In an embodiment, a pH-responsive drug delivery composition for prolonged drug delivery to a mucosal surface is provided. At acidic pH, the matrix self-seal and forms entity that protects the peptide/drug inside. Upon contact with fluids at neutral pH, the platform forms swollen gel-like matrix that can protect their cargoes, opens and adheres to mucosal surfaces and release their cargoes over extended period of time (e.g., up to one week). In some embodiments, the composition includes a polymer matrix comprising two or more layers and/or polymers, an agent, and one or more of a protease inhibitor and an absorption enhancer; and an enteric coating or capsule encapsulating the polymeric matrix. Methods of making and using the drug delivery platforms are also provided.

The present disclosure relates to a combination of abiraterone acetate and niraparib, free-dose and fixed-dose combinations of abiraterone acetate and niraparib, and methods of treatment of prostate cancer with said combinations.

The present invention relates to compositions comprising thymol and at least one amino acid for use in the preventive and/or curative treatment of inflammatory or functional diseases or symptoms of the intestinal tract by modulating the receptors and/or enzymes of the endocannabinoid system in mammalian or non-mammalian monogastric subjects, such as human subjects, pigs, poultry animals, fish or crustaceans.

In an embodiment, the present disclosure pertains to a stable formulation of a varenicline salt or base form containing composition that prevents or reduces formation of a nitroso impurity until the end of stated expiration or longer. In some embodiments, the composition includes varenicline and at least one pharmaceutical excipient. In some embodiments, the at least one pharmaceutical excipient includes a magnesium salt and at least one of dicalcium phosphate, polyethylene glycol, or polyethylene oxide. In some embodiments, the magnesium salt can include, without limitation, magnesium aluminum silicate, magnesium aluminometasilicate, magnesium carbonate, magnesium oxide, magnesium silicate, magnesium stearate, magnesium sulfate, magnesium trisilicate, and combinations thereof. In some embodiments, a weight ratio of the varenicline to the at least one pharmaceutical excipient ranges from 1 to 99 to 99 to 1% w/w. In some embodiments, the at least one pharmaceutical excipient is a protective pharmaceutical ingredient.

In an embodiment, the present disclosure pertains to a stable formulation of a primary, secondary, and/or tertiary amino group containing composition that prevents or reduces formation of a nitroso impurity until the end of stated expiration or longer. In some embodiments, the composition includes metformin and at least one pharmaceutical excipient. In some embodiments, the at least one pharmaceutical excipient includes a magnesium salt and at least one of a calcium salt, dicalcium phosphate, polyethylene glycol, or polyethylene oxide. In some embodiments, the magnesium salt can include, without limitation, magnesium aluminum silicate, magnesium aluminometasilicate, magnesium carbonate, magnesium oxide, magnesium silicate, magnesium stearate, magnesium sulfate, magnesium trisilicate, and combinations thereof. In some embodiments, a weight ratio of the drug to the at least one pharmaceutical excipient ranges from 1 to 99 to 99 to 1% w/w. In some embodiments, the at least one pharmaceutical excipient is a protective pharmaceutical ingredient.

The disclosure relates to a novel dosage form comprising hard gelatin or HPMC capsule having granule composition, spray dried or evaporated composition comprising tafamidis or its pharmaceutically acceptable salt particularly tafamidis meglumine or solid-state forms or polymorphic forms of tafamidis particularly tafamidis free acid fumaric acid cocrystal and tablet comprising tafamidis or its pharmaceutically acceptable salt particularly tafamidis meglumine or solid-state forms or polymorphic forms of tafamidis particularly tafamidis free acid fumaric acid cocrystal that would not form a rigid gel upon contacting with water or buffer solution in dissolution specifically pH 6.8 phosphate buffer and that composition is indicated for the treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.

The invention provides liquid formulation compositions and medicament delivery devices, and methods for preparing and using the same. For example, the liquid formulation composition is an emulsion including a solvent and liquid particles, which includes surfactants and are dispersed in the solvent. The volume average particle size of the liquid particles is less than about 100 μm; the surface tension of the liquid formulation composition is less than about 60 mN/m; and the absolute value of zeta potential is greater than about 15 mV. The containment vessel may be a sprayer or a dropping device. The invention also provides methods for preparation of the liquid formulation compositions and medicament delivery devices as well as methods for using the same in treatment of various diseases and condition, for example, otitis media, otitis externa, rhinitis, sinusitis, lower respiratory tract inflammation, xerostomia (dry mouth), xerophthalmia (dry eyes) and xeromycteria (dry nose).

Disclosed herein are nanoparticles suitable for use in vaccines. The nanoparticles present antigens from pathogens surrounded to and associated with a detergent core resulting in enhanced stability and good immunogenicity. Dosages, formulations, and methods for preparing the vaccines and nanoparticles are also disclosed.

A process for the preparation of oral delayed release solid formulations and the formulations obtainable from said process are now described. Said process comprises the following steps:

a) melting at least one lipid;

b) spraying said at least one melted lipid on at least one active ingredient in the form of a moving powder;

c) cooling the resulting mixture;

d) optional granulation of the mixture;

e) optional compression of the mixture.

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.