Solid dose delivery vehicle and methods of making same

Abstract

The present invention encompasses a solid dose delivery vehicle for ballistic administration of a bioactive material to subcutaneous and intradermal tissue, the delivery vehicle being sized and shaped for penetrating the epidermis. The delivery vehicle further comprises a stabilizing polyol glass loaded with the bioactive material and capable of releasing the bioactive material in situ. The present invention further includes methods of making and using the solid dose delivery vehicle of the invention.

1 - 14 . (cancel).  
     
     
         15 . A therapeutic dried composition in solid dose form suitable for transmucosal delivery, comprising a stabilizing polyol and a bioactive agent wherein the composition provides quick release of the bioactive agent after administration.  
     
     
         16 . The composition, according to  claim 15 , wherein the composition is freeze-dried, vacuum-dried, spray-dried or dried via critical fluid extraction.  
     
     
         17 . The composition, according to claim  1 , wherein the stabilizing polyol is in a glass form.  
     
     
         18 . The composition, according to  claim 15 , wherein the bioactive agent is selected from the group consisting of live and attenuated viruses, nucleotide vectors encoding antigens, bacteria and antigens.  
     
     
         19 . The composition, according to  claim 15 , wherein the bioactive agent is an antigen selected from the group consisting of diphtheria, tetanus, pertussis, botulinum, cholera, Dengue, hepatitis A, C and E, haemophilus influenzae b, herpes virus,  Hylobacterium pylori , influenza, Japanese encephalitis, meningococci A, B and C, measles, mumps, papilloma virus, pneumococci, polio, rubella, rotavirus, respiratory syncytial virus, Shigella, tuberculosis, yellow fever and combinations thereof.  
     
     
         20 . The composition, according to  claim 15 , wherein the bioactive agent is selected from the group consisting of pharmaceutical agents, subcellular compositions, cells, proteins and peptides, peptide mimetics, hormones, D and L amino acid polymers, oligosaccharides, polysaccharides, nucleotides, oligonucleotides and nucleic acids.  
     
     
         21 . The composition, according to  claim 20 , wherein said pharmaceutical agent is selected from the group consisting of anti-inflammatory drugs, analgesics, antiarthritic drugs, antispasmodics, antidepressants, antipsychotics, tranquillizers, antianxiety drugs, narcotic antagonist, antiparkinsonism agents, cholinergic agonists, chemotherapeutic drugs, immunosuppressive agents, antiviral agents, antibiotic agents, appetite suppressants, antiemetics, anticholinergics, antihistaminic, antimigraine agents, coronary, cerebral or peripheral vasodilators, hormonal agents, contraceptives, antithromobotic agents, antihypertensive agents, cardiovascular drugs and opioids.  
     
     
         22 . The composition, according to  claim 21 , wherein said biological modifier is an immunogen.  
     
     
         23 . The composition, according to  claim 15 , wherein the bioactive agent is a protein selected from the group consisting of enzymes, growth hormones, growth factors, insulin, monoclonal antibodies, interferons, interleukins and cytokines.  
     
     
         24 . The composition, according to  claim 15 , wherein the stabilizing polyol is selected from the group consisting of monosaccharides, disaccharides, trisaccharides, oligosaccharides and their corresponding sugar alcohols, polyhydroxy compounds such as carbohydrate derivatives and chemically modified carbohydrates, hydroxymethyl starch and sugar copolymers, or combinations thereof.  
     
     
         25 . The composition, according to  claim 24 , wherein the polyol is dextran.