Method of preparing a pharmaceutical composition
Inventors
Stein, Stephen W. • Schultz, David W. • Simons, John K. • Hansen, William F.
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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-11497712-B2
Publication Date
2022-11-15
Expiration Date
Abstract
The present disclosure provides a method of preparing a pharmaceutical composition. The method includes transferring a predetermined quantity of an excipient mixture from a second vessel to a first vessel. The excipient mixture transferred from the second vessel includes a liquid-state second quantity of a hydrofluoroalkane propellant and a first solubilized excipient comprising a low-molecular weight poly(ethylene oxide) polymer. The method further includes contacting at least one pharmaceutically-active compound with the excipient mixture under conditions that facilitate forming an intermixture comprising the propellant, the polymer, and the compound. Before transferring the excipient mixture, the first vessel contains a vapor-phase first quantity of the hydrofluoroalkane propellant and an effective amount of the at least one pharmaceutically-active compound.
Core Innovation
A method of making a pharmaceutical composition includes adding at least one pharmaceutically active compound to a first vessel and adding a first quantity of a hydrofluoroalkane propellant to the first vessel as a vapor. This creates a first mixture in the first vessel comprising the hydrofluoroalkane propellant and the at least one pharmaceutically active compound, where the hydrofluoroalkane propellant is in a vapor phase with less than 5% of the hydrofluoroalkane propellant in a liquid phase based on the total mass of the first mixture.
The method further includes transferring an excipient mixture from a second vessel into the first vessel such that an intermixture comprises the excipient mixture and the first mixture formed in the first vessel. The excipient mixture comprises a second quantity of the hydrofluoroalkane propellant in a liquid form, a poly(ethylene oxide) polymer having a molecular weight from 200 to 3000 Daltons, and a mass of polar co-solvent before transferring of no more than 1% of the total mass of the pharmaceutical composition.
Claims Coverage
The document provides one independent claim directed to a method of making a pharmaceutical composition using a first vessel with vapor-phase HFA, followed by transferring an excipient mixture from a second vessel to form an intermixture.
Vapor-phase HFA first mixture with low liquid-phase fraction
Adding at least one pharmaceutically active compound to a first vessel and adding a first quantity of a hydrofluoroalkane propellant to the first vessel where the first quantity is a vapor to create a first mixture comprising the first quantity of hydrofluoroalkane propellant and the pharmaceutically active compound, with the hydrofluoroalkane propellant in a vapor phase and less than 5% in a liquid phase based on the total mass of the first mixture.
Intermixture formed by transferring liquid HFA excipient mixture from a second vessel
Transferring an excipient mixture from a second vessel into the first vessel such that an intermixture comprises the excipient mixture and the first mixture, wherein the excipient mixture comprises a second quantity of hydrofluoroalkane propellant in a liquid form.
Excipient formulation with PEG 200–3000 Da and polar co-solvent ≤1%
The excipient mixture comprises a poly(ethylene oxide) polymer having a molecular weight from 200 to 3000 Daltons and a mass of polar co-solvent before transferring of no more than 1% of the total mass of the pharmaceutical composition.
Overall, the claim coverage centers on making a pharmaceutical composition by forming a vapor-phase HFA mixture in a first vessel with a low liquid-phase fraction, then transferring a PEG-containing liquid-HFA excipient mixture from a second vessel to create an intermixture, while limiting polar co-solvent content.
Stated Advantages
Lower residual (deposition loss) of active ingredients when using the inventive transfer/excipient-dissolution process versus a conventional single-vessel dissolution approach.
Documented Applications
Forming an intermixture suitable for delivery to a patient using a metered dose inhaler.
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