Embodiments of the invention provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents within the GI tract. Some embodiments provide a swallowable device such as a capsule for delivering drugs into the intestinal wall or other GI lumen. The device comprises a capsule sized to be swallowed and pass through the intestinal tract. The capsule can include at least one guide tube, one or more tissue penetrating members positioned in the guide tube, a delivery member, an actuating mechanism and a release element. The release element degrades upon exposure to various conditions in the intestine so as to release and actuate the actuating mechanism. Embodiments of the invention are particularly useful for the delivery of drugs which are poorly absorbed, tolerated and/or degraded within the GI tract.

This invention provides compositions comprising a protein, an absorption enhancer, a protease inhibitor, method for treating diabetes mellitus, comprising administering same, and methods for oral administration of a protein with an enzymatic activity, comprising orally administering same.

Compositions of and methods for formulating and delivering biologically active agent formulations having enhanced physical stability, and wherein deterioration from the presence of oxygen and/or water is minimized and/or controlled, to yield a stable formulation. The compositions of and methods for formulating and delivering biologically active agents of the present invention further facilitate their incorporation into a biocompatible coating which can be employed to coat a stratum-corneum piercing microprojection, or a plurality of stratum-corneum piercing microprojections of a delivery device, for delivery of the biocompatible coating through the skin of a subject, thus providing an effective means of delivering the biologically active agents.

Compositions of and methods for formulating and delivering biologically active agent formulations having enhanced physical stability, and wherein deterioration from the presence of oxygen and/or water is minimized and/or controlled, to yield a stable formulation. The compositions of and methods for formulating and delivering biologically active agents of the present invention further facilitate their incorporation into a biocompatible coating which can be employed to coat a stratum-corneum piercing microprojection, or a plurality of stratum-corneum piercing microprojections of a delivery device, for delivery of the biocompatible coating through the skin of a subject, thus providing an effective means of delivering the biologically active agents.

The present invention relates to method of preventing or treating disease or disorder comprising administration of oral pharmaceutical composition comprising therapeutically effective amount of PTH analog and at least one degradation preventing agent, wherein said composition provides relative bioavailability of at least 0.5%, compare to subcutaneous administration. The present invention also relates to the oral pharmaceutical composition comprising therapeutically effective amount of PTH analog and least one degradation preventing agent in physically separated dosage form and wherein said PTH analogue is in enteric coated form. At least one degradation preventing agent includes combination of at least one metal containing compound and at least one reducing agent where in at least one metal containing compound is selected for group consisting of vanadium containing compound, chromium containing compound and manganese containing compound. Preferably PTH analogue are teriparatide or abaloparatide.

The present invention relates to method of preventing or treating disease or disorder comprising administration of oral pharmaceutical composition comprising therapeutically effective amount of PTH analog and at least one degradation preventing agent, wherein said composition provides relative bioavailability of at least 0.5%, compare to subcutaneous administration. The present invention also relates to the oral pharmaceutical composition comprising therapeutically effective amount of PTH analog and least one degradation preventing agent in physically separated dosage form and wherein said PTH analogue is in enteric coated form. At least one degradation preventing agent includes combination of at least one metal containing compound and at least one reducing agent where in at least one metal containing compound is selected for group consisting of vanadium containing compound, chromium containing compound and manganese containing compound. Preferably PTH analogue are teriparatide or abaloparatide.

Described herein are methods and compositions using PTH and mesenchymal stem cells (MSCs) for treatment of osteoporosis, bone fractures, and related conditions. Administration of both PTH and MSCs leads to increased homing of MSCs to sites of vertebral bone and rib fracture. The described methods and compositions provide therapeutic approaches that rely, in-part, on stem cell capacity for regeneration and repair. The potential for enhanced bone formation and fracture repair may allow for both preventative and palliative treatments in osteoporotic patients, with combined PTH+MSC therapy producing bone regeneration capacity that is significantly superior to either treatment alone.

Described herein are methods and compositions using PTH and mesenchymal stem cells (MSCs) for treatment of osteoporosis, bone fractures, and related conditions. Administration of both PTH and MSCs leads to increased homing of MSCs to sites of vertebral bone and rib fracture. The described methods and compositions provide therapeutic approaches that rely, in-part, on stem cell capacity for regeneration and repair. The potential for enhanced bone formation and fracture repair may allow for both preventative and palliative treatments in osteoporotic patients, with combined PTH+MSC therapy producing bone regeneration capacity that is significantly superior to either treatment alone.

Described herein are methods and compositions using PTH and mesenchymal stem cells (MSCs) for treatment of osteoporosis, bone fractures, and related conditions. Administration of both PTH and MSCs leads to increased homing of MSCs to sites of vertebral bone and rib fracture. The described methods and compositions provide therapeutic approaches that rely, in-part, on stem cell capacity for regeneration and repair. The potential for enhanced bone formation and fracture repair may allow for both preventative and palliative treatments in osteoporotic patients, with combined PTH+MSC therapy producing bone regeneration capacity that is significantly superior to either treatment alone.

The present invention relates to a pharmaceutical composition comprising at least one controlled-release PTH compound or a pharmaceutically acceptable salt, hydrate or solvate thereof, for use in the treatment, control, delay or prevention of a condition that can be treated, controlled, delayed or prevented with PTH, pharmaceutical composition comprising at least one controlled-release PTH compound or a pharmaceutically acceptable salt, hydrate or solvate thereof, for use in the treatment, control, delay or prevention of a condition that can be treated, controlled, delayed or prevented with PTH, wherein said pharmaceutical composition is administered no more frequent than once every 24 hours with a dosage of the controlled-release PTH compound that corresponds to no more than 70% of the molar equivalent dose of PTH 1-84 administered every 24 hours required to maintain serum calcium within normal levels over said 24 hour period in humans.