Abstract: A dry granulation process using a twin-screw extruder for granulating a powder mixture which includes at least one active ingredient and at least one carrier. The process includes steps of kneading the powder mixture in the screw barrel of the twin-screw extruder at a barrel temperature below a melting point of the at least one active ingredient and a melting point or a glass transition temperature of the at least one carrier to provide a kneaded powder mixture, and extruding the kneaded powder mixture to form granules. Granules and tablets produced using the dry granulation process in the twin-screw extruder are also provided.

Abstract: The present disclosure is directed to a pharmaceutical formulation intended for oral delivery of synthetic or natural poorly permeable molecules or salts/solvates thereof having a therapeutic activity. The pharmaceutical formulation can include a synthetic or natural poorly permeable molecule or salt or solvate thereof in an amount 0.01-10 wt. % of the total weight of the formulation; a lipophilic phase comprising triglycerides of fatty acids in an amount of 50-80 wt. % of the total weight of the formulation; and at least one lipophilic surfactant comprising partial esters of polyol and fatty acids in an amount of about 10-50 wt. % of the total weight of the formulation.

Abstract: A dry granulation process using a twin-screw extruder for granulating a powder mixture which includes at least one active ingredient and at least one carrier. The process includes steps of kneading the powder mixture in the screw barrel of the twin-screw extruder at a barrel temperature below a melting point of the at least one active ingredient and a melting point or a glass transition temperature of the at least one carrier to provide a kneaded powder mixture, and extruding the kneaded powder mixture to form granules. Granules and tablets produced using the dry granulation process in the twin-screw extruder are also provided.

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: 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, tranquillizers, stimulants and narcotics.

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 of filling containers with liquid product includes receiving a signal from at least one sensor corresponding to an amount of liquid product in a holding tank, the holding tank having an outlet for feeding the liquid product to a container filling apparatus; transferring liquid product from the outlet of the holding tank to an inlet of the container filling apparatus; and filling at least one container with the liquid product through at least one nozzle of the container filling apparatus for a predetermined fill time, wherein an amount of the liquid product dispensed during the predetermined fill time is based on a pressure at the outlet of the holding tank, wherein a head pressure in the holding tank is increased based on the signal from the sensor to control the pressure at the outlet of the holding tank as the liquid product is fed from the holding tank.

Abstract: The invention provides a die suitable for producing a multi-chamber softgel capsule. The die comprises a die pocket defined by a die pocket wall and a bottom surface. The die comprises one or more partitioning walls dividing the die pocket into two or more chambers The top of the land of the partitioning walls have a lowest point that is lower than the plane formed by the top of the land along the perimeter of the die pocket wall by a gap. A die roll comprising a plurality of the dies is also provided, as well as rotary-die encapsulation machine comprising the die roll.

Abstract: A method of drying soft capsules including steps of: a) supplying a flow of air to said soft capsules at a velocity of the air across the soft capsules of from about 0.15 m/s to about 13 m/s; b) increasing, over time, a drying temperature to which said soft capsules are exposed while ensuring that the drying temperature remains below a melting temperature of a capsule shell of the soft capsules; c) exposing said soft capsules to an initial relative humidity of from about 49% RH to about 79% RH; d) decreasing the relative humidity to which the soft capsules are exposed as the capsules dry until an equilibrium relative humidity of the soft capsules reaches a desired relative humidity; and e) exposing the soft capsules from step d) to a temperature of from 20-25° C. Also disclosed is a drying system for carrying out the method.

Abstract: A method of treating a soft or hard capsule shell to reduce or alleviate stress in the capsule shell. The method includes a step of heating at least a portion of the soft or hard shell capsule capsule shell to a temperature above a glass transition temperature of the capsule shell but below a melt temperature of the capsule shell for a time sufficient to reduce internal stress in the capsule shell. The method can be used to reduce cracking of hard or soft capsule shells by application of the heat treatment to the filled capsule shells after fabrication and filling.

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 recovering gel-mass from a gel-mass-containing waste material. The system includes mangle rolls, a heated accumulator for receiving and melting the gel-mass-containing waste material to provide an oil phase and a non-oil phase; a pumping system; an optional mixer; and a control system.

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: A process and system for recovering gel-mass from a gel-mass-containing waste material. The process comprises retrieving the gel-mass-containing waste material from an encapsulation process; melting the retrieved waste material to provide an oil phase and a non-oil phase; retrieving the non-oil phase to produce a recovered gel-mass; and recycling the recovered gel-mass for combination with fresh encapsulating material to provide a combined encapsulating material for use in encapsulating a same lot of the same product which was being encapsulated in the step that produced the gel-mass-containing waste material from which the gel-mass was obtained. The system comprises a heated accumulator for receiving and melting the gel-mass-containing waste material to provide an oil phase and a non-oil phase; a pumping system; an optional mixer; and a control system.

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.