Abstract: The invention relates to powdered preparations containing tiotropium for inhalation, processes for preparing them as well as their use in preparing a pharmaceutical composition for the treatment of respiratory complaints, particularly for the treatment of COPD (chronic obstructive pulmonary disease) and asthma.

Abstract: Formulations have been developed for pulmonary delivery to treat or reduce the infectivity of diseases such as viral infections, especially tuberculosis, SARS, influenza and respiratory synticial virus in humans and hoof and mouth disease in animals, or to reduce the symptoms of allergy or other pulmonary disease. Formulations for pulmonary administration include a material that significantly alters physical properties such as surface tension and surface elasticity of lung mucus lining fluid, which may be isotonic saline and, optionally, a carrier. The formulation may be administered as a liquid solution, suspension, aerosol, or powder where the particles consist basically of an osmotically active solute. Drugs, especially antivirals or antibiotics, may optionally be included with the formulation. These may be administered with or incorporated into the formulation.

Abstract: The present invention is theobromine as an active agent to be delivered via the inhaled route, for the treatment of cough.

Abstract: The invention is related to compositions which can be used as dermal formulations for supporting the skin to restore normal conditions in case of e.g. irritated skin, or to support medical therapy of skin with atopic dermatitis symptoms, atopic dermatitis, psoriasis or related diseases (e.g. accompanied by distorted barrier function of the skin and microbial load). The compositions of the invention can be used for dermo-cosmetic products but also for pharmaceutical/-medical products, depending on the composition and the additional actives incorporated (cosmetic actives or drugs). The invention is based on the synergistic effect of metallic particles, in particular silver particles (such as microsilver, nanosilver) and lipid particles (lipid nanoparticles or lipid microparticles). As alternatives to silver particles, other metallic particles (e.g. zinc, copper) or nanocrystalline actives can be incorporated (e.g.

Abstract: A process for micronization of pharmaceutically active agents.

Abstract: A formulation for an inhaler device comprises carrier particles having a diameter of at least 50 ?m and a mass median diameter of at least 175 ?m; active particles; and additive material to which is able to promote release of the active particles from the carrier particles on actuation of the inhaler device. The formulation has excellent flowability even at relatively high fine particle contents.

Abstract: The present invention relates to particles and to methods of making particles. In particular, the invention relates to methods of making composite active particles comprising a pharmaceutically active material for pulmonary inhalation, the method comprising a jet milling process.

Abstract: The present disclosure relates to systems, methods, and formulations for the pulmonary administration of one or more therapeutic agents, in dry powder form, in a single, large dose quantity. These formulations, methods, and systems are useful in the treatment of patients suffering from toxic or harmful gas exposure, such as nerve gas exposure, as well as in the treatment of patients suffering from diseases of the pulmonary system, including tuberculosis, cystic fibrosis, and chronic obstructive pulmonary disease (COPD).

Abstract: The present invention relates to the delivery of antipsychotics through an inhalation route. Specifically, it relates to aerosols containing antipsychotics that are used in inhalation therapy. In a method aspect of the present invention, an antipsychotic is delivered to a patient through an inhalation route. The method comprises: a) heating a composition, wherein the composition comprises an antipsychotic, to form a vapor; and, b) allowing the vapor to cool, thereby forming a condensation aerosol comprising particles with less than 5% antipsychotic drug degradation products. In a kit aspect of the present invention, a kit for delivering an antipsychotic through an inhalation route is provided which comprises: a) a thin coating of an antipsychotic composition and b) a device for dispensing said thin coating as a condensation aerosol.

Abstract: Engineered particles are provided may be used for the delivery of a bioactive agent to the respiratory tract of a patient. The particles may be used in the form of dry powders or in the form of stabilized dispersions comprising a nonaqueous continuous phase. In particularly preferred embodiments the particles may be used in conjunction with an inhalation device such as a dry powder inhaler, metered dose inhaler or a nebulizer.

Abstract: The present invention relates to methods and compositions for prevention of graft rejection in lung transplant recipients and for treatment of subjects with pulmonary disorders. Specifically, the methods and compositions of the invention provide a means for inhibiting immune response mediated inflammatory processes in the lungs. The method of the invention comprises the administration of aerosolized cyclosporine for prevention of acute and/or chronic refractory rejection in lung transplant patients. The invention further provides for the use of aerosolized cyclosporine to treat subjects having immunologically mediated inflammatory pulmonary disorders including, but not limited to, asthma, cystic fibrosis, idiopathic pulmonary fibrosis, chronic bronchitis and allergic rhinitis.

Abstract: The present subject matter provides foamable suspension gels that foam after release from a container. The foamable suspension gels contain at least one pharmaceutically active agent that is sparingly soluble to insoluble in water, a second pharmaceutically active agent, and optionally a third active agent.

Abstract: The invention provides a formulation to be administered as dry powder for inhalation suitable for efficacious delivery of low-dosage strength active ingredients to the low respiratory tract of patient. In particular, the invention provides a formulation comprising microparticles constituted of microparticles of a low-dosage strength active ingredient and microparticles of an excipient wherein the MMD of the microparticles is comprised between 2 and 15 micron, at least 10% of the microparticles has a mass diameter (MD) higher than 0.5 micron, and the process of preparation thereof.

Abstract: The present invention relates to a process of a dispersion of an active substance or composition in a aqueous phase which comprises dispersing in an aqueous phase a solution of such substance or composition in dimethylether or in a C4-hydrocarbon or mixtures thereof in super- or nearcritical state, decompressing the mixture and separating the dispersion from the gaseous solvent.

Abstract: In a method of producing particles suitable for use as carrier particles in dry powder inhalers, particles (1) of a size suitable for use as carrier particles in dry powder inhalers are treated so as to dislodge small grains from the surface of the particles, without substantially changing the size of the particles during the treatment. The treatment gives improved efficiency of redispersion of active particles from the surfaces of carrier particles.

Abstract: The invention involves methods and formulations for treating or preventing rhinosinusitis, including fungus-induced rhinosinusitis in mammals. In one embodiment, the formulation of the present invention comprises a steroidal anti-inflammatory agent having a specific particle size distribution profile. The formulation may also comprise an antifungal agent, antibiotic or antiviral agent.

Abstract: An amphiphilic block copolymer. The amphiphilic block copolymer includes one or more hydrophilic polymers, one or more hydrophobic polymer, and one or more zwitterions. The invention also provides a nano particle and carrier comprising the amhpiphilic block copolymer for delivery of water-insoluble drugs, growth factors, genes, or cosmetic substances.

Abstract: The invention relates to an aerosol container for pharmaceutically active aerosols that are to be administered in predetermined amounts and that are supplied in the container in the form of a suspension, the suspension also comprising, in addition to a pharmaceutically active substance, at least a propellant gas. The aerosol container has a metering valve that comprises a metering chamber and a valve stem. In a first position of the valve stem, the metering chamber is in communication with the interior of the container and has been filled with a predetermined amount of the aerosol. In a second position of the valve stem, the amount of aerosol disposed in the metering chamber is released. The propellant gas is an alternative propellant gas that is free of fluorochlorohydrocarbons, preferably a propellant gas that comprises only fluorohydrocarbons, and the inner wall of the container is coated with a plastics coating.

Abstract: A composition and method which prevents or mitigates irritation on the skin of a subject by protecting against or relieving chafing, itching and moisture, and which provides a cooling sensation where applied.

Abstract: An inhalable dry powder formulation containing SAE-CD and an active agent is provided. The formulation is adapted for administration by DPI. The SAE-CD serves as a carrier rather than as an absorption enhancer. The average particle size of the SAE-CD is large enough to preclude (for the most part) pulmonary deposition thereof. Following release from the DPI device, the SAE-CD-containing particles dissociate from the active agent-containing particles in the buccal cavity or throat, after which the active agent-containing particles continue deeper into the respiratory tract. The physicochemical and morphological properties of the SAE-CD are easily modified to permit optimization of active agent and carrier interactions. Drugs having a positive, neutral or negative electrostatic charge can be delivered by DPI when SAE-CD is used as a carrier.

Abstract: A formulation for use in an inhaler device comprises carrier particles having a diameter of at least 50 ?m and a mass median diameter of at least 175 ?m; fine particles of an excipient material having a mass median aerodynamic diameter of not more than 20 ?m; and active particles. The formulation has excellent flowability even at relatively high contents of fine particles.

Abstract: Drug substance for use in a pharmaceutical formulation may be prepared by a process which process comprises co-milling a suspension of the drug substance and a pharmaceutically acceptable polymer in a liquid propellant.

Abstract: Embodiments of the invention relate to particles of active substances, methods for preparing the particles, formulations containing the particles, and metered dose inhalers containing the particles or formulations. In one embodiment, an inhaler contains an aerosol formulation containing a particulate active substance of non-micronized, solid particles having a mass median aerodynamic diameter of less than 10 ?m. The particles may be suspended in a nonsolvent hydrofluorocarbon fluid vehicle (e.g., HFA 134a or 227ea) at a concentration within a range from about 0.2% w/v to about 5% w/v. The formulation exhibits a flocculation volume of about 85% or greater about 1 minute after mixing the particulate active substance and the vehicle. The particulate active substance may contain salmeterol xinafoate, budesonide, salbutamol sulfate, dihydroergotamine mesylate, risperidone-(9-hydroxy)-palmitate, bromocriptine mesylate, or derivatives thereof. In some examples, the active substance is dihydroergotamine mesylate.

Abstract: The present invention relates to the inhalation delivery of aerosols containing small particles. Specifically, it relates to a method of forming an aerosol for use in inhalation therapy. In a method aspect of the present invention, a method of forming an aerosol for use in inhalation therapy is provided. The method involves the following steps: (a) heating a substrate coated with a composition comprising a drug at a rate greater than 1000° C./s, thereby forming an vapor; and, (b) allowing the vapor to cool, thereby forming an aerosol, which is used in inhalation therapy. In another method aspect of the present invention, a method of forming an aerosol for use in inhalation therapy is provided. The method involves the following steps: (a) heating a substrate coated with a composition comprising a drug to form a vapor, wherein the coated composition is in the form of a film less than 10? thick; and, (b) allowing the vapor to cool, thereby forming an aerosol, which is used in inhalation therapy.

Abstract: The invention provides a method of preparing a dry powder inhalation composition comprising a pharmaceutically acceptable particulate carrier, a first particulate inhalant medicament and a second particulate inhalant medicament. Also provided are dry powder compositions and methods of using them with a dry powder inhalation device.

Abstract: Hypersecretion of mucus in the lungs is inhibited by the administration of an epidermal growth factor receptor (EGF-R) antagonist. The EGF-R antagonist may be in the form of a small organic molecule, an antibody, or portion of an antibody that binds to and blocks the EGF receptor. The EGF-R antagonist is preferably administered by injection in an amount sufficient to inhibit formation of goblet cells in pulmonary airways. The degranulation of goblet cells that results in airway mucus production is thereby inhibited. Assays for screening candidate agents that inhibit goblet cell proliferation are also provided.

Abstract: The present invention relates to a composition of a temporary hair thickener. In particular, the present invention relates to a composition of a temporary hair thickener comprising bamboo charcoal powder, a hydrophobic waterproof coating agent, a low grade alcohol and a propellant in a specific amount. The composition of a temporary hair thickener in accordance with the present invention can be attached to hair for a longer time as compared with the prior art hair thickeners, thereby showing improved persistency. Further, since the thickener ingredients of the composition are hardly flowed down or detached from hairs by rain or sweat, the composition of the present invention solves the problem of blotting the skin and clothes.

Abstract: The invention relates to ethanol-containing pharmaceutical preparations for the production of propellant-free aerosols.

Abstract: A method and composition are disclosed utilizing the pure (R,R) isomer of formoterol, which is a potent bronchodilator with reduced adverse effects, a low incidence of the development of tolerance and an increased duration of action, as compared to racemic formoterol.

Abstract: Powder compositions exhibiting improved flow properties. The compositions generally contain a bulk solid material in the form of a powder and surface-modified nanoparticles. Methods of improving the flow of powder compositions and devices and articles made using such compositions are also disclosed.

Abstract: The invention provides microparticles for use in a pharmaceutical composition for pulmonary administration, each microparticle comprising a particle of an active substance having, on its surface, particles of a hydrophobic material suitable for delaying the dissolution of the active substance. The invention also provides a method for making the microparticles.

Abstract: The invention relates to 17-HPC pulmonary formulations for administration by inhalation comprising 17-HPC and a pharmaceutically acceptable excipient. Particle size reduction of 17-HPC is required for the pulmonary delivery, and can be achieved with a surfactant or water without the surfactant. Preferred pulmonary formulations include a powder blend comprising a therapeutically effective amount of at least one steroid hormone (progestogen) as a glucocorticoid sensitizer, and at least one pharmaceutically acceptable excipient, wherein the at least one steroid hormone (progestogen) has a particle size distribution profile ranging from about one nanometer to about ten microns in the powder blend.

Abstract: The invention relates to inhalable quinolonecarboxylic acid derivative compositions for local control of diseases of the respiratory organs, in particular of lung diseases.

Abstract: A pharmaceutical composition for pulmonary delivery comprises glycopyrrolate in a controlled release formulation, wherein, on administration, the glycopyrrolate exerts its pharmacological effect over a period greater than 12 hours.

Abstract: An inhalation kit comprising: (a) an inhaler displaying a flow resistance of about 0.01 to 0.1 ?{square root over (kPa)} min/L; and (b) an inhalable powder comprising tiotropium in admixture with a physiologically acceptable excipient with an average particle size of between 10 to 500 ?m, and a method of administering an inhalable powder containing tiotropium in admixture with a physiologically acceptable excipient with an average particle size of between 10 ?m to 500 ?m, the method comprising actuating an inhaler a flow resistance of about 0.01 to 0.1 ?{square root over (kPa)} min/L containing the inhalable powder.

Abstract: Nano-constructs comprising nanoshells and methods of using the nano-constructs for treating or ameliorating a medical condition are provided.

Abstract: Provided is an encapsulated functional fine particle composition capable of spraying that is useful for hemostasis and wound protection and allows a patient to treat the wound by oneself. Additionally, the composition can be rapidly applied on a large wound during an operation using an air gun in case of in-vivo application and shows prompt hemostasis.

Abstract: A method for improvement of tolerance for therapeutically effective agents delivered by inhalation comprising a pretreatment of a patient with a nebulized lidocaine or a lidocaine-like compound administered immediately or up to about thirty minutes before administration of the primary therapeutically effective agent. The pretreatment of the patient with the nebulized lidocaine or a lidocaine-like compound improves airway tolerance and deposition of the agent in the lungs and makes such deposition more safe, efficacious, controllable and predictable. The method of the invention is especially useful for enhancement of deposition of immunosuppressive agents in the lung(s) of transplant patients, improved tolerance of the drugs by reducing cough, and improving pulmonary drug deposition.

Abstract: A container for liquid inhalation anesthetics, more particularly, an aluminum container that is suitable for storing halogenated inhalation anesthetics is described.

Abstract: The present invention relates to the delivery of drug amines through an inhalation route. Specifically, it relates to aerosols containing drug amines that are used in inhalation therapy. In one aspect of the present invention, a method of delivering an amine drug in an aerosol form is provided. The method comprises: a) heating a coating, which includes an amine drug salt on a substrate contained in a device to a temperature sufficient to volatilize the amine drug from the coating, b) by said heating, forming an amine drug vapor, and c) during said heating, drawing air through said device, condensing said vapor to form aerosol particles containing less than 10% degradation products of the compound.

Abstract: An anti-tussive nebulized solution for targeted delivery of lidocaine into conducting and central airways. A method for treatment of cough and tussive attacks or episodes using said lidocaine solution. A nebulized lidocaine solution administered in daily dose from about 10 mg to 80 mg of lidocaine dissolved in a saline and nebulized into an aerosol having a mass median aerodynamic diameter 3 ?m to 10 ?m and a geometric standard deviation less than 1.7 using an electronic nebulizer.

Abstract: The present invention relates to the delivery of drug esters through an inhalation route. Specifically, it relates to aerosols containing drug esters that are used in inhalation therapy. In a method aspect of the present invention, a drug ester is delivered to a patient through an inhalation route. The method comprises: a) heating a composition, wherein the composition comprises a drug ester, to form a vapor; and, b) allowing the vapor to cool, thereby forming a condensation aerosol comprising particles with less than 5% drug ester degradation product. In a kit aspect of the present invention, a kit for delivering a drug ester through an inhalation route is provided which comprises: a) a thin coating of a drug ester composition and b) a device for dispensing said thin coating as a condensation aerosol.

Abstract: Nasal pharmaceutical formulations comprising a drug substance having a specific particle size distribution profile are disclosed herein. Such profile provides increased bioavailability, increased efficacy or prolonged therapeutic effect of the drug substance when administered intranasally. The formulations of the present invention may comprise one or more corticosteroids having a specific particle size distribution profile. In a preferred embodiment, the corticosteroid is beclomethasone or a pharmaceutically acceptable derivative thereof for the treatment of one or more symptoms of rhinitis. Preferably, the drug substance is beclomethasone dipropionate. The formulations herein may be provided as an aqueous suspension suitable for inhalation via the intranasal route.

Abstract: Nasal pharmaceutical formulations comprising a drug substance having a specific particle size distribution profile are disclosed herein. Such profile provides increased bioavailability, increased efficacy or prolonged therapeutic effect of the drug substance when administered intranasally. The formulations of the present invention may comprise one or more corticosteroids having a specific particle size distribution profile. In a preferred embodiment, the corticosteroid is fluticasone or a pharmaceutically acceptable derivative thereof for the treatment of one or more symptoms of rhinitis. Preferably, the drug substance is fluticasone propionate. The formulations herein may be provided as an aqueous suspension suitable for inhalation via the intranasal route.

Abstract: The invention relates to a method of delivering an agent to the pulmonary system of a compromised patient, in a single breath-activated step, comprising administering a particle mass comprising an agent from an inhaler containing less than 5 milligrams of the mass, wherein at least about 50% of the mass in the receptacle is delivered to the pulmonary system of a patient. The invention also relates to receptacles containing the particle mass and the inhaler for use therein.

Abstract: New solid drug dispersions are described in which a drug is present in amorphous form and dispersed within the particles of an organic carrier selected from cross-linked polymers and/or complexing agents. These dispersions are obtainable by mixing the drug and the carrier and applying an oscillating electromagnetic field in the microwave region according to a specific heating cycle wherein the drug-carrier mixture is heated at a temperature higher than the melting point of the drug for at least 5 minutes.

Abstract: Effervescent powders comprising inhalable particles are disclosed, as are methods for preparing these powders. The inhalable carrier particles comprise an inorganic or organic carbonate, and an acid, and exhibit effervescence when exposed to water or humid air. The particles have a mass median aerodynamic diameter suitable for nasal, bronchial, or pulmonary administration. The inhalable particles may be used as carriers for active agents. The inhalable particles may also be used to enhance permeability of mucosal and surface barriers on an inner surface of the nose, mouth, airway, and/or lungs of a patient, as well as to loosen, thin, cleanse, and remove mucus and extrinsic surface materials from an inner surface of the nose, mouth, airway, and/or lungs of a patient in need thereof.

Abstract: The present invention is directed toward particles for delivery of epinephrine to the respiratory system and methods for treating a patient in need of epinephrine. The particles and respirable compositions comprising the particles of the present invention described herein comprise the bioactive agent epinephrine, or a salt thereof, as a therapeutic agent. The particles are preferably formed by spray drying. Preferably, the particles and the respirable compositions are substantially dry and are substantially free of propellents. In a preferred embodiment, the particles have aerodynamic characteristics that permit targeted delivery of epinephrine to the site(s) of action.

Abstract: Provided herein is a stable pharmaceutical product comprising a dry powder inhalation device, and a pharmaceutical composition that comprises R,R-Formoterol L-tartrate salt, in particular crystalline R,R-formoterol L-tartrate; and ciclesonide.

Abstract: Methods are provided for purifying peptides and proteins by incorporating the peptide or protein into a diketopiperazine or competitive complexing agent to facilitate removal one or more impurities, from the peptide or protein. Formulations and methods also are provided for the improved transport of active agents across biological membranes, resulting for example in a rapid increase in blood agent concentration. The formulations include microparticles formed of (i) the active agent, which may be charged or neutral, and (ii) a transport enhancer that masks the charge of the agent and/or that forms hydrogen bonds with the target biological membrane in order to facilitate transport. In one embodiment, insulin is administered via the pulmonary delivery of microparticles comprising fumaryl diketopiperazine and insulin in its biologically active form. This method of delivering insulin results in a rapid increase in blood insulin concentration that is comparable to the increase resulting from intravenous delivery.