Abstract: This invention relates to the administration of proteins by absorption from the lungs. In particular, it is concerned with providing therapeutic doses of human growth hormone to the bloodstream without irritating or otherwise damaging lung tissue. This invention also relates to the methods of delivery of human growth hormone to the pulmonary system.

Abstract: A method for treating a disorder of the central nervous system includes administering to the respiratory tract of a patient a drug which is delivered to the pulmonary system, for instance to the alveoli or the deep lung. The drug is administered at a dose which is at least about two-fold less than the dose required by oral administration. Particles that include the drug can be employed. Preferred particles have a tap density of less than about 0.4 g/cm3. In addition to the medicament, the particles can include other materials such as, for example, phospholipids, amino acids, combinations thereof and others.

Abstract: The present invention is based, in part, on the unexpected discovery that aerosol particle formulations for pulmonary delivery of a therapeutic, prophylactic or diagnostic agent comprising an asymmetric phospholipid exhibit sustained release and/or sustained action of the agent. In some embodiments, as an alternative to one or more asymmetric phospholipids or in addition to one or more asymmetric phospholipids, the instant particles comprise one or more glycerol fatty acid esters. The present invention is directed to spray dried non-polymeric particles for pulmonary delivery and sustained release of a therapeutic, prophylactic or diagnostic agent and methods for delivery of said particles to the pulmonary system, the particles comprising a therapeutic, prophylactic or diagnostic agent and an asymmetric phospholipid and/or one or more glycerol fatty acid esters. In one embodiment, the particles comprise a combination of phospholipids wherein at least one of the phospholipids is an asymmetric phospholipid.

Abstract: The present invention features pharmaceutical compositions comprising nanoparticles containing a sustained release bioactive agent, method of making such compositions, and method of therapy using such compositions.

Abstract: A method for treating a disorder of the central nervous system includes administering to the respiratory tract of a patient a drug which is delivered to the pulmonary system, for instance to the alveoli or the deep lung. The drug is administered at a dose which is at least about two-fold less than the dose required by oral administration. Particles that include the drug can be employed. Preferred particles have a tap density of less than about 0.4 g/cm3. In addition to the medicament, the particles can include other materials such as, for example, phospholipids, amino acids, combinations thereof and others.

Abstract: The invention is drawn to particles for oral drug delivery produced by spray-drying a dilute solution of a poorly soluble agent. The particles comprise regions of poorly soluble agent wherein the dissolution rate enhancement is between about 2-fold and about 25-fold compared to the agent in bulk form.

Abstract: This invention concerns an improved particulate composition for delivering a drug to the pulmonary system. Applicants disclose a method of identifying an optimal form of aerodynamically light particles which are highly dispersible. The particles of the instant invention are made by creating hollow, spherical drug particles (i.e., progenitor particles) that collapse in the process of particle formation, leading to wrinkled, thin-walled drug particles of very low envelope density. Additionally, Applicants have found that such particles are especially optimal for inhaled aerosols when the surface area parameter (&sgr;) is greater than 2, optimally greater than 3.

Abstract: Particles having a tap density of less than 0.4 g/cm3 include a hydrophobic amino acid or salt thereof and a therapeutic, prophylactic or diagnostic agent or any combination thereof. Preferred particles include a phospholipid, have a median geometric diameter between about 5 and about 30 microns and an aerodynamic diameter between about 1 and about 5 microns. The particles can be formed by spray-drying and are useful for delivery to the pulmonary system.

Abstract: The invention generally relates to a method for pulmonary delivery of therapeutic, prophylactic and diagnostic agents to a patient wherein the agent is released in a sustained fashion, and to particles suitable for use in the method. In particular, the invention relates to a method for the pulmonary delivery of a therapeutic, prophylactic or diagnostic agent comprising administering to the respiratory tract of a patient in need of treatment, prophylaxis or diagnosis an effective amount of particles comprising a therapeutic, prophylactic or diagnostic agent or any combination thereof in association with a charged lipid, wherein the charged lipid has an overall net charge which is opposite to that of the agent upon association with the agent. Release of the agent from the administered particles occurs in a sustained fashion.

Abstract: A method of pulmonary delivery of a medicament, for example a dopamine precursor or a dopamine agonist, which includes administering to the respiratory tract of a patient in need of rescue therapy particles comprising an effective amount of a medicament. The particles are delivered to the pulmonary system and are released into the blood stream and delivered to the medicament's site of action in a time sufficiently short to provide the rescue therapy. In addition to the medicament, the particles can include other materials such as, for example, phospholipids, amino acids, combinations thereof and others. Preferred particles have a tap density of less than about 0.4 g/cm3.

Abstract: Spray dried particles having specified aerodynamic characteristics are produced by atomizing a liquid feed and contacting the liquid feed with a drying gas, such as, for example, air or nitrogen. The humidity of the drying gas is controlled to a value, expressed, for instance, as dew point, which is known to produce particles having a specified tap density or aerodynamic diameter. Particles having a volume median geometric diameter greater than about 5 microns and a tap density less than about 0.4 g/cm3 are preferred.

Abstract: The invention generally relates to formulations having particles comprising phospholipids, bioactive agent and excipients and the pulmonary delivery thereof. Dry powder inhaled insulin formulations are disclosed. Formulations comprising DPPC, insulin and sodium citrate which are useful in the treatment of diabetes are disclosed. Also, the invention relates to a method of for the pulmonary delivery of a bioactive agent comprising administering to the respiratory tract of a patient in need of treatment, or diagnosis an effective amount of particles comprising a bioactive agent or any combination thereof in association, wherein release of the agent from the administered particles occurs in a rapid fashion.

Abstract: A method for treating a disorder of the central nervous system includes administering to the respiratory tract of a patient a drug which is delivered to the pulmonary system, for instance to the alveoli or the deep lung. The drug is administered at a dose which is at least about two-fold less than the dose required by oral administration. Particles that include the drug can be employed. Preferred particles have a tap density of less than about 0.4 g/cm3. In addition to the medicament, the particles can include other materials such as, for example, phospholipids, amino acids, combinations thereof and others.

Abstract: A method for delivering an agent to the pulmonary system, in a single, breath-activated step or a single breath, comprises administering from a receptacle enclosing a mass of particles, to a subject's respiratory tract, particles which have a tap density of less than 0.4 g/cm3 and deliver at least about 50% of the mass of particles. The particles are capable of carrying agents. The agent is (1) part of the spray-drying pre-mixture and thereby incorporated into the particles, (2) added to separately-prepared particles so that the agent is in chemical association with the particles or (3) blended so that the agent is mixed with, and co-delivered with the particles.

Abstract: The invention generally relates to a method for pulmonary delivery of therapeutic, prophylactic and diagnostic agents to a patient wherein the agent is released in a sustained fashion, and to particles suitable for use in the method. In particular, the invention relates to a method for the pulmonary delivery of a therapeutic, prophylactic or diagnostic agent comprising administering to the respiratory tract of a patient in need of treatment, prophylaxis or diagnosis an effective amount of particles comprising a multivalent metal cation which is complexed with a therapeutic, prophylactic or diagnostic agent or any combination thereof having a charge capable of complexing with the cation upon association with the agent, a pharmaceutically acceptable carrier and optionally, a multivalent metal cation-containing component wherein the total amount of multivalent metal cation present in the particles is more than 1% weight/weight of the total weight of the agent (% w/w).

Abstract: Method and apparatus for providing a precisely controlled amount of dry material to a container. A powder slug is formed, preferably under vacuum, in a dosing hole formed in a dosing plate. The powder slug represents a precisely metered amount of material to be deposited into the container. The dosing plate is translated to a position such that the powder slug is above, and may be expelled into, a container located in a dosing wheel that has been moved into proper position for container filling to occur. In another embodiment, a system is provided for automated container filling.

Abstract: Particles which include a bioactive agent are prepared to have a desired matrix transition temperature. Delivery of the particles via the pulmonary system results in modulation of drug release from the particles. Sustained release and/or sustained pharmacologic action of the drug can be obtained by forming particles which include a combination of phospholipids that are miscible in one another and have a high matrix transition temperature.