(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2009/0196921 A1
`(43) Pub. Date:
`Aug. 6, 2009
`Ebel et al.
`
`US 20090196921A1
`
`(54) COMPOSITIONS METHODS AND KITS FOR
`ENHANCING IMMUNE RESPONSE TO A
`RESPRATORY CONDITION
`
`(75) Inventors:
`
`James Patrick Ebel, Lebanon, OH
`(US); Lucy Anne Gildea,
`Cincinnati, OH (US); David
`Alexander Lawson, Glendale, OH
`(US); Jeffrey Warren Clymer,
`Mason, OH (US)
`Correspondence Address:
`THE PROCTER & GAMBLE COMPANY
`Global Legal Department - IP
`Sycamore Building - 4th Floor, 299 East Sixth
`Street
`CINCINNATI, OH 45202 (US)
`(73) Assignee:
`The Procter & Gamble Company,
`Cincinnati, OH (US)
`12/366,987
`
`(21) Appl. No.:
`
`(22) Filed:
`
`Feb. 6, 2009
`Related U.S. Application Data
`(60) Provisional application No. 61/063,735, filed on Feb.
`6, 2008.
`
`Publication Classification
`
`(51) Int. Cl.
`A 6LX 9/52
`A6II 35/74
`A6IR 9/28
`A6IR 9/22
`A69/48
`A6IP37/00
`A6IP II/00
`
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`
`(52) U.S. Cl. ..................... 424/457; 424/93.4; 424/93.44;
`424/93.45; 424/93.46; 424/93.3; 424/474;
`424/468; 424/463
`
`ABSTRACT
`(57)
`Disclosed herein are compositions for treating a respiratory
`condition, preferably by enhancing immune response in a
`mammal, the compositions including atherapeutic amount of
`a probiotic strain of bacteria and a therapeutic amount of an
`additional component. Also included are methods of treating
`a respiratory condition, preferably by enhancing immune
`response, in a mammal. Kits containing the compositions,
`and instructions for applying the methods are also included.
`The method includes orally administering to the mammal a
`therapeutic amount of a probiotic strain of bacteria and a
`therapeutic amount of an additional component.
`
`MYLAN - EXHIBIT 1018
`
`

`

`US 2009/0196921 A1
`
`Aug. 6, 2009
`
`COMPOSITIONS METHODS AND KITS FOR
`ENHANCING IMMUNE RESPONSE TO A
`RESPRATORY CONDITION
`
`CROSS REFERENCE TO RELATED
`APPLICATIONS
`0001. This application claims the benefit of U.S. Provi
`sional Application No. 61/063,735, filed Feb. 6, 2008.
`
`FIELD OF THE INVENTION
`0002 The present invention relates to compositions and
`methods for treating a respiratory condition, preferably by
`enhancing immune response to a respiratory condition. More
`particularly, the present invention relates to compositions
`comprising a therapeutic amount of a probiotic strain of bac
`teria and a therapeutic amount of an additional component,
`and methods of using Such compositions. Most particularly,
`the present invention relates to compositions and methods of
`using a probiotic strain of bacteria for treating a respiratory
`condition, preferably by enhancing immune response to a
`respiratory condition.
`
`BACKGROUND OF THE INVENTION
`0003. According to the Centers for Disease Control
`(CDC), in 2006 an estimated 56% of students aged 5-17 years
`missed between 1 and 5 days of school due to illness or injury,
`10% missed 6 to 10 days, and 5% missed 11 or more days. In
`addition, it is estimated that 189 million school days are
`missed annually (an average of nearly 1 day per episode) due
`to a cold. In addition to children missing School, when chil
`dren miss School, as a consequence often a parent misses
`work to stay home and care for the child. Often one or both
`parents and any siblings also contract the cold from the sick
`child which results in the siblings missing school and the
`parent(s) missing additional days of work either due to their
`own illness or caring for the sick child(ren).
`0004. However, colds are only one type of respiratory
`condition affecting the population, and respiratory conditions
`can be or be triggered by any of a variety of sources including
`allergens and/or pathogens of viral, bacterial or fungal origin.
`Common respiratory conditions include cold, influenza (flu).
`respiratory allergies, and asthma. Symptoms of respiratory
`conditions typically include coughing, Sneezing, headaches,
`congestion, Sore throat, stuffy nose, runny nose, fever, and the
`like.
`0005 Respiratory product types commonly used to treat
`Such symptoms can generally be categorized as liquid elixirs,
`cough syrups, cold and flu capsules, cold and flu tablets,
`allergy tablets, effervescent tablets, mouth and nasal sprays,
`cough drops, and the like.
`0006. The most commonly employed products for treating
`respiratory conditions are ingested or bucally administered to
`inhibit and/or treat onset or fully developed respiratory symp
`toms. The products typically contain one or more actives
`dissolved or dispersed in a carrier system for ingestion or
`bucal delivery into the bloodstream. Although many consum
`ers prefer respiratory products in the form of cough drops,
`liquids, or capsules, respiratory products in the form of pow
`ders and effervescent tablets have also met consumer needs in
`combating respiratory conditions.
`0007 Some compositions and methods for the prevention
`and treatment of the common cold and other respiratory con
`ditions include treatments using combinations of anti-viral
`
`and anti-inflammatory compounds, treatments using orally
`administered aminocarboxylic acid compounds; treatment of
`cough and colds using compositions comprising non-steroi
`dal anti-inflammatory drugs such as NSAIDS with antihista
`minically effective materials such as chlorpheniramine; use
`of ionic Zinc Such that the ionic Zinc contacts the nasal mem
`brane; and use of probiotic strains of bacterial microorgan
`isms which have been shown to have immunomodulatory
`effects, for example for the treatment of allergies.
`0008. Many different viruses and strains thereof can result
`in respiratory conditions and symptoms associated with res
`piratory conditions. The common cold, for example, is a
`complex syndrome that may be caused by any of over 200
`antigenic viruses, among the most important of which is
`rhinovirus. Although distinct from the cold viruses, influenza
`viruses can and do produce many of the same symptoms.
`0009. Additionally, allergies are aparticularly bothersome
`respiratory condition. Allergies can be, without limitation by
`theory, the result of hyper-reactivity of the immune system to
`foreign or self antigens. Type I allergy, Such as allergic rhinitis
`(e.g., hay fever) or atopic dermatitis, occurs in allergic Sub
`jects upon exposure to environmental allergens (e.g., pollens
`or dust mites), and results in key clinical symptoms, similar to
`those of cold and flu, Such as Sore throat, cough, fatigue,
`Sneeze, running nose, nasal drip, stuffy nose, nasal conges
`tion, excessive mucus, sinus pressure, plugged ears, itchy
`nose, itchy, red, puffy, Swollen, irritated and watery eyes.
`0010. In healthy status, the immune system maintains a
`balance between cytokines produced by different helper T
`lymphocyte Subsets: Th1 and Th2 lymphocytes. In contrast,
`an allergic Subject demonstrates a biased dysfunction of Th2
`over Th1 that leads to an elevated IgE antibody production.
`The elevated production of IgE may be induced by hyper
`reactivity of Th2 lymphocytes that secrete cytokines (e.g.,
`IL-4, IL-5). Th1 cytokines (e.g., interferon-gamma, IL-12)
`may counteract Th2 cytokines and regain a healthy State in
`murine systems. IgE antibody-bound mast cells interact with
`allergen, triggering release of chemical mediators (e.g., his
`tamine, leukotriene) and cause vasodilation and hypersecre
`tion in various tissues. Antihistamines or leukotriene antago
`nists compete with the secreted inflammatory mediators from
`mast cells and significantly reduce clinical respiratory symp
`toms. Probiotic strains of bacteria have also been shown to
`have immunomodulatory effects when used in the treatment
`of allergies.
`0011 Thus, pinpointing specific causes of respiratory
`conditions can be difficult because there are a number of
`factors involved in the manifestation of respiratory conditions
`that are not fully understood. However, it is generally under
`stood that factors including lowered immunity, stress, lack of
`sleep, too much exercise, malnutrition, seasonal changes,
`Social activities, age, environmental toxins and even certain
`medications (i.e. immunosuppressive medications) can
`increase the risk of, and make individuals more Susceptible to,
`various respiratory conditions.
`0012. Therefore, there remains a need for compositions
`and methods for enhancing immune response to a respiratory
`condition, in mammals, including human children. This need
`is particularly apparent with respect to children because the
`use of common cold/flu actives for children 12 years of age
`and under has recently come into question with respect to
`both efficacy and safety of those actives in children. There
`fore, there is an unmet need for compositions and methods for
`enhancing immune response, including reducing Susceptibil
`
`

`

`US 2009/0196921 A1
`
`Aug. 6, 2009
`
`ity to respiratory conditions, preventing and treating respira
`tory conditions, and reducing the severity and duration of
`respiratory conditions, which are safe, effective, palatable
`and easy to administer and use.
`
`SUMMARY OF THE INVENTION
`0013 The present invention comprises compositions for
`treating a respiratory condition, preferably by enhancing
`immune response to a respiratory condition in a mammal,
`comprising a therapeutic amount of a probiotic strain of bac
`teria and a therapeutic amount of an additional component.
`The present invention also includes methods of treating a
`respiratory condition, preferably by enhancing immune
`response to a respiratory condition in a mammal, comprising
`orally administering to the mammal atherapeutic amount of
`a strain of Lactobacillus and a therapeutic amount of an
`additional component. The present invention also comprises
`kits containing the compositions. The present compositions
`and methods can also or alternatively include a strain of
`Bifidobacterium and/or other additional components. The
`compositions of the present invention can formed as a single
`composition or separate compositions packaged together in a
`kit.
`
`DETAILED DESCRIPTION OF THE INVENTION
`0014 Various documents including, for example, publica
`tions and patents, are recited throughout this disclosure. All
`documents are hereby incorporated by reference.
`0015 Referenced herein may be trade names for compo
`nents including various ingredients utilized in the present
`invention. The inventors herein do not intend to be limited by
`materials under a certain trade name. Equivalent materials
`(e.g., those obtained from a different source under a different
`name or reference number) to those referenced by trade name
`may be substituted and utilized in the descriptions herein.
`0016. In the description of the invention various embodi
`ments and/or individual components are disclosed. As will be
`apparent to the ordinarily skilled practitioner, all combina
`tions of Such embodiments and components taught in the
`disclosure are possible and can result in preferred executions
`of the present invention.
`0017 All percentages and ratios are calculated by weight
`unless otherwise indicated. All percentages, parts and ratios
`are calculated based on the total composition unless other
`wise indicated. Weights as they pertain to listed ingredients
`are based on the specific ingredient level and, therefore, do
`not include carriers or by-products that may be included in
`commercially available materials, unless otherwise specified.
`0.018. As used herein, the terms “mixture' and “combina
`tion' include multiple components or ingredients formed into
`one resulting component, components that can be separate
`but contained in a single dosage form, and components that
`can be administered in the same treatment regimen even if not
`physically formed into a single component or contained in a
`single dosage form. As used herein, the terms “mixture' and
`“combination' may be used interchangeably.
`0019. As used herein, “mammal’ includes but is not lim
`ited to humans as well as domestic animals including cat, dog,
`cow, rabbit, and horse.
`0020. As used herein, “respiratory condition includes
`Susceptibility to, risk of and onset of symptoms of the con
`ditions described herein. “Respiratory condition' as used
`herein refers to conditions including, but not limited to, res
`
`piratory tract viral infections, respiratory tract bacterial infec
`tions, respiratory tract fungal infections, allergies (for
`example to pollen, fungi, and environmental allergens),
`asthma, auto-immune conditions, rhinitis, sinusitis, bronchi
`olitis, acute respiratory distress syndrome (ARDS), severe
`acute respiratory syndrome (SARS), respiratory cancer,
`emphysema, COPD, difficulty breathing, cough, and condi
`tions pursuant to respiratory Surgeries (including pre- and
`post-operative management).
`0021. As used herein, “immune response' includes all of
`the specific and non-specific processes and mechanisms
`involved in how the body defends and repairs itself against
`bacteria, viruses, fungi, allergens and all Substances, insults,
`challenges, biological and/or physical invasions of the body
`that are harmful to the body.
`0022. As used herein "enhancing immune response'
`means a change to the immune system which provides a
`benefit to the mammal. “Enhancing the immune response
`also includes prevention, treatment, cure, mitigation amelio
`ration, inhibition and/or alleviation of a respiratory condition
`and/or symptoms thereof, “Enhancing the immune system'
`results in benefits including improved quality of life;
`improved mood and/or reduced stress; improved concentra
`tion; better overall health; improved respiratory health; pre
`serving, maintaining and/or restoring normal ability to per
`form normal daily tasks, including the ability to go to work
`and/or School; providing, Supporting and/or maintaining nor
`mal vitality and energy levels; and enhancing sleep including
`quality of sleep. “Enhancing the immune system” also
`includes maintaining, Supporting and/or strengthening natu
`ral defenses, and enhancing wellness and overall immune
`system health.
`0023. As used herein “cold, influenza and allergy-like
`symptoms’ refers to symptoms typically associated with res
`piratory conditions as defined herein. These symptoms
`include, but are not limited to, nasal congestion, chest con
`gestion, Sneezing, rhinorrhea, fatigue, malaise, cough, fever,
`chills, body ache, Sore throat, headache, excessive mucus,
`sinus pressure, nasal drip, runny nose, itchy eyes, watery eyes
`and other known cold, influenza and allergy-like symptoms.
`0024. As used herein “respiratory viruses' refers to those
`viruses that are causal agents of respiratory conditions that
`result in cold and influenza-like symptoms. Non-limiting
`examples of such viruses include Rhinovirus, Myxovirus (In
`fluenza virus), Paramyxovirus (Parainfluenza virus), Respi
`ratory Syncytial virus, Adenovirus and Coronavirus.
`0025. As used herein “respiratory bacteria' refers to those
`bacteria that are causal agents of respiratory conditions that
`result in cold and influenza-like symptoms. Non-limiting
`examples of Such bacteria include Hemophilus influenzae,
`mycobacteria, pasteurella, Pneumocystis jiro veci, Mycobac
`terium tuberculosis, Streptococcus pheumoniae, bacteria
`pneumonia and Klebsiella pneumoniae.
`0026. As used herein “respiratory fungi” refers to those
`fungi that are causal agents of respiratory conditions that
`result in cold and influenza-like symptoms. Non-limiting
`examples of respiratory fungi and fungally caused respiratory
`conditions include aspergillosis, hisoplasmosis, Blastomy
`ces, dermatitidis, Cryptococcus neoformas, Coccidioidomy
`cosis, and Pneumocystis iroeci.
`0027. As used herein, a “probiotic' microorganism or
`strain of microorganism confers beneficial functions and/or
`effects to a host animal when a “probiotic' microorganism is
`administered to a host animal at a therapeutically effective
`
`

`

`US 2009/0196921 A1
`
`Aug. 6, 2009
`
`amount. As used herein "probiotic' microorganism includes
`bacteria, bacterial homogenates, ground bacterial cells, bac
`terial proteins, bacterial extracts, bacterial ferment Superna
`tants, and mixtures thereof “Probiotic' microorganisms also
`include natural and/or genetically modified microorganisms,
`viable or dead; processed compositions of microorganisms;
`their constituents and components such as proteins and car
`bohydrates, extracts, distillates, isolates, purified fractions,
`and mixtures thereof of bacterial ferments that beneficially
`affect a host. Although a use of probiotic microorganisms
`herein can be in the form of viable cells, use can be extended
`to non-viable cells such as killed cultures, or compositions
`containing beneficial factors expressed by the probiotic
`microorganism. Killed cultures may include thermally killed
`microorganisms, or microorganisms killed by exposure to
`altered pH or subjected to pressure. “Probiotic' microorgan
`ism is further intended to include metabolites generated by
`the microorganisms during fermentation, if Such metabolites
`are not separately indicated. These metabolites may be
`released to the medium offermentation, or they may be stored
`within the microorganism.
`0028. The abbreviation CFU (referring to “colony-form
`ing unit') as used herein designates the number of bacterial
`cells revealed by microbiological counts on agar plates, as
`will be commonly understood in the art.
`0029. The term “pharmaceutically acceptable carrier'
`refers to any solid, liquid or gas combined with components
`of the compositions of the present invention to deliver the
`components to the user. These vehicles are generally regarded
`as safe for use in humans, and are also known as carriers or
`carrier systems.
`0030 The term “therapeutic amount of a component,
`composition, or like material as used herein refers to a con
`centration or amount of any active defined herein that is
`ingested, including ingestion by buccal administration, that is
`effective to provide the desired effect or benefit to a host
`animal without undue adverse side effects (such as toxicity,
`irritation, or allergic response), commensurate with a reason
`able benefit/risk ratio when used in the manner of this inven
`tion. In the present invention, desired effects and/or benefits
`include enhancement of the immune system including treat
`ment, prevention or resistance of respiratory conditions in a
`mammal. The specific “therapeutic amount” will, obviously,
`vary with Such factors as the particular condition being
`treated, the particular composition to be used, the physical
`condition of the treated mammal, the size and weight of the
`treated mammal, the duration of treatment, the nature of
`concurrent therapy (if any), the specific dosage form to be
`used, other components presentina given dosed composition,
`and the dosage regimen desired for the component or com
`position.
`0031 Additional definitions are provided as necessary
`herein as they occur.
`0032. The compositions and methods of the present inven
`tion can comprise, consist of or consist essentially of the
`elements and limitations of the invention described herein, as
`well as any of the additional or optional ingredients, compo
`nents, limitations, or steps described herein.
`Compositions
`0033. The present invention comprises compositions
`comprising a therapeutic amount of a probiotic strain of bac
`teria and a therapeutic amount of an additional component,
`and methods of using the compositions, in mammals, as
`
`defined herein. The present invention also can comprise kits
`containing the compositions, with the compositions formed
`as single compositions or as separate compositions packaged
`together in a kit.
`0034. In one embodiment, the probiotic strain of bacteria
`herein is able to maintain viability following transit through
`the gastrointestinal tract. This is desirable in order for live
`cultures of the bacteria to be taken orally, and for colonization
`to occur in the intestines and bowel following transit through
`the esophagus and stomach. Colonization of the intestine and
`bowel by the probiotic strain of bacteria is desirable for long
`term probiotic benefits to be delivered to the host. Oral admin
`istration of non-viable cells or purified isolates thereof can
`induce temporary benefits. However, if the bacteria are not
`viable, they are not able to grow, and are more limited in
`ability to continuously deliver a probiotic effect. As a result,
`this may require the host to be dosed regularly in order to
`maintain the health benefits. In contrast, viable cells that are
`able to Survive gastric transit in viable form, and Subsequently
`colonize by adhering to and proliferating on the gut mucosa,
`are better able to deliver probiotic effects continuously.
`0035. The compositions utilized in the compositions and
`methods herein comprise a probiotic strain of bacteria. Non
`limiting examples of bacteria suitable for use herein include
`strains of Streptococcus lactis, Streptococcus Cremoris,
`Streptococcus diacetylactis, Streptococcus thermophilus,
`Lactobacillus bulgaricus, Lactobacillus acidophilus, Lacto
`bacillus helveticus, Lactobacillus bifidus, Lactobacillus
`casei, Lactobacillus lactis, Lactobacillus plantarum, Lacto
`bacillus rhamnosus, Lactobacillus delbruekii, Lactobacillus
`thermophilus, Lactobacillus fermentii, Lactobacillus sali
`varius, Lactobacillus reuteri, Lactobacillus brevis, Lactoba
`cillus paracasei, Lactobacillus gasseri, Pediococcus cerevi
`siae, Bifidobacterium longum, Bifidobacterium infantis,
`Bifidobacterium adolescentis, Bifidobacterium bifidum, Bifi
`dobacterium animalis, Bifidobacterium pseudolongum, Bifi
`dobacterium thermophilum, Bifidobacterium lactis, Bifido
`bacterium
`bulgaricus,
`Bifidobacterium
`breve,
`Bifidobacterium subtilis, Escherichia coli and strains of the
`genera including Bacillus, Bacteroides, Enterococcus (e.g.,
`Enterococcus faecium) and Leuconostoc, and mixtures and/
`or combinations thereof.
`0036 Embodiments of the compositions and methods of
`the present invention comprise strains of lactic acid bacteria
`selected from the genera Lactobacillus and Bifidobacterium,
`Such as Lactobacillus acidophilus, Lactobacillus fermentum
`and Bifidobacterium lactis, and combinations and/or mix
`tures thereof. In one embodiment, the methods herein com
`prise administration of a composition comprising a therapeu
`tic amount of the lactic acid bacteria.
`0037 Non-limiting examples of Lactobacillus suitable for
`use herein include strains of Lactobacillus bulgaricus, Lac
`tobacillus acidophilus, Lactobacillus helveticus, Lactobacil
`lus bifidus, Lactobacillus casei, Lactobacillus lactis, Lacto
`bacillus plantarum, Lactobacillus rhamnosus, Lactobacillus
`delbruekii, Lactobacillus thermophilus, Lactobacillus fer
`mentii, Lactobacillus salivarius, Lactobacillus reuteri, Lac
`tobacillus brevis, Lactobacillus paracasei, Lactobacillus
`gasseri, and combinations thereof.
`0038 A non-limiting example of a Lactobacillus strain
`Suitable for use herein includes the Lactobacillus acidophilus
`strain identified as LAFTIR) L10 deposited under accession
`number CBS 116411 available from DSMCorporation based
`in the Netherlands.
`
`

`

`US 2009/0196921 A1
`
`Aug. 6, 2009
`
`0039. In one embodiment herein, the compositions can
`comprise at least about 10 CFU of Lactobacillus, alterna
`tively from about 10 to about 10' CFU of Lactobacillus, in
`another embodiment from about 10° to about 10' CFU of
`Lactobacillus, in another embodiment from about from about
`10 to about 10' CFU of Lactobacillus, per unit dose of the
`composition.
`0040. Other non-limiting examples of a Lactobacillus
`strains Suitable for use herein include the Lactobacillus aci
`dophilus strain identified as CL-92 deposited in Japan at
`International Patent Organism Depository, FERM BP-4981,
`the Lactobacillus acidophilus strain identified as CL0062
`deposited in Japan at International Patent Organism Deposi
`tory, FERM BP4980, and the Lactobacillus fermentum strain
`identified as CP34 and deposited in Japan at International
`Patent Organism Depository, FERM BP-8383. These organ
`isms, have been shown, as described in US Patent Application
`Publication Number US 2005/0214270, to provide anti-aller
`gic effects by Suppressing IgE levels in mice, and by reducing
`allergy symptoms and decreasing IgE titer in the blood in
`humans.
`0041. In one embodiment, the compositions can comprise
`at least about 1x10, alternatively at least about 1x10, alter
`natively at least about 1x10", and alternatively at least about
`5x10" cells per day of the probiotic strain of bacteria, which
`can be administered in a single dose, or in a plurality of doses.
`0042. In one embodiment, the methods herein comprise
`administration of a composition comprising a therapeutic
`amount a strain of Bifidobacterium, which can be mamma
`lian, in addition to, or in alternative to, a Lactobacillus as
`described herein. The mammal treated and a mammalian
`source of Bifidobacterium isolation may be, but need not be,
`independent.
`0043. Non-limiting examples of Bifidobacterium suitable
`for use herein include strains of Bifidobacterium longum,
`Bifidobacterium infantis, Bifidobacterium adolescentis, Bifi
`dobacterium bifidum, Bifidobacterium animalis, Bifidobac
`terium pseudolongum, Bifidobacterium thermophilum, Bifi
`dobacterium
`lactis,
`Bifidobacterium
`bulgaricus,
`Bifidobacterium breve, Bifidobacterium subtilis, and mix
`tures and/or combinations thereof.
`0044) A non-limiting example of a Bifidobacterium strain
`suitable for use herein includes Bifidobacterium lactis iden
`tified as LAFTIR 94 deposited under accession number CBS
`118529 that can be purchased from DSM Corporation. Other
`examples of useful Bifidobacterium strains include Bifido
`bacterium longum strain identified as BB-536 (Morinaga &
`Co., LTD, Japan)
`0045. In one embodiment herein, the compositions used in
`the methods herein comprise at least about 10 CFU of Bifi
`dobacterium, alternatively from about 10 to about 10 CFU
`of Bifidobacterium, in another embodiment from about 10° to
`about 10' CFU of Bifidobacterium, in another embodiment
`from about from about 10 to about 10' CFU of the Bifido
`bacterium, per unit dose of the composition.
`0046. In one embodiment, the probiotic strain of bacteria,
`can comprise a freeze-dried powder (as would be understood
`by one of skill in the art) can comprise from about 1% to about
`50%, alternatively from about 1% to about 40%, alternatively
`from about 1% to about 30%, and alternatively from about 2%
`to about 20%, by weight of the composition.
`Additional Components
`0047. The compositions of the present invention can
`optionally comprise one or more additional components. By
`
`way of non-limiting example, an additional probiotic strain of
`bacteria; one or more of prebiotics and/or fiber; vitamins:
`minerals, metals and elements; plant-derived components;
`fungal-derived components; carotenoids; anti-oxidants; and
`mixtures/combinations thereof can be used.
`0048. The compositions of the present invention can com
`prise, by way of non-limiting example, one or more probiotic
`strains of bacteria plus one or more of an additional probiotic
`strain of bacteria, a prebiotic, a fiber, vitamins, minerals,
`elements, plant-derived components, fungal-derived compo
`nents, carotenoids, and antioxidants. Non-limiting examples
`of some additional components are provided below.
`
`Prebiotics/Fiber
`0049. The compositions of the present invention compris
`ing the probiotic used herein can comprise a prebiotic and/or
`a fiber.
`0050. As used herein, the term “prebiotic’ includes sub
`stances or compounds that beneficially affect the host mam
`mal by selectively promoting the growth and/or activity of
`one or more probiotic bacteria in the gastro-intestinal tract of
`the host mammal, thus maintaining normal health or improv
`ing health of the host. Typically, prebiotics are carbohydrates,
`(such as oligosaccharides), but the term “prebiotic” as used
`herein does not preclude non-carbohydrates. Many forms of
`“fiber” exhibit some level of prebiotic effect. Thus, there is
`considerable overlap between Substances that can be classi
`fied as “prebiotics” and those that can be classified as “fibers’.
`0051. Non-limiting examples of prebiotics suitable for use
`in the compositions and methods include psyllium, fructo
`oligosaccharides, inulin, oligofructose, galacto-oligosaccha
`rides, isomalto-oligosaccharides Xylo-oligosaccharides, soy
`oligosaccharides,
`gluco-oligosaccharides,
`aal
`oligosaccharides,
`arabinogalactan,
`arabinxylan,
`lactosucrose, gluconannan, lactulose, polydextrose, oligo
`dextran, gentioligosaccharide, pectic oligosaccharide, Xan
`than gum, gum arabic, hemicellulose, resistant starch and its
`derivatives, and mixtures and/or combinations thereof.
`0052. When present, the compositions can comprise from
`about 100 mg to about 100 g, alternatively from about 500 mg
`to about 50 g, and alternatively from about 1 g to about 40 g,
`of prebiotic, per daily dose of the composition.
`
`Fiber
`0053 As used herein, the term “fiber’ means carbohydrate
`polymers including those naturally occurring in food as con
`sumed, those having been obtained from food raw material by
`physical, enzymatic or chemical means, and synthetic carbo
`hydrate polymers, which are resistant to digestion and
`absorption in the Small intestine and have partial fermentation
`in the large intestine.
`0054 Non-limiting examples of fiber and analogous car
`bohydrate polymers suitable for use in the compositions and
`methods of the present invention include pectins, psyllium,
`guar gum, Xanthan gum, alginates, gum arabic, fructo-oli
`gosaccharides, inulin, agar, beta-glucans, chitins, dextrins,
`lignin, celluloses, non-starch polysaccharides, carrageenan,
`and mixtures and/or combinations thereof.
`0055. In one embodiment, the fiber is glucose polymers,
`preferably those which have branched chains. Among Such
`suitable fibers is one marketed under the tradename “Fiber
`sol2, commercially available from Matsutani Chemical
`Industry Co., Itami City, Hyogo, Japan.
`
`

`

`US 2009/0196921 A1
`
`Aug. 6, 2009
`
`0056. Other non-limiting examples of suitable fibers
`include oligosaccharides, such as inulin and its hydrolysis
`products commonly known as fructo-oligosaccharides,
`galacto-oligosaccharides, Xylo-oligosaccharides, and oligo
`derivatives of starch.
`0057 The fiber can be provided in any suitable form. A
`non-limiting example is in the form of a plant material which
`contains the fiber. Non-limiting examples of suitable plant
`materials include asparagus, artichoke, onion, wheat,
`chicory, beet pulp, residues of these plant materials, and mix
`tures thereof.
`0058. A non-limiting example of a fiber from such a plant
`material is inulin extract from extract of chicory. Suitable
`inulin extracts can be obtained from Orafti SA of Belgium
`under the trademark Raftiline(R). Alternatively the fiber can be
`in the form of a fructo-oligosaccharide which can be obtained
`from Orafti SA of Belgium under the trademark Raftilose(R).
`Alternatively, an oligo-Saccharide can be obtained by hydro
`lyzing inulin, by enzymatic methods, or by using microor
`ganisms as will be understood by those of skill in the art.
`Alternatively the fiber can be Inulin and/or de-sugared inulin
`available from Cargill Health & Food Technologies, Wayzata,
`Minn., USA, or from Cosucra SA, Warcoing, Belgium.
`0059. When present, the compositions can comprise from
`about 100 mg to about 100 g, alternatively from about 500 mg
`to about 50 g, alternatively from about 1 g to about 40 g, of
`fiber, per daily dose of the composition.
`
`Vitamins
`0060. The compositions of the present invention can
`optionally comprise one or more vitamins. When certain Vita
`mins, minerals, metals, elements and the like are included as
`additional components in capsule, tablet and powder forms,
`the actual amounts of these many of these components, in
`grams per unit dose, are often extremely small, and make the
`individual components difficult to handle, measure and pro
`cess. Therefore such components are commonly prepared or
`purchased as a premix in or on a carrier Such as Sucrose or
`lactose. The total amount of vitamin(s), by weight, if pro
`vided in a premix on or in a Suitable carrier, can comprise
`from about 1% to about 50%, alternatively from about 1% to
`about 40%, and alternatively from about 2% to about 30%, by
`weight of the composition. Therefore, when Vitamins, min
`erals, metals and elements ar