Abstract: Disclosed herein are lipid compositions comprising a cationic lipid of formula (I), a neutral lipid, a sterol and a PEG or PEG-modified lipid, wherein formula (I) is Also disclosed are methods of producing the cationic lipid of formula (I).

Abstract: The present disclosure provides dry powder antibiotic compositions that are effective in the treatment of bacterial infections and associated conditions. Moreover, the present disclosure provides dry powder antibiotic compositions for the treatment of bacterial infections, by multi-drug resistant bacteria, resulting in the subsequent reduction in the prevalent rates of drug resistance.

Abstract: Aqueous surfactant compositions containing one or more alpha-sulfo fatty acid disalt (A) of general formula (I), R1CH(SO3M1)COOM2??(I), in which the radical R1 is a linear or branched alkyl or alkenyl radical having 6 to 18 carbon atoms and the radicals M1 and M2, independently of one another, are selected from H, Li, Na, K, Ca/2, Mg/2, ammonium, and alkanolamine, one or more N-acyl amino acid compound (B) selected from glycinates of general formula (IIa), sarcosinates of general formula (IIb), ?-alaninates of general formula (IIc), and ?-alaninates of general formula (IId) R23—CO—NH—CH2—COOM13??(IIa) R23—CO—N(CH3)—CH2—COOM13??(IIb) R23—CO—NH—CH(CH3)—COOM13??(IIc) R23—CO—NH—CH2—CH2—COOM13??(IId), wherein the radical R23 in the compounds (IIa), (IIb), (IIc) and (IId) is a linear or branched alkyl or alkenyl radical having 7 to 19 carbon atoms and the radical M13 is selected from H, Li, Na, K, Ca/2, Mg/2, ammonium, and alkanolamine, and water.

Abstract: The present disclosure relates to salts of the compound: polymorphic forms thereof, methods for preparation and use thereof, and pharmaceutical compositions thereof.

Abstract: Embodiments of the present invention are directed to a plurality of substantially spherical microspheres comprising at least one API substantially dispersed in at least one polymer and a lyoprotectant on an outside surface of the plurality of substantially spherical microspheres, wherein the plurality of substantially spherical microspheres have a D99[num] particle diameter of less than about 10 m; a D90[num] circularity value of from about 0.8 to about 1.0; and comprise API in a weight of about 20 to about 40 wt. % of the polymer. Other embodiments relate to injectable compositions comprising such microspheres and methods of treating a number of conditions by administering such injectable compositions to a subject.

Abstract: The present invention generally relates to the transdermal delivery of various compounds. In some aspects, transdermal delivery may be facilitated by the use of a hostile biophysical environment. One set of embodiments provides a composition for topical delivery comprising a phosphodiesterase type 5 inhibitor and/or a salt thereof, and optionally, a hostile biophysical environment and/or a nitric oxide donor. In some cases, the composition may be stabilized using a combination of a stabilization polymer (such as xanthan gum, KELTROL® BT and/or KELTROL® RD), propylene glycol, and a polysorbate surfactant such as Polysorbate 20, which combination unexpectedly provides temperature stability to the composition, e.g., at elevated temperatures such as at least 40° C. (at least about 104° F.), as compared to compositions lacking one or more of these.

Abstract: A composition and method for administering an active agent to a pet, such as a dog, a cat or a horse. The composition may comprise a yogurt-based chewable delivery matrix and a plurality of water-soluble film pieces dispersed throughout the chewable delivery matrix. The composition may also comprise a delivery matrix having at least 15% by weight of crude protein and a plurality of water-soluble film pieces dispersed throughout the delivery matrix. The plurality of water-soluble film pieces encompass an active agent therein, wherein the active agent is rapidly released from the composition upon contact with saliva from the pet. At least a portion of the released active agents may be oromucosally absorbed by the pet.

Abstract: Described herein are compositions including at least one omega-3 fatty acid (either in the triglyceride, ester or free fatty acid ester form) and at least one surface active agent; wherein the compositions form micelles when in contact with an aqueous medium. Also provided are methods of administering to a subject a composition including at least one omega-3 fatty acid (either in the triglyceride, ester or free fatty acid ester form) and at least one surface active agent, wherein the compositions form micelles when in contact with an aqueous medium, and the bioavailability of the omega-3 fatty acid is substantially independent of a food effect.

Abstract: Described herein are compositions including at least one omega-3 fatty acid (either in the triglyceride, ester or free fatty acid ester form) and at least one surface active agent; wherein the compositions form micelles when in contact with an aqueous medium. Also provided are methods of administering to a subject a composition including at least one omega-3 fatty acid (either in the triglyceride, ester or free fatty acid ester form) and at least one surface active agent, wherein the compositions form micelles when in contact with an aqueous medium, and the bioavailability of the omega-3 fatty acid is substantially independent of a food effect.

Abstract: Methods of treating neuropsychiatric disorders including affective disorders and addiction involve intranasal or transdermal administration of a substantially selective kappa-opioid-receptor agonist that is also a partial D2 agonist, such as the compound salvinorin A. Also disclosed are intranasal, transdermal and/or inhalation systems for delivering the kappa-opioid-receptor agonist.

Abstract: Compositions and methods of preparation and use are provided for an engineered tissue substitute system comprising collagen, glycosaminoglycan and hydrogel in a cross-linked matrix. The compositions may be further lyophilized and reconstituted with a physiological fluid prior to use in methods, such as in the treatment of wounds, tissue engineering and cell transplantation.

Abstract: A delayed release drug formulation includes a core and a coating. The coating includes a mixture of a first material selected from starch; amylose; amylopectin; chitosan; chondroitin sulfate; cyclodextrin; dextran; pullulan; carrageenan; scleroglucan; chitin; curdulan and levan, and a second material which has a pH threshold at about pH 5 or above. The delayed release drug formulation is used to target release of a drug from a core to the intestine, particularly the colon.

Abstract: Provided is a novel oral mucosa application material that has good handling properties, has excellent application properties for being applied to the oral mucosa even if moisture or saliva on the surface of the oral mucosa is heavy, and is provided with a property for improving the effect of physically protecting an application site by containing the moisture or saliva after application and showing elasticity, and further, a property for remaining at the application site for a long time. This oral mucosa application material is provided with a freeze-dried body containing a polymer on an adhesion surface to the oral mucosa. The content of the polymer in the freeze-dried body is 20 mass % or more, and the content of hyaluronic acid in the polymer is 50 mass % or more.

Abstract: The present invention provides lipids that are advantageously used in lipid particles for the in vivo delivery of therapeutic agents to cells.

Abstract: The present invention provides lipids that are advantageously used in lipid particles for the in vivo delivery of therapeutic agents to cells.

Abstract: 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.

Abstract: The present disclosure relates to delivery systems and methods for increasing the bioavailability and increasing the absorption rate by monolithic enteric capsule administration to humans of active ingredients compared to the bioavailability of active ingredients enterically coated for modified release or gastric protection, particularly acid sensitive active ingredients such as esomeprazole, omeprazole, and other proton pump inhibitors, systems for delivering active pharmaceutical ingredients to humans or animals via monolithic enteric capsules, and improved methods of treating gastrointestinal disorders with such methods and delivery systems.

Abstract: The present disclosure relates to a composition to aid in heavy metal detox. Metallothioneins (MT) are a family of cysteine-rich enzymes in the body that help remove and regulate heavy metals, copper, and other metals. Amino Acids in combination with zinc and/or molybdenum may provide improved production of MT over amino acid or zinc supplements alone. Additionally, Vitamin B6, Molybdenum, and Boron may be included to further enhance the efficacy of the composition.

Abstract: The invention discloses a trace element solution, which comprises at least the following metals: at least 65 mg/ml zinc directly and/or indirectly from mineral EDTA chelate(s) and/or Zn Oxide; at least 10 mg/ml manganese directly and/or indirectly from mineral EDTA chelate(s) and/or Mn carbonate; at least 15 mg/ml copper directly and/or indirectly from mineral EDTA chelate(s) and/or copper sulphate and/or copper oxide and/or carbonate; and at least 5 mg/ml selenium. The trace element solution comprises at least the following: at least 65 mg/ml zinc derived directly and/or indirectly from ZN-EDTA and/or Zn Oxide; at least 10 mg/ml manganese derived directly and/or indirectly from Mn-EDTA and/or Mn carbonate; at least 15 mg/ml copper derived directly and/or indirectly from Cu-EDTA and/or copper oxide and/or copper sulphate and/or copper carbonate; and at least 5 mg/ml selenium derived directly and/or indirectly from Na2SeO4 and/or Na2SeO3.

Abstract: A formulation includes a nanostructured lipid carrier (NLC) matrix and spironolactone as an active ingredient loaded within the NLC matrix, forming a spironolactone-loaded NLC (SP-NLC) gel or lotion.