Plastic Parenteral Container with Superior Barrier Properties for Biologics
Plastic Parenteral Container with Superior Barrier Properties for Biologics
批准号:
9252190
负责人:
Daniel Everett Jonsen
金额:
$22.5万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2017
资助国家:
美国
项目状态:
已结题
起止时间:
2017-02-01 至 2018-01-31
关键词:
AgingAluminum OxideBuffersChemical WarfareChemicalsChemistryComplexDimensionsDisadvantagedDrug IndustryDrug-sensitiveElectron BeamExcipientsFilmGlassGoalsIndustryIndustry StandardLifeLife Cycle StagesLubricantsLubricationMedicalMoldsOxygenPerformancePermeabilityPharmaceutical PreparationsPharmaceutical SolutionsPharmacologic SubstancePhasePlasticizersPlasticsPredispositionProcessPropertyResearchResistanceShapesSterilizationSurfaceSyringesSystemTechniquesTechnologyThickTimeVial deviceatomic layer depositioncostdesignexperimental studyirradiationparticle
中文摘要
项目摘要
作为注射用材料,塑料与 1 型硼硅酸盐玻璃相比具有几个关键优势
药品容器(例如小瓶和预装注射器)。 塑料不易破损,并且可以
模制成比玻璃更复杂的形状,具有更严格的尺寸公差。 此外,塑料不是
容易发生玻璃分层——这是该行业的一个主要问题,药品会对其进行化学攻击
玻璃容器,导致玻璃碎片剥落到药物中。
塑料肠胃外容器的主要缺点是其透氧性相对较高,
这会缩短对氧敏感的药品的保质期。 这个缺点可以通过以下方式消除
在容器上涂上一层阻隔涂层,大大降低容器的透氧性。 的
用于制造这种氧气阻隔涂层的可行候选材料具有与玻璃相似的化学性质,
因此对化学攻击具有相似的敏感性。 因此,氧气阻隔涂层需要
额外的钝化层的保护。
TriboFilm Research, Inc. (TriboFilm) 正在开发双层氧气阻隔钝化涂层
用于塑料注射容器的系统,称为 TriboShield™。 TriboShield™ 涂层系统是
预计其性能将优于所有现有的竞争产品,原因有两个。 首先,原子层沉积
TriboFilm 用于创建氧气阻隔层的 (ALD) 技术可制造出比普通薄膜更高质量的阻隔薄膜
可以使用其他阻隔涂层技术来实现。 更高质量的电影将显着降低
透氧性,因为薄膜中的裂纹和“针孔”较少,便于氧气渗透
通过。 其次,TriboFilm 开发了一种经过验证的玻璃预填充注射器钝化涂层,它将
经过修改,可用于带屏障涂层的塑料容器。 钝化涂层还可以充当高--
注射器用高性能润滑剂。
TriboFilm 第一阶段的目标是为塑料注射容器创建先进的涂层系统
提供出色的氧气阻隔性能,以延长氧气敏感产品的保质期,以及
为药品提供一个表面,该表面具有化学惰性并且能够抵抗来自容器的侵蚀
内容物,(b) 不会以可浸出物、可提取物或颗粒的形式迁移到药品中,并且 (c)
是一种有效的润滑剂,允许使用包含该系统的预填充注射器而无需任何润滑剂
额外的润滑。 成功后,TriboShield™ 技术可应用于预灌装的小瓶
注射器或任何其他塑料容器,为制药公司提供从注射器到注射器的无缝过渡
在药物的生命周期中,容器格式可以转换为另一种容器格式。 这可以为公司节省数百万美元
过渡时的重新配制成本和上市时间,例如从小瓶过渡到预装注射器。
英文摘要
PROJECT ABSTRACT
Plastic offers several key advantages over Type 1 borosilicate glass as a material for parenteral
pharmaceutical containers (e.g. vials and prefilled syringes). Plastic is less prone to breakage, and can be
molded into more complex shapes with tighter dimensional tolerances than glass. Additionally, plastic is not
susceptible to glass delamination — a major problem in the industry where a drug product chemically attacks its
glass container, resulting in glass fragments flaking off into the drug.
The primary disadvantage of plastic parenteral containers is their relatively high oxygen permeability,
which can reduce the shelf life of oxygen-‐‑sensitive drug products. This shortcoming can be eliminated by
applying a barrier coating to the container that drastically lowers the container'ʹs oxygen permeability. The
viable candidate materials from which to make this oxygen barrier coating have similar chemistries to glass,
and thus have similar susceptibility to chemical attack. Therefore, the oxygen barrier coating requires the
protection of an additional passivating layer.
TriboFilm Research, Inc. (TriboFilm) is developing a bi-‐‑layer oxygen barrier + passivation coating
system for use on plastic parenteral containers, called TriboShield™. The TriboShield™ coating system is
expected to outperform all existing competing products for two reasons. First, the Atomic Layer Deposition
(ALD) technique that TriboFilm uses to create the oxygen barrier layer makes higher quality barrier films than
can be achieved using other barrier coating techniques. Higher quality films will have significantly lower
oxygen permeability because they will have fewer cracks and 'ʹpinholes'ʹ in the film for oxygen to permeate
through. Second, TriboFilm has developed a proven passivating coating for glass prefilled syringes which will
be modified for use on barrier coated plastic containers. The passivating coating also acts as a high-‐‑
performance lubricant for syringes.
TriboFilm'ʹs goal for Phase I is to create an advanced coating system for plastic parenteral containers
that provides outstanding oxygen barrier properties to extend the shelf life of oxygen-‐‑sensitive products, and
presents a surface to the drug product that, (a) is chemically inert and resistant to attack from the container'ʹs
contents, (b) will not migrate into the drug product in the form of leachables, extractables, or particles, and (c)
is an effective lubricant, allowing a prefilled syringe incorporating the system to be used without any
additional lubrication. When successful, the TriboShield™ technology could be applied to vials, prefilled
syringes, or any other plastic container, offering seamless transition for a pharmaceutical company from one
container format to another during the life cycle of a drug. This could save a company millions of dollars in
reformulation costs and time to market while transitioning, e.g., from a vial to a prefilled syringe.
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Plastic Parenteral Containers With Superior Oxygen Barrier Properties
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批准号:9765366
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项目类别:
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资助金额:$91.38万
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财政年份:2017
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负责人:Daniel Everett Jonsen
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依托单位:
海外基金