A carrier free nanoparticle formulation with good circulation stability is made for anticancer drug delivery. Nanocrystals crystalized in the medium containing Pluronic F-127 then coated with albumin (Cim-F-Alb) had the smallest size and the most native albumin, and showed most favorable cell interaction profiles and better stability than commercial albumin based Abraxane formulation, while maintaining comparable cytotoxicity to those of Abraxane and solvent-dissolved paclitaxel (PTX).

Methods of making consolidated blend(s) of polymeric material(s) with one or more therapeutic agents (such as an antibiotic) are provided, wherein the method comprises the steps of providing a polymeric material, blending the polymeric material with one or more therapeutic agent(s), pelletizing the blended polymeric material, environmentally treating by various approaches the pelletized polymeric material, and consolidating the environmentally treated pellet. Products made by the methods and uses of the products also are provided.

The present application provides a microsphere in which a main agent is uniformly dispersed in a polymer matrix, wherein an average volume-based particle diameter of the microsphere is 1 μm or more and 150 μm or less, and a variation coefficient of area ratios in four regions is 0.35 or less, wherein the area ratios in four regions are calculated by (s/A)×100 (%) wherein the four regions are prepared by preparing a cross section observation sample obtained by cutting the microsphere; observing the cross section observation sample with an electron microscope at a magnification capable of confirming the main agent in the microsphere or a higher magnification; and dividing the electron microscope observation image into four regions; and A is an area of a respective divided region, and s is a sum of cross section areas of the main agent included in the respective divided region. The microsphere of the present invention can appropriately control the initial release amount of the main agent and its release rate during a subsequent release period, and can continuously release the main agent for a predetermined period of time.

The disclosure features novel lipids and compositions involving the same. Nanoparticle compositions include a novel lipid as well as additional lipids such as phospholipids, structural lipids, and PEG lipids. Nanoparticle compositions further including therapeutic and/or prophylactics such as RNA are useful in the delivery of therapeutic and/or prophylactics to mammalian cells or organs to, for example, regulate polypeptide, protein, or gene expression.

Formulations of tegavivint, methods of making such formulations, and methods of treatment of cancer by administering the formulations.

The present invention relates in part a to multiparticulate sprinkle dosage form comprising duloxetine or a pharmaceutically acceptable salt thereof, having higher acid resistance as compared to commercially available delayed release formulations. It further relates to various methods of administering the said multiparticulate sprinkle dosage forms.

The disclosure provides an injectable neurosteroid nanoparticle formulation comprising nanoparticles having a D50 of less than 2000 nm the nanoparticles comprising a neurosteroid of Formula I,

##STR00001##

where the variables R.sup.1-R.sup.9 and X are defined herein and at least one surface stabilizer. The surface stabilizer can be a polymeric surface stabilizer such as hydroxyethyl starch, dextran, or povidone. The injectable neurosteroid nanoparticle formulation can be an intravenous formulation. The disclosure also provides a lyophilized powder of the injectable neurosteroid nanoparticle formulation that can be reconstituted in an aqueous solution prior to administration. The disclosure provides injectable neurosteroid nanoparticle formulations and dry powders of such formulations that have been sterilized by ebeam irradiation. The disclosure provides a method of treating a patient having a seizure disorder, stroke, or traumatic brain injury, comprising administering an effective amount of the injectable neurosteroid nanoparticle formulation. The disclosure also provides combination methods in which the injectable neurosteroid nanoparticle formulation is a first active agent that is administered in combination with at least one additional active agent.

The present invention relates to a solid or liquisolid formulation comprising corallopyronin A, wherein the formulation comprises an amorphous solid dispersion of corallopyronin A embedded in a water-soluble polymer or corallopyronin A loaded onto porous silica.

Described here are various compositions for the delivery active agents, e.g., antifungal agents. The compositions may be beneficial due to the particular release kinetics associated with them. Various locations and methods for placement of the compositions into the tissues of the nail unit, as well as tissues surrounding the nail milt are also described.

The present invention includes compositions and methods of making a modified release pharmaceutical formulation and a method of preparation for the embedding of modified release multi-particulates into a polymeric or wax-like matrix. The modified release multi-particulates comprise an effective amount of a therapeutic compound having a known or desired drug-release profile. Modified release multi-particulates may include a polymeric coat or may be incorporated into particle or core material. The polymer matrix comprises a thermoplastic polymer or lipophilic carrier or a mixture thereof that softens or melts at elevated temperature and allows the distribution of the modified release multi-particulates in the polymer matrix during thermal processing. Formulation compounds and processing conditions are selected in a manner to preserve the controlled release characteristics and/or drug-protective properties of the original modified release multi-particulates.