Solid pharmaceutical and vaccine dose
Inventors
Potter, Charles David Ogilvy • Nabahi, Shohre
Assignees
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Publication Number
US-9693952-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 describes an elongate body for parenteral injection at low velocity from a device, where the body has a compressive strength between 50 and 500 Newton and a pointed end having an included angle of between 10 and 50°. The body is at least partly crystalline, does not contain a coating, and comprises at least one active material. The pointed geometry and the crystalline, uncoated nature of the body are used together to enable low-velocity needle-free delivery from a device.
The body comprises at least one active material selected from peptides, proteins, DNA, RNA, small molecules, labelled molecules, dyes, antigens, vaccines, whole cell vaccines, killed micro-organisms, attenuated micro-organisms, inactive toxic compounds, or polysaccharides. The formulation can include specific antigenic or immunogenic agent contents, and the patent describes presentation options such as antigenic or immunogenic agent being adsorbed on an elongate part of the body or being dispersed. The document further describes vaccine formulations including adjuvants such as aluminium hydroxide.
The patent also describes dependent embodiments that refine the pointed end geometry by tighter included-angle ranges and specific included-angle values, and defines tip shapes. Additional embodiments specify that a non-active material may be present at the pointed end and that the active material can be separated from the non-active material within the body. The document further describes that the invention supports various solid vaccine/pharmaceutical formulation types and packaging and body features suitable for slidable mounting to a delivery device.
Claims Coverage
The independent claims are clm-00001 and clm-00002. Each claim covers an elongate, needle-free, low-velocity parenteral injection body with specified mechanical strength and pointed-end geometry, with no coating and containing at least one selected active material.
Crystalline uncoated elongate low-velocity injection body with specified compressive strength and pointed end
An elongate body for parenteral injection at low velocity from a device, having a compressive strength between 50 and 500 Newton and a pointed end having an included angle of between 10–50°, wherein the body is at least partly crystalline, does not contain a coating, and comprises at least one active material selected from a peptide, a protein, a DNA, an RNA, a small molecule, a labelled molecule, a dye, an antigen, a vaccine, a whole cell vaccine, a killed micro-organism, an attenuated micro-organism, an inactive toxic compound, or a polysaccharide.
Crystalline uncoated elongate low-velocity injection body with specified compressive strength and at least one pointed end
An elongate body for parenteral injection at low velocity from a device, the body having a compressive strength between 50 and 500 Newton and at least one pointed end having an included angle of between 10–50°, wherein the body is at least partly crystalline, does not contain a coating, and comprises at least one active material selected from a peptide, a protein, a DNA, an RNA, a small molecule, a labelled molecule, a dye, an antigen, a vaccine, a whole cell vaccine, a killed micro-organism, an attenuated micro-organism, an inactive toxic compound, or a polysaccharide.
Across clm-00001 and clm-00002, the core claim coverage centers on a needle-free, low-velocity parenteral injection elongate body that is at least partly crystalline and uncoated, with compressive strength between 50 and 500 Newton and a pointed end included angle between 10–50°, while containing one of the listed active materials.
Stated Advantages
Allows parenteral injection at low velocity from a device using a needle-free elongate body.
Supports a variety of active materials including peptides, proteins, nucleic acids, antigens/vaccines, whole cell vaccines, micro-organisms, inactive toxic compounds, and polysaccharides.
Documented Applications
Parenteral injection at low velocity from a device using a needle-free elongate body, including delivery of solid vaccine/pharmaceutical formulations.
Vaccine use cases including diphtheria and Haemophilus influenzae type b (Hib) formulations as described in the document.
Ex vivo pig skin delivery tests are described in the document.
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