Amphastar Pharmaceuticals, Inc.

Mary Zi-Ping Luo

Jack Yongfeng Zhang

Frank Zhishi Xia

Ying Wang

Ray Lameng Lei

Jie Fei Ding

Christos Lymberopoulos

Tielong Gao

Pharmaceutical aerosol formulations containing pre-micronized epinephrine, co-solvent ethanol, surfactant polysorbate 80, and propellant trans-1,3,3,3-tetrafluoropropene (HFO-1234ze(E)) for use in a pressurized metered dose inhaler is described. The formulations provide a highly efficient delivery of pre-micronized epinephrine particles into the patients' respiratory tracts and have the advantages of high efficacy, improved safety, and a low global warming potential (GWP) for environmental impact.

Stable epinephrine suspension formulation for inhalation with HFO propellant

Pharmaceutical aerosol formulations containing pre-micronized albuterol sulfate, high amount of green propellant trans-1,3,3,3-tetrafluoropropene (HFO-1234ze(E)), and a surfactant (polysorbate 80 (polyoxyethylene (20) sorbitan monooleate), polysorbate 20 (polyoxyethylene (20) sorbitan monolaurate), polyethylene glycol 1000, span 85 (sorbitan trioleate), polyvinylpyrrolidone K25, or their combination) in a pressurized metered dose inhaler are described. The formulations do not use any co-solvent, i.e., they are co-solvent-free (e.g., free of ethanol, glycerol, propylene glycol, and a combination thereof). The formulations provide highly efficient delivery, through metered dose inhaler (MDI), of pre-micronized albuterol particles into the patients' respiratory tracts and have the advantages of high efficacy, improved safety, and a low global warming potential (GWP) for environmental impact.

Albuterol aerosol suspension formulation for oral inhalation with high amount of green propellant hydrofluoroolefin (HFO) and free of co-solvent

A pre-filled disposable pipette () consisting of a hollow bulb () dimensioned to enclose a medicinal product. From a lower end () of the bulb () is attached sequentially a medicinal transfer tube () and a medication fill tube (), from where the medicinal product is applied. Between a lower end () of the tube () and an upper end () of the tube () is formed a break-away notch (). When the tube () or the tube () is rotated, the notch () is twisted and breaks-off, thus allowing the medicinal product to flow from the bulb () and be released from the tube (). The pipette () includes a primary grasping tab () attached to an upper end () of the bulb (); a secondary grasping tab () attached to each side of the tube (); and a support tab () attached to each side of the tube (). The invention also discloses several methods for sealing the lower tip () of the medication fill tube ().

Easily sealed and opened pre-filled, disposable pipette

An improved pre-filled disposable pipette ( ) consisting of a hollow tube ( ) dimensioned to enclose a medicinal product and having attached a medication transfer tube ( ) from where the pipette is filled and the medicinal product released. The improvement consists in having a primary grasping tab ( ) attached to an upper end ( ) of the bulb ( ); a secondary grasping tab ( ) attached to each side of the tube ( ); and a support tab ( ) also attached to each side of the tube ( ) near the lower end ( ) of the tube ( ). The primary and secondary grasping tabs ( ) allow the pipette ( ) to be conveniently and easily handled without having to grasp the sensitive bulb ( ) or to directly grasp the tube ( ). The support tab ( ) functions to allow the pipette ( ) to be placed on a conveyor rack apparatus ( ) from where the pipette ( ) can be automatically filled and sealed by a cap ( ) or heat applied foil ( ).

Sealable and manipulable pre-filled disposable pipette

A sterile, stable pharmaceutical formulations of oil-in-water emulsions of Propofol containing no preservative are provided that comprise optimal amounts of egg lecithin and soybean oil, with a suitable pH range to prevent significant growth of microorganisms for at least 24 hours after adventitious, extrinsic contamination. The lower pH in the formulation has shown the most antimicrobial activity. The reduced amount of fat in the formulation also allows chronic sedation over extended periods of time with a reduced chance of fat overload in the blood.

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Rancho Cucamonga, CA, United States of America

Mary Zi-Ping Luo