Stable bacterial extracts as pharmaceuticals
AssigneeOm Pharma
InventorsJacques Bauer, Christian Pasquali
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Abstract
The present invention relates to novel stable bacterial extract preparations having substantial increased stability over time, 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.
Claims25
A physically stabilized bacterial extract liquid preparation obtained by alkaline lysis of Gram positive or Gram negative bacterial species chosen among Moraxella catarrhalis, Haemophilus influenzae, Klebsiella pneumoniae, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus sanguinis, Lactobacillus fermentum, Lactobacillus rhamnosus, Lactobacillus plantarum, Lactobacillus johnsonii, Lactobacillus helveticus, Lactobacillus casei defensis, Lactobacillus casei ssp. casei, Lactobacillus paracasei, Lactobacillus bulgaricus, Lactobacillus paracasei, Lactobacillus acidophilus, Lactobacillus reuteri, Lactobacillus salivarius, Lactobacillus lactis, and/or Lactobacillus delbrueckii and neutralization with one or more organic acid selected 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, followed by purification by filtration of the neutralized extract and adjusting to a final physiological pH by adding the one or more organic acid selected among acetic acid, propionic acid, lactic acid, 3-hydroxypropanoic acid, pyruvic acid, butanoic acid, 2-hydroxybutanoic acid, 3-hydroxybutanoic acid, glutamic acid, aspartic acid, and a combination thereof used for said neutralization, wherein said bacterial extract comprises less than 100 microgram/ml nucleic acids.
A process for preparing a physically stabilized bacterial extract liquid preparation, comprising the following steps:
- (a) culturing a Gram positive or Gram negative bacterial species chosen among Moraxella catarrhalis, Haemophilus influenzae, Klebsiella pneumoniae, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus sanguinis, Lactobacillus fermentum, Lactobacillus rhamnosus, Lactobacillus plantarum, Lactobacillus johnsonii, Lactobacillus helveticus, Lactobacillus casei defensis, Lactobacillus casei ssp. casei, Lactobacillus paracasei, Lactobacillus bulgaricus, Lactobacillus paracasei, Lactobacillus acidophilus, Lactobacillus reuteri, Lactobacillus salivarius, Lactobacillus lactis, and/or Lactobacillus delbrueckii in a suitable culture medium,
- (b) heat killing the bacteria, removing the culture medium and harvesting the concentrated biomass,
- (c) lysing each strain at an initial pH of greater than 10,
- (d) decreasing the pH of the extract(s) obtained in step (c) by 1 or 2 units by adding one or more organic acid selected 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, or pharmaceutically acceptable salts and esters thereof, and
- (d) passing the product of step (d) at least once through a microfilter and retaining the product on an ultrafilter so as to obtain a purified soluble extract.
Dependencies are inferred from the claim text.