Intra-oral formulations comprising soft anticholinergic alkyl esters are useful for treating excessive drooling conditions in subjects, such as humans, suffering from sialorrhea. Preferably, at least one soft anticholinergic ester is provided in an effective amount or concentration in an anhydrous intra-oral formulation that can inhibit excessive drooling resulting from a condition known as sialorrhea.

Pharmaceutical formulations including an inclusion complex of an API with a cyclic oligomer, and methods of forming such pharmaceutical formulations are described.

The present disclosure relates to a process for preparing pitolisant hydrochloride of Formula-(I) and solid-state forms thereof.

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An injectable pharmaceutical composition comprising carbamazepine and sulfobutylether-7-β-cyclodextrin, wherein said composition is essentially free of 10-Br-carbamazepine, is disclosed. Methods for the manufacture of said composition and methods for treatment of disease using said composition are also disclosed.

An injectable pharmaceutical composition comprising carbamazepine and sulfobutylether-7-β-cyclodextrin, wherein said composition is essentially free of 10-Br-carbamazepine, is disclosed. Methods for the manufacture of said composition and methods for treatment of disease using said composition are also disclosed.

The invention relates to a hydrogel matrix comprising a mixture of a covalent peptide-polymer conjugate and an oligosaccharide; wherein the oligosaccharide is a highly negatively charged sulfated oligosaccharide selected from the group consisting of heparin, dextran sulfate, α-cyclodextrin sulfate, β-cyclodextrin sulfate and γ-cyclodextrin sulfate; wherein said polymer comprised in said peptide-polymer conjugate is a linear or multi-arm polyethylene glycol; wherein said peptide comprised in said peptide-polymer conjugate is a peptide, which consists of an amino acid sequence selected from the group consisting of SEQ ID NO.4, SEQ ID NO.5, SEQ ID NO. 18 and SEQ ID NO. 19; and wherein said hydrogel matrix is configured in the form of an oligosaccharide/peptide/polymer system, in which said peptide is chemically conjugated to the polymer such that the hydrogel is obtained by mixing the peptide-polymer conjugate and the oligosaccharide.

The invention relates to a hydrogel matrix comprising a mixture of a covalent peptide-polymer conjugate and an oligosaccharide; wherein the oligosaccharide is a highly negatively charged sulfated oligosaccharide selected from the group consisting of heparin, dextran sulfate, α-cyclodextrin sulfate, β-cyclodextrin sulfate and γ-cyclodextrin sulfate; wherein said polymer comprised in said peptide-polymer conjugate is a linear or multi-arm polyethylene glycol; wherein said peptide comprised in said peptide-polymer conjugate is a peptide, which consists of an amino acid sequence selected from the group consisting of SEQ ID NO.4, SEQ ID NO.5, SEQ ID NO. 18 and SEQ ID NO. 19; and wherein said hydrogel matrix is configured in the form of an oligosaccharide/peptide/polymer system, in which said peptide is chemically conjugated to the polymer such that the hydrogel is obtained by mixing the peptide-polymer conjugate and the oligosaccharide.

The present invention provides highly bioavailable and stable edible, inhalable, soluble and drinkable pharmaceutical grade ultrafine active pharmaceutical ingredients having 99% purity, and methods for their production.

Provided are methods for treating a disease, disorder, or condition associated with an acid ceramidase (AC) biological activity. The methods include administering to a subject in need thereof a composition including an AC inhibitor and at least one additional active agent, such as a C6-ceramide nanoliposome (CNL); an inhibitor of a Bcl-2 family protein; a hypomethylating agent; an intensive chemotherapeutic agent such as cytarabine (AraC) and/or daunorubicin; a Hedgehog pathway inhibitor; a targeted agent, such as a FLT2 inhibitor or a EDH1/2 inhibitor; and/or an antibody drug conjugate that targets, for example, CD-33. The composition can include N-[(2S,3R)-1,3-dihydroxyoctadecan-2-yl]2-chloroacetamide (SACLAC) or a pharmaceutically acceptable salt thereof and at least one additional active agent. The disease, disorder, or condition associated with the AC biological activity can be a cancer, such as acute myeloid leukemia (AML).

The present invention can be usefully used as a liquid pharmaceutical composition of 1-(5-(2,4-difluorophenyl)-1-((3-fluorophenyl)sulfonyl)-4-methoxy-1H-pyrrol-3-yl)-N-methylmethanamine, or a pharmaceutically acceptable salt thereof.