Abstract: The present disclosure generally pertains to a medical device and more particularly, a metered-dose inhaler (“MDI”) actuator capable of a targeted delivery of fine API particles having particle diameters of about 1.1 ?m or less to a portion of a patient's lungs where alveoli are located.

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: The present disclosure introduces intranasal (IN) pharmaceutical formulations having naloxone or an opioid antagonist as the active agent, and an absorption enhancer, such as a bile acid, or a salt thereof, for IN delivery. The bile acid, or salt thereof, enhances absorption of naloxone or an opioid antagonist into the bloodstream of a human subject.

Abstract: Disclosed herein are pharmaceutical formulations including epinephrine that have increased epinephrine retention over long-term storage, e.g., 30-months. In one aspect, a formulation includes: one or more of 0.1 mg/mL of epinephrine or a pharmaceutically acceptable salt thereof provided without any overage, a tonicity regulating agent including 8.2 mg/mL of sodium chloride, a pH adjusting agent including a mixture of 1.5 mg/mL sodium citrate dihydrate, 3.3 mg/mL of citric acid monohydrate, and, optionally, an as-needed amount of sodium hydroxide to maintain the pH level of the formulation within a range of 3.6 to 4.0, 0.075 mg/mL of sodium metabisulfite, and 4 ?g/mL of ethylene diamine tetra-acetate disodium. The formulation has an API recovery of 94.5% or more after at least 30 months of storage at long-term storage conditions defined as 25° C.±2° C. at 1 atmosphere. In addition, in another aspect, a formulation includes 1 mg/mL of epinephrine and other ingredients.

Abstract: Disclosed herein are pharmaceutical formulations including epinephrine that have increased epinephrine retention over long-term storage, e.g., 30-months. In one aspect, a formulation includes: one or more of 0.1 mg/mL of epinephrine or a pharmaceutically acceptable salt thereof provided without any overage, a tonicity regulating agent including 8.2 mg/mL of sodium chloride, a pH adjusting agent including a mixture of 1.5 mg/mL sodium citrate dihydrate, 3.3 mg/mL of citric acid monohydrate, and, optionally, an as-needed amount of sodium hydroxide to maintain the pH level of the formulation within a range of 3.6 to 4.0, 0.075 mg/mL of sodium metabisulfite, and 4 ?g/mL of ethylene diamine tetra-acetate disodium. The formulation has an API recovery of 94.5% or more after at least 30 months of storage at long-term storage conditions defined as 25° C.±2° C. at 1 atmosphere. In addition, in another aspect, a formulation includes 1 mg/mL of epinephrine and other ingredients.

Abstract: The present disclosure provides NMR relaxation methods for characterizing iron carbohydrate drug products. The methods measure 13C and 1H nuclei relaxation parameters such as T1 and PWHH include performing 2D T1 NMR, 1D 13C NMR and 1H NMR to characterize certain physiochemical properties of iron sucrose drug products, for purposes of assessing bioequivalence between a tested iron sucrose product and a comparator product. The disclosure further provides a novel Fe(III)/Fe(II) reduction method using a new reducing agent Na2S2O5 and an 1H NMR method to monitor the Fe(III)/Fe(II) reduction process.

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: Disclosed herein are pharmaceutical formulations including epinephrine that have increased epinephrine retention over long-term storage, e.g., 30-months. In one aspect, a formulation includes: one or more of 0.1 mg/mL of epinephrine or a pharmaceutically acceptable salt thereof provided without any overage, a tonicity regulating agent including 8.2 mg/mL of sodium chloride, a pH adjusting agent including a mixture of 1.5 mg/mL sodium citrate dihydrate, 3.3 mg/mL of citric acid monohydrate, and, optionally, an as-needed amount of sodium hydroxide to maintain the pH level of the formulation within a range of 3.6 to 4.0, 0.075 mg/mL of sodium metabisulfite, and 4 ?g/mL of ethylene diamine tetra-acetate disodium. The formulation has an API recovery of 94.5% or more after at least 30 months of storage at long-term storage conditions defined as 25° C.±2° C. at 1 atmosphere. In addition, in another aspect, a formulation includes 1 mg/mL of epinephrine and other ingredients.

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: 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: 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: 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 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.

Abstract: A transmittance-adjustable window (20) that includes first and second polarizer sheets (34B)(46B) and an actuator (44) for relative movement between them. The first sheet (34B) has a translation direction Y and is formed from an alternating series of abutting, identically-shaped linear polarizer segments A and B distributed along translation direction Y. Each segment A has a first polarizing direction and each segment B has a second polarizing direction orthogonal to the first. The second sheet (46B) is substantially identical to the first sheet (34B) and positioned in an adjacent, substantially parallel plane. The actuator (44) moves one of the sheets with respect to the other between an OPEN alignment position and an OPAQUE alignment position. In the OPEN position, each segment of the first sheet superimposes a corresponding identical segment of the second sheet which allows light to pass.