Method and formulation for transdermal delivery of immunologically active agents
First Claim
1. A method for formulating an immunologically active agent comprising the steps of:
- providing a bulk immunologically active agent, subjecting said bulk immunologically active agent to tangential-flow filtration to provide an immunologically active agent solution, adding at least one excipient to said immunologically active agent solution, and spray-drying said immunologically active agent solution to form an immunologically active agent product.
2 Assignments
0 Petitions
Accused Products
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.
28 Citations
32 Claims
-
1. A method for formulating an immunologically active agent comprising the steps of:
-
providing a bulk immunologically active agent, subjecting said bulk immunologically active agent to tangential-flow filtration to provide an immunologically active agent solution, adding at least one excipient to said immunologically active agent solution, and spray-drying said immunologically active agent solution to form an immunologically active agent product. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 22)
-
- 20. An apparatus for transdermally delivering an immunologically active agent comprising a microprojection member having a plurality of stratum corneum-piercing microprojections, wherein said microprojection member has a biocompatible coating disposed thereon including a spray-dried immunologically active agent.
- 23. An apparatus for transdermally delivering an immunologically active agent comprising a microprojection member having a plurality of stratum corneum-piercing microprojections, and a reservoir adapted to receive said agent formulation, the agent formulation including a spray-dried immunologically active agent.
-
26. A method for delivering an immunologically active agent comprising the steps of:
-
providing a microprojection member having a plurality of microprojections, providing a bulk immunologically active agent, subjecting said bulk immunologically active agent to tangential-flow filtration to provide a first immunologically active agent solution, adding at least one excipient to said first agent solution, spray-drying said first agent solution to form a vaccine product, reconstituting said vaccine product with a first solution to form a second immunologically active agent solution, applying said second immunologically active agent solution to said microprojection member, and applying the coated microprojection member to the skin of a subject. - View Dependent Claims (27, 28, 29, 30, 31, 32)
-
Specification