Embodiments of stable topical compositions for administering fenoldopam (compound (I) or a pharmaceutically acceptable salt or solvate thereof are disclosed for immediate or continued slow release administration, over prolonged periods of time with safe minimal systemic exposure of fenoldopam (reducing the risk for lowering blood pressure). The compositions include those compositions that increase the stability and skin absorption of the drug, particularly anhydrous semi-solid compositions and creams. This is accomplished by incorporating fenoldopam in soluble or dispersed form into semi-solid compositions like ointments or anhydrous gels that are not irritative. Embodiments of methods for using the topical compositions in the treatment of dermatological disorders including psoriasis, alopecia atopic dermatitis and vitiligo are disclosed. ##STR00001##

The present invention relates to a new formulation of specific nutritional ingredients (nutraceuticals) and/or pharmaceutical compounds.

This invention provides, in part, various compositions and methods for protecting the gastrointestinal microbiome from antibiotic disruption.

The present invention provides, in part, formulations comprising an alkaline phosphatase. Particularly, modified-release formulations comprising an alkaline phosphatase are provided, which release a substantial amount of the alkaline phosphatase in the intestines. Therapeutic uses of the alkaline phosphatase formulations are also provided.

Pharmaceutical compositions comprising an immediate release component comprising 4-((L-valyl)oxy)butanoic acid and a modified release component comprising 4-((L-valyl)oxy)butanoic acid and the pharmacokinetics of 4-((L-valyl)oxy)butanoic acid and γ-hydroxybutyrate following oral administration of the pharmaceutical compositions is disclosed.

The present invention is concerned with controlled release compositions for oral administration comprising 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N- isopropylamino]butyloxy}-N-(methylsulfonyl)acetamide (selexipag, NS-304, ACT- 293987) and its pharmaceutically acceptable salts and/or 2-(4-((5,6-diphenylpyrazin-2-yl)(isopropyl)amino)butoxy)acetic acid (metabolite of selexipag, MRE-269, ACT- 333679) and its pharmaceutically acceptable salts; and with processes for preparing such controlled release compositions as well as to uses thereof.

The invention provides oral vaccine formulations which deliver an antigen in the vicinity of the distal ileum and the area of the ileal Brake and/or the appendix. These vaccines are useful in the treatment and/or prevention of variety of disorders, including viral and bacterial infections and cancers. Related methods of treatment which use the oral vaccine formulations of the invention are also provided.

Modified release formulations of gamma-hydroxybutyrate having improved dissolution and pharmacokinetic properties are provided, and therapeutic uses thereof.

In one aspect, the present invention is directed to a method of making a controlled release solid dosage form having an ethylcellulose coating layer, which layer comprises a coalescing agent which is an organic ester having an HLB Value of from 3 to 8. The use of such coalescing agent permits the formation of an effective controlled release coating without the need for a further curing step after the coating process. In other aspects, this invention relates to an aqueous dispersion useful in such method; as well as to the coated dosage form produced.

The present invention relates to delayed release pharmaceutical compositions comprising linaclotide or pharmaceutically acceptable salts thereof, as well as to various methods and processes for the preparation and use of the compositions.