Stable bacterial extracts as pharmaceuticals

Abstract

The present invention relates to novel stable bacterial extract preparations having substantial increased stability overtime, novel methods of preparation thereof, pharmaceutical formulations based on these novel stabilized bacterial extracts, as well as novel routes of administration and delivery devices for treating and/or preventing acute and chronic immunological disorders resulting from infections and/or inflammation and/or neoplasms and/or dysbiosis.

1 . A method of treating and/or preventing asthma and allergic asthma in a subject in need thereof comprising administering a therapeutically effective dose of a purified bacterial lysate extracted by alkaline lysis and neutralization of one or more bacterial species chosen among  Moraxella catarrhalis, Haemophilus influenzae, Klebsiella pneumoniae, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes , and/or  Streptococcus sanguini , wherein said administration consists of intranasal administration of said bacterial lysate only. 
     
     
         2 . The method of  claim 1  wherein said purified bacterial lysate comprises less than 100 microgram/ml nucleic acids. 
     
     
         3 . The method of  claim 1 , wherein said alkaline lysis is performed at a pH greater than 10. 
     
     
         4 . The method of  claim 1 , wherein said neutralization is performed by addition of HCl. 
     
     
         5 . The method of  claim 1 , wherein said neutralization is performed by addition of an organic acid chosen among acetic acid, propionic acid, lactic acid, 3-hydroxypropanoic acid, pyruvic acid, butanoic acid, 2-hydroxybutanoic acid, 3-hydroxybutanoic acid, glutamic acid, aspartic acid, a combination thereof, and/or pharmaceutically acceptable salts thereof. 
     
     
         6 . The method of  claim 1 , wherein said purified bacterial lysate is present in solid or semi-solid form and is formulated as microspheres, powder, or crushable tablet. 
     
     
         7 . The method of  claim 1 , wherein said purified bacterial lysate is present in liquid form, or aerosol, and is formulated as an emulsion, a suspension, a colloidal form, mist, nebulae, atomized vapor or a spray, or a nasal tampon. 
     
     
         8 . The method of  claim 1 , wherein said purified bacterial lysate further comprises a permeation enhancer. 
     
     
         9 . The method of  claim 1 , wherein said purified bacterial lysate is administered to said subject using an intranasal delivery device. 
     
     
         10 . The method of  claim 9 , wherein said intranasal delivery device is chosen among nasal spray, intranasal insufflator device, intranasal inhaler, nasal capsules, and/or nasal sponges.