Amphastar Pharmaceuticals, Inc.

Other

Amphastar Pharmaceutcals, Inc.

Amphastar Pharmaceuticals Incorporation

Jack Yongfeng Zhang

Mary Ziping Luo

Frank Zhishi Xia

Aili Bo

Mary Zi-Ping Luo

Jeffrey Ding

Jie Fei Ding

Rong Zhou

Ray Lameng Lei

Mary Zi-ping Luo

Ying Wang

Gunther L Maier

Tielong Gao

Kevin Xie

Christos Lymberopoulos

Thang Kien Chiu

Anthony Marrs

Selina Su

Anthony D Marrs

Denny R S Ko

Zhongli Bao

Dingyuan Fei

James Luo

Jianxin 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

The present disclosure introduces methods for characterizing iron core carbohydrate colloid drug products, such as iron sucrose drug products. Disclosed methods enable the characterization of the iron core size of the iron core nanoparticles in iron carbohydrates as they exist in the formulation in solution, such as e.g. iron sucrose drug products, and more particularly, the average particle diameter size and size distribution(s) of the iron core nanoparticles. The disclosed methods apply small-angle X-ray scattering (SAXS) in parallel beam transmission geometry, with a sample mounted inside a capillary and centered in the X-ray beam, to iron carbohydrates, such as iron sucrose, in solution without the need to modify the sample, such as to remove unbound carbohydrates, dilute, or dry the sample, to accurately characterize the average iron core particle diameter size of the iron core nanoparticles. An example application of the disclosed method is to perform SAXS measurements under identical instrument settings on two samples of the same type of iron core nanoparticle colloid drug product for the purpose of comparing their iron core structures. Such comparisons are typically performed during the iron core carbohydrate colloid drug development process, and can include comparisons of samples that have been manipulated.

Small angle x-ray scattering methods for characterizing the iron core of iron carbohydrate colloid drug products

Methods are disclosed for producing highly purified recombinant human insulin (RHI) having a purity of 99.0% (w/w) or greater, a Total Impurity (not including the related substance desamido Asn-RHI, as specified by USP) of 0.8% (w/w) or less, and an impurity C of 0.1% (w/w) or less. Also disclosed are API compositions of highly purified RHI having a purity of 99.0% (w/w) or greater, a Total Impurity of 0.8% (w/w) or less, and an impurity C of 0.1% (w/w) or less.

Highly purified recombinant human insulin (RHI) API and methods of producing the same

A high-purity inhalable insulin material, used for preparing a pulmonary pharmaceutical product, includes insulin particles having a particle size at the micrometer level and having the following characteristics: (i) the purity of insulin is not less than 96% on the dried basis; (ii) the total amount of insulin-related impurities is not more than 2%; (iii) the total amount of solvent impurities, which is not a co-solvent formulation component for a pulmonary product, is not more than 0.03%; and (iv) the total amount of non-solvent impurities is not more than 0.3%. Up to 99% by volume of the insulin particles in the inhalable insulin have a particle size of less than 5 &#x3bc;m, based on the total volume of the insulin particles. A high-efficiency method prepares high-purity inhalable insulin material. The yield rate for the high-efficiency method is 75 to 85% or more.

High-purity inhalable particles of insulin and insulin analogues, and high-efficiency methods of manufacturing the same

A method of preparing an inhalable insulin suitable for pulmonary delivery includes: dissolving an insulin raw material in an acidic solution to form a dissolved insulin solution; titrating the dissolved insulin solution with a buffer solution to form a suspension comprising micronized insulin particles; and stabilizing the micronized insulin particles.

Micronized insulin and micronized insulin analogues prepared under acidic conditions, and methods of manufacturing the same under acidic conditions

Pharmaceutical compositions for long-term sustained release of bisphosphonate drugs are provided. In one embodiment, the composition includes an aqueous suspension of a solid which includes a salt of a bisphosphonate drug and a salt of pentavalent phosphorus oxoacid. The compositions can be used to treat a variety of bone diseases, including osteoporosis.

Long term sustained release pharmaceutical composition containing aqueous suspension of bisphosphonate

A stable suspension aerosol formulation of epinephrine is suitable for administration through inhalation comprising a therapeutically effective amount of epinephrine, hydrofluorocarbon propellant, co-solvent, surfactant, and antioxidant. The suspension aerosol formulation further comprises [pre-] pre-micronized epinephrine suspended in an alcohol/surfactant solution with hydrofluoroalkane propellant. The suspension formulation provides a highly efficient delivery of drug microparticles into the respirable region of patients' lungs and has the following advantages: lower dosage requirement, minimum alcohol content, with less impurities generated during storage, improved efficacy and safety, and exhibits no ozone depleting potential compared to a formulation containing chlorofluorocarbon.

Stable epinephrine suspension formulation with high inhalation delivery efficiency

An oil-in-water propofol emulsion that contains soybean oil and egg lecithin, which provide a source of nutrition for microorganisms. Current products include additives to act as a microbial growth retardation agent, the processes described herein detail several methods for the optimization of the innate microbial retardation capability of propofol. Using this process improves the safety of a propofol emulsion solution by controlling microbial growth without the side effects associated with growth retardation additives.

Sterile pharmaceutical composition and process for a solution of propofol emulsion having microbial growth retardation

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

A uniform small particle homogenizer for liquid product comprising a pair of intensifier cylinder pumps ( ) driven by a hydraulic system ( ). The pumps have a power stroke side and a suction stroke side, and a pair of proximity sensors ( ) that interface with each pump to detect forward and rearward movement. A microprocessor ( ) with timing capabilities controls the sequential operation of each pump with the power stroke of each pump timed to alternately produce a flow of the liquid product with a precisely timed flow overlap period from the alternating pumps. Since the power stroke takes a longer time than the suction stroke, the instant each power stroke is started the opposite pump is timed to hesitate and slightly overlap until a constant product flow-rate is produced from the alternating pumps, which eliminates large variances in pressure and therefore achieves uniformity in product particle size.

Uniform small particle homogenizer and homogenizing process

A glass bottle protective enclosure ( ) designed to protect a glass bottle ( ) in the event the bottle is subjected to an impact shock. The enclosure is provided with a leak-proof seal and is particularly adapted for protecting glass bottles ( ) containing toxic injectable medication. The enclosure ( ), which is preferably made from a transparent plastic, consists of a lower bottle container ( ) which includes a base ( ) and a plurality of shock absorbing protrusions ( ), which are located to allow a bottle label to be clearly visible, on the base ( ) is located at least one sensor cavity ( ) into which is inserted an enclosure leakage sensor ( ) consisting of either a water soluble sensor ( ) or an electronic sensor ( ). Both of which provide an indication if a bottle leakage occurs. To complete the enclosure ( ) the container ( ) includes a threaded bottle container cap ( ) which includes a plurality of cap shock absorbing protrusions ( ).

Glass bottle protective enclosure

A controlled medicament security enclosure system that houses liquid filled reservoirs which consists of a portable enclosure ( ) formed with a top half ( ) and a bottom half ( ) that permanently snap together to form a secure inseparable repository for the reservoirs. Inside the enclosure is at least one glass vial ( ) for storing the liquid medicament with each vial having a sliding piston stopper ( ) within that seals the inside of the vial and slides to maintain the liquid air free regardless of the volume. An adapter socket ( ) is removably attached to the stopper and includes a hollow needle that pierces the stopper and permits a flowpath for the liquid. A flexible outlet tube ( ) along with connectors on each end transmit the medicament to a mechanical drug delivery system that has a peristaltic pump and a control module.

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Rancho Cucamonga, CA, United States of America

Jack Yongfeng Zhang