Gastric residence systems comprising therapeutic agent formulations for sustained gastric release of therapeutic agents are disclosed, as well as methods for using such systems. The systems are characterized by use of a dispersant in the formulations, which improves the burst release characteristics and long-term release rate characteristics of the systems. Milling of therapeutic agent can also be performed to prepare agent particles of desired size.

A phosphor-containing drug activator activatable from a Monte Carlo derived x-ray exposure for treatment of a diseased site. The activator includes an admixture or suspension of one or more phosphors capable of emitting ultraviolet and visible light upon interaction with x-rays, wherein a distribution of the phosphors in the diseased target site is based on a Monte Carlo derived x-ray dose distribution. A system for treating a disease in a subject in need thereof, includes the drug activator and a photoactivatable drug, one or more devices which infuse the photoactivatable drug and the activator including the pharmaceutically acceptable carrier into a diseased site in the subject; and an x-ray source which is controlled to deliver the Monte Carlo derived x-ray exposure to the subject for production of ultraviolet and visible light inside the subject to activate the photoactivatable drug and induce a persistent therapeutic response, the dose comprising a pulsed sequence of x-rays delivering from 0.5-2 Gy to the tumor.

The disclosure relates to methods for treating or preventing an Insomnia Disorder by administering to a human in need thereof a compound of formula (I), or a compound of formula (IA), (IB), or (IC), or a solvate thereof, in a daily dose of from about 0.5 mg to about 6.0 mg. In certain embodiments, such compounds effectively treat or prevent an Insomnia Disorder in the animal, while producing reduced side effects compared to previously available compounds. ##STR00001##

A probiotic composition and method for activating probiotic spores for consumption by a human to reduce inflammation in or treat inflammatory conditions in the gut. A probiotic composition comprises a nutrient-germinant composition, one or more species of Bacillus spores, and optionally a food or beverage product, which are mixed or pre-mixed in any combination. A nutrient-germinant composition comprises one or more L-amino acids, optionally a source of potassium ions, and optionally one or more buffers, if the source of potassium ions is not also a buffer. A method of activating the spores comprises heating the probiotic composition or food or beverage containing the probiotic composition to a temperature range of around 42° C.-100° C., more preferably 70° C.-85° C. prior to being administered to ingested. Dosing the probiotic composition at around 1 to 4 grams per day over a treatment cycle can reduce indicators of inflammation by at least 10-20% or more.

A topical treatment for anorectal disorders with and without utilization of a contoured seat cushion with a temperature-adapted or electrical stimulation element that can provide hot or cold temperatures or electrical stimulation to the anorectal region.

An application device for a fluid delivery includes a housing having a bore extending from a bottom of the housing. The bore is sized and shaped for receiving at least a portion of the fluid delivery apparatus. The application device also includes an impact component for impacting the fluid delivery apparatus and moving at least a portion of the fluid delivery apparatus towards a user's skin. The application device includes a safety arm that is positionable relative to the impact component between a locked configuration in which the impact component is secured in a safety position, and a released configuration in which the impact component is free to move within the housing for impacting the fluid delivery apparatus.

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.

Methods and compositions for delivering medicine and other substances to the brain and the body via the cribriform plate using foamable compositions are described. Methods and compositions for improving nasal hygiene and moisturizing the nasal cavity using foamable compositions are also described.

The present invention relates to pharmaceutical compositions comprising the selective beta 1 (B1)-receptor blocker nebivolol and/or a pharmaceutically acceptable salt thereof and a liquid vehicle comprising a semifluorinated alkane. The pharmaceutical composition of the present invention is useful for topical administration, for example ophthalmic topical administration and for use in the treatment of glaucoma, increased intraocular pressure, ocular hypertension and/or a symptom associated therewith.

Provided herein are variant adeno-associated virus (AAV) capsid proteins having one or more modifications in amino acid sequence relative to a parental AAV capsid protein, which, when present in an AAV virion, confer increased infectivity of one or more types of retinal cells as compared to the infectivity of the retinal cells by an AAV virion comprising the unmodified parental AAV capsid protein. Also provided are recombinant AAV virions and pharmaceutical compositions thereof comprising a variant AAV capsid protein as described herein, methods of making these rAAV capsid proteins and virions, and methods for using these rAAV capsid proteins and virions in research and clinical practice, for example in, e.g., the delivery of nucleic acid sequences to one or more ceils of the retina for the treatment of retinal disorders and diseases.