Solid Pharmaceutical And Vaccine Dose

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.

1 . An elongate body for parenteral injection at low velocity from a device, the body having at least one pointed end and comprising at least one active material, characterised in that 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°. 
   
   
       2 .- 120 . (canceled) 
   
   
       121 . The body as claimed in  claim 1 , wherein the compressive strength is approximately 10 Newton. 
   
   
       122 . The body as claimed in  claim 1 , wherein the velocity is between about 0.5 and 50 m/s. 
   
   
       123 . The body as claimed in  claim 1  wherein the pointed end is a central chisel-shaped tip. 
   
   
       124 . The body as claimed in  claim 1 , wherein the pointed end has an included angle of between about 30-50°. 
   
   
       125 . The body as claimed in  claim 1 , wherein the active material is selected from the group comprising pharmaceutically active compounds, peptides, proteins and small molecules. 
   
   
       126 . The body as claimed in  claim 1 , wherein the active material is present in an amount of between 0.1% and 99.9% by weight. 
   
   
       127 . The body as claimed in  claim 1 , the body being a solid vaccine formulation, for needle-free parenteral delivery, the formulation comprising one or more antigenic or immunogenic agents and optionally one or more adjuvants. 
   
   
       128 . The body as claimed in  claim 127 , wherein the formulation comprises a prime and at least one boost dose of the or each antigenic or immunogenic agent. 
   
   
       129 . The body as claimed in  claim 127 , wherein the or each antigenic or immunogenic agent is selected from the group comprising, killed, live, attenuated or combined micro-organisms, inactive toxic compounds, whole or fragments of proteins or polysaccharides, DNA and RNA. 
   
   
       130 . The body as claimed in  claim 127 , wherein the antigenic or immunogenic agent comprises or is an influenza antigen. 
   
   
       131 . The body as claimed in  claim 1 , wherein the body further comprises one or more excipients. 
   
   
       132 . The body as claimed in  claim 131 , wherein the one or more excipients is/are selected from the group consisting of sugars, carbohydrates, stabilising agents, disintegrants, dissolvable materials and biodegradable polymers and combinations thereof. 
   
   
       133 . The body as claimed in  claim 1 , wherein the body has a diameter of between about 0.5 mm and 3 mm. 
   
   
       134 . The body as claimed in  claim 1 , wherein the body has a length of between 1 mm and 15 mm. 
   
   
       135 . A method for making the elongate body of  claim 1 , the method comprising:
 i) mixing the at least one active material and any excipients as dry material with a fluid to produce a paste;   ii) forming the paste;   iii) optionally cutting the paste   wherein the mixture is formed to a shape having at least one pointed end with an included angle of between about 10-50°, the method further comprising drying the paste either before or after the cutting step.   
   
   
       136 . The method according to  claim 135 , wherein any excipients are mixed into a dry homogenous mix before being added to the active material and fluid. 
   
   
       137 . The method according to  claim 136 , wherein some or all of the active material and some or all of one or more excipients are added to the fluid before mixing with the remaining dry material. 
   
   
       138 . The method according to  claim 135 , wherein the paste is formed by extrusion, tabletting or injection moulding. 
   
   
       139 . Use of the body as claimed in  claim 127 , in the preparation of a medicament to enhance an immune response to one or more antigenic or immunological agents. 
   
   
       140 . A method of vaccination of a vertebrate from infection with a pathogen or a tumor cell, the method comprising administering an immunogenically or antigenically effective amount of a solid formulation of  claim 127 . 
   
   
       141 . A method for eliciting an enhanced immune response from an antigenic or immunogenic composition in a vertebrate, the method comprising dermal, intradermal, transdermal, subcutaneous or intramuscular administration of a solid vaccine composition of  claim 127 , wherein the solid vaccine composition comprises an effective amount of one or more antigenic or immunogenic agents. 
   
   
       142 . A method of enhancing direct or subsequent immunological responses to one or more antigenic or immunogenic agents in a vaccine formulation, the method comprising administering the one or more antigenic or immunogenic agents in a solid formulation as claimed in  claim 127 . 
   
   
       143 . The method as claimed in  claim 140 , wherein the formulation is administered at a velocity is less than 50 m/s, or less than 20 m/s, or less than 10 m/s. 
   
   
       144 . A packaged drug, for use with a drug delivery device, comprising the body as claimed in  claim 1  produced by the method of  claim 135 , and a packaging. 
   
   
       145 . The body as claimed in  claim 1 , wherein the compressive strength is approximately 30 Newton. 
   
   
       146 . The body as claimed in  claim 1 , wherein the velocity is between about 0.5 and 20 m/s. 
   
   
       147 . The body as claimed in  claim 1 , wherein the velocity is between about 0.5 and 10 m/s. 
   
   
       148 . A body as claimed in  claim 1 , wherein the pointed end has an included angle of about 46°. 
   
   
       149 . The body as claimed in  claim 1 , wherein the active material is present in an amount of between about 0.1 and 60% by weight. 
   
   
       150 . The body as claimed in  claim 1 , wherein the active material is present in an amount of between about 0.1 and 35% by weight. 
   
   
       151 . The body as claimed in  claim 1 , wherein the body has a diameter of between about 0.6 mm and 1.5 mm. 
   
   
       152 . The body as claimed in  claim 1 , wherein the body has a length of between about 2-8 mm. 
   
   
       153 . The method as claimed in  claim 140 , wherein the formulation is administered at a velocity is less than 50 m/s. 
   
   
       154 . A method as claimed in  claim 141 , wherein the formulation is administered at a velocity is less than 50 m/s, or less than 20 m/s.