The invention provides pharmaceutical compositions of berberine ursodeoxycholate (BUDCA) and methods of use thereof for the treatment fatty liver disease, diabetes, hyperlipidemia, and liver fibrosis, and related diseases and conditions.

Vaginal lubricants that have salts which are biomatched to salts that are naturally present in the vagina facilitate intercourse without toxic effects. Topical substances that have a low buffering capacity to promote fertility by providing lubricity while minimizing disturbance to the natural pH levels present during intercourse. A low buffering capacity reduces the extent to which a product interferes with natural pH and buffering capacity of fluids that are present during intercourse.

Vaginal lubricants that have salts which are biomatched to salts that are naturally present in the vagina facilitate intercourse without toxic effects. Topical substances that have a low buffering capacity to promote fertility by providing lubricity while minimizing disturbance to the natural pH levels present during intercourse. A low buffering capacity reduces the extent to which a product interferes with natural pH and buffering capacity of fluids that are present during intercourse.

The present invention provides a method of suppressing hunger by lowering plasma ghrelin levels comprising administration of a compound to a human or animal body, wherein the compound is selected from: (i) (R)-3-hydroxybutyrate; (ii) an ester of (R)-3-hydroxybutyrate; and (iii) an oligomer of (R)-3-hydroxybutyrate moieties; or a pharmaceutically acceptable salt or solvate thereof. The invention also provides a method of administering such a compound in a dosage effective to reduce hunger in order that a cosmetically beneficial loss or maintenance of body weight occurs, wherein in the method, plasma ghrelin levels are lowered. The aforementioned compound is also provided for use in a method of treatment of the human or animal body wherein the compound is administered and hunger is suppressed by lowering of plasma ghrelin levels. The compound is particularly useful for subjects having conditions associated with overeating, such as overweight, obese, severely obese patients or diabetic patients.

The subject matter described herein is directed to stable L-cysteine compositions for injection, comprising: L-cysteine or a pharmaceutically acceptable salt thereof and/or hydrate thereof in an amount from about 10 mg/mL to about 100 mg/mL; Aluminum in an amount from about 1.0 parts per billion (ppb) to about 250 ppb; cystine in an amount from about 0.01 wt % to about 2 wt % relative to L-cysteine; pyruvic acid in an amount from about 0.01 wt % to about 2 wt % relative to L-cysteine; a pharmaceutically acceptable carrier, comprising water; headspace O.sub.2 that is less than 1.0%; dissolved oxygen present in the carrier in an amount from about 0.01 parts per million (ppm) to about 1 ppm, wherein the composition is enclosed in a single-use container having a volume of from 10 mL to 100 mL. Also described are compositions for a total parenteral nutrition regimen and methods for their use.

The subject matter described herein is directed to stable L-cysteine compositions for injection, comprising: L-cysteine or a pharmaceutically acceptable salt thereof and/or hydrate thereof in an amount from about 10 mg/mL to about 100 mg/mL; Aluminum in an amount from about 1.0 parts per billion (ppb) to about 250 ppb; cystine in an amount from about 0.01 wt % to about 2 wt % relative to L-cysteine; pyruvic acid in an amount from about 0.01 wt % to about 2 wt % relative to L-cysteine; a pharmaceutically acceptable carrier, comprising water; headspace O.sub.2 that is less than 1.0%; dissolved oxygen present in the carrier in an amount from about 0.01 parts per million (ppm) to about 1 ppm, wherein the composition is enclosed in a single-use container having a volume of from 10 mL to 100 mL. Also described are compositions for a total parenteral nutrition regimen and methods for their use.

The present invention relates to a reconstitution solution for spray dried plasma having a non-anticoagulant compound that does not bind calcium. When the reconstitution solution of the present invention is mixed with spray dry plasma, the reconstituted plasma mediates platelet adhesion and aggregation about the same as or greater than the starting plasma prior to spray drying. The present invention also relates to an assay for determining platelet adhesion and aggregation using microfluidic flow cell system having a shear flow. The assay assesses labeled whole blood samples having reconstituted plasma having spray dried plasma and a reconstitution solution; platelets; and red blood cells. After inducing a shear flow under conditions suitable for clot formation, coverage area of the platelets, intensity of the platelets, morphology, or a combination thereof is detected to determine platelet accumulation (e.g., platelet adhesion and aggregation).

The present invention relates to a reconstitution solution for spray dried plasma having a non-anticoagulant compound that does not bind calcium. When the reconstitution solution of the present invention is mixed with spray dry plasma, the reconstituted plasma mediates platelet adhesion and aggregation about the same as or greater than the starting plasma prior to spray drying. The present invention also relates to an assay for determining platelet adhesion and aggregation using microfluidic flow cell system having a shear flow. The assay assesses labeled whole blood samples having reconstituted plasma having spray dried plasma and a reconstitution solution; platelets; and red blood cells. After inducing a shear flow under conditions suitable for clot formation, coverage area of the platelets, intensity of the platelets, morphology, or a combination thereof is detected to determine platelet accumulation (e.g., platelet adhesion and aggregation).

A natural water soluble protocatechuic acid and L-theanine cocrystal composition is described. The cocrystal composition may be created by a method including solvent-assisted mechanical grinding. The natural water soluble cocrystal composition is suitable for sublingual administration, preferably to humans.

A natural water soluble protocatechuic acid and L-theanine cocrystal composition is described. The cocrystal composition may be created by a method including solvent-assisted mechanical grinding. The natural water soluble cocrystal composition is suitable for sublingual administration, preferably to humans.