Pharmaceutical composition for administration to mucosal surfaces - Patents

Pharmaceutical composition for administration to mucosal surfaces

Agent: John S. Pratt, Esq Kilpatrick Stockton, LLP - Atlanta, GA, US
Inventors: Hazire Oya Alpar, James Edward Eyles, Ethel Diane Williamson
Class: 424490000 (USPTO)
Related Patents: Drug, Bio-affecting And Body Treating Compositions, Preparations Characterized By Special Physical Form, Particulate Form (e.g., Powders, Granules, Beads, Microcapsules, And Pellets), Coated (e.g., Microcapsules)
#20050181063
08/18/05
A pharmaceutical composition for administration to mucosal surfaces, which composition comprises a biologically active agent, a first amount of said agent being encapsulated within microspheres which comprise a polymer which has a molecular weight in excess of 94 kDa and a maximum diameter of 20 ?m, and a second amount of said agent being in a form which has a higher bioavailability than said first amount. The composition is particularly useful for the intra-nasal administration of vaccines in a single shot vaccination.
[0001] The present invention relates to a composition which is particularly useful for delivering pharmaceuticals such as vaccines to mucosal surfaces, for example intranasal formulations. The invention further comprises methods of treating individuals using the composition and methods of preparing the composition.
[0002] A prime objective in the field of vaccination is the development of a non-parenteral immunisation regimen which facilitate induction of comparable levels of systemic immunity to that elicited by conventional sub-cutaneous and intra-muscular injections.
[0003] The nasopharyngeal passages and pulmonary regions of the respiratory tract represent potential targets for the systemic delivery of peptidergic drugs and vaccines. The relative ease with which therapeutic agents can be inhaled, or introduced into the nose, make these modes of immunisation attractive in terms of probable patient compliance. Furthermore, respiratory mucosae offer certain morphological, physiological and immunological advantages over other non-parenteral sites in terms of immunisation, particularly against pathogenic entitities which affect or utilise mucosal surfaces as portals of entry. This is because effective vaccination against these pathogens normally requires mucosae to the adequately protected with locally produced antibodies of the secretory IgA (sIgA) isotype. Whilst mucosal surfaces are usually poorly protected with IgA following parenteral administration of vaccines, it is now apparent that successful delivery of antigenic material to immunoresponsive elements in mucosa-associated lymphoid tissue (MALT) can result in vigorous stimulation of the mucosal arm of the immune system. By means of the common mucosal immune system (CMIS) it is feasible that several anatomically disparate mucosal surfaces could be protected through mucosal administration of a vaccine at a single site. Mucosal vaccination offers the added advantage that some degree of systemic immunity can be induced in concert with local responses due to translocation of antigenic material from sub-epithelial compartments to systemic immunoresponsive tissues such as the spleen.
Complete article is available online.