Abstract: The present invention provides pharmaceutical compositions comprising a pharmaceutically acceptable excipient and a conjugate having a degradable linkage. The conjugates include at least one of each the following: an aromatic moiety comprising an ionizable hydrogen atom, a spacer moiety, and a water-soluble polymer. Methods for delivering such compositions are also provided.

Abstract: The present invention provides phenylalkylcarboxylic acid compounds and compositions containing such compounds which facilitate the delivery of biologically active agents.

Abstract: The invention relates to biopolymer-gel based depot systems for prolonged and/or controlled release delivery of biologically active agents, methods for the manufacture of the biopolymer based gel-depots which include a biologically active agent, and uses of such biopolymer gel-depots in therapy. The biopolymer-gel based depot systems comprise a biocompatible polyaminosaccharide and/or protein; a biocompatible phosphate and/or sulphonamide compound; a biologically active agent; an aqueous insoluble alkaline earth metal phosphate; and a biocompatible glycan and/or proteoglycan.

Abstract: Combination therapy comprising PPAR modulators and glucose reabsorption inhibitors useful for the treatment of diabetes and Syndrome X are disclosed.

Abstract: The invention relates to a method for producing an aqueous, pharmaceutical formulation comprising an insulin, an insulin analog, or an insulin derivative, wherein the ready-made formulation takes place directly by dissolving the insulin, the insulin analog, or the insulin derivative as a solid in a suitable solvent mixture.

Abstract: A formulation of a diluted amino acid segment is prepared by mixing an amino acid segment and a diluting agent to form a mixture. The mixture is serially diluted to produce a diluted formulation. The amino acid segment includes a peptide sequence that is the same as a portion of a longer peptide sequence found in a naturally occurring material. A homeopathic remedy can be prepared using the formulation.

Abstract: The invention provides a pharmaceutical composition that can be used for an efficient administration of a water-soluble polymer drug by a method other than injection, and a method for production of the pharmaceutical composition. The pharmaceutical composition contains a small particle comprised of (a) a water-soluble drug and (b) a pharmaceutically acceptable ionic crystalline compound which is solid at room temperature, wherein the ionic crystalline compound is crystallized in the small particle.

Abstract: The present invention relates to compositions and methods for transdermal drug delivery comprising formulating a phosphatidylcholine carrier composition containing the drug and applying the composition to the skin.

Abstract: The present invention provides methods of forming a solid, biodegradable implant in-situ in a body by administering a liquid pharmaceutical composition comprising an effective amount of a biocompatible, water-insoluble, biodegradable polymer and an effective amount of a therapeutic peptide covalently modified with one or more lipophilic or amphiphilic moieties, which are dissolved or dispersed in a biocompatible, water-soluble organic solvent. This invention also provides related compositions and methods.

Abstract: Compositions and methods for treating type 2 diabetes and its sequelae by intravenous or subcutaneous administration of formulations of synthesized curcumin (diferuloylmethane) and concomitantly one or more anti-diabetic agents to human subjects are disclosed herein. The composition of the present invention may be used to: (i) treat patients with diabetes in advanced stages with evidence of any or all encephalopathy, retinopathy, nephropathy, pancreatitis or neoplasias; (ii) treat patients with diabetic disease status without symptomatic or pathologic evidence of associated sequelae but requiring better glycemic control than that offered by standard of care anti-diabetic; and (iii) patients with objective signs or symptoms of sequelae from diabetes of anti-diabetic drugs. One three-drug combination of the present invention includes a slow release PLGA-curcumin and an oral gliptin (DPP-4)-inhibitor or any incretin-mimetic and metformin.

Abstract: Stable formulations for parenteral injection of peptide drugs and methods of using such stable formulations are provided. In particular, the present invention provides stable formulations for parenteral injection of glucagon and methods of using such glucagon formulations to treat hypoglycemia, especially severe hypoglycemia in emergency situations.

Abstract: The invention provides methods and compositions for increasing the intracellular sodium concentration in a cell.

Abstract: Vesicle compositions are provided that comprise a therapeutic compound. The vesicle compositions may be capable of releasing the therapeutic compound in response to the presence of an external trigger. The vesicle compositions may comprise a plurality of biocompatible vesicles. The biocompatible vesicles may comprise a therapeutic compound for treatment of a patient in need thereof, and one or more cross-linkages between two or more of the biocompatible vesicles, each cross-linkage comprising a chemical sensing moiety and a sensed moiety. In some embodiments, the therapeutic compound may be any compound that provides palliative, curative, or otherwise beneficial effects to a patent.

Abstract: The present invention relates to pharmaceutical formulations comprising insulin, an insulin analog, an insulin derivative, or a combination of any of the foregoing, and a salt of protamine, to methods of preparing such formulations, and to uses of such formulations in the treatment of diseases and conditions for which use of the insulin peptide(s) contained in such formulations is indicated. The present invention further relates to methods for increasing the stability and/or solubility of insulin in insulin-containing formulations at a pH less than 7.0 by adding a salt of protamine to the insulin-containing formulations.

Abstract: A composition comprising chromium and insulin and/or a chromium-insulin complex, its method of preparation, and its use in the prevention and treatment of hypoglycemia and hypoglycemia-related conditions. This composition can be administered in numerous ways, including parenterally, intranasally, and orally. The composition stabilizes serum glucose levels and has a synergistic effect compared to chromium and insulin administered separately.

Abstract: The present invention relates to pharmaceutical formulations comprising a peptide and propylene glycol, to methods of preparing such formulations, and to uses of such formulations in the treatment of diseases and conditions for which use of the peptide contained in such formulations is indicated. The present invention further relates to methods for reducing the clogging of injection devices by a peptide formulation and for reducing deposits on production equipment during production of a peptide formulation.

Abstract: Disclosed herein are improved methods of treating hyperglycemia with a combination of an ultrarapid acting insulin and insulin glargine comprising prandial administration of the ultrarapid insulin, and administration of a first dose of insulin glargine within 6 hours of waking for a day.

Abstract: A liquid composition in an osmotic drug delivery system and a dosage form in an osmotic drug delivery system is disclosed comprising an amphiphilic molecule, a non-aqueous liquid solvent, and a pharmaceutically active agent.

Abstract: The invention relates to a method for treating disorders or diseases of a tight junction comprising delivering a pharmaceutical composition of nanoparticles to the tight junction, wherein the nanoparticles consist of positively charged chitosan, a negatively charged substrate, optionally a zero-charge compound, and at least one bioactive agent for treating said disorders or diseases of the tight junction of an animal subject.

Abstract: A composition suitable for use in a transdermal delivery patch for administration of a biologically active compound, the composition comprising a phosphate compound of tocopherol and a polymer carrier.

Abstract: The present invention provides a method and product for transdermal delivery of therapeutics, including neurotoxins and methods for use thereof. The method and system comprises pharmaceutical compositions for facilitating transdermal delivery of therapeutics without pain by absorption and more particularly a series of pharmaceutical formulations for topical administration of neurotoxins to humans, including a neurotoxin, such as a botulinum toxin, and absorption enhancing agents that facilitate absorption of the neurotoxin through the skin of the patient and do not eliminate the bioactivity associated with the neurotoxin. The pharmaceutical compositions are topically applied on a patient, and are generally in a cream or gel form.

Abstract: The invention describes a non-aqueous liquid pharmaceutical composition comprising at least one lipid and at least one insulin. Also described is a method of producing a pharmaceutical composition comprising a lipid and a method of purifying a lipid, a cosolvent, a surfactant or a pharmaceutical composition comprising a lipid.

Abstract: The present invention provides a use of an insulin for manufacture of a medicament for treating or preventing a disorder or disease of a central nervous system of an adult individual, wherein the disorder or disease is associated with tissue shrinkage or atrophy. Also provided are methods of treating such disorder or disease using a pharmaceutically effective amount of an insulin or composition that enhances the activity of endogenous insulin.

Abstract: The present invention provides geodate delivery vehicles and methods of manufacture and administration. A vehicle including a lipid monolayer disposed about a hydrophobic domain is disclosed, that can be part of an emulsion or other mixture, or further disposed in a lipid strata. A vehicle including a lipid strata disposed about a hydrophobic domain is also disclosed. The vehicle can be incorporated into a variety of medicinal, food preparations, and personal care products to deliver or stabilize a cargo moiety. Packaged delivery vehicles for to later addition of cargo moieties are also contemplated.

Abstract: The present invention provides a carrier component. The carrier component includes a carrier core body including a dispersive object and a dualistic self-assembly material for encapsulating the dispersive object, wherein the dualistic self-assembly material has an electric charge; and a first shell layer having an electric charge opposite to the electric charge of the dualistic self-assembly material, and coating the carrier core body, and thus avoids inactivation of a medicine, eliminates medicine leakage and reduces medicine releasing. The present invention further provides a method for forming a carrier component.

Abstract: Pharmaceutical form containing at least an active compound and a polymeric matrix, wherein said polymeric matrix comprises at least one polymer of cationic nature and at least one biodegradable polymer, process for the preparation thereof, pharmaceutical formulations comprising said pharmaceutical form, and their uses. The pharmaceutical form provides enhanced absorption of active compounds across the mucosa.

Abstract: Disclosed herein are fumaryl diketopiperazine (FDKP) compositions and microparticles having a specific trans isomer content of about 45% to about 65%. The FDKP microparticles can comprise a drug such as an endocrine hormone, including, peptide, including, insulin, glucagon, parathyroid hormones and the like and can be used to make a powder formulation for pulmonary delivery of the drug.

Abstract: The invention therefore relates to protein-containing powders, wherein the proportion of phenylalanine is at least 30% (w/w), or at least 40% (w/w). It has been shown that phenylalanine-containing powders, particularly after spray drying, are very suitable in terms of their aerodynamic characteristics and protein stabilization for preparing powders or protein compositions with improved aerodynamic properties. The main component is phenylalanine and the optional further component is an excipient which has good water-solubility compared with phenylalanine, preferably a sugar or a polyol.

Abstract: The present invention relates to a pharmaceutical composition comprising an insulin compound in a concentration that is sufficient to maintain a therapeutically effective level of the insulin compound in blood plasma for at least 3 days characterized by having a pharmacokinetic profile in vivo with substantially no burst of the insulin compound. The present invention further relates to the use of an insulin compound for preparing said pharmaceutical composition as well as a kit of parts comprising said pharmaceutical composition.

Abstract: The present invention relates to a prodrug or a pharmaceutically acceptable salt thereof comprising an insulin linker conjugate D-L, wherein D represents the insulin moiety; and -L is a non-biologically active linker moiety -L1 represented by formula (I), wherein the dashed line indicates the attachment to one of the amino groups of the insulin by forming an amide bond. The invention further relates to pharmaceutical compositions comprising said prodrugs as well as their use as a medicament for treating or preventing diseases or disorders which can be treated by insulin.

Abstract: This invention provides a polymeric drug delivery system including a hydrogel containing one or more drugs for the treatment of a posterior segment disease. Allowing passive transference of this drug from a dilute solution into the hydrogel produces the delivery system. The hydrogel, when placed in contact with the eye, delivers the drug. The delivery of the drug is sustained over an extended period of time, which is of particular utility in the eye, which is periodically flushed with tears. This sustained delivery accelerates the treatment process while avoiding potential damaging effects of localized delivery of high concentrations of compounds, e.g., from eye drops.

Abstract: The present invention realtes to compositions and methods to improve the microenvironments in and around the wound in an effort to enhance healing. Specifically, the present invention comprises application of tissue and cells culture nutrient media, such as minimum essential media, supplemented with insulin and/or with substances exhibiting insulin-like activity, such as cinnamon or cinnamon extracts including but not limited to MHCP. The media is applied to the wound to stimulate the viable cells in the wound bed and the adjacent cells in the periphery of the wound to proliferate and grow into the wound in order to achieve wound closure.

Abstract: This invention discloses bioerodible devices, such as implants for delivering therapeutic agents, particularly large molecules such as proteins and antibodies, in a controlled manner. The devices comprise a porous silicon-based carrier material impregnated with the therapeutic agent. The device may be used in vitro or in vivo to deliver the therapeutic agent, preferably in a controlled fashion over an intended period of time such as over multiple days, weeks or months. The device may be used for treating or preventing conditions of a patient such as chronic diseases.

Abstract: A pharmaceutical composition comprising a mixture of: (c) an active macromolecular principle; (d) an aromatic alcohol absorption enhancer chosen from propyl gallate, butylated hydroxy toluene (BHT), butylated hydroxy anisole (BHA) and analogues and derivatives thereof, or mixtures thereof; and (d) a biguanide or a pharmaceutically acceptable salt thereof, capable of increasing the solubility of the aromatic alcohol absorption enhancer in an aqueous medium, wherein the aromatic alcohol absorption enhancer is present in an amount by weight greater than or equal to that of the active principle.

Abstract: Described herein is a transmucosal delivery device and their use for delivering bioactive agents across a mucosal membrane. The delivery devices contain a pharmaceutically acceptable oxidizing and agents that facilitates the delivery of the blood stream across the mucosal membrane.

Abstract: Nanoparticles having a core and a corona of ligands covalently linked to the core, wherein peptides are bound to or associated with the nanoparticles.

Abstract: A pharmaceutical formulation for absorption through oral mucosae comprising an effective amount of (a) a pharmaceutical agent in mixed micellar form, (b) at least one micelle-forming compound selected from the group comprising an alkali metal alkyl sulfate and a polyoxyethylene sorbitan monooleate, (c) a block copolymer of polyoxyethylene and polyoxypropylene, (d) at least one additional micelle-forming compound, and (e) a suitable solvent. The invention also provides a metered dose dispenser (aerosol or non-aerosol) containing the present formulation and a method of administering insulin using the metered dose dispenser comprising administering split doses of a formulation containing insulin before and after each meal.

Abstract: The presently described subject matter is directed to a water-soluble conjugated polyene compound and the derivatives thereof that exhibit aggregation induced emission, as well as any water dispersible, fluorescent, polymeric microparticles, nanoparticles, and/or pharmaceutical composition comprising the water-soluble conjugated polyene compound and/or the derivatives thereof. Also provided are methods of making and using the compound, derivatives and particles of the presently described subject matter. The presently described water-soluble conjugated polyene compound are useful as bioprobes for the detection of biomacromolecules, in the manufacture of sensors, in monitoring and retarding formation of amyloid protein fibril in vitro and in vivo, and in developing anti-cancer drugs.

Abstract: Nano-sized particles are provided comprising at least one multi-headed amphiphilic compound, in which at least one headgroup of said multi-headed amphiphilic compound is selectively cleavable or contains a selectively cleavable group, and at least one biologically active agent, which is both encapsulated within the nano-particle and non-covalently associated thereto.

Abstract: Disclosed herein are diketopiperazine microparticles having a specific surface area of less than about 67 m2/g. The diketopiperazine microparticle can be fumaryl diketopiperazine and can comprise a drug such as insulin.

Abstract: A method for treating age related macular degeneration (AMD) using an insulin preparation applied topically to the conjunctival sac of the affected eye. Another aspect of this invention is using antiangiogenic adjuvant therapeutic agents such as bevacizumab, ranibizumab, pegaptanib, etanercept, instilled in to the afflicted eye conjunctival sac with insulin to prevent further formation of new blood vessels, and shrink the existing pathologically formed blood vessels and reduce the edema in wet AMD. This method incorporates putting the patients on low fat diet, aerobic exercise, ketamine-a NMDA blocker, reducing the blood cholesterol using adjuvant therapeutic agents selected from Statins, that are inhibitors of 3-hydroxy-3-methylglutaryl coenzyme A, (i.e. HMG-Co A) reductase which in turn reduce drusen formation that leads to AMD, combined with insulin ophthalmic drops.

Abstract: The present invention relates to the use of inclusion bodies as vehicles for therapeutic protein delivery. This method is applicable to the delivery of therapeutic proteins to intracellular locations. In addition, the invention also relates to the administration of a cell or a pharmaceutical composition comprising inclusion bodies formed by therapeutic proteins. These inclusion bodies formed by therapeutic proteins could be used for the treatment of different diseases.

Abstract: The present invention provides a sheet-form preparation that can be easily dissolved intraorally, allows the dissolution time thereof to be easily controlled, and can stably contain a drug except an allergenic protein from cedar pollen. The sheet-form preparation contains water, gelatin, and a drug except an allergenic protein from cedar pollen.

Abstract: A polymer capsule manufactured by polymerizing a compound represented by Formula 1, or polymerizing the compound of Formula 1 and a compound of Formula 2, wherein a detailed structure of the compounds of Formulae 1 and 2 is presented in the detailed description.

Abstract: A conjugate that includes a drug covalently linked to a polymer. Upon administration, the conjugate is digested by an enzyme that is present at the site of administration thereby releasing a therapeutic agent. The conjugate may demonstrate substantially the same pharmacokinetic and pharmacodynamic behavior as the drug itself. A material for controllably releasing a conjugate in response to the local concentration of a molecular indicator. The material includes a plurality of conjugates and a plurality of multivalent cross-linking agents. The polymers of the conjugates include an analog of the indicator within their covalent structure. The multivalent cross-linking agents include cross-link receptors that interact with the indicator analog and thereby cross-link the conjugates.

Abstract: The present invention provides albumin-binding probes capable of reversibly linking to short-lived amino-containing drugs and non-covalently associating with albumin in-vivo, thereby converting said drugs into inactive reactivable prodrugs having prolonged lifetime in-vivo. The invention further provides conjugates of said probes with amino-containing drugs, as well as pharmaceutical compositions and uses thereof.

Abstract: Insulin preparations comprising an insulin compound or a mixture of two or more insulin compounds, a nicotinic compound and an amino acid.

Abstract: An inhaler includes a first body member and a second body member fit closely together to form an inhaler body, and an outlet. The first body member has a medicament chamber containing a unit dose of powdered medicament. A seal such as a foil strip seals the medicament chamber and extends outwardly of the inhaler body. In use, one end of the seal can be grasped by a user and withdrawn, fully or partially, from the inhaler body, to release the powdered medicament from the medicament chamber. The second body member includes a medicament collection well in which the medicament is collected upon its release from the medicament chamber. The medicament collection well forms part of an airway connecting into the outlet. In use, air can be drawn by inhalation at the outlet to entrain the powder medicament in the collection well for inhalation by a user.

Abstract: A safe and effective treatment to curtail and cure autism spectrum disorders has been described in this invention using insulin, IGF-1, with multiple known adjuvant therapeutic agents, as well as other pharmaceutical, biochemical, nurticeuticals, and biological agents or compounds delivered through the olfactory mucosal region of the nose and external auditory meatus.

Abstract: The present invention provides novel calcium phosphate nanoparticles suitable for efficient encapsulation of biologically active molecules. The invention further provides pharmaceutical compositions comprising these nanoparticles, as well as methods of making such nanoparticles and using them as carriers for therapeutic delivery of biologically active macromolecules.