Abstract: According to the subject invention, dispersible dry powder pharmaceutical-based compositions are provided, including methods for their manufacture and dry powder dispersion devices. A dispersible dry powder pharmaceutical-based composition is one having a moisture content of less than about 10% by weight (%w) water, usually below about 5%w and preferably less than about 3%w; a particle size of about 1.0-5.0 &mgr;m mass median diameter (MMD), usually 1.0-4.0 &mgr;m MMD, and preferably 1.0-3.0 &mgr;m MMD; a delivered dose of about >30%, usually >40%, preferably >50%, and most preferred >60%; and an aerosol particle size distribution of about 1.0-5.0 &mgr;m mass median aerodynamic diameter (MMAD), usually 1.5-4.5 &mgr;m MMAD, and preferably 1.5-4.0 MMAD. Such composition are of pharmaceutical grade purity.

Abstract: Materials which are not themselves storage-stable at room temperature are made suitable for storage by mixing them with a carrier substance and spray drying the resulting mixture so as to form particles containing both the material and the carrier substance in which the carrier substance is in an amorphous, i.e. glassy or rubbery, state. Formation of such a composition greatly enhances stability. The material stored may be a biological material such as an enzyme, the components of a chemical reaction such as reagents for carrying out an assay, or even viable biological cells.

Abstract: According to the subject invention, dispersible dry powder pharmaceutical-based compositions are provided, including methods for their manufacture and dry powder dispersion devices. A dispersible dry powder pharmaceutical-based composition is one having a moisture content of less than about 10% by weight (% w) water, usually below about 5% w and preferably less than about 3% w; a particle size of about 1.0-5.0 &mgr;m mass median diameter (MMD), usually 1.0-4.0 &mgr;m MMD, and preferably 1.0-3.0 &mgr;m MMD; a delivered dose of about >30%, usually >40%, preferably >50%, and most preferred >60%; and an aerosol particle size distribution of about 1.0-5.0 &mgr;m mass median aerodynamic diameter (MMAD), usually 1.5-4.5 &mgr;m MMAD, and preferably 1.5-4.0 MMAD. Such composition are of pharmaceutical grade purity.

Abstract: Dispersibility of a respirable powder, administrable by inhalation, is increased by including a pharmaceutically acceptable water-soluble polypeptide.

Abstract: A powdered, dispersible composition having stable dispersibility over time is provided. The composition exhibits a characteristic glass transition temperature (Tg) and a recommended storage temperature (Ts), wherein the difference between Tg and Ts is at least about 10° C. (i.e. Tg−Ts is greater than 10° C.). The composition comprises a mixture of a pharmaceutically-acceptable glassy matrix and at least one pharmacologically active material within the glassy matrix. It may be further mixed with a powdered, pharmaceutically-acceptable carrier. It is particularly valuable in unit dosage form having a moisture barrier, in combination with appropriate labelling instructions.

Abstract: A dry powder composition comprises nucleic acid constructs dispersed within with a hydrophilic excipient material, where the powder particles have an average size in the range from 0.5 &mgr;m to 50 &mgr;m. Nucleic acid constructs may comprise bare nucleic acid molecules, viral vectors, or vesicle structures. The hydrophilic excipient material will be selected to stabilize the nucleic acid molecules in the constructs, enhance dispersion of the nucleic acid in dry powder aerosols, and enhance wetting of the nucleic acid constructs as they are delivered to moist target locations within the body.

Abstract: A powdered, dispersible composition having stable dispersibility over time is provided. The composition exhibits a characteristic glass transition temperature (Tg) and a recommended storage temperature (Ts), wherein the difference between Tg and Ts is at least about 10° C. (i.e. Tg−Ts is greater than 10° C.). The composition comprises a mixture of a pharmaceutically-acceptable glassy matrix and at least one pharmacologically active material within the glassy matrix. It may be further mixed with a powdered, pharmaceutically-acceptable carrier. It is particularly valuable in unit dosage from having a moisture barrier, in combination with appropriate labelling instructions.

Abstract: According to the present invention, methods and compositions are provided for spray-dried, interferon-based dry powder compositions, particularly interferon-beta. The compositions are useful for treating conditions in humans that are responsive to treatment with interferons. In particular, the methods of the present invention rely on spray drying to produce stable, high-potency dry powder formulations of interferons, including but not limited to IFN-beta. Surprisingly, it has been found that IFN can be prepared in high potency, dry powder formulations by spray drying. Such dry powder formulations find particular utility in the pulmonary delivery of IFN.

Abstract: Dispersibility of a respirable powder, administrable by inhalation, is increased by including a pharmaceutically acceptable water-soluble polypeptide.

Abstract: Dispersibility of a respirable powder, administrable by inhalation, is increased by including a pharmaceutically acceptable water-soluble polypeptide.

Abstract: In a composition which has an amorphous, undercooled, glassy phase containing a water-soluble or water-swellable substance in an amorphous form, a sugar, which is capable of existing as a crystalline hydrate, is used as an agent to dehydrate the amorphous phase by crystallization therefrom, and thereby enhance the glass transition temperature of the residual amorphous phase.

Abstract: The present invention provides novel methods for the treatment of retroviral infection, particularly HIV disease. According to the present invention, human HIV infected hosts were selected who had been on a stable dose of an anti-retroviral agent, such as zidovudine, for up to two years prior to administration of the ribosomal inhibiting protein trichosanthin, and who had failed anti-retroviral therapy, as manifest by decrease in CD4+ cells on at least two serial measurements, or loss of over 50 CD4+ cells/mm.sup.3 /year. These patients remained on the same dose of anti-retroviral agent (AZT or ddI) and received trichosanthin, 1.2 mg weekly, then monthly. A significant number of patients demonstrated improved CD4+ cell counts following administration of trichosanthin as compared to CD4+ cell counts prior to adminstration of the drug.

Abstract: The present invention provides novel hybridoma cell lines which produce monoclonal antibodies (MoAbs) that bind epitopes found on lipopolysaccharide most commonly associated with the endotoxin core of gram negative bacteria and exhibit broad cross-reactivity with gram negative bacteria of different genera and effectively neutralize endotoxin. At least one of the MoAbs disclosed (XMMEN-J5D) binds an epitope also found on gram positive bacteria. The hybridomas are produced by fusing an immortal cell, a cell having the ability to replicate indefinitely in myeloma cell culture, and an effector immune cell following immunization of the immune cell host with a preparation of a gram negative bacteria. While several individual hybridoma cell lines producing monoclonal antibodies to lipopolysaccharide are described, the present invention adds to the state of the art an entire family of hybridoma producing monoclonal antibodies to lipopolysaccharide-associated epitopes.