The disclosure concerns methods for executing PBV protocols to preserve biopharmaceuticals using a conventional lyophilizer. Also described are steps for maintaining isolation of a biopharmaceuticals for achieving aseptic drying using the conventional lyophilizer. As a collateral benefit, the invention provides good manufacturing practice (GMP) compliant methods for achieving aseptic drying of biopharmaceutical compositions using a conventional lyophilizer disposed outside of a clean-room area. Finally, methods and formulations str disclosed for preserving biopharmaceuticals suitable for mucosal or transdermal delivery to a patient.

The invention relates to stable preparations of thymoquinone and methods of making and administering stable preparations of thymoquinone. Embodiments of the methods provide compositions comprising thymoquinone with phosphatidylcholine and/or guggulsterol and/or guggulsterol derivatives and/or sodium cholesteryl sulfate, in tablet, capsule, gel, or ointment forms, and method of administering the preparations.

The present disclosure relates to inhalable dry powder compositions comprising cannabinoids. In particular, the formulations are intended for use with dry powder inhalers for single use or multiple use comprising replaceable cartridges for delivery to the deep lung as medicinal agents. The inhalable dry powders are useful in the treatment of diseases and disorders, including pain.

Disclosed herein are nanostructures, compositions, and methods for treating ocular disorders, injuries, and infections using RNA complexed nanoparticles (e.g., RNA-templated lipoprotein particles, miRNA-high density lipoprotein particles). These nanostructures are contemplated in topical therapies.

The present disclosure provides a novel animal model of NEHI, and method of preventing and/or treating a pulmonary disease, particularly the lung-based complications in NEHI, such as pulmonary edema, by targeting the PNEC product, such as the CGRP signaling. Also disclosed is the pharmaceutical composition for preventing and/or treating a pulmonary edema and/or other pulmonary disease, particularly, NEHI, comprising one or more CGRP signaling antagonist and/or inhibitor of the present disclosure.

The invention provides methods for treating a patient with a disorder, such as a GI disorder or symptoms associated with a GI or non-GI disorder, by administering a therapeutically effective amount of a delayed release pharmaceutical composition comprising linaclotide.

The present disclosure provides a microparticulate comprising one or more cannabinoids and a pH dependent release polymer. In embodiments, the one or more cannabinoids are present in an amount ranging from 10% w/w to about 50% w/w. In embodiments, the pH dependent release polymer is present in an amount ranging from ranging from about 5% w/w to about 85% w/w.

The present disclosure provides extended release trihexyphenidyl compositions suitable for once- or twice-daily administration. The compositions comprise a core comprising at least one organic acid; at least one drug layer comprising trihexyphenidyl or a pharmaceutically acceptable salt thereof over the core; and a functional coat over the drug-layered core. The compositions of the disclosure provide extended release with reduced C.sub.max, a C.sub.min:C.sub.max ratio of ≥0.4, Fluctuation Index of ≤1, while providing and maintaining at least a minimum therapeutically effective plasma concentration, of the trihexyphenidyl or the pharmaceutically acceptable salt thereof for at least about 10 hours. The compositions of the disclosure improve solubility of the trihexyphenidyl or the pharmaceutically acceptable salt thereof at a pH of greater than or equal to 5, to provide and maintain at least a minimum effective concentration of the drug at such pH.

The present disclosure is directed to an extended release composition containing Vitamin C in a lipid matrix, which releases the Vitamin C over a period of time.

The disclosure provides new, stable, pharmaceutically acceptable amorphous solid dispersions of 1-(4-fluoro-phenyl)-4-((6bR,10aS)-3-methyl-2,3,6b,9,10,10a-hexahydro-1H,7H-pyrido[3′,4′:4,5]pyrrolo[1,2,3-de]quinoxalin-8-yl)-butan-1-one, together with methods of making and using them, and pharmaceutical compositions comprising them.