Abstract: The present disclosure relates to a medication delivery system including a medication administration device, a medication within the medication administration device, a container defining a cavity receiving the medication administration device, and a cap attached to the container and sealing the medication administration device within the cavity. The medication administration device includes an actuator extending from a body and operable to expel the medication by depressing the actuator into the body. The cap includes hold down members positioned to bear against the body of the medication administration device to prevent movement of the medication administration device toward the cap beyond a predetermined distance. The medication administration device is thereby prevented, inter alia, from prematurely discharging the medication during storage and transport.

Abstract: 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.

Abstract: 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 AsnA21-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.

Abstract: 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 ?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.

Abstract: 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 ?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.

Abstract: A method of resolving a racemic mixture of (±)-Huperzine A to (?)-Huperzine A includes: separating the (?)-Huperzine A from the racemic mixture of (±)-Huperzine A by chiral high performance liquid chromatography (HPLC), the chiral HPLC being performed utilizing a mobile phase including a solution including an alcohol and one selected from dichloromethane, trichloromethane, and a mixture thereof, and the chiral HPLC being performed utilizing a chiral stationary phase including a polysaccharide derivative.

Abstract: 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.

Abstract: A method for the purification of idraparinux sodium includes: passing a solution including a crude idraparinux sodium through a column including a sodium ion exchange resin to obtain a first mixture; passing a solution including the first mixture through a gel chromatogaphy column to obtain a second mixture; and precipitating a purified idraparinux sodium from a solution including the second mixture.

Abstract: 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 ?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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: An automatic bulk filling process for filling a large number of liquid containers (20) simultaneously which consists of placing the open-topped liquid containers upside down in a rack (22). The rack is then inserted into a vacuum chamber (28) and positioned directly above a tray (38) that contains a liquid medicinal product (40). The next step is to evacuate the chamber to a predetermined level below atmospheric pressure and then lowering the rack until the containers are partially immersed in the liquid product. Following that step, nitrogen is introduced into the vacuum chamber at a predetermined gradual rate, thereby quickly forcing the medicinal liquid product into the containers. The rack is then raised from the tray containing the liquid medicinal product and removed from the chamber as another rack full of containers is simultaneously inserted into the chamber from the other end.

Abstract: A pre-filled disposable pipette (10) consisting of a hollow bulb (12) dimensioned to enclose a medicinal product. From a lower end (16) of the bulb (12) is attached sequentially a medicinal transfer tube (24) and a medication fill tube (32), from where the medicinal product is applied. Between a lower end (28) of the tube (24) and an upper end (34) of the tube (32) is formed a break-away notch (40). When the tube (24) or the tube (32) is rotated, the notch (40) is twisted and breaks-off, thus allowing the medicinal product to flow from the bulb (12) and be released from the tube (24). The pipette (10) includes a primary grasping tab (46) attached to an upper end (14) of the bulb (12); a secondary grasping tab (54) attached to each side of the tube (24); and a support tab (70) attached to each side of the tube (32). The invention also discloses several methods for sealing the lower tip (36) of the medication fill tube (32).

Abstract: A uniform small particle homogenizer for liquid product comprising a pair of intensifier cylinder pumps (20) driven by a hydraulic system (22). The pumps have a power stroke side and a suction stroke side, and a pair of proximity sensors (24) that interface with each pump to detect forward and rearward movement. A microprocessor (26) 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.

Abstract: A glass bottle protective enclosure (10) designed to protect a glass bottle (100) 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 (100) containing toxic injectable medication. The enclosure (10), which is preferably made from a transparent plastic, consists of a lower bottle container (12) which includes a base (14) and a plurality of shock absorbing protrusions (30), which are located to allow a bottle label to be clearly visible, on the base (14) is located at least one sensor cavity (120) into which is inserted an enclosure leakage sensor (122) consisting of either a water soluble sensor (124) or an electronic sensor (126). Both of which provide an indication if a bottle leakage occurs. To complete the enclosure (10) the container (12) includes a threaded bottle container cap (36) which includes a plurality of cap shock absorbing protrusions (52).

Abstract: An improved pre-filled disposable pipette (10) consisting of a hollow tube (12) dimensioned to enclose a medicinal product and having attached a medication transfer tube (22) from where the pipette is filled and the medicinal product released. The improvement consists in having a primary grasping tab (32) attached to an upper end (14) of the bulb (12); a secondary grasping tab (38) attached to each side of the tube (22); and a support tab (52) also attached to each side of the tube (22) near the lower end (26) of the tube (22). The primary and secondary grasping tabs (32, 38) allow the pipette (10) to be conveniently and easily handled without having to grasp the sensitive bulb (12) or to directly grasp the tube (22). The support tab (52) functions to allow the pipette (10) to be placed on a conveyor rack apparatus (88) from where the pipette (10) can be automatically filled and sealed by a cap (72) or heat applied foil (82).

Abstract: A process of bulk filling containers which includes the steps of arranging a number of containers upside down in a tray (24) that has a raised peripheral lip (26). This tray full of containers is then placed in a vacuum chamber (28) which is then evacuated to a predetermined level below atmospheric pressure. Liquid (36) is then introduced into the tray through a reservoir (38) and conduit (40) 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 (74) and positioning the rack directly above the tray containing the liquid.

Abstract: 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.