Abstract: The invention generally encompasses compositions and methods including inhalable voriconazole or a pharmaceutically acceptable salt thereof manufactured in amorphous form using thin film freezing. In various embodiments, the invention includes a dry powder voriconazole formulation that can be inhaled, for example, using a dry powder inhaler, and is well tolerated as a daily regimen for treating or preventing fungal infections. The compositions and methods of the invention avoid or reduce the systemic circulation of voriconazole and accordingly overcome the adverse events associated circulating voriconazole.

Abstract: Described herein are cholix-IL-10 fusion proteins, and methods of use thereof, which can be characterized by a distinct response in an individual when administered. This distinct response can comprise changes in levels of one or more markers in the individual and/or co-localization of IL-10 in the lamina propria of the individual. Further described herein, in some embodiments, are oral formulations of the cholix-IL-10 fusion proteins. Described herein are methods for the purification of an IL-10 delivery construct, including methods for refolding and enrichment, which can result in maintenance of a high percentage of the IL-10 delivery constructs in the biologically active dimer form. Described herein are oral formulations configured for site-specific release of a therapeutic protein in the small intestines or colon. In some cases, the therapeutic protein is in the form of a dimer, such as an IL-10 delivery construct capable of crossing the gut epithelium.

Abstract: Described herein are cholix-IL-10 fusion proteins, and methods of use thereof, which can be characterized by a distinct response in an individual when administered. This distinct response can comprise changes in levels of one or more markers in the individual and/or co-localization of IL-10 in the lamina propria of the individual. Further described herein, in some embodiments, are oral formulations of the cholix-IL-10 fusion proteins. Described herein are methods for the purification of an IL-10 delivery construct, including methods for refolding and enrichment, which can result in maintenance of a high percentage of the IL-10 delivery constructs in the biologically active dimer form. Described herein are oral formulations configured for site-specific release of a therapeutic protein in the small intestines or colon. In some cases, the therapeutic protein is in the form of a dimer, such as an IL-10 delivery construct capable of crossing the gut epithelium.

Abstract: An applicator and applicator system are provided for a topically or transdermally applying a pharmaceutical preparation or formulation. The applicator and applicator system can reduce drip during use, provide efficient transfer of a dose of the pharmaceutical preparation or formulation from the applicator to the skin of a patient, and can be used hands-free, which can reduce, prevent or eliminate cross-contamination to other areas, including undesired application to other parts of the skin or to other individuals. The applicator and applicator system include a therapeutic surface which can receive a single dose of the pharmaceutical preparation and can be manipulated by the user to transfer and apply the pharmaceutical preparation on a body surface.

Abstract: Described herein are cholix-IL-10 fusion proteins, and methods of use thereof, which can be characterized by a distinct response in an individual when administered. This distinct response can comprise changes in levels of one or more markers in the individual and/or co-localization of IL-10 in the lamina propria of the individual. Further described herein, in some embodiments, are oral formulations of the cholix-IL-10 fusion proteins. Described herein are methods for the purification of an IL-10 delivery construct, including methods for refolding and enrichment, which can result in maintenance of a high percentage of the IL-10 delivery constructs in the biologically active dimer form. Described herein are oral formulations configured for site-specific release of a therapeutic protein in the small intestines or colon. In some cases, the therapeutic protein is in the form of a dimer, such as an IL-10 delivery construct capable of crossing the gut epithelium.

Abstract: The present invention provides a medicament which results in delivery of a therapeutic level of one or more cannabinoids during a clinically relevant therapeutic window. The therapeutic window is a longer window than provided by an immediate release medicament such as Marinol containing an equivalent amount of the cannabinoid. Oral administration of the present compositions provides therapeutic dosing while maintaining safe, side effect sparing, levels of a cannabinoid. The present invention also provides methods of treating cannabinoid-sensitive disorders.

Abstract: Analgesic sublingual formulations of dexmedetomidine and methods of use thereof are provided for use in the prevention, treatment and management of pain and other conditions.

Abstract: Disclosed herein are oral dosage forms of hydromorphone that are resistant to abuse and methods of their formulation. In particular, oral dosage forms that are resistant to dissolution in aqueous solutions of ethanol are described.

Abstract: Disclosed herein are oral dosage forms of therapeutic agents that are resistant to abuse and methods of their formulation. In particular, oral dosage forms that are resistant to dissolution in aqueous solutions of ethanol are described.

Abstract: Disclosed herein are oral dosage forms of opioid therapeutic agents that are resistant to abuse and methods of their formulation. In particular, oral dosage forms that are resistant to dissolution in aqueous solutions of ethanol are described. The oral dosage forms may include one or more opioid antagonists that are sequestered from the opioid therapeutic agent such that the opioid antagonist has no substantial effect on the activity of the opioid therapeutic agent when the dosage form is taken orally as prescribed, but the opioid antagonist is released in an amount that reduces the effectiveness of the opioid therapeutic agent contained in the dosage form when the dosage form is crushed.

Abstract: Disclosed herein are oral dosage forms of opioid therapeutic agents that are resistant to abuse and methods of their formulation. In particular, oral dosage forms that are resistant to dissolution in aqueous solutions of ethanol are described. The oral dosage forms may include one or more opioid antagonists that are sequestered from the opioid therapeutic agent such that the opioid antagonist has no substantial effect on the activity of the opioid therapeutic agent when the dosage form is taken orally as prescribed, but the opioid antagonist is released in an amount that reduces the effectiveness of the opioid therapeutic agent contained in the dosage form when the dosage form is crushed.

Abstract: Disclosed herein are oral dosage forms of therapeutic agents that are resistant to abuse and methods of their formulation. In particular, oral dosage forms that are resistant to dissolution in aqueous solutions of ethanol are described.

Abstract: Disclosed herein are oral dosage forms of hydromorphone that are resistant to abuse and methods of their formulation. In particular, oral dosage forms that are resistant to dissolution in aqueous solutions of ethanol are described.

Abstract: An extended release pharmaceutical compressed composition and dosage form comprising poorly water soluble macrolide antibiotic, surfactant and non-lipophilic, non-polymeric excipient is disclosed. The composition releases the macrolide antibiotic over an extended period of time, generally at least over 12 hours, even in the absence of a release rate-retarding polymer, release rate-retarding coating or release rate-retarding lipophilic excipient. The composition is suitable for once daily or twice daily oral administration for the treatment of many different types of bacterial infections. One embodiment of the compressed composition includes a drug-containing granular composition and a binding composition, wherein the two are mixed together and then compressed into a tablet or pill. The surfactant is in admixture with or coated onto the macrolide antibiotic, and it can be included in the granular composition and/or the binding composition.

Abstract: An oral solid compress composition comprising a magnesium salt is provided. The composition provides a rapid dissolution of the magnesium salt, wherein not less than 75% of the magnesium salt dissolves within 45 minutes after placement in hydrochloric acid (0.1 N, 900 mL) as per USP Method <711>. In a particular embodiment, the magnesium salt is an inorganic salt such as MgO, Mg(OH)2, MgCl2, and others. The composition can be prepared by dry granulation, direct compression or another suitable process. The composition provides a substantially stable dissolution profile for the magnesium salt so that the dissolution profile changes only minimally even after an extended period of storage under pharmaceutically acceptable conditions when packaged in a sealed container-enclosure system. The solid composition may also exclude a cellulose-based composition. The compressed composition can be prepared and stored under anhydrous conditions.