The present invention discloses dry formulations of room temperature stable vaccines that comprise a live attenuated virus, a sugar stabilizer, and an amino acid stabilizer. The present invention also discloses the manufacture of such vaccines and methods of protecting an animal by administration of such vaccines.

A novel highly stable sodium diacetate crystal, in which the volatilization of acetic acid can be suppressed for a long period. More specifically, a sodium diacetate crystal having a median diameter in the range of 300 to 3000 μm.

The present invention relates to a starch-free soft chew formulation for oral delivery of at least one active ingredient to an animal, and a starch-free soft chew containing the formulation and at least one active ingredient. The starch-free soft chew includes one or more active ingredients and excipients, such as a bulking agent, a flavoring agent, a humectant, a preservative, an antioxidant, and a lubricant, but no added water. In addition, the invention relates to a composition of starch-free, non-water excipients for use in the final dosage form of a soft chew for oral administration of at least one active ingredient to an animal. Also provided are processes for making the starch-free soft chew formulation and the starch-free soft chew.

A water-insoluble composition, solid in appearance at a temperature of less than or equal to 20° C., comprising, for 100% of the mass of same:—X1% by mass of at least one lipophilic surfactant having a value HLB, H1, greater than or equal to 1 and less than 10;—X2% by mass of at least one hydrophilic surfactant having a value HLB, H2, greater than or equal to 10 and less than or equal to 20; characterised by the fact that the HLB of same=X1.H1+X2.H2, X1 and X2 varying from 2 to 60, and characterised in that it is free of acrylic polymer and/or of acetate succinate.

The present invention has an object providing microparticles having an average particle size of 100 μm or less.

The present invention provides microparticles having an average particle size of 100 μm or less and a method for producing thereof. In addition, the present invention provides medicine, food and feedstuff comprising the microparticles having an average particle size of 100 μm or less.

Disclosed herein are diketopiperazine microparticles having a specific surface area of less than about 67 m.sup.2/g. The diketopiperazine microparticle can be fumaryl diketopiperazine and can comprise a drug such as insulin.

A respirable dry powder can include acetylsalicylic acid in particles having a mass median aerodynamic diameter (MMAD) within a range of about 0.5 μm to about 10 μm. The respirable dry powder may contain a pharmaceutically acceptable excipient, such as an amino acid (e.g., Leucine), in an amount ranging from about 0.1% (w/w) to about 40% (w/w) of the particles.

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,

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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.

A new process for making ivabradine hydrochloride drug product reduces the amount of amorphous ivabradine hydrochloride in the drug product.

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The present invention describes a pharmaceutical and/or nutritional composition comprising methylfolate in the form of granules, together with a carnitine derivative salt, pharmaceutically acceptable excipients, and optionally other pharmaceutical or nutraceutical active ingredients. The composition is useful for oral administration. The invention also relates to the process for obtaining the composition comprising methylfolate in the form of granules and the use thereof for the treatment of disorders associated with a reduction of methylfolate, wherein methylfolate is useful.