 7,985,188) filed May 12, 2010, which claimed July 2, 2009 U.S. provisional serial numbers 61 / 222,727 filed; 61 / 213,904 filed July 24, 2009; 61 / 234,505 filed August 17, 2009; 61 / 261,321 filed November 14, 2009; November 2009 61 / 263,289 filed on 20th; 61 / 285,813 filed on December 11, 2009; 61 / 298,159 filed on January 25, 2010; 61 / 299,888 filed on January 29, 2010; 61 / 318,197 filed, and priority of 61 / 333,625 filed May 11, 2010. The above patents and applications are hereby incorporated by reference in their entireties. [0002] U.S. Patent No. 7,985,188; International Application PCT / US11 / 36097, filed May 11, 2011; U.S. Serial No. 61 / 558,885, filed November 11, 2011; and ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C23C16/40C23C16/04A61J1/00
CPCA61J1/05A61M5/3129A61M2005/3131A61J1/00C03C17/245C03C2217/213C03C2218/153C23C16/045C23C16/401
Inventor C·威卡尔特J·T·费尔特斯T·E·费斯克R·S·阿伯拉姆斯J·弗格森J·R·弗里德曼R·J·潘格伯恩P·J·萨高纳
Owner SI02 MEDICAL PRODS
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