The invention relates to an oral polymeric pharmaceutical dosage form which comprises a thermoresponsive eutectic composition which is solid at or about room temperature and fluid at or about body temperature, the eutectic composition mixed together with a crosslinking agent and an active pharmaceutical ingredient (API) to form an API loaded region; and a porous polymeric composition at least partially surrounding the API loaded region to protect the API when the dosage form is in a stomach of the human or animal body, the porous polymeric composition allowing the ingress of water to contact the crosslinking agent thereby facilitating the crosslinking agent to cause crosslinking of the porous polymeric composition, which crosslinked porous polymeric composition allows controlled egress of API via egress of fluid thermoresponsive eutectic composition at the intestine. In a preferred embodiment, the dosage form further comprises a coating there around.

The present invention provides novel pharmaceutical compositions of dimethyl fumarate. The pharmaceutical compositions of the present invention are in the form of a bead and comprise (i) an inert core; (ii) a first layer surrounding the inert core, wherein the first layer comprises dimethyl fumarate; and (iii) an enteric coating surrounding the first layer. Also provided are pharmaceutical compositions in the form of a bead comprising a core and an enteric coating surrounding the core, wherein the core comprises dimethyl fumarate. Methods of using the pharmaceutical compositions of the present invention for treating multiple sclerosis are also included.

The disclosure provides oral cysteamine and cystamine formulations useful for treating cystinosis and neurodegenerative diseases and disorders. The formulations provide controlled release compositions that improve quality of life and reduced side-effects.

The disclosure provides oral cysteamine and cystamine formulations useful for treating cystinosis and neurodegenerative diseases and disorders. The formulations provide controlled release compositions that improve quality of life and reduced side-effects.

The disclosure provides oral cysteamine and cystamine formulations useful for treating cystinosis and neurodegenerative diseases and disorders. The formulations provide controlled release compositions that improve quality of life and reduced side-effects.

A rotary die system that includes first and second axially aligned, coacting rotary dies positioned adjacent one another. Each die includes a working surface having a plurality of recesses defined therein. The recesses in the first die are each configured to align with a recess in the second die to form a product cavity upon coaction of the first and second dies. The product cavity is configured to receive a product. Each recess in at least one of the first or second dies includes a pin therein that is configured to puncture a film that at least partially surrounds the product.

Embodiments of the instant disclosure relate to novel methods and compositions for treating tumors resistant to immune checkpoint inhibitors. In certain embodiments, compositions herein can have at least one nanoparticle formed of Prussian blue materials and, optionally, one or more CD137 agonists. In other embodiments, methods of treating tumors herein can include administering an effective amount of at least photothermal therapy agent in combination with at least one CD137 agonist separately or in a combination therapy/combination composition.

Agents, kits, and methods that utilize oxygenation to prevent and/or treat intestinal inflammation and/or infections caused by anaerobic microorganisms are provided. In several embodiments, the formulations are provided as a capsule within a capsule in order to separate an oxygen prodrug from a catalyst until the formulation is at a target site within the intestine. In several embodiments, the catalyst is provided in an excess of the oxygen prodrug. In several embodiments, the prodrug is within an inner capsule or coating and a biological material comprising a catalyst (e.g., yeast, spirulina, chlorella, etc.) surrounds the encapsulated prodrug and the biological material is within a capsule or coating. The agents, kits, and methods can be utilized to prevent and/or treat anaerobic bacterial infections of the intestinal lumen by enteric aerobization therapy.

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

Provided are pharmaceutical compositions and methods for preparing pharmaceutical compositions comprising coated API. Excess coating material that is not bound to coated API may be removed by a sieving process. Coating and dosing ratios can also be optimized to minimize the amount of excess unbound coating material. Additionally, the compositions can be formulated to preserve the functional coating of coated API and to minimize aeration of API when mixed into suspension.