Pharmaceutical package for ophthalmic formulations
Inventors
Weikart, Christopher • Bennett, Murray Stephen • Giraud, Jean-Pierre
Assignees
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Publication Number
US-11654046-B2
Publication Date
2023-05-23
Expiration Date
Abstract
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.
Core Innovation
The invention relates to an ophthalmic drug in a pre-filled pharmaceutical package for intravitreal injection. The package includes a syringe barrel with a thermoplastic wall and a coating set on at least one of the interior surface or the exterior surface, the coating set including a tie coating or layer, a barrier coating or layer, and a pH protective coating or layer defined by SiOxCyHz-based composition ranges measured by XPS and at least one of RBS or HFS.
The package further includes a liquid formulation of an ophthalmic drug suitable for intravitreal injection in the lumen, and a closure seated in the lumen with a front face facing the liquid formulation. The closure is an axially stretchable plunger with an elastomeric sleeve having a stretch zone adapted to undergo axial elongation to convert the plunger from a storage mode to a dispensing mode.
The elongation reduces an outer profile of at least a portion of the sidewall to reduce the plunger to a constricted state, and the closure includes a liquid sealing section comprising a non-stretch zone of the sidewall of the elastomeric sleeve. The syringe barrel and closure are free of silicone oil and baked-on silicone.
Claims Coverage
Two independent claims are present in the provided material. The claims cover a pre-filled ophthalmic syringe package and a convertible axially stretchable elastomeric plunger, with a combined focus on coating layers, mode conversion, sealing, and exclusion of silicone oil and baked-on silicone.
SiOxCyHz coating set with defined composition ranges measured by XPS, RBS, or HFS
A syringe barrel with a thermoplastic wall having a coating set on the interior surface and/or the exterior surface, where the coating set comprises a tie coating or layer, a barrier coating or layer, and a pH protective coating or layer, each defined by SiOxCyHz-based composition ranges measured by XPS and at least one of RBS or HFS.
Axially stretchable elastomeric plunger converting from storage mode to dispensing mode by axial elongation
A closure seated in the lumen, comprising an axially stretchable plunger in the syringe barrel, where an elastomeric sleeve sidewall includes a stretch zone adapted to undergo axial elongation to convert the plunger from a storage mode to a dispensing mode, reducing an outer profile of at least a portion of the sidewall to a constricted state.
Liquid sealing section in the constricted state using a non-stretch zone
The plunger further comprises a liquid sealing section when the plunger is in the constricted state, and the liquid sealing section comprises a non-stretch zone of the sidewall of the elastomeric sleeve.
Silicone oil and baked-on silicone exclusion
The syringe barrel and closure are free of silicone oil and baked-on silicone.
Ophthalmic drug in the lumen suitable for intravitreal injection
A liquid formulation of an ophthalmic drug suitable for intravitreal injection is located in the lumen and is faced by the closure front face.
VEGF antagonist formulation comprising an anti-VEGF antibody or antigen-binding fragment
The lumen contains a liquid formulation of a VEGF antagonist comprising an anti-VEGF antibody or an antigen-binding fragment of such antibody, where the liquid formulation is suitable for intravitreal injection.
The claims jointly recite a pre-filled ophthalmic syringe package with defined multi-layer SiOxCyHz coatings and a convertible axially stretchable elastomeric plunger that transitions from storage mode to a constricted dispensing state with a non-stretch liquid sealing section, while excluding silicone oil and baked-on silicone.
Stated Advantages
Improved shelf life by protecting the SiOx barrier from erosion or dissolution by formulation pH.
Reduced breakout or glide forces.
Low particle count.
Reducing plunger force.
Avoiding lubricants contaminating drug.
Providing an ophthalmic prefilled package system with compatibility while being free of silicone oil and baked-on silicone.
Documented Applications
Pre-filled ophthalmic drug product for intravitreal injection in an ophthalmic setting using a syringe barrel and closure package with specified coatings and plunger transition behavior.
VEGF antagonist ocular drug delivery in a liquid formulation suitable for intravitreal injection, including anti-VEGF antibody or antigen-binding fragment formulations.
Ophthalmic drug intravitreal injection from a pre-filled pharmaceutical package using the described syringe barrel and axially stretchable plunger.
Uses involving ophthalmic conditions including AMD, DME, RVO, and CNV.
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