Abstract: Apparatus, systems and methods for use in three-dimensional printing are shown and described. Various embodiments of the invention allow for more precise and controlled delivery of heat to achieve interlayer drying; isolation of the working region from the outside for reasons of cleanliness and in connection with the vapors of organic solvents; better control of the temperature of the working region; better accuracy in the flowrates of binder fluid dispensed; matching of delivered flowrates for multiple dispensers; verification of delivered flowrate or drops; provision for easier changeover of the machine from one powder to another; cleanability; and other needs.

Abstract: Apparatus, systems and methods for use in three-dimensional printing are shown and described. Various embodiments of the invention allow for more precise and controlled delivery of heat to achieve interlayer drying; isolation of the working region from the outside for reasons of cleanliness and in connection with the vapors of organic solvents; better control of the temperature of the working region; better accuracy in the flowrates of binder fluid dispensed; matching of delivered flowrates for multiple dispensers; verification of delivered flowrate or drops; provision for easier changeover of the machine from one powder to another; cleanability; and other needs.

Abstract: The present invention includes controlled release dosage forms and methods of designing and manufacturing dosage forms to obtain specific release profiles, for example, zero-order release profiles, escalating release profiles or decreasing release profiles. The dosage forms of the present invention can include spatial variation of API concentration in the dosage form and can include nested regions. Dosage forms according to the present invention may be manufactured by any appropriate method for obtaining the internal structure as disclosed herein for producing zero-order release profiles and increasing or decreasing release profiles. The invention further includes methods of manufacturing such dosage forms, such as by three-dimensional printing, possibly also including compression of the dosage form after three-dimensional printing. The invention further includes methods of designing such dosage forms.

Abstract: A fabrication method to rapidly fabricate different prototypes of drug delivery systems, medical devices, pharmaceutical dosage forms, tissue scaffolds or other bioaffecting agents in small batches or individual forms using a computer-guided system to vary the composition and structure in order to optimize the product and the manufacturing process. The process is immediately scalable. An Expert System can be used with the method to recommend different compositions and designs of the prototypes, devices, dosage forms, tissue scaffold or other bioaffecting agents.

Abstract: A uniaxially compressed dosage form manufactured by three-dimensional printing that preserves the predetermined internal architecture of the dosage form while producing an improved surface finish. The compression compacts the dosage form, eliminating at least some of the void space that remains at the end of conventional three-dimensional printing. Surface finish obtained as a result of the uniaxial compression process can be essentially equal to that obtained from conventional tablet pressing. Additionally, the internal structure or spatial variation of composition of the dosage form is preserved during the pressing operation, with geometric shrinkage occurring mostly in the direction of the axis of pressing. Further, as a result of compression, a greater quantity of API can be packed into a given final volume of dosage form.

Abstract: A rapidly dispersing dosage form is described, which releases its active ingredients within a period of less than about ninety seconds. These dosage forms exhibit a three-dimensional shape that is retained for adequate storage but is readily dispersed in the presence of excess moisture. Also disclosed are methods of administration of a medicament and a process for the preparation of rapidly dispersing dosage forms.

Abstract: A device for controlling or altering the temperature of a liquid at the point of dispensing. A temperature-altering device is thermally coupled to a dispensing device to compensate for heat dissipated into the liquid as it passes through the dispensing device during dispensing. The dispensing device may be for example, a miniature solenoid valve (microvalve), a piezoelectric printhead, or the like. According to aspects of the invention, a temperature-altering device provides or reduces heat at the point of dispensing in order to alter, control or maintain a constant temperature of the dispensed liquid. As a result, improvement is obtained in the consistency of the fluid regime of the dispensed droplet stream. The temperature-altering device may be a thermoelectric device capable of moving heat either from or to the dispensing structure, or may be a heater.

Abstract: The devices disclosed herein are composite implantable devices having a gradient of one or more of the following: materials, macroarchitecture, microarchitecture, or mechanical properties, which can be used to select or promote attachment of specific cell types on and in the devices prior to and/or after implantation. In preferred embodiments, the implants include complex three-dimensional structure, including curved regions and saddle-shaped areas. In various embodiments, the gradient forms a transition zone in the device from a region composed of materials or having properties best suited for one type of tissue to a region composed of materials or having properties suited for a different type of tissue.

Abstract: The invention includes dispensing a suspension containing solid particles for use in manufacturing a dosage form or other biomedical article by 3DP. The suspension contains solid particles suspended in a liquid. The solid particles may be one or more Active Pharmaceutical Ingredients. The solid particles may be particles of material that are insoluble in the liquid, or they may be particles of a substance that have already dissolved in the liquid up to the saturation level and are present in a concentration beyond what can be dissolved. In addition to solid particles, the liquid may also contain other substances dissolved in it, either substances containing Active Pharmaceutical Ingredients (API) or substances without API. One aspect of the invention includes prevention of agglomeration by adding one or more of several categories of additives to the suspending liquid.

Abstract: A fabrication method to rapidly fabricate different prototypes of drug delivery systems, medical devices, pharmaceutical dosage forms, tissue scaffolds or other bioaffecting agents in small batches or individual forms using a computer-guided system to vary the composition and structure in order to optimize the product and the manufacturing process. The process is immediately scalable. An Expert System can be used with the method to recommend different compositions and designs of the prototypes, devices, dosage forms, tissue scaffold or other bioaffecting agents.

Abstract: Dosage forms prepared by solid free form fabrication (SFF) provide release of medicament in multiple phases.

Abstract: A rapidly dispersing dosage form is described, which releases its active ingredients within a period of less than about ninety seconds. These dosage forms exhibit a three-dimensional shape that is retained for adequate storage but is readily dispersed in the presence of excess moisture. Also disclosed are methods of administration of a medicament and a process for the preparation of rapidly dispersing dosage forms.

Abstract: Composite devices for tissue engineering are provided having a gradient of one or more of the following: materials, macroarchitecture, microarchitecture, or mechanical properties, which can be used to select or promote attachment of specific cell types on and in the devices prior to and/or after implantation. In various embodiments, the gradient forms a transition zone in the device from a region composed of materials or having properties best suited for one type of tissue to a region composed of materials or having properties suited for a different type of tissue. The devices are made in a continuous process that imparts structural integrity as well as a unique gradient of materials in the architecture. The gradient may relate to the materials, the macroarchitecture, the microarchitecture, the mechanical properties of the device, or several of these together. The devices disclosed herein typically are made using solid free form processes, especially three-dimensional printing process (3DP™).

Abstract: A method and apparatus for controlling the migration of binder liquid in a bulk powder. The bulk powder may be deposited in a powder bed and contains at least two different substances, each in powder form. One substance gives the printed part its bulk properties, forms most of the powder, and preferably is either insoluble or not significantly soluble in the binder liquid. The other powder substance is a migration control substance. Upon interaction with the binder liquid, this substance may absorb the binder liquid and form a gel or dissolve into the binder liquid increasing viscosity thereby inhibiting binder migration. No chemical reactions occur between the binder liquid and any of the substances in the powder bed. In another embodiment of the instant invention, binder migration may be further controlled by first printing a barrier region in the powder bed containing the migration control substance.

Abstract: The invention is the use of an optical fiber to bring visual information to a camera or various types of instruments from a printhead as the printhead is printing product. Coherent optical fibers offer the ability to view an actual picture of a process such as drop generation, while requiring minimal space near the drop generator. Optical fibers also permit the observing end of the fiber to move relative to the receiving end while observations are being taken. Images may be acquired and electronically processed in ways that include identifying fluid flow regime and obtaining dimensional information including dimensions of individual drops. Volumetric flow rate may be calculated from the spatial dimension of drops together with timing information. Colorimetric analysis of the returned light may also yield information about the contents of the drop. It is possible to use any of this information as feedback to control operation of the printhead or dispenser.

Abstract: A wetting-resistant nozzle for accurately and precisely dispensing small volumes of liquids. The nozzle comprises an internal flowpath, and an external surface that recedes from the discharge point at an angle greater than 90 degrees, and an exceptionally low surface energy for the external surface. The low surface energy material may exist as a coating on top of a shaped substrate. A flat land region may be included and may have sharp edges, one of which may define the boundary of the low surface energy region. Another embodiment includes the low surface energy material as a bulk material through which a hole is drilled. The internal flowpath inside the nozzle may be smoothly tapered. Liquid being dispensed tends not to advance past the edge of the low surface energy region, which may coincide with a geometrically sharp edge. Such nozzles provide improved dispensing of liquids that have both low surface tension and low viscosity, such as organic solvents.

Abstract: The rapid design and manufacture of biomedical devices such as implants, oral dosage pills and implantable pharmaceuticals employs electronic data and modeling transmissions via a computer network. Patient information and patient-specific radiological data is captured and transmitted via a computer network to a design and/or manufacturing site. A multi-dimensional digital model is created based on the radiological data and patient information. Communications interchanges between a clinical/diagnostic site and a design/manufacturing site permit modification of the digital model until approved. The approved digital model is converted into machine instructions to construct the biomedical device. Alternatively, the digital model is employed in a best fit selection of a biomedical device from a pre-existing set of biomedical devices or machine-instructions. Transmittal of data over computer networks is further directed to the use of a Website to perform various client-interaction and follow-up tasks.

Abstract: A system for molding a tissue or substitute tissue product in a mold having an exterior surface, and an interior surface, wherein at least one portion of the interior surface is porous and whose pores are in continuous communication with the exterior surface, and wherein said mold can be fabricated using solid free-form fabrication techniques is disclosed.

Abstract: A method and apparatus for dispensing and distributing a powder is disclosed that uses a rotary dispenser to dispense the powder by gravity onto a movable platen, the platen being movable to a position adjacent to a build bed where the powder can be distributed across the build bed using a spreader. The method and apparatus are also suited to dispensing of a plurality of powders used in build beds for solid free-form fabrication and three-dimensional printing. It is preferred that a powder contacting surface of the apparatus be coated with a coating selected from the group consisting of: an anodized finish, a hardcoat anodized finish, siloxane, baked enamel, electroplated enamel, electroless nickel, coated elastomer, laminated elastomer, dipped latex, sprayed latex, polyvinyl chloride, nylon, polytetrafluoroethylene, polyurethane, an epoxy resin, or a polyester.

Abstract: Dosage forms prepared by solid free form fabrication (SFF) provide release of medicament in multiple phases.