Abstract: Provided herein are microprojections and microprojection arrays for delivering biologically active agents. Also provided herein are compositions suitable for coating such microprojections and microprojection arrays.

Abstract: Provided herein are microprojections and microprojection arrays wherein a microprojection is coated with at least two layers. One layer comprises a biologically active agent, for example, a PTH agent and optionally other excipients. Another layer, which is generally, initially devoid of active agent comprises a polymer or a mix of polymers to provide controlled release, for example sustained release, of the biologically active agent contained in the first layer. Microprojections coated with multiple layers, some layers containing a biologically active agent and other layers containing a polymer for controlled release are also contemplated herein.

Abstract: An apparatus and method for transdermally delivering a biologically active agent to prevent or treat osteopenia, comprising a delivery system having a microprojection member (or system) that includes a plurality of microprojections (or array thereof) that are adapted to pierce through the stratum corneum into the underlying epidermis layer, or epidermis and dermis layers. In one embodiment, the PTH-based agent is contained in a biocompatible coating that is applied to the microprojection member.

Abstract: A process for producing a powder comprises spray freeze-drying an aqueous solution or suspension comprising a pharmaceutical agent, said solution or suspension having a solids content of 20% by weight or more. The spray freeze-dried powder may be administered to a subject via a needleless syringe.

Abstract: Compositions of and methods for formulating and delivering biologically active agent formulations having enhanced physical stability, and wherein deterioration from the presence of oxygen and/or water is minimized and/or controlled, to yield a stable formulation. The compositions of and methods for formulating and delivering biologically active agents of the present invention further facilitate their incorporation into a biocompatible coating which can be employed to coat a stratum-corneum piercing microprojection, or a plurality of stratum-corneum piercing microprojections of a delivery device, for delivery of the biocompatible coating through the skin of a subject, thus providing an effective means of delivering the biologically active agents.

Abstract: A process for producing a powder comprises spray freeze-drying an aqueous solution or suspension comprising a pharmaceutical agent, said solution or suspension having a solids content of 20% by weight or more. The spray freeze-dried powder may be administered to a subject via a needleless syringe.

Abstract: A method and system for providing a terminally sterilized transdermal influenza vaccine delivery device. A microprojection member having a plurality of stratum corneum-piercing microprojections is coated with an influenza vaccine-formulation and exposed to sufficient radiation to sterilize the microprojection member while retaining sufficient potency of the influenza vaccine. Preferably, the microprojection member is sealed in packaging, such as a foil pouch. Also preferably, a retainer ring and adhesive are included within the packaging. The sterilizing radiation can be gamma radiation or e-beam, preferably delivered in a dose in the range of approximately 7-21 kGy. Also preferably, the irradiation is performed from ?78.5-25° C. In preferred embodiments, the radiation is delivered at a rate greater than 3.0 kGy/hr.

Abstract: A method and system for providing a terminally sterilized transdermal natriuretic peptide delivery device. A microprojection member having a plurality of stratum corneum-piercing microprojections is coated with a natriuretic peptide- formulation an exposed to sufficient radiation to sterilize the microprojection member while retaining sufficient activity of the natriuretic peptide. Preferably, the microprojection member is sealed in packing with an inert atmosphere and reduced moisture. The sterilizing radiation can be gamma radiation or e-beam, preferably delivered in a dose in the range of approximately 14-21 kGy. Also preferably, the irradiation is performed at ?78.5-25° C. In preferred embodiments, the radiation is delivered at a rate greater than 3.0 kGy/hr.

Abstract: An method and system for providing a terminally sterilized transdermal device adapted to delivery a PTH-based agent. A microprojection member that includes a plurality of stratum comeum-piercing microprojections is coated with PTH-based agent formulation an exposed to sufficient radiation to sterilize the microprojection member while retaining sufficient activity of the PTH-based agent. Preferably, the microprojection member is sealed in packing with an inert atmosphere and reduced moisture. The sterilizing radiation can be gamma radiation or e-beam, preferably delivered in a dose in the range of approximately 5-50 kGy. Also preferably, the irradiation is performed at ?78.5-25° C. In preferred embodiments, the radiation is delivered at a rate greater than 3.0 kGy/hr.

Abstract: An apparatus and method for transdermally delivering a biologically active agent comprising a delivery system having a microprojection member (or system) that includes a plurality of microprojections (or array thereof) that are adapted to pierce through the stratum corneum into the underlying epidermis layer, or epidermis and dermis layers. In one embodiment, an Epoetin-based agent is contained in a biocompatible coating that is applied to the microprojection member. In a further embodiment, the delivery system includes a gel pack having an Epoetin-based agent-containing hydrogel formulation that is disposed on the microprojection member after application to the skin of a patient. In an alternative embodiment, the Epoetin-based agent is contained in both the coating and the hydrogel formulation.

Abstract: New compositions formed from the combination of an active substance with a hydrogel carrier moiety are provided. The compositions are suitable for use in high-velocity transdermal particle injection techniques. Methods of providing the new compositions are also provided. In addition, methods for administering pharmacologically active agent to a subject are provided. These methods are useful for delivering drugs, biopharmaceuticals, vaccines and diagnostics agents.

Abstract: A composition and method for formulating and delivering an adjuvanted immunological active agent, especially a vaccine, wherein adjuvant coagulation and concomitant loss of vaccine efficacy enhancement is mitigated or avoided. The adjuvanted, immunologically-active agent can be subjected to freezing, drying, freeze-drying, or lyophilization, and when reconstituted, retains a high level of potency. The present invention further provides for a composition and method for formulating and delivering a stable, adjuvanted, immunologically-active agent capable of being deposited on a transdermal delivery device or microprojection or array thereof.

Abstract: An apparatus and method for transdermally delivering a biologically active agent comprising a delivery system having a microprojection member (or assembly) that includes a plurality of microprojections (or array thereof) that are adapted to pierce through the stratum corneum into the underlying epidermis layer, or epidermis and dermis layers. In one embodiment, the VEGF-based agent is contained in a biocompatible coating that is applied to the microprojection member.

Abstract: An apparatus and method for transdermally delivering a natriuretic peptide comprising a delivery system having a microprojection member that includes a plurality of microprojections (or array thereof) that are adapted to pierce through the stratum corneum into the underlying epidermis layer, or epidermis and dermis layers. In one embodiment, the natriuretic peptide is contained in a biocompatible coating that is applied to the microprojection member. In a further embodiment, the delivery system includes a natriuretic peptide-containing hydrogel formulation. In an alternative embodiment, the natriuretic peptide is contained in both the coating and the hydrogel formulation. In yet another embodiment, the natriuretic peptide is contained in a solid state formulation.

Abstract: A method for formulating an immunologically active agent and an apparatus for delivery same, the method comprising the steps of providing a bulk immunologically active agent, subjecting the bulk immunologically active agent to tangential-flow filtration to provide an immunologically active agent solution, adding at least one excipient to the agent solution and spray-drying the agent solution to form an immunologically active agent product; the apparatus comprising a microprojection member that includes a plurality of microprojections having a biocompatible coating disposed thereon that includes a spray-dried immunologically active agent. In a preferred embodiment, the immunologically active agent comprises an influenza vaccine, more preferably, a split-varion influenza vaccine.

Abstract: A gel-forming free-flowing powder suitable for use as a vaccine is prepared by spray-drying or spray freeze-drying an aqueous suspension that contains an antigen adsorbed to an aluminum salt or calcium salt adjuvant, a saccharide, an amino acid or a salt thereof, and a colloidal substance. Powder for vaccine purposes are also prepared by spray freeze-drying an aqueous suspension of such an adjuvant having an antigen adsorbed therein. Processes for forming these powder compositions are also described, as well as methods of using the compositions in a vaccination procedure.

Abstract: An apparatus and method for transdermally delivering a biologically active agent comprising a delivery system having a microprojection member (or system) that includes a plurality of microprojections (or array thereof) that are adapted to pierce through the stratum corneum into the underlying epidermis layer, or epidermis and dermis layers. In one embodiment, the PTH-based agent is contained in a biocompatible coating that is applied to the microprojection member.

Abstract: An apparatus and method for transdermally delivering a biologically active agent comprising a delivery system having a microprojection member (or system) that includes a plurality of microprojections (or array thereof) that are adapted to pierce through the stratum corneum into the underlying epidermis layer, or epidermis and dermis layers. In one embodiment, the fentanyl-based agent is contained in a biocompatible coating that is applied to the microprojection member. In a further embodiment, the delivery system includes a gel pack having a fentanyl-based agent-containing hydrogel formulation that is disposed on the microprojection member after application to the skin of a patient. In an alternative embodiment, the fentanyl-based agent is contained in both the coating and the hydrogel formulation.

Abstract: An apparatus and method for transdermally delivering an immunologically active agent comprising a delivery system having a microprojection member (or system) that includes a plurality of microprojections (or array thereof) that are adapted to pierce through the stratum corneum into the underlying epidermis layer, or epidermis and dermis layers, the microprojection member having a biocompatible coating disposed thereon that includes the immunologically active agent. Preferably, the biocompatible coating is formed from a vaccine coating formulation.

Abstract: New compositions formed from the combination of an active substance with a hydrogel carrier moiety are provided. The compositions are suitable for use in high-velocity transdermal particle injection techniques. Methods of providing the new compositions are also provided. In addition, methods for administering pharmacologically active agent to a subject are provided. These methods are useful for delivering drugs, biopharmaceuticals, vaccines and diagnostics agents.