Solid pharmaceutical and vaccine dose
Inventors
Potter, Charles David Ogilvy • Nabahi, Shohre
Assignees
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Publication Number
US-9693951-B2
Publication Date
2017-07-04
Expiration Date
Abstract
An elongate body for parenteral injection at low velocity from a device is described. The body has at least one pointed end and comprises at least one active material. In addition, the body has a compressive strength of greater than or equal to 5 Newton and the pointed end has an included angle of between about 10-50°. A solid vaccine formulation for needle-free parenteral delivery, methods for making the body, packaging of the body and use of the body, packaging and suitable delivery device are also described.
Core Innovation
The invention relates to a method of vaccination of a vertebrate from infection with a pathogen or a tumor cell by administering an immunogenically or antigenically effective amount of a solid vaccine formulation for parenteral injection at low velocity from a device. The solid vaccine formulation has at least one pointed end with an included angle of between 10-50°, wherein the pointed end penetrates the skin in use. The solid vaccine formulation is crystalline and does not contain a coating.
The solid vaccine formulation further has a compressive strength of greater than 5 Newton and comprises one or more antigenic or immunogenic agents capable of eliciting an immune response, optionally with one or more adjuvants. Administration is characterized as low velocity from a device and is directed to skin penetration using the pointed-end geometry while maintaining the crystalline, coating-free solid formulation.
The invention also covers related methods for eliciting an enhanced immune response and for enhancing direct or subsequent immunological responses by administering the same solid, crystalline, coating-free vaccine formulation with a pointed end and compressive strength greater than 5 Newton. The administration is performed as dermal, intradermal, transdermal, subcutaneous or intramuscular delivery for the enhanced-immune-response method, with skin penetration in use, and optional inclusion of antigenic/immunogenic agents and adjuvants.
Claims Coverage
The document includes three independent claims (clm-00001, clm-00002, clm-00003). Across these claims, the main inventive features are the combination of a solid crystalline, coating-free vaccine formulation with a pointed end having a specific included angle, a compressive strength constraint, low-velocity parenteral injection from a device, and antigenic or immunogenic agents for immune-response enhancement.
Crystalline, coating-free solid vaccine with pointed end geometry for skin penetration
A solid vaccine formulation for parenteral injection at low velocity from a device, the solid vaccine formulation having at least one pointed end with an included angle of between 10-50° which penetrates the skin in use, wherein the solid vaccine formulation is crystalline and does not contain a coating.
Compressive strength greater than 5 Newton for the solid vaccine formulation
The solid vaccine formulation has a compressive strength of greater than 5 Newton.
Low-velocity device-based parenteral injection of a solid crystalline vaccine
Administering the solid vaccine formulation for parenteral injection at low velocity from a device.
Antigenic or immunogenic agent (optionally with adjuvant) to elicit an immune response
The solid vaccine formulation comprising one or more antigenic or immunogenic agents capable of eliciting an immune response and optionally one or more adjuvants.
Skin-directed administration sites for enhanced immune response
Dermal, intradermal, transdermal, subcutaneous or intramuscular administration of the solid vaccine formulation for parenteral injection at low velocity from a device, the solid vaccine formulation having at least one pointed end with an included angle of between 10-50° which, in use, penetrates the skin, wherein the solid vaccine formulation is crystalline and does not contain a coating.
Enhancing direct or subsequent immunological responses
A method of enhancing direct or subsequent immunological responses to one or more antigenic or immunogenic agents in a solid vaccine formulation by administering the one or more antigenic or immunogenic agents in a solid vaccine formulation for parenteral injection at low velocity from a device, wherein the solid vaccine formulation has compressive strength of greater than 5 Newton and at least one pointed end with an included angle of between 10-50° that penetrates the skin, and wherein the solid vaccine formulation is crystalline and does not contain a coating.
The claim set centers on a crystalline, coating-free solid vaccine formulation with a pointed end (included angle 10-50°) designed to penetrate the skin, combined with a compressive strength greater than 5 Newton, administered at low velocity from a device, and comprising one or more antigenic or immunogenic agents optionally with adjuvants to elicit and enhance immune responses.
Stated Advantages
Documented Applications
No documented applications found
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