Method for making medicinal delivery device having multi-layer coating
Inventors
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Assignees
Member
Kindeva Drug DeliveryKindeva Drug Delivery is a contract development and manufacturing organization specializing in advanced drug delivery systems including pulmonary, nasal, injectable, transdermal, and intradermal therapies. Services range from formulation and analytical development to commercial-scale, Annex 1-compliant GMP manufacturing across global facilities. The company brings integrated expertise in regulatory strategy, device engineering, process and technology transfer, and quality assurance, with a focus on sustainable solutions such as low-GWP propellants and microneedle patch platforms. Kindeva supports complex, patient-centric, and environmentally optimized therapies from product conception through commercialization.
Kindeva Drug Delivery is a contract development and manufacturing organization specializing in advanced drug delivery systems including pulmonary, nasal, injectable, transdermal, and intradermal therapies. Services range from formulation and analytical development to commercial-scale, Annex 1-compliant GMP manufacturing across global facilities. The company brings integrated expertise in regulatory strategy, device engineering, process and technology transfer, and quality assurance, with a focus on sustainable solutions such as low-GWP propellants and microneedle patch platforms. Kindeva supports complex, patient-centric, and environmentally optimized therapies from product conception through commercialization.
Publication Number
US-11779716-B2
Publication Date
2023-10-10
Expiration Date
Abstract
Methods of making components for a medicinal delivery device are described, in which a base composition comprising a polysulphone is applied to the surface of a component to create a base layer, a primer composition comprising a silane having two or more reactive silane groups separated by an organic linker group is applied to the base layer to create primed surface, and a coating composition comprising an at least partially fluorinated compound is applied to the primed surface. Corresponding coated components and a medicinal delivery device are disclosed.
Core Innovation
The invention relates to a method of making a component for a medicinal delivery device. The method provides a component and applies, in sequence, a base composition comprising a polysulphone to at least a portion of the surface of the component to form a base layer.
After the base composition is applied, the method applies a primer composition to the surface portion. The primer composition comprises a silane having two or more reactive silane groups separated by an organic linker group, and the reactive silane groups are linked through the organic linker group to promote formation of a surface interface.
After the primer composition is applied, the method applies a coating composition comprising an at least partially fluorinated compound to the portion of the surface after application of the primer composition. The fluorinated compound is described as a polyfluoropolyether silane, including perfluorinated polyfluoropolyether moieties.
The disclosed approach is used to reduce salbutamol sulphate deposition and to reduce non-stick behavior on medicinal delivery device components, including valves and other inhaler components.
Claims Coverage
The input provides two independent claims. Across them, the claims cover sequential coating methods for medicinal delivery device components with a polysulphone or polyethersulphone base, a primer silane with two or more reactive silane groups separated by an organic linker group, and an at least partially fluorinated coating composition.
Sequential base-primer-fluorinated coating for medicinal delivery device components
A method of making a component for a medicinal delivery device by providing a component; providing a base composition comprising a polysulphone; providing a primer composition comprising a silane having two or more reactive silane groups separated by an organic linker group; providing a coating composition comprising an at least partially fluorinated compound; applying the base composition to at least a portion of the surface; applying the primer composition after the application of the base composition; and applying the coating composition to the portion after application of the primer composition.
Polyethersulphone-limited base layer followed by fluorinated coating
A method of making a component for a medicinal delivery device by providing a component; providing a coating composition comprising an at least partially fluorinated compound; providing a base composition comprising polyethersulphone in an amount of less than 20% by weight; applying the base composition to at least a portion of the surface of the component to provide a base layer; and applying the coating composition to at least a portion of the surface after application of the base layer.
The claims define coating methods for medicinal delivery device components using sequential application of a polysulphone or polyethersulphone-limited base, a primer silane with multiple reactive silane groups separated by an organic linker, and an at least partially fluorinated coating composition.
Stated Advantages
Reduced dose-to-dose/unit variability.
Reduced drug deposition/non-stick behavior, including reduced salbutamol sulphate deposition versus washed uncoated controls.
Documented Applications
Coating aluminium canisters and medicinal delivery device components including valves and other inhaler components for reduced salbutamol sulphate deposition.
Use in metered dose inhaler components, including actuator, aerosol container, ferrule, valve body, valve stem, and compression spring.
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