Formulation and aerosol canisters, inhalers, and the like containing the formulation
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-11207477-B2
Publication Date
2021-12-28
Expiration Date
Abstract
Formulations containing pharmaceutical active agent, propellant, and water at least partially adsorbed on or absorbed within one or more nylon pellets or nylon components of, for example, an inhaler such as a metered dose inhaler. Canisters, typically sealed canisters, containing such formulations. Inhalers, such as metered dose inhalers, containing such canisters. Methods of making and using the same.
Core Innovation
The disclosed invention relates to aerosol compositions and methods of making an aerosol composition. The aerosol composition comprises a liquid comprising a propellant, where the propellant comprises one or more of HFA-134a and HFA-227, and one or more pharmaceutical active agents dissolved or dispersed in the liquid, wherein the one or more pharmaceutical active agents is a hydrate. Hydrate dehydration is recognized as a problem when water is too low, and the disclosure addresses maintaining a target water level for stability.
The method includes soaking one or more nylon pellets in water to form one or more water soaked nylon pellets, where at least some of the water is adsorbed on or absorbed within the one or more water soaked nylon pellets. The method further removes at least some water from a surface of the one or more water soaked nylon pellets, and adds the resulting one or more water soaked nylon pellets to the aerosol composition to form the aerosol composition.
The disclosure connects the controlled water content to achieving and maintaining a specified water concentration in the liquid, including water dissolved or dispersed in the liquid between 50 ppm and 500 ppm. The aerosol compositions are described in connection with pressurized aerosol canisters and metered dose inhalers, with packaging and component concepts for moisture control, including moisture-barrier pouches without desiccant and internal component coatings.
Claims Coverage
The partial content includes one independent claim and multiple dependent claims. The independent claim centers on using water-soaked nylon pellets to introduce and manage water in an HFA-based propellant system containing hydrate pharmaceutical active agents, followed by adding the water-soaked pellets to form the aerosol composition.
Aerosol composition with HFA propellant and hydrate pharmaceutical active agents using water-soaked nylon pellets
Forming an aerosol composition by forming a composition comprising a liquid comprising a propellant comprising one or more of HFA-134a and HFA-227 and one or more pharmaceutical active agents dissolved or dispersed in the liquid, wherein the one or more pharmaceutical active agents is a hydrate; soaking one or more nylon pellets in water to form water soaked nylon pellets with at least some water adsorbed on or absorbed within the pellets; removing at least some water from a surface of the water soaked pellets; and adding the water soaked nylon pellets obtained from the removing step to the composition to form the aerosol composition.
Hydrate ipratropium or hydrate of an ipratropium salt in the aerosol composition
The hydrate pharmaceutical active agents include a hydrate of ipratropium or a hydrate of an ipratropium salt.
Ipratropium bromide monohydrate as the hydrate active agent
At least one pharmaceutical active agent comprises ipratropium bromide monohydrate.
Specified water concentration in the liquid
At least some water is dissolved or dispersed in the liquid, where the concentration of the water dissolved or dispersed in the liquid is between 50 ppm and 500 ppm based on the liquid and any components dissolved or dispersed in the liquid.
Nylon 6,6 pellets for water soaking
The nylon used is nylon 6,6.
Blotting to remove water from the pellet surface
The removing step of at least some water from a surface of the water soaked nylon pellets is accomplished by blotting the water soaked nylon pellets.
Across the independent claim and its dependents, the inventive coverage is directed to forming an HFA-134a/HFA-227 aerosol composition containing hydrate pharmaceutical active agents by soaking nylon pellets in water, partially removing surface water, and adding the resulting water soaked nylon pellets to the composition, with dependent claims specifying hydrate ipratropium forms, ipratropium bromide monohydrate, a water concentration range of 50 ppm to 500 ppm, nylon 6,6, and blotting as the water removal mechanism.
Stated Advantages
Maintaining stability by controlling water content to address hydrate dehydration when water is too low.
Provides practical manufacturing advantages over directly adding small water amounts during canister filling, as described in the disclosure.
Documented Applications
Pressurized aerosol canisters and metered dose inhalers incorporating the disclosed aerosol compositions.
Moisture-barrier packaging concepts for storage of the aerosol compositions, including moisture-barrier pouches without desiccant and internal component coatings.
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