Abstract: A high throughput, efficient, and simplified unloading and packaging systems and methods for large-scale production of pharmaceutical units (104) using additive manufacturing. The systems and methods may unload, inspect, package, and trace pharmaceutical units, produced by an additive manufacturing system (900), that are not damaged or deformed. The unloading and packaging system can include one or more unloading and packaging devices (100). The unloading and packaging device can include a modular configuration having modules. Individual modules to be arranged in any relative order, at any location, and with any number in the unloading and packaging device. The flexibility of the modular configuration allows one or more modules to be removed or added at any given time due to, e.g., expansion, downsizing, module repair, module upgrades, etc. High throughput can be achieved by operating unloading and packaging devices independently.

Abstract: Provided herein are devices and systems for depositing a material or manufacturing a product, such as a pharmaceutical dosage form, by additive manufacturing. Further provided are methods of using the devices and systems, as well as methods of manufacturing a product, such as a pharmaceutical dosage form, by additive manufacturing. In certain embodiments, the device includes a material supply system configured to melt an pressurized a material, a pressure sensor configured to detect a pressure of the material within the device, and a control switch comprising a sealing needle operable in an open position and closed position. The sealing needle extends through a feed channel containing the material and includes a taper end, wherein the tapered end of the sealing needle engages a tapered inner surface of a nozzle to inhibit flow of the material through the nozzle when the sealing needle is in the closed position.

Abstract: A dosage form of controlled release at specific gastrointestinal sites is provided. The dosage form includes a shell defining a first and a second compartment, a first active pharmaceutical ingredient (API) loaded in the first compartment, and a second API loaded in the second compartment, wherein the first API and the second API can be the same or different. The shell includes a first material soluble in a first gastrointestinal site and a second material soluble in a second gastrointestinal site.

Abstract: The present disclosure generally relates to an additive manufacturing system. The system can comprise a material supply module for melting and pressurizing a printing material; a micro-screw printing head comprising: a micro-screw comprising a threaded stem portion and a conical head portion, wherein the threaded stem portion is threaded throughout its length for volume measurement; a sleeve, and a nozzle, wherein a distal end of the nozzle comprises: a conical inner surface, and an outlet port for dispensing the print material, wherein the conical inner surface of the nozzle is configured to be in contact with the conical head portion of the micro-screw to stop dispensing the printing material at the nozzle when the micro-screw printing head is in a closed position; a driving module comprising: a rotation motor for driving a rotating motion of the micro-screw, and an actuator for driving a vertical motion of the micro-screw.

Abstract: The present disclosure provides a stable solid pharmaceutical dosage form for oral administration. The dosage form includes a substrate that forms at least one compartment and a drug content loaded into the compartment. The dosage form is so designed that the active pharmaceutical ingredient of the drug content is released in a controlled manner.

Abstract: Provided herein are devices and systems for depositing a material or manufacturing a product, such as a pharmaceutical dosage form, by additive manufacturing. Further provided are methods of using the devices and systems, as well as methods of manufacturing a product, such as a pharmaceutical dosage form, by additive manufacturing. In certain embodiments, the device includes a material supply system configured to melt an pressurized a material, a pressure sensor configured to detect a pressure of the material within the device, and a control switch comprising a sealing needle operable in an open position and closed position. The sealing needle extends through a feed channel containing the material and includes a taper end, wherein the tapered end of the sealing needle engages a tapered inner surface of a nozzle to inhibit flow of the material through the nozzle when the sealing needle is in the closed position.

Abstract: The present disclosure relates generally to manufacturing pharmaceutical products using additive manufacturing technology.

Abstract: The present disclosure provides oral drug dosage forms comprising: (a) an erodible non-stimulant material admixed with an ADHD non-stimulant; and (b) an erodible stimulant material admixed with an ADHD stimulant, wherein the erodible non-stimulant material admixed with the ADHD non-stimulant is embedded in a substrate material, and wherein upon exposure to gastrointestinal fluid the ADHD non-stimulant is released according to a desired non-stimulant release profile and the ADHD stimulant is released according to a desired stimulant release profile. In some embodiment, the ADHD non-stimulant is released according to a sustained release profile. In some embodiments, the ADHD stimulant is released according to an immediate release profile. The oral drug dosage forms of the present disclosure are useful for the treatment of attention deficit hyperactivity disorder (ADHD). Also provided herein are methods of designing and manufacturing the oral drug dosage forms described herein.

Abstract: The present disclosure relates generally to manufacturing pharmaceutical products using additive manufacturing technology.

Abstract: The present disclosure relates generally to manufacturing pharmaceutical products using additive manufacturing technology.

Abstract: A 3D printing device (100), comprising a melt extrusion module (102), a printing module (103), and a platform module (104). The melt extrusion module (102) comprises a processing chamber (121) consisting of a feed inlet (124) and a discharge outlet (125), as well as an extrusion means (122) and a heating means (123) disposed at the processing chamber; the melt extrusion module (102) is configured to receive an initial material from the feed inlet (124) of the processing chamber (121), and heat and extrude the initial material to convert the initial material into a molten body, which is extruded out of the discharge outlet (125) of the processing chamber (121). The printing module (103) is communicated with the discharge outlet (125) of the processing chamber (121) and is provided with a nozzle (131); the printing module (103) is configured to receive the molten body extruded from the discharge outlet (125) of the processing chamber (121) and guide the molten body to be extruded out of the nozzle (131).

Abstract: The present disclosure relates generally to manufacturing pharmaceutical products using additive manufacturing technology.

Abstract: The present disclosure provides a stable solid pharmaceutical dosage form for oral administration. The dosage form includes a substrate that forms at least one compartment and a drug content loaded into the compartment. The dosage form is so designed that the active pharmaceutical ingredient of the drug content is released in a controlled manner.

Abstract: The present disclosure provides a stable solid pharmaceutical dosage form for oral administration. The dosage form includes a substrate that forms at least one compartment and a drug content loaded into the compartment. The dosage form is so designed that the active pharmaceutical ingredient of the drug content is released in a controlled manner.

Abstract: Provided herein are devices and systems for depositing a material or manufacturing a product, such as a pharmaceutical dosage form, by additive manufacturing. Further provided are methods of using the devices and systems, as well as methods of manufacturing a product, such as a pharmaceutical dosage form, by additive manufacturing. In certain embodiments, the device includes a material supply system configured to melt an pressurized a material, a pressure sensor configured to detect a pressure of the material within the device, and a control switch comprising a sealing needle operable in an open position and closed position. The sealing needle extends through a feed channel containing the material and includes a taper end, wherein the tapered end of the sealing needle engages a tapered inner surface of a nozzle to inhibit flow of the material through the nozzle when the sealing needle is in the closed position.

Abstract: The present disclosure provides a stable solid pharmaceutical dosage form for oral administration. The dosage form includes a substrate that forms at least one compartment and a drug content loaded into the compartment. The dosage form is so designed that the active pharmaceutical ingredient of the drug content is released in a controlled manner.

Abstract: In some aspects, the present disclosure provides dosage forms, such as oral drug dosage forms, configured to provide a desired release profile, the dosage forms comprising a multi-layered structure comprising a plurality of layers of a first erodible material admixed with a compound (e.g., a drug) or a reagent, wherein the first erodible material is embedded in a second material not admixed with the compound (e.g., the drug) or the reagent. In other aspects, the present disclosure provides methods of designing, such as obtaining a thickness and/or surface area of a layer comprising an erodible material admixed with a compound (e.g., a drug) or a reagent, and/or amount of the compound (e.g., the drug) or the reagent admixed in the erodible material, and methods of making, such as three-dimensional printing, dosage forms configured to provide desired release profiles.

Abstract: The present disclosure provides a stable solid pharmaceutical dosage form for oral administration. The dosage form includes a substrate that forms at least one compartment and a drug content loaded into the compartment. The dosage form is so designed that the active pharmaceutical ingredient of the drug content is released in a controlled manner.

Abstract: Provided herein are devices and systems for depositing a material or manufacturing a product, such as a pharmaceutical dosage form, by additive manufacturing. Further provided are methods of using the devices and systems, as well as methods of manufacturing a product, such as a pharmaceutical dosage form, by additive manufacturing. In certain embodiments, the device includes a material supply system configured to melt an pressurized a material, a pressure sensor configured to detect a pressure of the material within the device, and a control switch comprising a sealing needle operable in an open position and closed position. The sealing needle extends through a feed channel containing the material and includes a taper end, wherein the tapered end of the sealing needle engages a tapered inner surface of a nozzle to inhibit flow of the material through the nozzle when the sealing needle is in the closed position.

Abstract: The present invention generally relates to a pharmaceutical dosage form and controlled release of biologically active agents, diagnostic agents, reagents, cosmetic agents, and agricultural/insecticide agents. In one embodiment, the dosage form has a substrate that forms a compartment, wherein the substrate includes at least a first piece and a second piece, wherein the first piece operably links to the second piece. The dosage form contains a drug content that is loaded into the compartment. The dosage form also has a releaser operably linked to the substrate which upon contact with water or body fluid is capable of separating the first and second piece to open the compartment and release the drug content.