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: Immunogenic anthrax compositions, such as anthrax vaccines, and methods for delivering immunogenic anthrax compositions and/or vaccines to a mammal. Methods include delivery to mucosal membranes and to skin.

Abstract: A method and device for the delivery of a substance into skin via the rotational movement of a microabrader device reduces the effects of operator variability. The method includes applying a substance to an area of a patient's skin through the rotational movement of microprotrusions which may be imparted by a spring device present in the microabrader device or the motion of the operator through the handle of the microabrader device. The device may further include system and methods for monitoring pressure of the device against the skin and thereby promote consistency between applications and control of penetration depth. The delivered substance may be placed on the microprotrusions and a reconstituting liquid included in the microabrader device.

Abstract: The present invention relates to immunogenic compositions containing an immunogen and a specific combination of two or more traditional excipients. The excipients in the composition act in combination and enhance immune responses to the immunogen from a subject. The combination of excipients may be used as adjuvant in immunogenic compositions, regardless of route or target of delivery. The compositions can be administered, for example, intradermally, epidermally, transdermally, junctionally, nasally, or subcutaneously.

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 therapeutic agents into the intradermal layer of the skin. The methods of the present invention elicit increased humoral and/or cellular response as compared to conventional vaccine delivery methods, e.g., intramuscular route. Furthermore, the methods of the present invention facilitate induction of an immune response by an amount of vaccine which is otherwise insufficient for inducing an immune response when delivered via conventional vaccine routes, e.g., intramuscular route.

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: 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 relates to methods and devices for intradermal delivery of substances, preferably therapeutic substances by targeting the substance to the intradermal compartment of a subject's skin. Substances delivered in accordance with the methods of the invention have an improved clinical utility and therapeutic efficacy relative to other drug delivery methods including intramuscular, and subcutaneous delivery. The present invention provides benefits and improvements over conventional drug delivery methods including but not limited to, improved pharmacokinetics and bioavailability.

Abstract: The present invention relates to methods and devices for delivering one or more biologically active agents, particularly therapeutic agents, to the intradermal compartment of a subject's skin. The present invention provides an improved method of delivery of biologically active agents, such as therapeutic agents, through lymphatic vasculature accessed by intradermal delivery. Therapeutic agents to be delivered in accordance with the present invention include, but are not limited to, antineoplastic agents, chemotherapeutic agents, antibodies, antibiotics, anti-angiogenesis agents, anti-inflammatory agents, and immunotherapeutic agents. Therapeutic agents delivered in accordance with the present invention have improved bioavailability, including improved systemic distribution and improved delivery to particular tissues.

Abstract: The present invention relates to methods and devices for intradermal delivery of substances, preferably therapeutic substances by targeting the substance to the intradermal compartment of a subject's skin. Substances delivered in accordance with the methods of the invention have an improved clinical utility and therapeutic efficacy relative to other drug delivery methods including intramuscular, and subcutaneous delivery. The present invention provides benefits and improvements over conventional drug delivery methods including but not limited to, improved pharmacokinetics and bioavailability.

Abstract: The present invention relates to methods and devices for delivering one or more biologically active agents, particularly a diagnostic agent to the intradermal compartment of a subject's skin. The present invention provides an improved method of delivery of biologically active agents in that it provides among other benefits, rapid uptake into the local lymphatics, improved targeting to a particular tissue, improved bioavailability, improved tissue bioavailability, improved tissue specific kinetics, improved deposition of a pre-selected volume of the agent to be administered, and rapid biological and pharmacodynamics and biological and pharmacokinetics. This invention provides methods for rapid transport of agents through lymphatic vasculature accessed by intradermal delivery of the agent. Methods of the invention are particularly useful for delivery of diagnostic agents.

Abstract: The invention relates to an immunogenic composition and methods of making and using the composition. The immunogenic composition contains a directing molecule, a stimulant and an immunogen. The stimulant and directing molecule are chemically distinct. The stimulant and immunogen are present in relative amounts to result in an improved immune response relative to that resulting from the immunogen and just one of the directing molecule or stimulant.

Abstract: A method and device for administration of a high molecular weight protein into the intradermal space.

Abstract: The present invention relates to methods and devices for intradermal delivery of substances, preferably therapeutic substances by targeting the substance to the intradermal compartment of a subject's skin. Substances delivered in accordance with the methods of the invention have an improved clinical utility and therapeutic efficacy relative to other drug delivery methods including intramuscular, and subcutaneous delivery. The present invention provides benefits and improvements over conventional drug delivery methods including but not limited to, improved pharmacokinetics and bioavailability.

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 to produce a powder. Compositions made by the above methods, and methods of using the compositions, are also described.

Abstract: A method and device for the delivery of a substance into skin via the rotational movement of a microabrader device reduces the effects of operator variability. The method includes applying a substance to an area of a patient's skin through the rotational movement of microprotrusions. The movement of the microprotrusions can be imparted by a spring device or the like present in the microabrader device or the motion of the operator through the handle of the microabrader device. The rotational motion localizes the administration of the drug or vaccine dosage in the abraded skin area. The device can include means for monitoring pressure of the device against the skin and thereby promote consistency between applications and control of penetration depth. The substance, drug or vaccine may be placed on the microprotrusions and a reconstituting liquid included in the microabrader device.

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 relates to a method of vaccinating a subject comprising delivering a chimeric yellow fever 17D strain vector expressing an envelope protein gene product of a heterologous flavivirus to the epidermal compartment or the intradermal compartment of the subject's skin. The invention encompasses vaccine compositions comprising the chimeric yellow fever viruses expressing an envelope protein gene product of a heterologous flavivirus. The compositions of the invention result in an enhanced therapeutic efficacy, e.g., enhanced protective immune response as they enhance the presentation and availability of the chimeric vaccine to the targeted compartment of the subject's skin.