Abstract: The present invention is directed to an immediate release and extended release capsule or capsule fill which mitigates the abuse of abuse-susceptible active pharmaceutical ingredients by direct intravenous injection. The fill comprises a parenteral abuse resistant liquid formulation which when mixed with water and heated, results in a turbid, viscous or bubbling mixture that is not injectable with a standard insulin syringe. The abuse-susceptible active pharmaceutical ingredient is selected from the group consisting of opiates, opioids, tranquilizers, stimulants and narcotics.

Abstract: An improved process for producing an oil-in-water emulsion to deliver a substantially water insoluble active pharmaceutical ingredient includes creating a microemulsion containing such ingredient in the oil phase of the emulsion by mixing an aqueous phase including non-ionic surfactant, polyol, and water, wherein the weight ratio of the surfactant to polyol to water is between 10:20:70 and 1:1:1, to generate a mixture, with an oil phase comprising a substantially water insoluble active pharmaceutical ingredient and a long-chain triglyceride; circulating the said mixture through a homogenizer at a temperature from 20° C. to 60° C. to generate a coarse emulsion; passing the coarse emulsion through a microfluidizer at a pressure of from 70 MPa to 150 MPa at least once to produce an oil-in-water microemulsion; and, optionally, filtering the microemulsion through a 0.2 ?m filter and/or mixing the microemulsion with a polymeric stabilizer.

Abstract: The invention provides a pump for dispensing a plurality of fluids at predetermined volumes to a common location and a method of using the pump to deliver such plurality of fluids. The pump comprises one or more first syringe units, each first syringe unit comprising a first plunger and a first chamber within which the first plunger slides. A first inlet channel is fluidly connected to the first chamber of each first syringe unit and configured to receive the first fluid. The pump also comprises one or more second syringe units, each second syringe unit comprising a second plunger and a second chamber within which the second plunger slides. A second inlet channel is fluidly connected to the second chamber of each second syringe unit and configured to receive the second fluid.

Abstract: A system for filling a blow-fill-seal (BFS) container is provided. The system includes a first fluid circuit constructed to selectively deliver a purge fluid to an open BFS container. A second fluid circuit selectively delivers a product to the open BFS container. A third fluid circuit, having a vent line in fluid communication with the open BFS container and to the ambient, directs a bulk fluid comprising at least the purge fluid from the container when the purge fluid is introduced into the BFS container. The second circuit selectively delivers product when the first fluid circuit selectively does not deliver the purge fluid, and the second circuit selectively does not deliver product when the first circuit selectively delivers the purge fluid.

Abstract: Disclosed is a method for shortening the drying time for drying an encapsulated material including a coating material containing water without causing deformation of the coating when drying. The method employs a fluidized bed dryer for drying coating materials that contain water and that form a coating when the water evaporates. A first drying step involves floating and fluidizing the encapsulated material and limiting a theorisable evaporating water content ?W so that dimples or deformation do not occur in the coating of the encapsulated granular material while measuring a water content or temperature of gas exhausted from the fluidized bed dryer; and a second drying step, performed after the measure water content is reduced below a prescribed amount or the measured temperature has increased, of blowing in gas to the fluidized bed dryer so that the theorisable evaporating water content ?W rises above that during the first drying step.

Abstract: The present disclosure provides conjugate structures and hydrazinyl-substituted heteroaryl compounds used to produce these conjugates. The disclosure also encompasses methods of production of such conjugates and compounds, as well as methods of using the same.

Abstract: A method for blow-fill-seal (BFS) packaging of a product and a BFS package. The method forms a BFS package with a twist-off top, container body and information panel in a main mold. The container is filled via a fill opening located distal to the twist-off top and the fill opening is sealed with a base portion. This provides a container having a twist-off top that is more reliably secured to the container body. A plurality of containers may be attached to a single information panel. The BFS packaging system may employ a quick change insert to reduce lost production time when changing products or lots. The package includes an information panel integrally formed with a plurality of twist-off tops, each of which is removably attached to a container body whereby each container body can be removed from the package without removing the remaining container bodies from the information panel.

Abstract: A fluid container is provided that comprises a body portion configured to at least partially surround fluid. The container also includes a cap portion connected to and above the body portion at a frangible separation site surrounding an opening between the body portion and the cap portion. The cap portion is configured to separate from the body portion at the separation site to expose the opening when a substantially downwardly directed force is applied to a part of the cap portion at a certain radial distance from a longitudinal axis through the opening. The container can include a collar configured to be disposed at least around a part of the body portion. A portion of the collar can be configured to facilitate separation of the cap portion.

Abstract: A fast-dissolving dosage form (FDDF) for the delivery of a vaccine is prepared using a formulation containing a starch, optionally, along with at least one additional matrix forming agent, preferably, a combination of gelatin and mannitol, where an immune response is induced in a patient in need thereof.

Abstract: The present disclosure provides activated formylglycine-generating enzymes (FGE), methods of producing activated FGE, and their use in methods of producing a protein comprising a formylglycine (FGly) residue. The methods of producing activated FGE, as well as methods of use of activated FGE in producing FGly-containing proteins, include both cell-based and cell-free methods. Compositions and kits that find use, e.g., in practicing the methods of the present disclosure are also provided.

Abstract: A method for blow-fill-seal (BFS) packaging of a product and a BFS package. The method forms a BFS package with a twist-off top, container body and information panel in a main mold. The container is filled via a fill opening located distal to the twist-off top and the fill opening is sealed with a base portion. This provides a container having a twist-off top that is more reliably secured to the container body. A plurality of containers may be attached to a single information panel. The BFS packaging system may employ a quick change insert to reduce lost production time when changing products or lots. The package includes an information panel integrally formed with a plurality of twist-off tops, each of which is removably attached to a container body whereby each container body can be removed from the package without removing the remaining container bodies from the information panel.

Abstract: An improved process for producing an oil-in-water emulsion to deliver a substantially water insoluble active pharmaceutical ingredient includes creating a microemulsion containing such ingredient in the oil phase of the emulsion by mixing an aqueous phase including non-ionic surfactant, polyol, and water, wherein the weight ratio of the surfactant to polyol to water is between 10:20:70 and 1:1:1, to generate a mixture, with an oil phase comprising a substantially water insoluble active pharmaceutical ingredient and a long-chain triglyceride; circulating the said mixture through a homogenizer at a temperature from 20° C. to 60° C. to generate a coarse emulsion; passing the coarse emulsion through a microfluidizer at a pressure of from 70 MPa to 150 MPa at least once to produce an oil-in-water microemulsion; and, optionally, filtering the microemulsion through a 0.2 ?m filter and/or mixing the microemulsion with a polymeric stabilizer.

Abstract: The invention described herein provides a fast dispersing oral solid dosage form containing monoamine oxidase B inhibitor (MAO-B inhibitor) as the active ingredient, and method of treating disease therewith, such as Parkinson's disease. In one embodiment, the monoamine oxidase B inhibitor selegiline or its analog can be the sole active ingredient in the composition administered. The dosage form composition is formulated to promote absorption through the buccal, sublingual, pharyngeal and/or esophageal mucous membrane tissue, such that at least 5% of the active ingredient is absorbed within one minute of placement in the oral cavity, as determined by a buccal absorption test. Monoamine oxidase B inhibitor compounds administered in accordance with the invention decrease the amount of undesirable metabolites associated with first pass effect of selegiline, for example, such as amphetamine and methamphetamine.

Abstract: A shell-forming composition for a soft capsule comprising a non-gelatin component as the chief component, wherein the shell-forming composition is able to inhibit a decrease in physical strength (breaking strength) of the capsule when a phospholipid-containing oil with a phospholipid concentration of 20% or more by mass is used as the core of the capsule. The shell-forming composition for the soft capsule comprises (A) starch and/or dextrin, (B) a gelatinizer, (C) glycerin and (D) sorbitol, and the mass ratio of (C) glycerin:(D) sorbitol ranges from 100:30 to 100:120.

Abstract: An oral solid dosage form containing nanoparticles is made by (a) reducing the particle size of at least one pharmaceutically active ingredient dispersed in a solution containing fish gelatin to form a nanosuspension and (b) freeze-drying the nanosuspension of step (a) to form the oral solid dosage form.

Abstract: The invention provides a pump for dispensing a plurality of fluids at predetermined volumes to a common location and a method of using the pump to deliver such plurality of fluids. The pump comprises one or more first syringe units, each first syringe unit comprising a first plunger and a first chamber within which the first plunger slides. A first inlet channel is fluidly connected to the first chamber of each first syringe unit and configured to receive the first fluid. The pump also comprises one or more second syringe units, each second syringe unit comprising a second plunger and a second chamber within which the second plunger slides. A second inlet channel is fluidly connected to the second chamber of each second syringe unit and configured to receive the second fluid.

Abstract: A package for delivering a single-dose product includes a softgel capsule which is comprised of at least one gelling agent selected from protein-based gelling agents and polysaccharide-based gelling agents. The capsule shell includes one or more areas of reduced thickness that are preferentially ruptured by exertion of a compressive force on the softgel capsule to create an opening in the capsule shell through which the fill composition can be delivered by spraying or squeezing. A method for manufacturing the softgel capsule having one or more areas of reduced shell thickness is also described.

Abstract: A solution that is stable at 5° C. to 30° C. for at least 24 hours, comprising: (a) water, (b) montelukast sodium; (c) a carrier material for a fast disintegrating dosage form; and (d) a component selected from a strong base, a bicarbonate salt and mixtures thereof. The solution comprising montelukast sodium is stable under conditions that are typically encountered during certain phases of the manufacturing process of fast disintegrating dosage form that contain the montelukast sodium. The solution can be used to form fast disintegrating dosage form tablets. A method of preparing a fast disintegrating dosage form tablet including preparing such solution, and forming a tablet, and a fast disintegrating dosage form that is prepared from the montelukast sodium solution are also described.

Abstract: Improved formulations containing substituted imidazole derivatives of the general formula 1, formula (I) wherein Y is —CH2— or —CO—, R1 is H, halo or hydroxy, R2 is H or halo, and R3 is H or lower alkyl (e.g. C1 to C4 alkyl, preferably C1 or C2 alkyl), or a pharmaceutically acceptable salt, such as an acid addition salt, e.g. the hydrochloride, of a compound of the general formula (I), are in solid fast-dispersing dosage form suitable for pre-gastric absorption.

Abstract: Single use containers designed to store and dispense liquid substances having a wide variation in viscosities. The container includes a container body that defines a storage compartment for storing the liquid substance and is provided with a neck including a seal positioned in the neck to seal a liquid substance in the storage compartment during storage. The container also includes a cap defining a recess and being adapted for engaging the neck and including structure for piercing the seal and a channel which passes through the structure for piercing the seal to the recess. An applicator is located in the recess such that the applicator and recess together define a chamber between an end of the channel and the applicator to allow liquid to flow from said channel into said chamber.