A consumable macromolecular article of manufacture formed by the complexation of protein and polysaccharide polymers stabilized by chemical or physical crosslinking and subsequently cast and molded into macrocapsules of at least 1 mm in diameter. The resulting macrocapsules are a highly versatile delivery product capable of encapsulating and stably retaining a wide range of active ingredients, both liquids and solids, in the amorphous regions of the complexed and crosslinked macromolecular structure, and releasing such active ingredients only upon chewing and/or upon exposure to the digestive environment. Dissimilar layers may be utilized to combine multiple active ingredients and/or control the active ingredient release profiles. The article of manufacture is thermally stable and structurally robust providing relatively low-cost commercial manufacture and distribution and exhibiting a texture and consistency that is organolepically pleasing.

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.

Aspects of the present invention are directed to abuse resistant oral dosage forms comprising a compressed microtablet that is coated with a water-retardant polymer. Additional aspects of the present invention are directed to an oral dosage form comprising an opioid agonist and at least one compressed microtablet coated with a water retardant polymer. The compressed microtablet may comprise an opioid antagonist.

A dosage form comprising a tablet core and one or more discontinuous coated regions in various configurations on the surface of the dosage form is disclosed. A method for making the dosage form is also disclosed.

The present invention relates to an improved gelatinous coated dosage form having two end regions coated with gelatinous materials and an exposed circumferential band. Openings are provided in at least the exposed band to reveal the core material. The invention also relates to methods for manufacturing such gelatinous coated dosage forms.

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.

The present disclosure is directed to compositions and methods for the production of a fast dissolving tablets to be used for the delivery of an agent. An agent can be an active pharmaceutical agent or a non-pharmacological agent, which is needed to be delivered by means of a fast dissolving delivery system. The invention solves many industry challenges within the field of fast dissolve technologies, specifically coupling of fast dissolve properties with required physical attributes of strength/robustness required for commercial production and distribution.

A delivery vehicle with a core surrounded by a digestible polymer shell having a melting and/or softening point above the body temperature of an animal or human, and where the core has a lipid and/or lipophilic active ingredient dispersed in a continuous polymer matrix. The delivery vehicle can be used to release lipid and/or lipophilic active ingredients, such as pharmaceuticals, nutraceuticals, supplements, traditional/herbal medicine, or combinations thereof, after a predetermined lag time following ingestion.

The disclosure provides a bi-layer, pressed particles, adhering troche, comprising, (a) a first layer of pressed particles comprising an ingredient to be released; (b) a second, adhesive layer of pressed particles comprising a mixture of at least 80% by weight gelatin particles and 1-15% by weight compression binder particles so that the gelatin particles have a greater tensile strength from one to another than if the gelatin particles had been pressed without the binder; wherein the troche has a first non-adhesive side and a second adhesive side; wherein the troche is at least 5 mm in two dimensions; and wherein the troche adhered in a mouth dissolves without smearing or breaking apart.

A delivery vehicle comprising a core (1) surrounded by a digestible polymer shell (4) having a melting and/or softening point above the body temperature of an animal or human, wherein said core comprises a lipid and/or lipophilic active ingredient (2) dispersed in a continuous polymer matrix (3). The delivery vehicle can be used to release lipid and/or lipophilic active ingredients, such as pharmaceuticals, nutraceuticals, supplements, traditional/herbal medicine, or combinations thereof, after a predetermined lag time following ingestion.