Abstract: An auto-injector device includes a pre-filled syringe including a container and a stainless steel needle adhered to the container with at least one of a urethane acrylate adhesive or a urethane methacrylate adhesive. The container is filled with at least 1 mL of a pharmaceutical composition comprising epinephrine, a buffer, and water, where the pharmaceutical composition has a pH ranging between 3 and 4. The auto-injector device also includes a firing mechanism that expels about 0.3 mL of the pharmaceutical composition from the container in less than 0.5 seconds during a single injection.

Abstract: The invention relates to a pre-filled syringe, an auto-injector device comprising such pre-filled syringe, a method of administering a pharmaceutical composition with such auto-injector device, and a manufacturing method for such auto-injector device. The pre-filled syringe comprises a container and a needle. The container is filled with a pharmaceutical composition comprising epinephrine, a buffer, and water. The buffer is configured to buffer in a pH range between 3 and 4. The needle is adhered to the container by means of a urethane acrylate or urethane methacrylate acrylic light cure adhesive, which is configured to provide a pull out resistance of the needle relative to the container which is between 30 N to 100 N, preferably between 50 N to 70 N, more preferably greater than 60 N after 90 days exposure to the pharmaceutical composition at 40° C. and 75% relative humidity (RH). In an example, the pharmaceutical composition is for the treatment of an anaphylactic event.

Abstract: The present invention relates to novel substituted pyridine carboxylic acid derivatives and their preparation methods. This invention is also directed to pharmaceutical compositions containing such compounds and combinations thereof with at least one therapeutic agent. These substituted pyridine carboxylic acid compounds and their pharmaceutical acceptable salts and esters are useful in the treatment or control of various metabolic disorders.

Abstract: The invention relates to a pre-filled syringe, an auto-injector device comprising such pre-filled syringe, a method of administering a pharmaceutical composition with such auto-injector device, and a manufacturing method for such auto-injector device. The pre-filled syringe comprises a container and a needle. The container is filled with a pharmaceutical composition comprising epinephrine, a buffer, and water. The buffer is configured to buffer in a pH range between 3 and 4. The needle is adhered to the container by means of a urethane acrylate or urethane methacrylate acrylic light cure adhesive, which is configured to provide a pull out resistance of the needle relative to the container which is between 30 N to 100 N, preferably between 50 N to 70 N, more preferably greater than 60 N after 90 days exposure to the pharmaceutical composition at 40° C. and 75% relative humidity (RH). In an example, the pharmaceutical composition is for the treatment of an anaphylactic event.

Abstract: The invention relates to a pre-filled syringe, an auto-injector device comprising such pre-filled syringe, a method of administering a pharmaceutical composition with such auto-injector device, and a manufacturing method for such auto-injector device. The pre-filled syringe comprises a container and a needle. The container is filled with a pharmaceutical composition comprising epinephrine, a buffer, and water. The buffer is configured to buffer in a pH range between 3 and 4. The needle is adhered to the container by means of a urethane acrylate or urethane methacrylate acrylic light cure adhesive, which is configured to provide a pull out resistance of the needle relative to the container which is between 30 N to 100 N, preferably between 50 N to 70 N, more preferably greater than 60 N after 90 days exposure to the pharmaceutical composition at 40° C. and 75% relative humidity (RH). In an example, the pharmaceutical composition is for the treatment of an anaphylactic event.

Abstract: A pharmaceutical composition for administration of Dabigatran zetexilate through the mucous membranes of the oral cavity, characterized in that the composition comprises a therapeutically effective amount of Dabigatran etexilate and a solubilizer for Dabigatran etixilate selected from at least one of a water soluble derivative of tocopherol and a polymeric derivative of sorbitan. The composition may be in the form of solid oral film. The composition may be suitable for dropwise administration. A method of manufacturing the film composition is also included.

Abstract: The invention relates to a pre-filled syringe, an auto-injector device comprising such pre-filled syringe, a method of administering a pharmaceutical composition with such auto-injector device, and a manufacturing method for such auto-injector device. The pre-filled syringe comprises a container and a needle. The container is filled with a pharmaceutical composition comprising epinephrine, a buffer, and water. The buffer is configured to buffer in a pH range between 3 and 4. The needle is adhered to the container by means of a urethane acrylate or urethane methacrylate acrylic light cure adhesive, which is configured to provide a pull out resistance of the needle relative to the container which is between 30 N to 100 N, preferably between 50 N to 70 N, more preferably greater than 60 N after 90 days exposure to the pharmaceutical composition at 40° C. and 75% relative humidity (RH). In an example, the pharmaceutical composition is for the treatment of an anaphylactic event.

Abstract: A method for preparing a stable dispersion of a camptothecin, camptothecin prodrug, or analog thereof for administration to a patient in need thereof includes preparing a solution of the camptothecin, wherein the solution has a pH which places substantially an entirety of that camptothecin in a carboxylate form. The camptothecin may be a neutral camptothecin. The solution is next loaded into a liposome including at least one lipid, which may be a phospholipid. An intraliposomal pH is maintained which preserves substantially an entirety of the camptothecin in the carboxylate form. The liposomal dispersion is administered to an individual in need thereof, whereby the liposomes accumulate at and permeate into tumor tissue and an active, lactone form camptothecin is released in situ at the tumor site. Compositions formulated in accordance with the described method for treatment of a cancer in an animal in need thereof are provided also.

Abstract: A method for preparing a stable dispersion of a camptothecin, camptothecin prodrug, or analog thereof for administration to a patient in need thereof includes preparing a solution of the camptothecin, wherein the solution has a pH which places substantially an entirety of that camptothecin in a carboxylate form. The camptothecin may be a neutral camptothecin. The solution is next loaded into a liposome including at least one lipid, which may be a phospholipid. An intraliposomal pH is maintained which preserves substantially an entirety of the camptothecin in the carboxylate form. The liposomal dispersion is administered to an individual in need thereof, whereby the liposomes accumulate at and permeate into tumor tissue and an active, lactone form camptothecin is released in situ at the tumor site. Compositions formulated in accordance with the described method for treatment of a cancer in an animal in need thereof are provided also.

Abstract: Provided is a liposome comprising a hydrophobic lactone drug and a cyclodextrin, wherein the liposome has an intraliposomal pH and cyclodextrin concentration such that upon administration of the liposome to a subject, the liposome exhibits a uniform release profile of the hydrophobic lactone drug. Also provided is a method of administering a hydrophobic lactone drug to a subject in need thereof. The method comprises administering a liposome to the subject in need, wherein the liposome comprises the hydrophobic lactone drug and a cyclodextrin. The liposome has an intraliposomal pH and cyclodextrin concentration such that upon administration of the liposome to the subject, the liposome exhibits a uniform release profile of the hydrophobic lactone drug.

Abstract: Disclosed herein is a liposomal formulation that comprises a liposome and a liquid carrier. In the liposomal formulation, the liposome comprises a hydrophobic lactone drug and has an intraliposomal metal ion concentration higher than the metal ion concentration of the liquid carrier. Also disclosed herein is a method for active loading of a hydrophobic lactone drug into a liposome. The method includes preparing a liposome in the presence of a metal salt solution, an acid form of a counterion of the metal salt being membrane permeable, such that the liposome preparation contains entrapped metal ion. The method further includes forming a liposome with high intraliposomal pH by separating extravesicular metal salt solution from the liposome by exposing the liposome to a metal salt-free solution, resulting in diffusion of the acid form of the counterion out of the liposome and formation of an intraliposomal pH higher than that of the metal salt-free solution.