Abstract: A method and device for intradermal delivery of a reconstituted medicament. The device includes a chamber, which is in fluid communication with a microdevice, e.g. microabrader or one or more microneedles. A cartridge containing the medicament may be located within said chamber. At least one burstable membrane retains a medicament within the housing. The method involves the steps of positioning the device at a delivery site on the skin of a patient and intradermally administering the medicament by dispensing a diluent from a diluent source an through inlet port to rupture the membranes, reconstitute the medicament and deliver the reconstituted medicament through the microdevice to the dermal region of the skin.

Abstract: Improved microprotrusion abrasion devices having fluid retaining or directing patterns, and specific design parameters and method for delivery of substances into the skin. Various configurations of such devices are disclosed, including domed, channeled, patterned and stepped.

Abstract: A method and device for intradermal delivery of a reconstituted medicament. The device includes a chamber, which is in fluid communication with a microdevice, e.g. microabrader or one or more microneedles. A cartridge containing the medicament may be located within said chamber. At least one burstable membrane retains a medicament within the housing. The method involves the steps of positioning the device at a delivery site on the skin of a patient and intradermally administering the medicament by dispensing a diluent from a diluent source an through inlet port to rupture the membranes, reconstitute the medicament and deliver the reconstituted medicament through the microdevice to the dermal region of the skin.

Abstract: The present invention is directed to methods for preparing a stable powder formulation of an alum-adsorbed vaccine. The methods comprise atomizing a liquid formulation comprising an immunogen adsorbed onto an aluminum adjuvant to produce an atomized formulation, freezing the atomized formulation to produce frozen particles, and drying the frozen particles to produce dried powder particles. Pharmaceutical compositions comprising a stable powder formulation of an alum-adsorbed vaccine are also disclosed herein. The pharmaceutical compositions are stable at high temperatures and can be reconstituted in a pharmaceutically acceptable carrier to produce a reconstituted liquid vaccine that exhibits little or no particle agglomeration and retains immunogenicity. Methods of using the alum-adsorbed vaccine compositions for preventing and treating a disease in a subject, wherein the disease is associated with the particular immunogen, are further provided.

Abstract: A method and device for intradermal delivery of a reconstituted powdered medicament. The device includes a chamber, which is in fluid communication with a microdevice, e.g. microabrader or one or more microneedles. A cartridge containing the powdered medicament may be located within said chamber. At least one burstable membrane retains a powdered medicament within the housing. The method involves the steps of positioning the device at a delivery site on the skin of a patient and intradermally administering the medicament by dispensing a diluent from a diluent source an through inlet port to rupture the membranes, reconstitute the powdered medicament and deliver the reconstituted medicament through the microdevice to the dermal region of the skin.

Abstract: A method of preparing a pharmaceutical composition is described, comprising 1) atomizing a liquid formulation of a therapeutic agent to produce an atomized formulation; 2) freezing said atomized formulation to form solid particles; and 3) drying said solid particles at about atmospheric pressure to produce a powder, wherein said drying is performed in the presence of vibration, internals, mechanical stirring, or a combination thereof. Another method is described, comprising 1) atomizing a liquid formulation of a therapeutic agent to produce an atomized formulation; 2) freezing said atomized formulation to form solid particles; and 3) drying said solid particles to produce a powder; wherein the atomized formulation comprises droplets having an average mean diameter of between about 35? and about 300?, and/or the powder comprises dried particles having an average mean diameter of between about 35? and about 300?. Compositions made by the above methods, and methods of using the compositions, are also described.

Abstract: The present invention provides improved methods for delivery of substances into the skin. It has been discovered that delivery of substances such as nucleic acids, amino acids, amino acid derivatives, peptides and polypeptides simultaneously with abrasion of the skin enhances delivery and the biological response as compared to application of the substance to previously abraded skin.

Abstract: The present invention relates to immunogenic compositions for intradermal delivery of an antigenic or immunogenic agent in combination with one or more excipients. The immunogenic compositions of the invention comprise an antigenic or immunogenic agent and at least one excipient which acts as an adjuvant, i.e., enhances the immune response to the antigenic or immunogenic agent, once delivered to the intradermal compartment of a subject's skin. The immunogenic compositions of the invention comprise an excipient which when administered to the intradermal compartment of skin in accordance with the invention demonstrate adjuvant activity. The immunogenic compositions of the invention have enhanced efficacy as the excipients of the composition cause an asymptomatic skin irritation and recruit antigen presenting cells to the intradermal compartment and thus enhance presentation and/or availability of the antigenic or immunogenic agent to the antigen presenting cells.

Abstract: An abrasion device and method for delivery of substances into the skin using a microabrader for delivering a substance into the skin are disclosed. An abrasion device with a cover is also disclosed. Such devices and methods can be effectively used to deliver bioactive substances into skin.

Abstract: Improved microprotrusion abrasion devices having fluid retaining or directing patterns, and specific design parameters and method for delivery of substances into the skin. Various configurations of such devices are disclosed, including domed, channeled, patterned and stepped.

Abstract: An abrasion device and method for delivery of substances into the skin using a microabrader for delivering a substance into the skin are disclosed. An abrasion device with a cover is also disclosed. Such devices and methods can be effectively used to deliver bioactive substances into skin.

Abstract: The present invention relates to methods and devices for administration of vaccines and gene therapeutic agents into the intradermal layer of skin.

Abstract: The present invention is directed to methods for preparing a stable powder formulation of an alum-adsorbed vaccine. The methods comprise atomizing a liquid formulation comprising an immunogen adsorbed onto an aluminum adjuvant to produce an atomized formulation, freezing the atomized formulation to produce frozen particles, and drying the frozen particles to produce dried powder particles. Pharmaceutical compositions comprising a stable powder formulation of an alum-adsorbed vaccine are also disclosed herein. The pharmaceutical compositions are stable at high temperatures and can be reconstituted in a pharmaceutically acceptable carrier to produce a reconstituted liquid vaccine that exhibits little or no particle agglomeration and retains immunogenicity. Methods of using the alum-adsorbed vaccine compositions for preventing and treating a disease in a subject, wherein the disease is associated with the particular immunogen, are further provided.

Abstract: An abrader device for delivering a substance into skin via an abrasion process includes a housing adapted to be pressed against the skin at a desired delivery site, an applicator head disposed in an upper opening of the housing and movable across a lower opening of the housing to abrade the delivery site in at least one furrow, and an abrader surface attached to the applicator head whereby the housing remains firm and stationary at the delivery site and structure of the housing and the applicator head controls parameters of the abrasion process. In particular, the amount of force or pressure applied to the abrader surface, the speed at which the abrader surface moves across the skin and the number of lateral passes of the abrader surface across the skin are controlled so that the abrader device provides a furrow with a length of substantially the same depth thereby providing reproducible results, even though different technicians are applying the abrader device against a patient's skin.

Abstract: Improved microprotrusion abrasion devices having fluid retaining or directing patterns, and specific design parameters and method for delivery of substances into the skin. Various configurations of such devices are disclosed, including domed, channeled, patterned and stepped.

Abstract: An abrasion device and method for delivery of substances into the skin using a microabrader for delivering a substance into the skin are disclosed. An abrasion device with a cover is also disclosed. Such devices and methods can be effectively used to deliver bioactive substances into skin.

Abstract: A method for delivering cells into a subject by administering cells into the intradermal space of the skin of the subject by a microneedle. The cells are associated with cellular based therapeutics and vaccines and delivered by perpendicular insertion of the microneedle. The microneedle is a hollow needle having an exposed height of between about 0 and 1 mm, a total length of between about 0.3 mm to 2.5 mm, and a size of equal to or less than 30 gauge. An array of microneedles can also be used.

Abstract: The present invention provides improved methods for delivery of substances into the skin. It has been discovered that delivery of substances such as nucleic acids, amino acids, amino acid derivatives, peptides and polypeptides simultaneously with abrasion of the skin enhances delivery and the biological response as compared to application of the substance to previously abraded skin.

Abstract: An abrasion device and method for delivery of substances into the skin using a microabrader for delivering a substance into the skin are disclosed. An abrasion device with a cover is also disclosed. Such devices and methods can be effectively used to deliver bioactive substances into skin.

Abstract: Improved microprotrusion abrasion devices having fluid retaining or directing patterns, and specific design parameters and method for delivery of substances into the skin. Various configurations of such devices are disclosed, including domed, channeled, patterned and stepped.