Amphastar Pharmaceuticals, Inc.

Other

Amphastar Pharmaceutcals, Inc.

Amphastar Pharmaceuticals Incorporation

Mary Ziping Luo

Jack Yongfeng Zhang

Frank Zhishi Xia

Aili Bo

Jeffrey Ding

Rong Zhou

Ying T Chen

Jie Fei Ding

Gunther L Maier

Dingyuan Fei

Kevin Xie

Jianxin Gao

James Luo

Denny R S Ko

Anthony D Marrs

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 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.

Controlled medicament security enclosure system

A process of bulk filling containers which includes the steps of arranging a number of containers upside down in a tray ( ) that has a raised peripheral lip ( ). This tray full of containers is then placed in a vacuum chamber ( ) which is then evacuated to a predetermined level below atmospheric pressure. Liquid ( ) is then introduced into the tray through a reservoir ( ) and conduit ( ) which penetrates the wall of the vacuum chamber and the vacuum within the chamber is gradually released at a rate that draws the liquid into the containers. At this point in the process unwanted liquid is rinsed away and the tray is removed from the chamber and turned right side up. The final step is to seal the top of the containers with an appropriate cap, barrier, tip or connection. A second embodiment adds a step to the process by positioning the containers upside down in a rack ( ) and positioning the rack directly above the tray containing the liquid. The rack is then lowered until the container necks are immersed in the liquid. The level of liquid is maintained as above and the balance of the process is conducted the same as the preferred embodiment.

Process of bulk filling

A pre-filled oral liquid disposable plastic container along with its storage means are provided to deliver medication to a patient in a easy to use and sanitary manner. The plastic container ( ) includes a hollow bulb portion ( ) on one end and a hollow stem portion ( ) on the other. A bulbous flange ( ) is integrally formed onto the distal end or the hollow stem, thus permitting comfortable insertion of the container into a patient's mouth. A specified quantity of liquid medication ( ) is pre-filled into the container with the container sized appropriately. The plastic in the container is colored, thereby indicating the type of liquid medication, and permitting the medication to be colorless and still maintain its identity. All of the containers have a recognizable shape on the bulb portion, such as a cylinder with spherical ends for adult medicine, or in some shape attractive to infants and small children. A metallic foil closure ( ) is attached to the distal end of the container for sealing the liquid medication within, and a tab ( ) is included for ease of removal.

Pre-filled oral liquid disposable plastic container

A pre-filled disposable pipette for pharmaceutical and cosmetic products which has a hollow, round pipette body ( ). The body consists of a hollow, rigid bulb section ( ) forming a reservoir for storage and dispersion of the liquid pharmaceutical or cosmetic product which is pre-filled within the body. The body ( ) further includes a hollow tubular section ( ) that is smaller in diameter and contiguous with the bulb section, for ease of handling the pipette. The preferred embodiment has a hollow, frangible upper tube ( ) with a distal end that is sealed for introducing air into the body ( ) when the seal is broken, thus releasing the liquid from the tubular section. The liquid is dispensed from the body by breaking the upper tube allowing air to enter the pipette with the liquid flowing by gravity. The second embodiment has a resilient bulb section and omits the upper tube. A tapered section ( ) is added to the tubular section, with a hollow tip ( ) on the end. The liquid is dispensed from the body ( ) by squeezing the bulb. A seal is in contact with the hollow tubular section, or tip, for retaining the liquid within the body and storage, consisting of either a liquid seal ( ) or a resilient cap ( ).

Pre-filled disposable pipettes

A hypodermic needle capping device (10) that attaches to a hypodermic syringe (100). The device (10) consists of two separate elements: the first consists of a collar (12) having integrally attached a snap-lock structure (24) that includes a locking barb (40) and slide member retaining structure (42). The second consists of a slide member (54) which includes a barb receiving and locking slot (58) and a needle point barrier (76). The collar (12) is frictionally inserted over the upper edge (108) of the syringe (100). The slide member (54) is slidably attached to the slide member retaining structure (42) and is designed to be placed in two positions. When the syringe (100) is to be used, the slide member (54) is positioned along the side of the syringe (100). After the syringe has been used, but prior to being discarded, the slide member (54) is single-handedly slid upward until the locking barb (40) is inserted into the slot (58) at which time the slide member (54) is positioned with the syringe needle (104) point adjacent the needle point barrier (76).

Hypodermic needle capping device

A dual water-level toilet flushing apparatus (10) that allows a toilet user to easily and quickly select either a partial or a full toilet flush. The partial flush which is normally preset is recommended for flushing liquid waste while the full flush is recommended for flushing solid waste. The apparatus (10) which is easily installed and requires no modification to the toilet water tank (60) consists of three major elements: an overflow tube sleeve (12) that attaches to an overflow tube (64) and that has swivelly attached the back end of a floating inverted pendulum (20). The front of the pendulum is attached, via a pendulum/flapper valve link (24), to the front of a toilet flapper valve (30) having its back swivelly attached to the bottom of the overflow tube (64). To effect a partial flush, the toilet flush handle (68) is depressed and immediately released; to effect a full flush the handle (60) is depressed and held for a few seconds.

Growing community of inventors

Rancho Cucamonga, CA, United States of America

Mary Ziping Luo