Described herein are RPE cells engineered to secrete a FVII protein, as well as compositions, pharmaceutical preparations, and implantable devices comprising the engineered RPE cells, and methods of making and using the same for treating a patient with hemophilia or FVII deficiency.

Embodiments provide swallowable devices, preparations and methods for delivering viable cells (VC) into the GI tract including GI wall tissue or other tissue site. Particular embodiments provide a swallowable device such as a capsule for delivering VC into an intestinal wall or other site. The VC can be contained within a tissue-penetrating shell disposed in the capsule that protects the VC as they pass through the GI tract until they are inserted into GI tract tissue or other location. The shell desirably has shape, size and material consistency to be contained in a swallowable capsule, delivered from the capsule into solid tissue by the application of force on the shell and biodegrade within the solid tissue to release the VC into the tissue. Within the shell or other structure the VC can be maintained in a viability-sustaining gel that preserves the viability of the VC for selected time periods.

The present disclosure generally relates to preservation and delivery of a bioactive composition to a biological subject. In some embodiments, the bioactive composition include bioactives of at least one of microbes, cells, tissue, vaccines, probiotics, antibiotics, vitamins, or mRNA. Some embodiments include preserving the bioactive composition using vitrification of the bioactive composition in a vitrifying mixture of intrinsically disordered proteins and saccharides. The vitrified bioactive composition is configured to release the bioactive composition from the vitrifying mixture. Some embodiments include administering the vitrified bioactive composition to the biological subject, such that the administering includes applying the vitrified bioactive composition to a microbiome of the biological subject. Some embodiments may further include providing an enteric encapsulation of the vitrified bioactive composition that is configured to protect the vitrified bioactive composition from a first set of environmental conditions, but release the vitrified bioactive composition in a second set of environmental conditions.

A subcritical liquid extraction process for the production of oleandrin or oleandrin-containing extract is provided. The process provides improvements over other methods of preparing oleandrin-containing extract. The extract, pharmaceutical compositions, dosage forms and nutraceutical compositions comprising oleandrin or said extract are provided. Methods of treating diseases, disorders or conditions that are therapeutically responsive to oleandrin are also provided.

Embodiments of the invention provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents within the GI tract. Many embodiments provide a swallowable device for delivering the agents. Particular embodiments provide a swallowable device such as a capsule for delivering drugs into the intestinal wall or other GI lumen. Embodiments also provide various drug preparations that are configured to be contained within the capsule, advanced from the capsule into the intestinal wall and degrade to release the drug into the bloodstream to produce a therapeutic effect. The preparation can be operably coupled to delivery means having a first configuration where the preparation is contained in the capsule and a second configuration where the preparation is advanced out of the capsule into the intestinal wall. Embodiments of the invention are particularly useful for the delivery of drugs which are poorly absorbed, tolerated and/or degraded within the GI tract.

The invention relates to floating drug delivery systems (FDDS) that provide solutions to the particular problems often encountered with floating drug delivery systems described in the art. On such generally recognized problem is the vulnerability of the systems, especially damage to the gas-filled compartment making it accessible to water so as to impair its buoyancy, ultimately resulting in insufficient gastric residence time. The invention, in an aspect, provides a self-repairing FDDS that maintains its floating capacity after damaging. The floating drug delivery systems of the invention, furthermore, allow for incorporation of high loads of active ingredients. The floating drug delivery systems can be designed in such a way that release of active ingredient from the system occurs entirely independent from the pH of the fluid surrounding the system. Furthermore, the procedure of manufacturing the floating drug delivery system of the invention is simple and straightforward, and therefore economically attractive.

The present invention is directed to an immediate release and extended release capsule or capsule fill which mitigates the abuse of abuse-susceptible active pharmaceutical ingredients by direct intravenous injection. The fill comprises a parenteral abuse resistant liquid formulation which when mixed with water and heated, results in a turbid, viscous or bubbling mixture that is not injectable with a standard insulin syringe. The abuse-susceptible active pharmaceutical ingredient is selected from the group consisting of opiates, opioids, tranquilizers, stimulants and narcotics.

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.

The present invention includes a medicated dental floss and a method of making a medicated dental floss comprising: stretching a dental floss; dipping the dental floss in a biocompatible polymer—solvent bath to coat the braided dental floss; drying the coated braided dental floss; dipping the coated dental floss in a medicated solution comprising an encapsulated medicament; and drying the medicated encapsulant on the coated dental floss.

The invention provides an oral solid formulation comprising (a) a controlled release component comprising a core comprising levodopa, wherein the core is coated with a layer of a muco-adhesive polymer and externally coated with a layer of an enteric polymer; and (b) an immediate release component comprising carbidopa and levodopa.