Compositions and methods for mucosal delivery of agents are provided. The emulsion compositions are intended for administration to a mucosal surface, such as oral, gastrointestinal and nasal mucosa. The emulsion compositions provided contain one or more mucoadhesive proteins and an agent to be delivered. Methods for delivery of agents using the compositions provided herein are also provided.

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##

This invention provides compositions for controlled localized depositing of one or more drugs within a subject. More particularly, described herein are compositions comprising a) a polyethylene glycol (PEG) composition having a first low molecular weight PEG (Mw between 200-500 Da) and a second low molecular weight PEG (Mw between 500-2000 Da) and b) a mucoadhesive in polymer. Alternatively, composition may comprise a) a polyethylene glycol (PEG) composition having a first low molecular weight PEG (Mw between 200-500 Da) and a second low molecular weight PEG (Mw between 500-2000 Da), b) a water insoluble polymer and c) a mucoadhesive polymer. Furthermore, the composition may further comprise one or more drugs. Also provided are methods of manufacturing and administering the compositions described herein, which are used as biodegradable, injectable mucoadhesive low-viscosity pastes.

The present invention relates to a formulation or composition for the treatment, repair, formation or regeneration of bone tissue in a subject, comprising Histatin-1 or its derivatives. The present invention also relates to a biomaterial comprising Histatin-1 or its derivatives in a biocompatible material, and a method for the treatment, repair, formation or regeneration of bone tissues in a subject comprising administering to the subject a therapeutically effective amount of Histatin-1 or its derivatives.

The present invention relates to products and methods for treatment of various symptoms in a patient, including treatment of pain suffered by a patient. The invention more particularly relates to self-supporting dosage forms which provide an active agent while providing sufficient buccal adhesion of the dosage form. Further, the present invention provides a dosage form which is useful in reducing the likelihood of diversion abuse of the active agent.

Vaccine compositions that may be administered to a subject via the buccal and/or sublingual mucosa are provided. Methods for administration and preparation of such vaccine compositions are also provided.

A supplement includes plant-derived phosphatidylserine in a physiologically beneficial amount and at least one plant-based concentrate or extract which promotes a melatonergic benefit.

Provided herein are methods for preparing stable solutions containing 5-methyltetrahydrofolate (MTHF). Also provided herein are stable compositions containing calcium 5-methyltetrahydrofolate (MTHF-Ca).

Disclosed herein are stable complexes with controlled particle size, increased apparent solubility and increased dissolution rate comprising as active compound Celecoxib, its salts, or derivatives thereof, which is useful in the treatment of osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, acute pain especially in cancer related acute pain, primary dysmenorrhea. More specifically, the complexes possess instantaneous redispersibility, increased apparent solubility and permeability that provide faster onset of action for acute pain relief and lower GI related side effects. Further disclosed are methods of formulating and manufacturing the complexes described herein, pharmaceutical compositions, and uses and methods of treatment.

The present invention relates to a buccal delivery dosage form and its use for administration of a therapeutic gas for buccal mucosal absorption of the therapeutic gas in the mouth of a subject. The buccal delivery dosage form comprises at least one crystallized excipient and at least one therapeutic gas entrapped within the crystallized excipient.