Abstract: The present disclosure provides pharmaceutical compositions of remdesivir that may be administered by inhalation. These compositions may allow the achievement of a therapeutically effective dose of remdesivir directly to the lungs. These compositions may be used to treat one or more diseases or disorders such as a viral infection like an infection of a coronavirus.

Abstract: The present disclosure provides pharmaceutical compositions prepared using an additive manufacturing process where the active pharmaceutical ingredient has been rendered into the amorphous form or prepared as an amorphous solid dispersion at a temperature below the melting point of the active pharmaceutical ingredient or the glass transition of the physical mixture or composition of the individual components. The present disclosure also provides methods of preparing these compositions by using properties such as the chamber and surface temperature and the electron laser density.

Abstract: Described herein are dry vaccine compositions and methods of freezing aluminum-containing vaccines such that when converted into a dried powder, the dry vaccine can be readily reconstituted to form a stable liquid vaccine without significant loss of activity.

Abstract: Compositions and methods for making a pharmaceutical dosage form include making a pharmaceutical composition that includes one or more active pharmaceutical ingredients (API) with one or more pharmaceutically acceptable excipients by thermokinetic compounding into a composite. Compositions and methods of preprocessing a composite comprising one or more APIs with one or more excipients include thermokinetic compounding, comprising thermokinetic processing the APIs with the excipients into a composite, wherein the composite can be further processed by conventional methods known in the art, such as hot melt extrusion, melt granulation, compression molding, tablet compression, capsule filling, film-coating, or injection molding.

Abstract: The present disclosure provides pharmaceutical compositions comprising a thermally conductive excipient which may be used to improve the heat transfer within the pharmaceutical compositions in a high energy mixing process. The resultant pharmaceutical compositions may be amorphous in nature and improve the processability of thermally labile or shear sensitive active agents.

Abstract: The present disclosure provides pharmaceutical compositions of niclosamide that may be administered orally. These compositions may allow the achievement of a therapeutically effective dose of niclosamide while preventing crystallization in the stomach which reduces bioavailability. These compositions may be used to treat one or more diseases or disorders such as a viral infection or cancer.

Abstract: Dry powder compositions comprising biologically active antibodies or antibody fragments thereof are provided herein. In some aspects, the present disclosure includes methods of manufacturing these compositions and methods of using them in pulmonary administration or applying them to a tissue surface through a medical dry powder blower/sprayer/insufflator.

Abstract: Described herein is the use of thin film freeze drying methods with oil-in-water adjuvants to produce improved vaccine compositions. This approach solves several major problems associated with the emulsion-adjuvanted vaccines. Additionally, the developed dry powder compositions have the potential to be administered via non-invasive routes (such as intranasal, pulmonary, transcutaneous with or without microneedles) and be stored at ambient temperatures which significantly reduce the costs of vaccination programs.

Abstract: Described herein are dry powder compositions of liposomes, liposomal adjuvant or liposomal adjuvanted vaccines. Formulations containing a cryoprotectant can be converted to dry powders using, e.g., thin-film freeze-drying (TFFD). The composition may comprise a liposomal adjuvant, such as AS01B adjuvant, or also including an antigen, i.e., AS01B-adjuvanted vaccine compositions.

Abstract: Described herein are dry powder compositions of liposomes. Formulations containing a cryoprotectant can be converted to dry powders using, e.g., thin-film freeze-drying (TFFD) to obtain stabilized composition that show improved properties.

Abstract: The present invention includes compositions and methods for making and using a rapid dissolving, high potency, substantially amorphous nanostructured aggregate for pulmonary delivery of tacrolimus and a stabilizer matrix comprising, optionally, a polymeric or non-polymeric surfactant, a polymeric or non-polymeric saccharide or both, wherein the aggregate comprises a surface area greater than 5 m2/g as measured by BET analysis and exhibiting supersaturation for at least 0.5 hours when 11-15-times the aqueous crystalline solubility of tacrolimus is added to simulated lung fluid.

Abstract: Pharmaceutical formulations including an inclusion complex of an API with a cyclic oligomer, and methods of forming such pharmaceutical formulations are described.

Abstract: The present disclosure relates to pharmaceutical formulations including abiraterone and a cyclic oligomer, as well as tablets including such pharmaceutical formulations, methods of forming such pharmaceutical formulations, and methods of administering such pharmaceutical formulations or tablets.

Abstract: The present invention includes compositions and methods for treating and delivering medicinal formulations using an inhaler. The composition includes a space filled flocculated suspension having one or more flocculated particles of one or more active agents and a hydrofluoroalkane propellant. A portion of the one or more flocculated particles is templated by the formation of hydrofluoroalkane droplets upon atomization and the templated floc compacts upon the evaporation of the hydrofluoroalkane propellant to form a porous particle for deep lung delivery.

Abstract: The disclosure relates to dry powder compositions of (a) a plant-based cannabidiol (pCBD) composition, or (b) a plant-based tetrahydrocannabinol composition (pTHC); or (c) a synthetic cannabidiol composition (sCBD), or (d) a synthetic tetrahydrocannabinol composition (sTHC), or (e) a plant-based cannabidiol (pCBD) composition in combination with a plant-based tetrahydrocannabinol composition (pTHC), or (f) a synthetic cannabidiol composition (sCBD) in combination with a synthetic tetrahydrocannabinol composition (sTHC) and their delivery to the airway of a subject using a dry powder inhaler.

Abstract: In some aspects, the present disclosure provides methods of preparing pharmaceutical compositions using an suspension based thin film freezing method to obtain inhalable compositions. These compositions may have a higher homogeneity compared to compositions prepared using conventional methods. These compositions may be used to treat or prevent one or more diseases or disorders.

Abstract: In some aspects, the present disclosure provides pharmaceutical compositions comprising particles, wherein individual particles of the composition comprise a combination of two or more active pharmaceutical ingredients selected from: (A) nintedanib; (B) pirfenidone; and/or (C) mycophenolic acid. These compositions may be formulated for administration via inhalation. In some aspects, the present disclosure provides methods for preparing the pharmaceutical compositions of the present disclosure and methods of treating or preventing a disease or disorder using the pharmaceutical compositions of the present disclosure.

Abstract: Compositions and methods for making a pharmaceutical dosage form include making a pharmaceutical composition that includes one or more active pharmaceutical ingredients (API) with one or more pharmaceutically acceptable excipients by thermokinetic compounding into a composite. Compositions and methods of preprocessing a composite comprising one or more APIs with one or more excipients include thermokinetic compounding, comprising thermokinetic processing the APIs with the excipients into a composite, wherein the composite can be further processed by conventional methods known in the art, such as hot melt extrusion, melt granulation, compression molding, tablet compression, capsule filling, film-coating, or injection molding.

Abstract: The present invention includes compositions and methods for making and using a rapid dissolving, high potency, substantially amorphous nanostructured aggregate for pulmonary delivery of tacrolimus and a stabilizer matrix comprising, optionally, a polymeric or non-polymeric surfactant, a polymeric or non-polymeric saccharide or both, wherein the aggregate comprises a surface area greater than 5 m2/g as measured by BET analysis and exhibiting supersaturation for at least 0.5 hours when 11-15-times the aqueous crystalline solubility of tacrolimus is added to simulated lung fluid.

Abstract: The present invention includes compositions and methods for treating and delivering medicinal formulations using an inhaler. The composition includes a space filled flocculated suspension having one or more flocculated particles of one or more active agents and a hydrofluoroalkane propellant. A portion of the one or more flocculated particles is templated by the formation of hydrofluoroalkane droplets upon atomization and the templated floc compacts upon the evaporation of the hydrofluoroalkane propellant to form a porous particle for deep lung delivery.