Disclosed herein, in part, is a pharmaceutical formulation comprising isotretinoin or a pharmaceutically acceptable salt thereof, and a mucoadhesive polymer. A method of treating a mucosal disease comprising administering a disclosed pharmaceutical formulation to a subject in need thereof is also provided herein.

The present invention relates to novel pharmaceutical formulations which have controlled, delayed release of active ingredient, and to a process for the preparation of such formulations. The invention additionally relates to the use of these novel pharmaceutical administration forms as medicaments for the treatment of diseases which require delayed release of the active ingredient, such as hypertension, or asthmatic diseases.

Described herein are pharmaceutical compositions for the oral administration of mesalazine, as well as methods of making such pharmaceutical compositions, and therapeutic methods for using them. The compositions comprise delayed-immediate release and delayed-extended release formulation of mesalazine.

The present invention includes compositions and methods for providing a therapeutically acceptable dose of an active pharmaceutical agent for once a day delivery of the active pharmaceutical compound in an amount effective to treat at least one of: Sjogren's syndrome, Xerostomia, dry mouth, hypo-salivation, or dental carries due to reduced or compromised salivation, wherein both the peak and trough times in the blood level at 8 hours is greater than 25% of the peak value in the blood level concentration.

Amorphous solid dispersions of nilotinib fumarate or nilotinib tartrate are provided, as well as pharmaceutical compositions thereof, wherein the compositions exhibit enhanced bioavailability in the fasted state. Preferably, the compositions may be orally administered to a patient in either the fed or fasted state, with a decrease or elimination of the food effect. Preferably, following oral administration of the pharmaceutical compositions, there is no substantial difference in the pharmacokinetic parameters (e.g., C.sub.max, AUC.sub.0-t and/or AUC.sub.0-infinity) of nilotinib, regardless of whether the pharmaceutical compositions are administered to a subject in the fed or fasted state.

The present invention relates to an abuse-proofed, oral dosage form with controlled opioid-release for once daily administration, characterised in that it comprises at least one opioid with potential for abuse (A), at least one synthetic or natural polymer (C), optionally delayed-release matrix auxiliary substances, physiologically acceptable auxiliary substances (B), optionally a wax (D) and optionally at least one delayed-release coating, component (C) or (D) in each case exhibiting a breaking strength of at least 500 N, preferably of at least 1000 N.

The present invention relates to new rifaximin forms comprising solid dispersions of rifaximin, methods of making same and to their use in medicinal preparations and therapeutic methods.

The present invention provides a method of treating insulin-dependent diabetes mellitus in a subject, comprising administering to the subject a therapeutically effective amount of a Janus kinase inhibitor, or a pharmaceutically acceptable salt or ester thereof, or a therapeutically effective amount of intravenous immunoglobulin, or a therapeutically effective amount of a therapeutic agent that destroys B lymphocytes, or a combination thereof. The present invention also provides kits containing the same.

The present invention relates to pharmaceutical compositions, each comprising a multitude of granules that make up an intragranular phase of the composition, wherein the granules are produced by fluid bed granulation and comprise a HCl salt of Compound (1).xH.sub.2O wherein x is from 0 to 3, and one or more excipients selected from a disintegrant, a binder, and a wetting agent. The pharmaceutical composition also comprises one or more excipients that make up an extragranular phase of the composition, selected from a diluent, a disintegrant, a glidant, and a lubricant. The invention also relates to processes for producing the pharmaceutical compositions of the invention. The invention further relates to uses and methods of the pharmaceutical compositions in reducing the amount of influenza viruses in a biological in vitro sample or in a subject, inhibiting the replication of influenza viruses in a biological in vitro sample or in a subject, and treating influenza in a subject.

The present invention relates to certain compositions of a 5-HT.sub.2A serotonin receptor modulator and methods for their preparation. The compositions disclosed herein are useful for increasing slow wave sleep, improving sleep consolidation, improving sleep maintenance and improving sleep quality, and for treating insomnia and related sleep disorders, dyssomnias, parasomnias and nonrestorative sleep and the like. The compositions disclosed herein are further useful for treating platelet aggregation, coronary artery disease, myocardial infarction, transient ischemic attack, angina, stroke, atrial fibrillation, thrombosis, asthma or symptoms thereof, agitation or symptoms thereof, behavioral disorders, drug induced psychosis, excitative psychosis, Gilles de la Tourette's syndrome, manic disorder, organic or NOS psychosis, psychotic disorders, psychosis, acute schizophrenia, chronic schizophrenia, NOS schizophrenia and related disorders, diabetic-related disorders and progressive multifocal leukoencephalopathy and the like.