Abstract: The preparation and use of systems to provide surrogate whole blood controls using coagulation modifiers to simulate human whole blood in coagulation assays are disclosed.

Abstract: Novel anticoagulant reversal compounds are disclosed, as well as methods of making the compounds, pharmaceutical compositions including the compounds, methods of using the compounds to reverse the anticoagulant effects of coagulation inhibitors, and diagnostic assays comprising the compounds.

Abstract: Methods and compositions for delivering antigens to the lymphatic system in doses that desensitize patients to future exposure to antigens have been developed. Rapid desensitization is achieved by introducing small quantities of antigen into the lymphatic system. In preferred embodiments, the compositions are administered to yield therapeutically effective levels of antigen within the lymph, where macrophages reside in the greatest concentration, by intradermal administration, using for example, microneedles or microparticles, oral administration, using for example, enteric coated capsules or tablets, or autologous transfusion. In some embodiments, the methods and compositions for delivering antigens orally achieve uptake by the Peyer's patches of the small intestines.

Abstract: Methods and compositions for delivering antigens to the lymphatic system in doses that desensitize patients to future exposure to antigens have been developed. Rapid desensitization is achieved by introducing small quantities of antigen into the lymphatic system. In preferred embodiments, the compositions are administered to yield therapeutically effective levels of antigen within the lymph, where macrophages reside in the greatest concentration, by intradermal administration, using for example, microneedles or micro articles, oral administration, using for example, enteric coated capsules or tablets, or autologous transfusion. In some embodiments, the methods and compositions for delivering antigens orally achieve uptake by the Peyer's patches of the small intestines.

Abstract: Novel anticoagulant reversal compounds are disclosed, as well as methods of making the compounds, pharmaceutical compositions including the compounds, methods of using the compounds to reverse the anticoagulant effects of coagulation inhibitors, and diagnostic assays comprising the compounds.

Abstract: Novel labeled compounds and metabolites thereof are disclosed, as well as pharmaceutical compositions including the compounds, and methods of using the labeled and unlabeled compounds, and specifically, 2-Amino-5-guanidino-pentanoic acid (3-{4-[3-(2-amino-5-guanidino-pentanoylamino)-propyl]-piperazin-1-yl}-propyl)-amide and metabolites thereof, for imaging, detecting and assessing disorders and diseases, such as arthritis and, more specifically, osteoarthritis by tracking proteoglycan and glycosaminoglycan content of cartilage. Also, pharmaceutical compositions comprising labeled and/or unlabeled 1,4-Bis(3-aminopropyl)piperazine are disclosed and methods of using the same.

Abstract: Stabilized formulations containing a peptide, such as a glucagon, are described herein. The formulations are in the form of a solution or suspension, which exhibit little or no chemical degradation and/or aggregation of the peptide over an extended period of time. In some embodiments, the formulations are in the form of a solution containing the peptide, a solvent such as glycerin, and one or more thermal stabilizers. In other embodiments, the formulation is in the form of a suspension containing nano- and/or microparticles containing the peptide suspended in a non-aqueous, non-solvent. The nano- and/or microparticles can be prepared by micronizing the peptide with one or more humectants, such as salts, sugars, water-soluble polymers, and combinations thereof which increase the rate of dissolution of the peptide upon administration.

Abstract: Novel anticoagulant reversal compounds are disclosed, as well as methods of making the compounds, pharmaceutical compositions including the compounds, methods of using the compounds to reverse the anticoagulant effects of coagulation inhibitors, and diagnostic assays comprising the compounds.

Abstract: Methods and compositions for delivering antigens to the lymphatic system in doses that desensitize patients to future exposure to antigens have been developed. Rapid desensitization is achieved by introducing small quantities of antigen into the lymphatic system. In preferred embodiments, the compositions are administered to yield therapeutically effective levels of antigen within the lymph, where macrophages reside in the greatest concentration, by intradermal administration, using for example, microneedles or micro articles, oral administration, using for example, enteric coated capsules or tablets, or autologous transfusion. In some embodiments, the methods and compositions for delivering antigens orally achieve uptake by the Peyer's patches of the small intestines.

Abstract: Formulations of a neuroprotective agent for parenteral administration are described herein. The formulation is in the form of a concentrated (supersaturated) solution or a concentrated suspension of microparticles. The suspension medium or the solution solvent carrier may also contain dissolved neuroprotective agent. For the supersaturated solutions, the agent is dissolved a high concentrations of at least about 1% by weight, 5% by weight, 10% by weight, 15% by weight, or 20% by weight in a solvent suitable for parenteral administration. For the concentrated suspension, the microparticles have an effective particle size form about 100 nm to about 5 microns, preferably form about 50 nm to about 3 microns, more preferably from about 10 nm to about 2 microns. The formulations described herein can be used to treat a variety of neurological disease/disorders and/or neurological injury or trauma.

Abstract: Novel anticoagulant reversal compounds are disclosed, as well as methods of making the compounds, pharmaceutical compositions including the compounds, methods of using the compounds to reverse the anticoagulant effects of coagulation inhibitors, and diagnostic assays comprising the compounds.

Abstract: Novel anticoagulant reversal compounds are disclosed, as well as methods of making the compounds, pharmaceutical compositions including the compounds, methods of using the compounds to reverse the anticoagulant effects of coagulation inhibitors, and diagnostic assays comprising the compounds.

Abstract: Stabilized formulations containing a peptide, such as a glucagon, are described herein. The formulations are in the form of a solution or suspension, which exhibit ttle or no chemical degradation and/or aggregation of the peptide over an extended period of time. In some embodiments, the formulations are in the form of a solution containing the peptide, a solvent such as glycerin, and one or more thermal stabilizers. In other embodiments, the formulation is in the form of a suspension containing nano- and/or microparticles containing the peptide suspended in a non- aqueous, non-solvent. The nano- and/or microparticles can be prepared by micronizing the peptide with one or more humectants, such as salts, sugars, water-soluble polymers, and combinations thereof which increase the rate of dissolution of the peptide upon administration.

Abstract: Novel labeled compounds and metabolites thereof are disclosed, as well as pharmaceutical compositions including the compounds, and methods of using the labeled and unlabeled compounds, and specifically, 2-Amino-5-guanidino-pentanoic acid (3-{4-[3-(2-amino-5-guanidino-pentanoylamino)-propyl]-piperazin-1-yl}-propyl)-amide and metabolites thereof, for imaging, detecting and assessing disorders and diseases, such as arthritis and, more specifically, osteoarthritis by tracking proteoglycan and glycosaminoglycan content of cartilage. Also, pharmaceutical compositions comprising labeled and/or unlabeled 1,4-Bis(3-aminopropyl)piperazine are disclosed and methods of using the same.

Abstract: A rapid acting injectable formulation is provided comprising a therapeutic peptide and a vasodilatory agent. The therapeutic peptide has a molecular weight of greater than about 500 Daltons, and the vasodilatory agent is present in an amount effective to increase the absorption of the therapeutic peptide. A method of increasing absorption of a therapeutic peptide by using such a formulation is also provided.

Abstract: Topical formulations containing one or more pharmaceutically acceptable bioadhesive film-forming agent, one or more anti-acne agent, and an aqueous solvent in the form of a solution or suspension are described herein. The formulation may further contain one or more excipients, including evaporation suppressants, humectants, or plasticizers. When the formulation is contacted with the skin of a patient, the solvent evaporates and forms a thin, transparent, and solid bioadhesive film. The bioadhesive film adheres to the skin surface for a prolonged period of time and the anti-acne agent is released into the skin over a prolonged period of time. Typically, the bioadhesive film adheres to the skin for at least 60 minutes following administration of the formulation, preferably for at least 8 hours following administration, more preferably up to 24 hours following administration. The prolonged retention of the anti-acne agent at the site increases the amount of uptake into the skin.

Abstract: Methods and compositions for delivering antigens to the lymphatic system in doses that desensitize patients to future exposure to antigens have been developed. Rapid desensitization is achieved by introducing small quantities of antigen into the lymphatic system. In preferred embodiments, the compositions are administered to yield therapeutically effective levels of antigen within the lymph, where macrophages reside in the greatest concentration, by intradermal administration, using for example, microneedles or microparticles, oral administration, using for example, enteric coated capsules or tablets, or autologous transfusion. In some embodiments, the methods and compositions for delivering antigens orally achieve uptake by the Peyer's patches of the small intestines.

Abstract: Formulations of a neuroprotective agent for parenteral administration are described herein. The formulation is in the form of a concentrated (supersaturated) solution or a concentrated suspension of microparticles. The suspension medium or the solution solvent carrier may also contain dissolved neuroprotective agent. For the supersaturated solutions, the agent is dissolved at high concentrations of at least about 1% by weight, 5% by weight, 10% by weight, 15% by weight, or 20% by weight in a solvent suitable for parenteral administration. For the concentrated suspension, the microparticles have an effective particle size from about 100 nm to about 5 microns, preferably from about 50 nm to about 3 microns, more preferably from about 10 nm to about 2 microns. The formulations described herein can be used to treat a variety of neurological diseases/disorders and/or neurological injury or trauma.