Patent Description:
The invention in general relates to probiotics. More specifically the invention relates to alcoholic beverage compositions comprising probiotic bacterium Bacillus coagulans of strain Bacillus coagulans MTCC <NUM> and the method of brewing said alcoholic beverage.

Probiotics offer a wide range of health benefits. They are administered as a dietary supplement for the effective management of various diseases like gastrointestinal infections, inflammatory bowel disease, acute and chronic diarrhoea, constipation, abnormal intestinal fermentation, dysbiosis, functional abdominal pain, lactose intolerance, allergies, urogenital infections, cystic fibrosis, metabolic disorders, various cancers, reduction of antibiotic side effects, in oral health such as prevention of dental caries, periodontal diseases and oral malodour, maintenance of a good intestinal environment and balancing the intestinal flora by reducing harmful bacteria (<NPL>; <NPL>).

Consuming alcohol on the pretext of socializing, relaxing and enjoying is on the rise, even with the knowledge that consuming excess alcohol has side effects on the health. Alcohol affects the gut by disturbing intestinal absorption of nutrients including several important vitamins. Studies also report that alcohol significantly modulates the mucosal immune system of the gut (<NPL>). Alcohol consumption also modifies the gut microflora thereby neutralizing the beneficial effects, the gut microbes provide to the overall health (<NPL>).

There have been many efforts on reversing the effect of alcohol on the gut microflora. Probiotic supplementation has been found to be effective in restoring bowel flora and improving live enzymes in alcohol induced liver damage and hepatotoxicity (<NPL>). A Beer, with probiotics present within was also developed to ward off the harmful effects on beer consumption in the gut flora (SG <NUM>, PROBIOTIC SOUR BEER). However, developing a alcoholic drink with live probiotics is a difficult task since the presence of acidic conditions hinder the growth and survival of the probiotics. The property of the probiotic, in sustaining the harmful conditions also plays a major role in developing an alcoholic beverage containing probiotics. There still exists an unmet industrial need to find a suitable probiotic strain for the development of an alcoholic beverage containing probiotics. The present invention solves the above problem by disclosing an alcoholic beverage composition containing Bacillus coagulans of strain Bacillus coagulans MTCC <NUM>, with increased recovery, tolerability, compatibility and viability of spores and vegetative cells of probiotic bacteria Bacillus coagulans of strain Bacillus coagulans MTCC <NUM> and the method of brewing the same.

It is the principle objective of the invention to disclose an alcoholic beverage composition containing probiotic bacteria Bacillus coagulans.

It is another objective of the invention to disclose a method of brewing an alcoholic beverage composition containing probiotic bacteria Bacillus coagulans.

The present invention solves the above objective and provides further related advantages.

The present invention discloses an alcoholic beverage composition comprising Bacillus coagulans of strain Bacillus coagulans MTCC <NUM> in the form of spores or bacterium wherein said spore or bacterium exhibit high recovery, tolerability, compatibility and viability of spores and vegetative cells after brewing. The invention also discloses a method of brewing an alcoholic beverage composition comprising Bacillus coagulans of strain Bacillus coagulans MTCC <NUM> wherein said spore or bacterium is added prior to fermentation, during fermentation and post fermentation.

Other features and advantages of the present invention will become apparent from the following more detailed description, taken in conjunction with the accompanying images, which illustrate, by way of example, the principle of the invention.

In a most preferred embodiment, the invention discloses an alcoholic beverage composition comprising Bacillus coagulans of strain Bacillus coagulans MTCC <NUM> in the form of spores or bacterium wherein said spores or bacterium exhibit high recovery, tolerability, compatibility and viability of spores and vegetative cells after brewing. In a related embodiment, the alcoholic beverage is fermented and distilled. In another related embodiment, the alcoholic beverage is carbonated or non-carbonated.

In yet another related embodiment, the fermented alcoholic beverage is selected from the group consisting of, but not limited to, Beer, Ale, Barleywine, Bitter ale, Brown ale, Cask ale, Mild ale, Old ale, Pale ale, Scotch ale, Porter, Stout, Stock ale, Fruit beer, Beer, Lager, Pale lager, Bock, Maerzen/Oktoberfest Beer, Pilsener, Schwarzbier, Sahti, Small beer, Wheat beer, and Witbier.

In another related embodiment, the distilled alcoholic beverage is selected from the group consisting of Whisky, Bourbon whiskey , Canadian whisky, Irish whiskey, Japanese whisky, ManX Spirit, Rye whiskey, Scotch whisky, and Tennessee whiskey.

The another embodiment the alcohol content of the beverage composition is between <NUM>% to <NUM>%.

In another related aspect, the Bacillus coagulans live spores/vegetative cells of Bacillus coagulans of strain Bacillus coagulans MTCC <NUM> are present in the alcoholic beverages at a concentration of <NUM>× <NUM><NUM> to <NUM>× <NUM><NUM>cfu.

In another aspect not part of the invention the composition containing alcoholic beverage and Bacillus coagulans is used for therapeutic management of diseases selected from the group consisting of, but not limited to, like gastrointestinal infections, inflammatory bowel disease, acute and chronic diarrhoea, constipation, abnormal intestinal fermentation, dysbiosis, functional abdominal pain, lactose intolerance, allergies, urogenital infections, cystic fibrosis, metabolic disorders, various cancers, reduction of antibiotic side effects, in oral health such as prevention of dental caries, periodontal diseases and oral malodour, maintenance of a good intestinal environment and balancing the intestinal flora by reducing harmful bacteria.

In another preferred embodiment, the invention discloses a method of brewing alcoholic beverage with Bacillus coagulans of strain Bacillus coagulans MTCC <NUM>, said method comprising steps of.

In a related aspect, the Bacillus coagulans spores/vegetative cells of Bacillus coagulans of strain Bacillus coagulans MTCC <NUM> are added during pre-fermentation, fermentation and post fermentation stages. In another related aspect, the Bacillus coagulans spores/vegetative cells of Bacillus coagulans of strain Bacillus coagulans MTCC <NUM> are added during pre-fermentation stage at step a). In another related aspect, the Bacillus coagulans spores/vegetative cells of Bacillus coagulans of strain Bacillus coagulans MTCC <NUM> are added during pre-fermentation stage at step e). In another related aspect, the Bacillus coagulans spores/vegetative cells are added during fermentation stage at step g). In another related aspect, spores/vegetative cells of Bacillus coagulans of strain Bacillus coagulans MTCC <NUM> are added during secondary fermentation stage at step i). In another related aspect, the Bacillus coagulans spores/vegetative cells of Bacillus coagulans of strain Bacillus cooagulans MTCC <NUM> are added during post fermentation stage at step j). In another related aspect, the Bacillus coagulans spores/vegetative cells of Bacillus coagulans of strain Bacillus coagulans MTCC <NUM> are added during post fermentation stage at step k).

In yet another related aspect, the alcoholic beverage is pasteurized at <NUM>° C after step i), followed by carbonation/no carbonation step after the addition of spores of Bacillus coagulans of strain Bacillus coagulans MTCC <NUM>.

In another related aspect, the Bacillus coagulans spores/vegetative cells of Bacillus coagulans of strain Bacillus coagulans MTCC <NUM> exhibited increased viability and stability throughout the fermentation process.

The specific examples included herein below illustrate the aforesaid most preferred embodiments of the present invention.

Methods: Beer samples were procured from local market manufactured by Kingfisher and whisky from McDowell's No.<NUM>. The alcohol content in the Mild lager, Lager, and strong Beer was <NUM>%, <NUM>% and <NUM>% respectively. In whisky the alcohol content was <NUM>%. Bacillus coagulans MTCC <NUM> (Commercially sold as LactoSpore® - from Sabinsa Corporation, NJ, USA) was added to the Beer (Mild lager, Lager, and strong Beer) and Whisky. Beer samples were carbonated and packed in <NUM> container and subjected for stability studies as per the guidelines of International Council for Harmonisation (ICH guidelines QI A (R2) (ICH <NUM>). Description of the samples was done based on Visual and organoleptic methods. Specific gravity and pH was determined as per the United State Pharmacopoeia chapter USP<<NUM>> and <<NUM>> respectively. Other Aerobic micro-organism count was tested as per modified USP <<NUM>> method. Yeasts and molds count, Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, and Salmonella spp. were tested as per USP method chapter <<NUM>> and <<NUM>>. Enterobacteriaceae test as per USP chapter <<NUM>> and Coliforms as per BAM, Chapter <NUM> was performed.

Table <NUM> and Table <NUM> discloses the Recovery and Tolerability of Bacillus coagulans MTCC <NUM> spores in alcoholic beverages determined by standard pour plate method.

Stability Studies at Room temperature (<NUM> ± <NUM>° C, <NUM>% ± <NUM>% Relative humidity) and accelerated conditions (<NUM> ± <NUM>° C, <NUM>% ± <NUM>% Relative humidity) were also performed in to determine the stability of the probiotic composition in different alcoholic beverages. The tables <NUM> - <NUM> describe the stability studies of the alcoholic beverage containing probiotic bacteria Bacillus coagulans MTCC <NUM>.

Results of the stability studies of alcoholic beverages (beer and whisky) suggested that inclusion of probiotic strain B. coagulans MTCC <NUM> did not affect the Specific gravity, pH and Alcohol content suggesting its compatibility and stability when stored at room temperature (<NUM> ± <NUM>° C, <NUM>% ± <NUM>% Relative humidity) and accelerated conditions (<NUM> ± <NUM>° C, <NUM>% ± <NUM>% Relative humidity).

Further, there was no significant change in the microbial parameter was observed suggesting that probiotic alcoholic beverage did not alter the microbial profile.

The different methods for brewing alcoholic beverage by adding probiotic bacterial Bacillus coagulans is disclosed herewith.

The following flow chart describes the method of brewing alcoholic beverage by the addition of Bacillus coagulans at the stage of malting
<IMG>.

The stability and viability of Bacillus coagulans spore/vegetative cells were tested. The results indicated that Bacillus coagulans showed increased stability (<FIG>) and viability (<FIG>) when added at the stage of malting.

The following flow chart describes the method of brewing alcoholic beverage by the addition of Bacillus coagulans at the stage of hops addition
<IMG>.

The stability and viability of Bacillus coagulans spore/vegetative cells were tested. The results indicated that Bacillus coagulans showed increased stability (<FIG>) and viability (<FIG>) when added at the stage of Hops addition.

The following flow chart describes the method of brewing alcoholic beverage by the addition of Bacillus coagulans during the fermentation stage
<IMG>.

The stability and viability of Bacillus coagulans spore/vegetative cells were tested. The results indicated that Bacillus coagulans showed increased stability (<FIG>) and viability (<FIG>) when added during the fermentation stage.

The following flow chart describes the method of brewing alcoholic beverage by the addition of Bacillus coagulans during the secondary fermentation stage
<IMG>.

The stability and viability of Bacillus coagulans spore/vegetative cells were tested. The results indicated that Bacillus coagulans showed increased stability (<FIG>) and viability (<FIG>) when added during the secondary fermentation stage.

The following flow chart describes the method of brewing alcoholic beverage by the addition of Bacillus coagulans at the step of carbonation
<IMG>.

The stability and viability of Bacillus coagulans spore/vegetative cells were tested. The results indicated that Bacillus coagulans showed increased stability (<FIG>) and viability (<FIG>) when added during the post fermentation stage of carbonation.

The following flow chart describes the method of brewing alcoholic beverage by the addition of Bacillus coagulans at the step of packing and pasteruization
<IMG>.

The stability and viability of Bacillus coagulans spore/vegetative cells were tested. The results indicated that Bacillus coagulans showed increased stability (<FIG>) and viability (<FIG>) when added during the post fermentation stage of packing and pasteurization.

he following flow chart describes the method of brewing alcoholic beverage by the addition of Bacillus coagulans at the step of packing and pasteruization
<IMG>.

The stability and viability of Bacillus coagulans spore/vegetative cells were tested. The results indicated that Bacillus coagulans showed increased stability at <NUM> (<FIG>) and <NUM> (<FIG>) and viability at <NUM> (<FIG>) and <NUM> (<FIG>) when added during the post fermentation stage.

The above results indicate that the Bacillus coagulans is stable and viable during the entire fermentation process and is the first go-to-probiotic to be added along with alcoholic beverages.

The deposit of biological material Bacillus coagulans SBC37-<NUM> bearing accession number MTCC <NUM>, mentioned in the instant application has been made on <NUM>th September <NUM> at Microbial Type Culture Collection & Gene Bank (MTCC), CSIR-Institute of Microbial Technology, Sector <NUM>-A, Chandigarh - <NUM>, India.

Claim 1:
A method of brewing alcoholic beverage with Bacillus coagulans of strain Bacillus coagulans MTCC <NUM>, said method comprising steps of
a) Malting,
b) Mashing,
c) Filtration,
d) Kettle boiling,
e) Hops addition,
f) Cooling,
g) Fermentation with yeast,
h) Ageing and clarification,
i) Secondary fermentation,
j) Carbonation/No carbonation,
k) Pasteurization and Packing.