Abstract: Various aspects of the present invention provide for methods of manufacturing a pharmaceutical drug product, which include storing a container at a temperature greater than ambient conditions for at least about seven days and conducting release testing on the container after storing. Products manufactured by this method have a more consistent fine particle size distribution (FSD) and fine particle fraction (FPF) at ambient conditions and at accelerated stability conditions over the life of the drug product. Advantageously, such products may more reliably and regularly pass testing requirements as required for an approved drug product by regulatory authorities such as the United States Food and Drug Administration (USFDA).

Abstract: Various embodiments of the present invention provide drug products, inhalation systems and methods of treating respiratory diseases. Several embodiments provide an inhalation system including a pressurized metered dose inhaler and a chamber. The chamber may be an anti-static chamber with a chamber volume of about 145 milliliters (ml) to about 200 ml.

Abstract: A drug delivery device such as an oral dosage form (ODF) with a toxic or potent core encapsulated by a non-toxic region. The non-toxic region may be a region including multiple layers, coatings, shells, and combinations thereof, which provides protection to and isolation from the toxic or potent core. The drug in the toxic or potent core is incorporated into the dosage form via, for example, three-dimensional printing, as a solution, solubilization or suspension of solid particles in liquid, rather than by the more conventional handling and compressing of dry powder. This minimizes the likelihood of creating airborne particles of the toxic drug during manufacturing, hence controlling and minimizing the exposure of manufacturing personnel to the hazardous substance. Wet dispensing of the toxic or potent drug further provides greater bioavailability of the drug to the patient.

Abstract: Various aspects of the present invention provide for methods of manufacturing a pharmaceutical drug product, which include storing a container at a temperature greater than ambient conditions for at least about seven days and conducting release testing on the container after storing. Products manufactured by this method have a more consistent fine particle size distribution (FSD) and fine particle fraction (FPF) at ambient conditions and at accelerated stability conditions over the life of the drug product. Advantageously, such products may more reliably and regularly pass testing requirements as required for an approved drug product by regulatory authorities such as the United States Food and Drug Administration (USFDA).

Abstract: A drug delivery device such as an oral dosage form (ODF) with a toxic or potent core encapsulated by a non-toxic region. The non-toxic region may be a region including multiple layers, coatings, shells, and combinations thereof, which provides protection to and isolation from the toxic or potent core. The drug in the toxic or potent core is incorporated into the dosage form via, for example, three-dimensional printing, as a solution, solubilization or suspension of solid particles in liquid, rather than by the more conventional handling and compressing of dry powder. This minimizes the likelihood of creating airborne particles of the toxic drug during manufacturing, hence controlling and minimizing the exposure of manufacturing personnel to the hazardous substance. Wet dispensing of the toxic or potent drug further provides greater bioavailability of the drug to the patient.

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

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

Abstract: A drug delivery device such as an oral dosage form (ODF) with a toxic or potent core encapsulated by a non-toxic region. The non-toxic region may be a region including multiple layers, coatings, shells, and combinations thereof, which provides protection to and isolation from the toxic or potent core. The drug in the toxic or potent core is incorporated into the dosage form via, for example, three-dimensional printing, as a solution, solubilization or suspension of solid particles in liquid, rather than by the more conventional handling and compressing of dry powder. This minimizes the likelihood of creating airborne particles of the toxic drug during manufacturing, hence controlling and minimizing the exposure of manufacturing personnel to the hazardous substance. Wet dispensing of the toxic or potent drug further provides greater bioavailability of the drug to the patient.

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