Abstract: This invention relates to compounds that are agonists of the muscarinic M1 and/or M4 receptor and which are useful in the treatment of diseases mediated by the muscarinic M1 and M4 receptors. Also provided are pharmaceutical compositions containing the compounds and the therapeutic uses of the compounds. Compounds provided are of formula where X1; X2; R1 and R4 are as defined herein.

Abstract: The present disclosure provides methods for the acute treatment of migraine with or without aura, comprising the administration of ubrogepant. In particular, the present disclosure provides methods for the acute treatment of migraine in patients having hepatic impairment; in patients with renal impairment; and in patients concurrently taking CYP3A4 modulators or BCRP and/or P-gp only inhibitors.

Abstract: The present disclosure provides methods for the acute treatment of migraine with or without aura, comprising the administration of ubrogepant. In particular, the present disclosure provides methods for the acute treatment of migraine in patients having hepatic impairment; in patients with renal impairment; and in patients concurrently taking CYP3A4 modulators or BCRP and/or P-gp only inhibitors.

Abstract: The present disclosure relates to a hybrid material, such as a hybrid yarn, as well as methods of making and using the same. The hybrid material may include tropoelastin. Further, the hybrid material can also include a biodegradable polymer. In addition, the disclosure is also directed to compositions and methods for treating a tissue, such as treatment of organ prolapse.

Abstract: Provided herein are compositions, comprising hyaluronic acid in three different forms. The compositions are in a form of an essentially homogeneous gel with improved rheological properties enabling improved clinical performance.

Abstract: A method of healing a wound including contacting a wound edge with a tropoelastin or elastin derived peptide in conditions for enabling a sustained contact of the tropoelastin with the wound edge for a time period for enabling re-epithelialization of the wound.

Abstract: Tissue repair and restoration can be performed using an elastic material formed from tropoelastin. The elastic material can be formed by providing a solution of tropoelastin monomers, applying the solution to a surface, and heating the solution on the surface in absence of a cross-linking agent to enable the tropoelastin monomers to bind to each other to form an elastic material that does not dissociate into tropoelastin monomers when the elastic material is contacted with an aqueous solution.

Abstract: Therapeutic compositions and/or formulations are provided, comprising: at least one cross-linked protein matrix, wherein the at least one cross-linked protein matrix comprises at least one protein residue and at least one saccharide-containing residue, and methods of producing the same. The cross-linked protein matrix may be derived from cross-linking a full length or substantially full length protein, such as tropoelastin, elastin, albumin, collagen, collagen monomers, immunoglobulins, insulin, and/or derivatives or combinations thereof, with a saccharide containing cross-linking agent, such as a polysaccharide cross-linking agent derived from, for example, hyaluronic acid or a cellulose derivative. The therapeutic compositions may be administered topically or by injection. The present disclosure also provides methods, systems, and/or kits for the preparation and/or formulation of the compositions disclosed herein.

Abstract: The present invention is directed to a digestive enzyme composition comprising an enterically coated digestive enzyme product, administrable nutritional medium, and a pharmaceutically acceptable low viscosity oily ingredient. The process for the preparation of the digestive enzyme composition comprises adding an enterically coated digestive enzyme product to a administrable nutritional medium and pharmaceutically acceptable low viscosity oily ingredient. The invention further provides a method for treating a patient suffering from exocrine pancreatic insufficiency related condition comprising administering to the patient a therapeutically effective dose of the digestive enzyme composition by means of a feeding tube.

Abstract: Tissue repair and restoration can be performed using an elastic material formed from tropoelastin. The elastic material can be formed by providing a solution of tropoelastin monomers, applying the solution to a surface, and heating the solution on the surface in absence of a cross-linking agent to enable the tropoelastin monomers to bind to each other to form an elastic material that does not dissociate into tropoelastin monomers when the elastic material is contacted with an aqueous solution.

Abstract: A pharmaceutical soft gelatin capsule dosage form that includes (a) a shell that includes gelatin; and (b) a fill that includes at least one active ingredient, one or more polyethylene glycol, and a modified guar gum. The pharmaceutical soft gelatin capsule dosage form maintains its shell integrity (hardness) and fill viscosity after storage.

Abstract: Provided herein are two-step, multi-step and double precipitation processes used to prepare HA-pancreatin having a specific lipase activity of at least 120 USP IU/mg. The present two-step processes include suspending pancreatin in an aqueous solvent and adding an organic solvent with a Hildebrand solubility parameter between about 38 and 45 (MPa)0.5 to precipitate HA-pancreatin. The present multi-step processes produce HA-pancreatin using additional solvents. Double precipitation processes are directed to the use of solvents having different Hildebrand solubility parameters to produce HA-pancreatin product for use as a therapeutic agent.

Abstract: Compositions and methods for inducing or promoting repair of a bone fracture.

Abstract: A dosage form comprising a capsule containing one or more tablets of 5-aminosalicylic acid or a salt thereof as an active ingredient where each of the one or more tablets is enterically coated is disclosed.

Abstract: Therapeutic compositions and/or formulations are provided, comprising: at least one cross-linked protein matrix, wherein the at least one cross-linked protein matrix comprises at least one protein residue and at least one saccharide-containing residue, and methods of producing the same. The cross-linked protein matrix may be derived from cross-linking a full length or substantially full length protein, such as tropoelastin, elastin, albumin, collagen, collagen monomers, immunoglobulins, insulin, and/or derivatives or combinations thereof, with a saccharide containing cross-linking agent, such as a polysaccharide cross-linking agent derived from, for example, hyaluronic acid or a cellulose derivative. The therapeutic compositions may be administered topically or by injection. The present disclosure also provides methods, systems, and/or kits for the preparation and/or formulation of the compositions disclosed herein.

Abstract: The subject matter of the present invention is pertinent to the field of vaginal delivery of pharmaceutically active agents. Embodiments of the instant invention disclose methods for treating a variety of progesterone related disorders by vaginal administration of a pullulan capsule and a fill formulation comprising one or more antiprogestins dispersed in a mixture of isopropyl palmitate or isopropyl myristate and a polyethylene glycol.

Abstract: An improved injector needle apparatus is described with inherent properties for increasing linear flow rates when inserted into a subcutaneous port during tissue expansion thus decreasing procedure time.

Abstract: A solid dosage form comprises coated particles of bisphosphonate or a pharmaceutically acceptable analog or derivative thereof.

Abstract: A dosage form comprising a capsule containing one or more tablets of 5-aminosalicylic acid or a salt thereof as an active ingredient where each of the one or more tablets is enterically coated is disclosed.

Abstract: The present invention relates generally to antifugal compositions. In an embodiment, the antifungal compositions are effective for application to nails and surrounding skin, and comprise at least one volatile solvent, at least one film forming substance, and at least one pyrimidone derivative of formula I, such as albaconazole. These compositions are capable of treating an infection caused by fungi, such as onychomychosis.