Pharmaceutical Compositions for Treating Diseases

Abstract

Provided herein is a pharmaceutical composition comprising a bacterial population and one or more pharma- ceutically acceptable excipients. The pharmaceutical composition can be contained in a container or packaged form. Such pharmaceutical composition can be orally administered to a subject for the prevention and / or treatment of dysbiosis, dysbiosis-related conditions, inflammation and / or metabolic diseases. Also provided herein is a method for producing the pharmaceutical composition.

Description

[Technical field]

[0001] cross reference This application claims the benefit of U.S. Provisional Patent Application No. 63 / 171,804, filed April 7, 2021, which is incorporated by reference in its entirety. [Background technology]

[0002] Recent developments in the fields of microbiome and genomics research provide evidence that microbe-host relationships fundamentally affect human health, disease onset and progression. For example, they are involved in inflammatory and metabolic diseases and play a key role in the pathogenesis of these disorders. The rising incidence of these diseases is a matter of concern and represents a major public health challenge.

[0003] Restoring the microbe-host balance may aid in the treatment of these disorders. Effective treatments include the administration of live biotherapeutics. However, currently available pharmaceutical compositions may be limited due to lack of efficacy, scalability, reliability, or stability. Summary of the Invention [Means for solving the problem]

[0004] In one embodiment, the pharmaceutical composition comprises a purified bacterial population comprising at least one strain of Akkermansia sp., at least one strain of Faecalibacterium sp., or at least one strain of Lactobacillus sp., and the pharmaceutical composition is storage stable after storage in an anaerobic environment at a temperature of at least 15° C. for at least 3 days.

[0005] In some embodiments, the storage stability of the pharmaceutical composition comprises a ratio of the viability of at least one strain of the purified bacterial population of the pharmaceutical composition to the viability of at least one strain of the purified bacterial population of a comparable pharmaceutical composition before or after storage in an anaerobic environment for at least 3 days at a temperature of at least 15° C. In some embodiments, the viability of at least one strain of the purified bacterial population of the pharmaceutical composition or the viability of at least one strain of the purified bacterial population of the comparable pharmaceutical composition is measured in colony forming units (CFU). In some embodiments, the ratio is at least about 1×10^-5%. In some embodiments, the ratio is at least about 1×10^-4%. In some embodiments, the ratio is at least about 1×10^-2%. In some embodiments, the ratio is at least about 1%. In some embodiments, the ratio is at least about 10%. In some embodiments, the ratio is at least about 20%. In some embodiments, the ratio is at least about 50%. In some embodiments, the pharmaceutical composition is stored in an anaerobic environment for at least 3 days at a temperature of about 25° C. In some embodiments, the pharmaceutical composition is stored in an anaerobic environment at a temperature of at least 15° C. for at least 10 days. In some embodiments, the pharmaceutical composition is stored in an anaerobic environment at a temperature of at least 15° C. for at least 100 days. In some embodiments, the pharmaceutical composition comprises a cryoprotectant. In some embodiments, the pharmaceutical composition is lyophilized. In some embodiments, the pharmaceutical composition comprises a pharma- ceutical acceptable excipient. In some embodiments, the pharma- ceutical acceptable excipient comprises maltodextrin, cellulose, methionine, ascorbic acid, magnesium stearate, beta-cyclodextrin, dextrin, 2-hydroxypropyl-β-cyclodextrin cysteine, riboflavin, starch, Glucidex, mannitol, sucrose, trehalose, anhydrous lactose, or combinations thereof. In some embodiments, the pharmaceutical composition is encapsulated. In some embodiments, the capsule is a vegetable-based capsule. In some embodiments, the pharmaceutical composition is contained by a blister pack, a sachet pack, a vial, a bottle, an ampoule, or combinations thereof.In some embodiments, the pharmaceutical composition is contained in a blister pack. In some embodiments, the pharmaceutical composition is contained in a sachet pack. In some embodiments, the pharmaceutical composition is formulated into a suspension. In some embodiments, the pharmaceutical composition is formulated as an oral dosage form. In some embodiments, the oral dosage form is a capsule, tablet, emulsion, suspension, syrup, gel, gum, paste, herbal tea, drop, dissolved granule, powder, tablet, lyophilisate, popsicle, foam, or ice cream. In some embodiments, the purified bacterial population comprises at least two of at least one strain of Ackermansia spp., at least one strain of Faecalibacterium spp., and at least one strain of Lactobacillus spp. In some embodiments, the purified bacterial population comprises at least one strain of Ackermansia spp., at least one strain of Faecalibacterium spp., and at least one strain of Lactobacillus spp.

[0006] In some embodiments, pharmaceutical compositions are disclosed herein.In one aspect, the pharmaceutical composition comprises: i. a purified bacterial population comprising at least one strain of Ackermansia species, at least one strain of Faecalibacterium species, or at least one strain of Lactobacillus species; and ii. a pharmaceutically acceptable excipient, comprising a hygroscopic material.

[0007] In one aspect, the pharmaceutical composition comprises: i. a purified bacterial population comprising at least one strain of an Ackermansia species, at least one strain of a Faecalibacterium species, or at least one strain of a Lactobacillaceae species; and ii. a pharmaceutically acceptable excipient, the pharmaceutically acceptable excipient comprising a hygroscopic material.

[0008] In some embodiments, the hygroscopic material is selected from the group consisting of microcrystalline cellulose (MCC), hydroxypropyl methylcellulose, silicon dioxide (SiO2), polyethylene glycol 8000, lactose, D-trehalose dihydrate, mannitol, tribasic calcium phosphate, calcium sulfate, corn starch, fructose, xylitol, maltitol, anhydrous lactose, and dicalcium phosphate (DCP). In some embodiments, the hygroscopic material comprises SiO2. In some embodiments, the SiO2 is present in an amount of about 0.1% to about 10% by weight. In some embodiments, the SiO2 is present in an amount of about 1% by weight. In some embodiments, the hygroscopic material comprises mannitol. In some embodiments, the mannitol is present in an amount of about 1% to about 90% by weight. In some embodiments, the mannitol is present in an amount of about 5% to about 81.5% by weight. In some embodiments, the hygroscopic material comprises anhydrous lactose. In some embodiments, the anhydrous lactose is present in an amount of about 1% to about 90% by weight. In some embodiments, the anhydrous lactose is present in an amount of about 5% to about 81.5% by weight. In some embodiments, the pharma- ceutically acceptable excipient further comprises magnesium stearate. In some embodiments, the magnesium stearate is present in an amount of about 0.1% to about 10% by weight. In some embodiments, the magnesium stearate is present in an amount of about 1.5% by weight. In some embodiments, the pharma- ceutically acceptable excipient further comprises microcrystalline cellulose. In some embodiments, the pharmaceutical composition is formulated into a suspension. In some embodiments, the pharmaceutical composition is formulated as an oral dosage form. In some embodiments, the oral dosage form is a capsule, tablet, emulsion, suspension, syrup, gel, gum, paste, herbal tea, drop, dissolved granule, powder, tablet, lyophilisate, popsicle, foam, or ice cream. In some embodiments, the purified bacterial population comprises at least two of at least one strain of Ackermansia spp., at least one strain of Faecalibacterium spp., and at least one strain of Lactobacillus spp.In some embodiments, the purified bacterial population comprises at least two of at least one strain of Ackermansia species, at least one strain of Faecalibacterium species, and at least one strain of Lactobacillaceae species.In some embodiments, the purified bacterial population comprises at least one strain of Ackermansia species, at least one strain of Faecalibacterium species, and at least one strain of Lactobacillus species.In some embodiments, the purified bacterial population comprises at least one strain of Lactobacillaceae species.In some embodiments, the purified bacterial population is freeze-dried.

[0009] In some embodiments, pharmaceutical compositions are disclosed herein.In one aspect, the pharmaceutical composition comprises a purified bacterial population comprising i. at least one strain of Ackermansia species, at least one strain of Lactobacillus species, or at least one strain of Faecalibacterium species, and ii. a pharmaceutical acceptable excipient, wherein the pharmaceutical composition is contained in a plant-based capsule.

[0010] In one embodiment, the pharmaceutical composition comprises i. a purified bacterial population comprising at least one strain of an Ackermansia species, at least one strain of a Lactobacillaceae species, or at least one strain of a Faecalibacterium species, and ii. a pharmaceutically acceptable excipient, wherein the pharmaceutical composition is contained in a plant-based capsule.

[0011] In some embodiments, the plant-based capsule is contained in a blister pack. In some embodiments, the plant-based capsule is a hypromellose capsule. In some embodiments, the blister pack is selected from the group consisting of polyethylene terephthalate (PET), polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), polychlorotrifluoroethylene (PCTFE), cyclic olefin polymer (COP), oriented polyamide (OPA), aluminum foil, and plastic film. In some embodiments, the blister pack is an aluminum blister pack. In some embodiments, the blister pack is filled with nitrogen gas. In some embodiments, the pharma- ceutically acceptable excipient comprises a hygroscopic material. In some embodiments, the hygroscopic material is selected from the group consisting of microcrystalline cellulose (MCC), hydroxypropyl methylcellulose, silicon dioxide (SiO2), polyethylene glycol 8000, lactose, D-trehalose dihydrate, mannitol, tribasic calcium phosphate, calcium sulfate, corn starch, fructose, xylitol, maltitol, anhydrous lactose, and dicalcium phosphate (DCP). In some embodiments, the hygroscopic material comprises SiO2. In some embodiments, SiO2 is present in an amount of about 0.1% to about 10% by weight. In some embodiments, SiO2 is present in an amount of about 1% by weight. In some embodiments, the hygroscopic material comprises mannitol. In some embodiments, mannitol is present in an amount of about 1% to about 90% by weight. In some embodiments, mannitol is present in an amount of about 5% to about 81.5% by weight. In some embodiments, the hygroscopic material comprises anhydrous lactose. In some embodiments, anhydrous lactose is present in an amount of about 1% to about 90% by weight. In some embodiments, anhydrous lactose is present in an amount of about 5% to about 81.5% by weight. In some embodiments, the pharma- ceutically acceptable excipient further comprises magnesium stearate. In some embodiments, magnesium stearate is present in an amount of about 0.1% to about 10% by weight. In some embodiments, magnesium stearate is present in an amount of about 1.5% by weight.In some embodiments, the pharma- ceutically acceptable excipient further comprises microcrystalline cellulose. In some embodiments, the purified bacterial population comprises at least two of at least one strain of Ackermansia species, at least one strain of Faecalibacterium species, and at least one strain of Lactobacillus species. In some embodiments, the purified bacterial population comprises at least two of at least one strain of Ackermansia species, at least one strain of Faecalibacterium species, and at least one strain of Lactobacillaceae species. In some embodiments, the purified bacterial population comprises at least one strain of Ackermansia species, at least one strain of Faecalibacterium species, and at least one strain of Lactobacillaceae species. In some embodiments, the purified bacterial population comprises at least one strain of Ackermansia species, at least one strain of Faecalibacterium species, and at least one strain of Lactobacillaceae species. In some embodiments, the purified bacterial population comprises at least one strain of Ackermansia species, at least one strain of Faecalibacterium species, and at least one strain of Lactobacillaceae species.

[0012] In some embodiments, pharmaceutical compositions are disclosed herein.In one aspect, the pharmaceutical composition comprises: i. At least one strain of Ackermansia species, at least one strain of Lactobacillus species, or at least one strain of Faecalibacterium species; and ii. A pharmacy acceptable excipient; and the pharmaceutical composition is contained in a blister pack.

[0013] In one embodiment, the pharmaceutical composition comprises i. a purified bacterial population comprising at least one strain of an Ackermansia species, at least one strain of a Lactobacillaceae species, or at least one strain of a Faecalibacterium species, and ii. a pharmaceutically acceptable excipient, wherein the pharmaceutical composition is contained in a blister pack.

[0014] In some embodiments, the blister pack is selected from the group consisting of polyethylene terephthalate (PET), polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), polychlorotrifluoroethylene (PCTFE), cyclic olefin polymer (COP), oriented polyamide (OPA), aluminum foil, plastic film. In some embodiments, the blister pack is an aluminum blister pack. In some embodiments, the blister pack is filled with nitrogen gas. In some embodiments, the pharma- ceutically acceptable excipient comprises a hygroscopic material. In some embodiments, the hygroscopic material is selected from the group consisting of microcrystalline cellulose (MCC), hydroxypropyl methylcellulose, silicon dioxide (SiO2), polyethylene glycol 8000, lactose, D-trehalose dihydrate, mannitol, tribasic calcium phosphate, calcium sulfate, corn starch, fructose, xylitol, maltitol, anhydrous lactose, and dicalcium phosphate (DCP). In some embodiments, the hygroscopic material comprises SiO2. In some embodiments, SiO2 is present in an amount of about 0.1% to about 10% by weight. In some embodiments, SiO2 is present in an amount of about 1% by weight. In some embodiments, the hygroscopic material includes mannitol. In some embodiments, mannitol is present in an amount of about 1% to about 90% by weight. In some embodiments, mannitol is present in an amount of about 5% to about 81.5% by weight. In some embodiments, the hygroscopic material includes anhydrous lactose. In some embodiments, anhydrous lactose is present in an amount of about 1% to about 90% by weight. In some embodiments, anhydrous lactose is present in an amount of about 5% to about 81.5% by weight. In some embodiments, the pharma- ceutically acceptable excipient further includes magnesium stearate. In some embodiments, magnesium stearate is present in an amount of about 0.1% to about 10% by weight. In some embodiments, magnesium stearate is present in an amount of about 1.5% by weight. In some embodiments, the pharma- ceutically acceptable excipient further includes microcrystalline cellulose.

[0015] In some embodiments, the purified bacterial population comprises at least two of at least one strain of Ackermansia species, at least one strain of Faecalibacterium species, and at least one strain of Lactobacillus species. In some embodiments, the purified bacterial population comprises at least two of at least one strain of Ackermansia species, at least one strain of Faecalibacterium species, and at least one strain of Lactobacillaceae family species. In some embodiments, the purified bacterial population comprises at least one strain of Ackermansia species, at least one strain of Faecalibacterium species, and at least one strain of Lactobacillaceae family species. In some embodiments, the purified bacterial population comprises at least one strain of Ackermansia species, at least one strain of Faecalibacterium species, and at least one strain of Lactobacillaceae family species. In some embodiments, the purified bacterial population is freeze-dried. In some embodiments, the at least one strain of Ackermansia species, at least one strain of Faecalibacterium species, and at least one strain of Lactobacillaceae family species are selected from the strains listed in Table 1. In some embodiments, the at least one strain of Ackermansia species, the at least one strain of Faecalibacterium species, and the at least one strain of Lactobacillaceae species are selected from the strains listed in Table 1. In some embodiments, the bacterial population comprises A. muciniphila (DSM 33213), F. prausnitzii (DSM 33185), or L. crispatus (DSM 33187). In some embodiments, the bacterial population comprises at least two of the bacterial strains A. muciniphila (DSM 33213), F. prausnitzii (DSM 33185), and L. crispatus (DSM 33187). In some embodiments, the bacterial population comprises the bacterial strains A. muciniphila (DSM 33213), F. prausnitzii (DSM 33185), and L. crispatus (DSM 33187). In some embodiments, each bacterial strain is present in an amount of about 10^3 CFU / dose to about 10^12 CFU / dose.In some embodiments, each bacterial strain is present in an amount of about 10^7 CFU / dose to about 10^10 CFU / dose. In some embodiments, at least one strain of Ackermansia species is present in an amount of about 10^6 CFU / dose to about 2x10^9 CFU / dose. In some embodiments, at least one strain of Faecalibacterium species is present in an amount of about 10^6 CFU / dose to about 2x10^9 CFU / dose. In some embodiments, at least one strain of Lactobacillus species is present in an amount of about 10^7 CFU / dose to about 5x10^9 CFU / dose. In some embodiments, at least one strain of Lactobacillaceae species is present in an amount of about 10^7 CFU / dose to about 5x10^9 CFU / dose. In some embodiments, the bacterial population is present in a total amount of about 10^3 CFU / dose to about 10^12 CFU / dose. In some embodiments, the bacterial population is present in a total amount of about 10^7 CFU / dose to about 10^10 CFU / dose.

[0016] In some embodiments, methods are disclosed herein for treating a subject having or suspected of having a disease. In some aspects, the methods for treating a subject having or suspected of having a disease comprise administering to the subject a pharmaceutical composition of any of the disclosed pharmaceutical compositions.

[0017] In some embodiments, the disease is an inflammatory disease. In some embodiments, the inflammatory disease is an allergy or dermatitis. In some embodiments, the allergy is allergic asthma, allergic childhood asthma, or food allergy. In some embodiments, the disease is a metabolic disease. In some embodiments, the metabolic disease is obesity, diabetes, or metabolic syndrome.

[0018] In some embodiments, the method for the large-scale growth of Lactobacillus species is disclosed herein.In one aspect, the method for the large-scale growth of Lactobacillus species comprises carrying out multiple inoculation rounds with increasing amounts of growth medium, and each inoculation round comprises at least about 0.5% of the total batch material of the preceding inoculation round.

[0019] In some embodiments, the method disclosed herein is for the large-scale growth of Lactobacillaceae species.In one aspect, the method for the large-scale growth of Lactobacillaceae species comprises carrying out multiple inoculation rounds with increasing amounts of growth medium, and each inoculation round comprises at least about 0.5% of the total batch material of the preceding inoculation round.

[0020] In some embodiments, the method for the large-scale growth of Lactobacillaceae species is disclosed herein.In one aspect, the method for the large-scale growth of Lactobacillaceae species comprises carrying out multiple inoculation rounds with increasing amounts of growth medium, wherein each inoculation round comprises at least about 0.5% by volume of the total batch material of the preceding inoculation round, and the growth medium of each inoculation round is at least about 50L.

[0021] In some embodiments, the Lactobacillus species comprises Lactobacillus crispatus. In some embodiments, the Lactobacillaceae species comprises Lactobacillus crispatus. In some embodiments, the Lactobacillus species comprises Lactobacillus crispatus (DSM 33187). In some embodiments, the Lactobacillaceae species comprises Lactobacillus crispatus (DSM 33187). In some embodiments, the growth medium is from about 100 mL to about 4,000 L. In some embodiments, the growth medium is from about 50 L to about 4,000 L. In some embodiments, the method further comprises an initial inoculation round of about 500 mL growth medium. In some embodiments, at least one of the inoculation rounds is about 3500 L volume of growth medium. In some embodiments, at least one of the inoculation rounds is about 50 L volume. In some embodiments, the initial inoculation round comprises a frozen stock of Lactobacillus crispatus at about 0.4% of the initial inoculation round growth medium. In some embodiments, the initial inoculation round comprises growing Lactobacillus crispatus under anaerobic conditions. In some embodiments, the method further comprises subjecting the growth medium to multiple sterilization and degassing rounds. In some embodiments, the method further comprises lyophilizing the batch. In some embodiments, the method further comprises centrifuging the batch prior to lyophilization. In some embodiments, the method further comprises grinding the batch after lyophilization.

[0022] In some embodiments, the method for producing pharmaceutical composition is disclosed herein.The method for producing pharmaceutical composition includes: 1) providing a mixture comprising purified bacterial population, comprising at least one strain of Ackermansia species, at least one strain of Faecalibacterium species, or at least one strain of Lactobacillus species; 2) filling the mixture into capsule; and 3) packaging the capsule into blister pack, wherein providing and filling are in an oxygen-free atmosphere.

[0023] A method for producing a pharmaceutical composition includes: 1) providing a mixture comprising a purified bacterial population comprising at least one strain of Ackermansia species, at least one strain of Faecalibacterium species, or at least one strain of Lactobacillaceae species; 2) filling the mixture into a capsule; and 3) packaging the capsule into a blister pack, wherein the providing and filling are in an oxygen-free atmosphere.

[0024] In some embodiments, the method further comprises storing the capsule in a container prior to packaging. In some embodiments, the storage is in an oxygen-free atmosphere. In some embodiments, the oxygen-free atmosphere is achieved by injecting nitrogen gas or an oxygen scrubber. In some embodiments, the filling is achieved by a capsule filling machine. In some embodiments, the filling is achieved in an anaerobic chamber. In some embodiments, the capsule is a vegetable-based capsule. In some embodiments, the vegetable-based capsule is a hypromellose capsule. In some embodiments, the blister pack is selected from polyethylene terephthalate (PET), polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), polychlorotrifluoroethylene (PCTFE), cyclic olefin polymer (COP), oriented polyamide (OPA), aluminum foil, plastic film. In some embodiments, the blister pack is an aluminum blister pack. In some embodiments, the blister pack is filled with nitrogen gas. In some embodiments, the pharmaceutical composition further comprises a pharma- ceutically acceptable excipient.

[0025] In some embodiments, the pharma- ceutically acceptable excipient comprises a hygroscopic material. In some embodiments, the hygroscopic material is selected from the group consisting of microcrystalline cellulose (MCC), hydroxypropyl methylcellulose, silicon dioxide (SiO2), polyethylene glycol 8000, lactose, D-trehalose dihydrate, mannitol, tribasic calcium phosphate, calcium sulfate, corn starch, fructose, xylitol, maltitol, anhydrous lactose, and dicalcium phosphate (DCP). In some embodiments, the hygroscopic material comprises SiO2. In some embodiments, the SiO2 is present in an amount of about 0.1% to about 10% by weight. In some embodiments, the SiO2 is present in an amount of about 1% by weight. In some embodiments, the hygroscopic material comprises mannitol. In some embodiments, the mannitol is present in an amount of about 1% to about 90% by weight. In some embodiments, the mannitol is present in an amount of about 5% to about 81.5% by weight. In some embodiments, the hygroscopic material comprises anhydrous lactose. In some embodiments, the anhydrous lactose is present in an amount of about 1% to about 90% by weight. In some embodiments, the anhydrous lactose is present in an amount of about 5% to about 81.5% by weight. In some embodiments, the pharma- ceutically acceptable excipient further comprises magnesium stearate. In some embodiments, the magnesium stearate is present in an amount of about 0.1% to about 10% by weight. In some embodiments, the magnesium stearate is present in an amount of about 1.5% by weight. In some embodiments, the pharma- ceutically acceptable excipient further comprises microcrystalline cellulose. In some embodiments, the purified bacterial population comprises at least two of at least one strain of Ackermansia species, at least one strain of Faecalibacterium species, or at least one strain of Lactobacillus species. In some embodiments, the purified bacterial population comprises at least two of at least one strain of Ackermansia species, at least one strain of Faecalibacterium species, or at least one strain of Lactobacillaceae species.In some embodiments, the purified bacterial population comprises at least one strain of Ackermansia species, at least one strain of Faecalibacterium species, and at least one strain of Lactobacillus species. In some embodiments, the purified bacterial population comprises at least one strain of Ackermansia species, at least one strain of Faecalibacterium species, and at least one strain of Lactobacillaceae species. In some embodiments, the bacterial population is freeze-dried.

[0026] Further aspects and advantages of the present disclosure will become readily apparent to those skilled in the art from the following detailed description, in which only illustrative embodiments of the present disclosure are shown and described. As will be understood, the present disclosure is capable of other and different embodiments, and its several details are capable of modification in various obvious respects, all without departing from the present disclosure. Accordingly, the drawings and description are to be regarded as illustrative in nature, and not as restrictive.

[0027] The features of the present disclosure are set forth with particularity in the appended claims. A better understanding of the features and disclosure will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings (also referred to herein as "Figure" and "FIG."). [Brief description of the drawings]

[0028] [Figure 1]Figure 1 shows a schematic flow chart of the optimized ultra-large scale growth and production process of L. crispatus (DSM 33187) in a culture volume of 3500 L. Approximately 1.84 mL of Working Cell Bank (WCB) L. crispatus (DSM 33187) was thawed in an anaerobic chamber and inoculated into 0.5 L reduced LC100 medium (0.4% v / v inoculation rate) in a 2 L flask 101 in the anaerobic chamber. The culture was stopped when the optical density at 583 nm (OD583) was >4.5 or the culture had grown for 20 hours. 0.1 L culture in 101 was used to inoculate 20 L medium in a 20 L fermenter 102 (0.5% v / v inoculation rate). The culture was stopped for one of the following criteria: a) OD583>6, b) glucose concentration<2g / L, c) total culture time reaches 20 hours, or d) a slowdown in growth rate is detected after three subsequent OD583 readings. 250L as defined in Table 3 was prepared. 160L of sugar feed was added to the 3500L fermenter 103. The entire content of 102 or about 20L culture was used to inoculate 3400L medium in the 3500L fermenter 103 (0.59% v / v inoculation rate). The culture was stopped when it was stopped for one of the following criteria: a) OD583>8, b) glucose concentration<2g / L, c) total culture time reaches 20 hours, or d) a slowdown in growth rate is detected after three subsequent OD583 readings. The entire 103 culture was then centrifuged under anaerobic atmosphere and harvested as biomass. 150 L of filter-sterilized, degassed cryoprotectant, defined in Table 5, was mixed with the biomass in a mixing tank purged with anaerobic gas. The biomass with cryoprotectant was lyophilized (frozen to dryness) and ground. For each step, media used for bacterial culture was sterilized (autoclaved at 121 °C) and degassed with N2H2CO2 (90:5:5) before use. The sugar component (glucose) was prepared separately from the remaining LC100 medium components. The sugar feed was filter-sterilized, degassed, and added to the remaining LC100 medium components to generate the complete culture medium. [Diagram 2] FIG. 2 shows a schematic flow chart summarizing the manufacturing process of the drug product (DP). [Diagram 3]Figure 3 shows a schematic flow chart summarizing the manufacturing process of the drug product (DP) after a drug substance (DS) batch has been confirmed. The DS contains A. muciniphila (DSM 33213), L. crispatus (DSM 33187), and F. prausnitzii (DSM 33185). [Figure 4A] Figure 4A shows a schematic flow chart summarizing the efficacy testing of formulations mixed with different excipients. Excipients tested include Vivapur 103, Vivapur 112, Vivapur 200 XLM, Vivapur Prosolv SMCC90 and EMDEX. Formulations were mixed with excipients in a ratio of 1:1, 1:2 or 1:3. Formulations without excipients were used as negative controls. [Figure 4B] Figure 4B shows that Vivapur 103, Vivapur 112, Vivapur 200 XLM, Vivapur Prosolv SMCC90 were not soluble in water. Formulations mixed with different excipients in Eppendorf tubes after 5 minutes of room temperature incubation are shown. [Figure 5A] The results show that F. prausnitzii (DSM 33185) in formulations (DP) with different excipients is stable at 4°C and -20°C. Figure 5A shows a schematic flow chart summarizing the efficacy testing of formulations mixed with different excipients. The formulations contain a drug substance (DS) with A. muciniphila (DSM 33213), L. crispatus (DSM 33187), and F. prausnitzii (DSM 33185). The excipients tested include EMDEX, mannitol, and anhydrous lactose. The formulations and excipients were mixed in a 1:2 ratio with and without silicon dioxide (SiO2). Each formulation mixture contains approximately 0.3 g of formulation and excipients and is stored in a 5 / 6 glass vial. A desiccant packet was placed in the freezer box containing the glass vials. A formulation without excipients was used as a negative control. The efficacy of the formulations was scored on day 0 (D0), D7, D14, D28 and D60. [Figure 5B]Figure 5B shows that F. prausnitzii (DSM 33185) in formulations (DP) with different excipients is stable at 4°C and -20°C. Figure 5B shows that F. prausnitzii (DSM 33185) in formulations with various excipients is stable at 4°C. The viable cell count as colony forming units per gram of formulation (CFU / g) of F. prausnitzii (DSM 33185) stored at 4°C was scored at D0, D7, D14 and D28 and is shown on the Y-axis. The X-axis shows the formulations mixed with different excipients with or without silicon dioxide. [Figure 5C] Figure 5C shows that F. prausnitzii (DSM 33185) in formulations (DP) with different excipients is stable at 4°C and -20°C. Figure 5C shows that F. prausnitzii (DSM 33185) in formulations with various excipients is stable at -20°C. The viable cell count as colony forming units per gram of formulation (CFU / g) of F. prausnitzii (DSM 33185) stored at -20°C was scored at D0, D7, D14 and D28 and is shown on the Y-axis. The X-axis shows the formulations mixed with different excipients with or without silicon dioxide. [Figure 6A] The results show that F. prausnitzii (DSM 33185) in the formulation (DP) is stable at low humidity, and A. muciniphila (DSM 33213) and L. crispatus (DSM 33187) are stable at low and high humidity. Figure 6A shows a schematic flow chart summarizing the efficacy testing of the formulation mixed with mannitol and anhydrous lactose and silicon dioxide (SiO2). The formulation contains drug substance (DS) with A. muciniphila (DSM 33213), L. crispatus (DSM 33187), and F. prausnitzii (DSM 33185). Approximately 0.3 g of the formulation mixture was filled into eight capsules per condition in an anaerobic chamber (AS-150; approximately 40% humidity) and a biosafety cabinet (BSC; >60% humidity). The capsules were stored in glass vials at 4 °C and -20 °C. The desiccant packets were placed in a freezer containing glass vials. The potency of the mixture was tested on day 0 (D0), D7, D14, D21, D28, D60, D90 and D120. [Figure 6B] Figure 6B shows that F. prausnitzii (DSM 33185) in formulation (DP) is stable at low humidity, while A. muciniphila (DSM 33213) and L. crispatus (DSM 33187) are stable at low and high humidity. Figure 6B shows that F. prausnitzii (DSM 33185) in formulation mixture with anhydrous lactose and SiO2 is stable at 4°C and low humidity, but not at high humidity. A. muciniphila (DSM 33213) and L. crispatus (DSM 33187) are stable at low and high humidity. The viable cell count as colony forming units per gram of preparation (CFU / g) of F. prausnitzii (DSM 33185), A. muciniphila (DSM 33213) and L. crispatus (DSM 33187) stored at 4° C. and −20° C. was scored at DO, D7, D14 and D21 and is shown on the Y-axis. The X-axis indicates the day on which the viable cell count was recorded. [Figure 6C] Figure 6C shows that F. prausnitzii (DSM 33185) in formulation (DP) is stable at low humidity, while A. muciniphila (DSM 33213) and L. crispatus (DSM 33187) are stable at low and high humidity. Figure 6C shows that F. prausnitzii (DSM 33185) in formulation mixture mannitol and SiO2 is stable at 4°C and -20°C at low humidity, but not at high humidity. A. muciniphila (DSM 33213) and L. crispatus (DSM 33187) are stable at low and high humidity. The viable cell count as colony forming units per gram of preparation (CFU / g) of F. prausnitzii (DSM 33185), A. muciniphila (DSM 33213) and L. crispatus (DSM 33187) stored at -20°C was scored at DO, D7, D14 and D21 and is shown on the Y-axis. The X-axis indicates the day on which the viable cell count was recorded. [Figure 7A]Figure 7A shows that F. prausnitzii (DSM 33185), A. muciniphila (DSM 33213) and L. crispatus (DSM 33187) in formulation (DP) are stable in the formulation line environment (DP). The formulation line environment (DP) was maintained at 25°C and humidity below 30%. The anaerobic chamber (AC) was maintained at room temperature and humidity above 50%. Figure 7B shows that F. prausnitzii (DSM 33185) is stable in the formulation line environment but not in the aerobic chamber. The viable cell count as colony forming units per gram (CFU / g) of F. prausnitzii (DSM 33185) was scored and shown on the Y-axis. The X-axis shows the time points at which the viable cell count was recorded: at the start of the experiment (t=0 h), 1 h (t=1 h), t=2 h, t=4 h, t=8 h, and t=24 h. [Figure 7B] Figure 7B shows that F. prausnitzii (DSM 33185), A. muciniphila (DSM 33213) and L. crispatus (DSM 33187) in formulation (DP) are stable in the formulation line environment (DP). Figure 7B shows that A. muciniphila (DSM 33213) is stable in the formulation line environment and in the aerobic chamber. The viable cell count as colony forming units per gram (CFU / g) of F. prausnitzii (DSM 33185) was scored and shown on the Y-axis. The X-axis shows the time points at which the viable cell count was recorded: at the start of the experiment (t=0 h), 1 h (t=1 h), t=2 h, t=4 h, t=8 h, and t=24 h. [Figure 7C] Figure 7C shows that F. prausnitzii (DSM 33185), A. muciniphila (DSM 33213) and L. crispatus (DSM 33187) in formulation (DP) are stable in the formulation line environment (DP). Figure 7C shows that L. crispatus (DSM 33187) is stable in the formulation line environment and in the aerobic chamber. The viable cell count as colony forming units per gram (CFU / g) of F. prausnitzii (DSM 33185) was scored and shown on the Y-axis. The X-axis shows the time points at which the viable cell count was recorded: at the start of the experiment (t=0 h), 1 h (t=1 h), t=2 h, t=4 h, t=8 h, and t=24 h. [Figure 8] FIG. 8 shows the schematic distribution of A. muciniphila (DSM 33213), L. crispatus (DSM 33187), and F. prausnitzii (DSM 33185), mannitol, and silicon dioxide within the feasible batches. [Figure 9A] Figure 9A shows the distribution of the ingredients of the formulation of the feasibility batch before mixing, showing that the ingredients form a visually homogenous mixture. [Figure 9B] It is shown that the ingredients of the formulation of the feasibility batch form a visually homogenous mixture. Figure 9B shows the distribution of the ingredients of Figure 8 after mixing. [Figure 10] Figure 10 shows that the formulation of the feasibility batch has particles of different sizes. The distribution of particle sizes in the formulation of the feasibility batch is plotted. The X-axis shows the sieve size. The Y-axis shows the percentage of particles retained by the sieve. [Figure 11] Figure 11 shows that the formulation of the feasibility batch has particles of different sizes. A micrograph of the formulation under 40x magnification is shown. Particles of different sizes are observed. [Figure 12] Figure 12 shows that the formulation of the feasibility batch is soluble in water. After homogenization at 150 rpm for 10 seconds, most of the material in the formulation was dissolved in water. [Figure 13A] FIG. 13A shows a schematic flow chart summarizing an exemplary drug product production process. [Figure 13B] FIG. 13B shows a schematic flow chart summarizing another exemplary drug product production process. [Figure 14A]FIG. 14A shows that achievement of anaerobic conditions in the capsule is slower in the anaerobic chamber. Photographs of the capsule at different time points in the anaerobic chamber are shown. The capsule color is labeled at the top of each image. The V-cap capsule was moved into the anaerobic chamber. The capsule was filled with YFAP broth + 0.12% Rezasurin. The capsule was incubated in the anaerobic chamber. Rezasurin is an oxygen indicator: in the presence of oxygen it appears pink and in the absence of oxygen it appears yellow. The capsule was loaded into the anaerobic chamber and it took about an hour for the oxygen gas in the capsule to be removed. [Figure 14B] FIG. 14B shows rapid oxygen transfer into the capsule outside the anaerobic chamber. Photographs of the capsule at different time points outside the anaerobic chamber are shown. The capsule color is labeled at the top of each image. The V-cap capsule was incubated overnight in the anaerobic chamber. The capsule was filled with YFAP broth + 0.12% Rezasurin. The capsule was left out of the anaerobic chamber and incubated. Once out of the anaerobic chamber, it took approximately 8 minutes for oxygen gas to transfer into the capsule. [Figure 15A] The formulations are shown to be stable under multiple freeze-thaw cycles. Figure 15A shows a schematic flow chart summarizing the method to evaluate the formulation stability under freeze-thaw cycles. Formulations containing F. prausnitzii (DSM 33185), A. muciniphila (DSM 33213), and L. crispatus (DSM 33187) in capsules filled in aluminum blister packs were stored in a -20°C freezer. The blister packs were removed from the freezer and thawed at room temperature for 30 min on days (D1), D2, D3, D4, D5, D6, D7, and D8, which represent 1, 2, 3, 4, 5, 6, 7, and 8 freeze-thaw cycles. After thawing, the capsules were opened in a biosafety cabinet and transferred into an anaerobic chamber. The formulations were serially diluted in PBS-C and inoculated into growth plate medium. The colony forming units per capsule (CFU / capsule) were scored. [Figure 15B]The formulations are stable under multiple freeze-thaw cycles. Figure 15B shows that F. prausnitzii (DSM 33185), A. muciniphila (DSM 33213), and L. crispatus (DSM 33187) are stable under multiple freeze-thaw cycles. The Y-axis shows the CFU / capsule of the strain. The X-axis shows the number of freeze-thaw cycles that the tested formulations have accumulated. [Figure 16] Figures 16A and 16B show that the formulation is stable when shipped in a cooler. Figure 16A shows a schematic flow chart summarizing the method to evaluate the formulation stability in a cooler. A formulation containing F. prausnitzii (DSM 33185), A. muciniphila (DSM 33213), and L. crispatus (DSM 33187) in capsules filled in aluminum blister packs was stored in a -20°C freezer. The blister packs were transferred to a cooler equipped with ice packs and a temperature tail monitor. The temperature in the cooler was monitored. The blisters were removed from the cooler after 6 hours and thawed at room temperature for 30 minutes. After thawing, the capsules were opened in a biosafety cabinet and transferred into an anaerobic chamber. The formulation was serially diluted in PBS-C and inoculated on growth plate media. The colony forming units per capsule (CFU / capsule) were scored. Different numbers of blisters were tested in the cooler on different days. DP was not moved in the cooler and was used as a control. Figure 16B shows the cooler temperature on day 1 with 4 blister packs. Figure 16C shows the cooler temperature on day 2 with 4 blister packs. Figure 16D shows the cooler temperature on day 3 with 12 blister packs. Figure 16E shows the cooler temperature on day 4 with 12 blister packs. In Figures 16B, 16C, 16D, and 16E, the Y-axis shows the cooler temperature and the X-axis shows the temperature over time inside the cooler. Figure 16F shows that F. prausnitzii (DSM 33185), A. muciniphila (DSM 33213), and L. crispatus (DSM 33187) are stable during transportation in the cooler. The Y-axis shows the CFU / capsule of the strain. The X-axis shows the day the formulation was tested and the number of blister packs tested is shown. [Figure 17]FIG. 17 shows a schematic flow chart summarizing an exemplary method for assessing formulation stability. [Figure 18] FIG. 18 shows a schematic flow chart summarizing an exemplary method for evaluating different cryoprotectants. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0029] The present disclosure provides pharmaceutical compositions that may include, consist essentially of, or consist of a bacterial population and one or more pharma- ceutical acceptable excipients. The pharmaceutical compositions may also be contained in a vegetable capsule, a blister pack, a sachet pack, or any combination thereof. The medicament may be used to treat inflammatory or metabolic diseases.

[0030] A pharmaceutical composition comprising live bacteria is prone to degradation or loss of activity (e.g., pharmacological stability, pharmaceutical activity, biological / physiological activity induced by the pharmaceutical composition when administered by a subject). Loss of activity of the pharmaceutical composition may be associated with loss of viability of the bacteria. Loss of activity of the pharmaceutical composition can be prevented by using pharmaceutically acceptable excipients, cryoprotectants, containers (including but not limited to capsules), improved packaging form, or any combination thereof. Loss of activity of the pharmaceutical composition can also be prevented by packaging or manufacturing the pharmaceutical composition under various conditions. The present disclosure provides pharmaceutically acceptable excipients, cryoprotectants, containers, packaging form, packaging or manufacturing conditions, or any combination thereof, for maintaining the activity of the pharmaceutical composition or the viability of the live bacteria of the pharmaceutical composition.

[0031] Inoculation and growth of bacteria in large volumes (e.g., beyond routine laboratory scale, such as less than about 50 L) in pharmaceutical composition manufacturing can be difficult due to the inability of bacteria to sustain robust growth at large volumes. Sustaining robust growth at large volumes can be achieved by inoculating and / or growing bacteria in a variety of conditions or on a variety of substances. The present disclosure provides methods and compositions for sustaining robust bacterial growth at large volumes.

[0032] Provided herein is a method for producing a pharmaceutical composition comprising a bacterial population. The method may include blending and packaging the pharmaceutical composition in an oxygen-free atmosphere.

[0033] Also disclosed is a method for the large-scale growth of Lactobacillus species. Also disclosed is a method for the large-scale growth of Lactobacillaceae species. The method can include carrying out multiple inoculation rounds with increasing amounts of growth medium. Each of the multiple inoculation rounds can include at least 0.5% of the total batch material of the preceding round.

[0034] definition The term "purified" or "substantially purified" as used herein when referring to a bacterial strain or a mixture of two or more bacterial strains refers to one or more bacterial strains in which the sample is substantially enriched. A purified or substantially purified bacterial strain(s) in a sample may comprise at least about 50%, 60%, 70%, 80%, 85%, 90%, 95%, 99% or more of the bacterial strain(s) in the sample. A purified or substantially purified bacterial strain(s) in a sample may also comprise about 40%, 30%, 20%, 15%, 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1% or less of strains other than the bacterial strain(s) present in the sample. Such strains may include bacterial strains. Such strains may also include any non-bacterial strains, such as strains from other organisms.

[0035] The term "pharmaceutical composition" or "composition", when referring to a pharmaceutical product, refers to a composition that can induce or induce at least one physiological effect in a subject when administered by a subject, preferably a human. Such physiological effects can positively contribute to the overall health of the subject. In some cases, such physiological effects can also suppress, inhibit, reduce, or diminish a negative physiological phenomenon in the subject.

[0036] The term "pharmaceutical acceptable excipient" or "excipient", when referring to a pharmaceutical composition, refers to an excipient that does not cause adverse allergic reactions or other untoward reactions when administered to a subject, preferably a human. A pharmaceutical acceptable excipient, when administered alone or in combination with a pharmaceutical composition, may not cause adverse allergic reactions or other untoward reactions when administered to a subject. A pharmaceutical acceptable excipient may include any solvent, dispersion medium, coating, isotonicity agent, absorption delaying agent, and the like. A pharmaceutical acceptable excipient may be added to a pharmaceutical composition to stabilize the pharmaceutical composition. A pharmaceutical acceptable excipient may be added to a pharmaceutical composition to prevent contamination of the pharmaceutical composition. A pharmaceutical acceptable excipient may be an inert substance added to a pharmaceutical composition to facilitate processing, handling, administration, and the like of the pharmaceutical composition.

[0037] The term "hygroscopic material" refers to a material that can absorb water. A hygroscopic material can reduce the moisture content or relative humidity (RH) of an environment compared to a comparable environment without the hygroscopic material. Storage of a hygroscopic material with other substances (e.g., pharmaceutical compositions) can reduce the amount of moisture compared to a comparable substance without the hygroscopic material.

[0038] The term "lyophilization" refers to a water removal process that includes freezing and drying cycles. A freeze-dried material may have a water content of 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1% or less by weight in the material. Freeze-drying may include an initial freezing cycle followed by a subsequent drying cycle. The freezing cycle may freeze the material such that a sublimation state rather than a melting state of the material occurs in the subsequent drying cycle. The first drying cycle may include reducing the pressure and increasing the temperature to remove the water content from the material. The first drying cycle may include placing the material in a vacuum. The first drying cycle may include slow heating. A second drying cycle may be used following the first drying cycle. The second drying cycle may include rapid heating to break the bonds between the material and the water molecules.

[0039] As used herein, the terms "anoxic" or "anaerobic" refer to low or oxygen-free conditions. An anoxic or anaerobic environment can have 21%, 20%, 19%, 18%, 17%, 16%, 15%, 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 1x10^-1%, 1x10^-2%, 1x10^-3%, 1x10^-4%, 1x10^-5%, 1x10^-6%, 1x10^-7%, 1x10^-8%, 1x10^-9%, 1x10^-10%, 1x10^-11%, or less oxygen by volume in the atmosphere of the environment.

[0040] As used herein, the term "oxygen scrubber" refers to a material that can absorb or remove oxygen. An oxygen scrubber may isolate oxygen from contact with other materials. An oxygen scrubber may remove oxygen through a chemical reaction. An oxygen scrubber may also remove oxygen from an environment so that other materials in the environment do not come into contact with the oxygen. An oxygen scrubber may be used to create an anoxic or anaerobic environment.

[0041] As used herein, the term "capsule" refers to a container that includes a membrane-covered sac for containing a pharmaceutical composition. In some cases, the capsule may not be administered to a subject. In some cases, the capsule may not be administered to a subject together with a pharmaceutical composition. In other cases, the capsule may be administered to a subject.

[0042] As used herein, the term "blister pack" refers to a preformed pack for storing and sealing a capsule or pharmaceutical composition. The blister may comprise a cavity or pocket and a lid that seals the cavity or pocket. The capsule or pharmaceutical composition may be sealed within the blister such that the capsule or pharmaceutical composition is not in direct contact with molecules or substances outside the sealed cavity or pocket.

[0043] As used herein, the term "capsule filling machine" refers to a means for filling capsules with a pharmaceutical composition. The capsule filling machine may include a mechanical capsule filling machine. In some cases, the capsule filling machine may include an automated mechanical capsule filling machine. In other cases, the capsules are filled manually. In other cases, the capsules are filled manually in an anaerobic chamber.

[0044] As used herein, the term "plant-based" refers to a substance or material derived from a plant. Plant-based substances or materials do not include any animal or animal-derived meat, products, or by-products. Plant-based substances or materials do not include any meat, products, or by-products derived from slaughtered animals.

[0045] As used herein, the term "inflammatory disease" refers to a type of disease, condition, or state in which a subject's immune system attacks tissues or cells of a subject, where the tissues or cells are not infected, damaged, or in a diseased state. The tissues or cells may also be in a healthy state.

[0046] As used herein, the term "metabolic disease" refers to a type of disease, condition, or state that disrupts or has a disrupted metabolic process. A disrupted metabolic process may have an increased or decreased activity or efficiency compared to a comparable metabolic process that is not disrupted. A disrupted metabolic process may also have a different frequency of activity or efficiency compared to a comparable metabolic process that is not disrupted.

[0047] As used herein, the term "inoculation" refers to the process of introducing a microorganism (e.g., a bacterial strain described herein) into any substantially pure growth medium. Inoculation can result in an increase in mass, either by an increase in cell number through cell division or an increase in cell mass through cell proliferation, if the microorganism is given time and conditions to undergo cell division or cell proliferation.

[0048] As used herein, the term "storage stability" refers to the stability of a pharmaceutical composition.

[0049] The term "about" or "approximately" as used herein when referring to a measurable value, such as an amount or concentration, is meant to encompass a variation of 20%, 10%, 5%, 1%, 0.5%, or even 0.1% of the specified amount. For example, "about" can mean plus or minus 10%, as is customary in the art. Alternatively, "about" can mean a range of ±20%, ±10%, ±5%, or ±1% of a given value. Alternatively, particularly with respect to biological systems or processes, the term can mean within an order of magnitude, up to 5-fold, or up to 2-fold the value. Where particular values ​​may be described in the present application and claims, unless otherwise indicated, the term "about" should be assumed to mean up to an acceptable range of error for the particular value. Also, where ranges, subranges, or both of values ​​may be provided, the ranges or subranges may include the endpoints of the ranges or subranges. The terms "substantially," "substantially free," "substantially free," and "approximately" are used when describing a size, a location, or both to indicate that the described value may be up to a reasonable range of expected values. For example, a numerical value may have a value that may be + / - 0.1% of the stated value (or range of values), + / - 1% of the stated value (or range of values), + / - 2% of the stated value (or range of values), + / - 5% of the stated value (or range of values), + / - 10% of the stated value (or range of values), etc. Any numerical range recited herein may be intended to include all subranges subsumed therein.

[0050] The term "and / or" as used herein in phrases such as "A and / or B" is intended to include both A and B, A or B, A (alone), and B (alone). Similarly, the term "and / or" as used in phrases such as "A, B, and / or C" is intended to encompass each of the following embodiments: A, B, and C; A, B, or C; A or C; A or B; B or C; A and C; A and B; B and C; A (alone); B (alone); and C (alone).

[0051] Whenever the terms "no more than," "less than," or "less than or equal to" precede a first number in a series of two or more numerical values, the terms "no more than," "less than," or "less than or equal to" apply to each number in the series. For example, 3, 2, or 1 or less is equivalent to 3 or less, 2 or less, or 1 or less.

[0052] As used herein, "a" or "an" refers to one or to more than one (i.e., to at least one) of the grammatical object of the article. By way of example, "an element" means one element or more than one element.

[0053] Pharmaceutical Compositions Pharmaceutically acceptable excipients In some examples, the pharmaceutical composition may include a pharma- ceutically acceptable excipient.

[0054] In some cases, the pharma- ceutically acceptable excipient may include at least a hygroscopic material, an adjuvant, an anti-adherent, a binder, a carrier, a disintegrant, a filler, a flavoring agent, a coloring agent, a diluent, a lubricant, a glidant, a preservative, an adsorbent, a solvent, a surfactant, a sweetener, or any combination thereof. In some cases, the pharma- ceutically acceptable excipient may include a hygroscopic material. In some cases, the pharma- ceutically acceptable excipient may include an adjuvant. In some cases, the pharma- ceutical acceptable excipient may include an anti-adherent. In some cases, the pharma- ceutical acceptable excipient may include a binder. In some cases, the pharma- ceutical acceptable excipient may include a carrier. In some cases, the pharma- ceutical acceptable excipient may include a disintegrant. In some cases, the pharma- ceutical acceptable excipient may include a filler. In some cases, the pharma- ceutical acceptable excipient may include a flavoring agent. In some cases, the pharma- ceutical acceptable excipient may include a coloring agent. In some cases, the pharma- ceutically acceptable excipients may include a diluent. In some cases, the pharma- ceutically acceptable excipients may include a lubricant. In some cases, the pharma- ceutically acceptable excipients may include a glidant. In some cases, the pharma- ceutically acceptable excipients may include a preservative. In some cases, the pharma- ceutically acceptable excipients may include an adsorbent. In some cases, the pharma- ceutically acceptable excipients may include a solvent. In some cases, the pharma- ceutically acceptable excipients may include a surfactant. In some cases, the pharma- ceutically acceptable excipients may include a sweetener.

[0055] In some cases, the hygroscopic material may include microcrystalline cellulose (MCC), hydroxypropyl methylcellulose, silicon dioxide (SiO2), polyethylene glycol 8000, lactose, D-trehalose dihydrate, mannitol, tribasic calcium phosphate, calcium sulfate, corn starch, fructose, xylitol, maltitol, anhydrous lactose, and dicalcium phosphate (DCP). In some cases, the hygroscopic material may include microcrystalline cellulose (MCC), hydroxypropyl methylcellulose, silicon dioxide (SiO2), polyethylene glycol 8000, lactose, D-trehalose dihydrate, mannitol, tribasic calcium phosphate, calcium sulfate, corn starch, fructose, xylitol, maltitol, anhydrous lactose, or dicalcium phosphate (DCP). In some cases, the hygroscopic material may include SiO2. In some cases, the hygroscopic material may include MCC. In some cases, the hygroscopic material may include anhydrous lactose. In some cases, the hygroscopic material may include hydroxypropyl methylcellulose. In some cases, the hygroscopic material may include polyethylene glycol 8000. In some cases, the hygroscopic material may include lactose. In some cases, the hygroscopic material may include d-trehalose dihydrate. In some cases, the hygroscopic material may include mannitol. In some cases, the hygroscopic material may include tribasic calcium phosphate. In some cases, the hygroscopic material may include calcium sulfate. In some cases, the hygroscopic material may include corn starch. In some cases, the hygroscopic material may include fructose. In some cases, the hygroscopic material may include xylitol. In some cases, the hygroscopic material may include maltitol. In some cases, the hygroscopic material may include DCP. The pharma- ceutically acceptable excipient may be present in an amount of at least about 0.001%, 0.005%, 0.01%, 0.05%, 0.1%, 0.5%, 1%, 1.5%, 2%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 99% or more of the pharmaceutical composition.Pharmaceutically acceptable excipients may be present in an amount up to about 0.001%, 0.005%, 0.01%, 0.05%, 0.1%, 0.5%, 1%, 1.5%, 2%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, or 99% of the pharmaceutical composition. The pharma- ceutically acceptable excipient may be present in an amount of about 0.001%-0.005%, 0.0051%-0.01%, 0.011%-0.05%, 0.05%-0.1%, 0.051%-0.1%, 0.11%-0.5%, 0.51%-1%, 1.1%-1.5%, 1.5%-2%, 2.1%-5%, or 5.1%-10% of the pharmaceutical composition. The percentage of the pharma- ceutically acceptable excipient may be measured by weight or volume of the pharmaceutical composition. The percentage of the pharma- ceutical acceptable excipient may be measured by weight or volume of the pharmaceutical composition. The amount of any of the pharma- ceutical acceptable excipients or components of the multiple pharma- ceutical acceptable excipients may be listed as a ratio between each component of the one or more pharma- ceutical acceptable excipients. For example, if a first pharma- ceutically acceptable excipient and a second pharma- ceutically acceptable excipient are present at 1% and 1% of the pharmaceutical composition, respectively, the first pharma- ceutically acceptable excipient may be listed as 1:1 with the second pharma- ceutically acceptable excipient. The manner in which the amount of the pharmaceutical composition is listed may depend on the type and amount of the pharma- ceutical acceptable excipient or other ingredient in the pharmaceutical composition. The percentage of hygroscopic material may be measured by weight, volume, weight / volume, or volume / weight of the pharmaceutical composition.

[0056] When the pharma- ceutically acceptable excipient comprises any or more of the ingredients described herein, the proportions may be measured as a percentage of each of the individual ingredients or mixtures of ingredients relative to the pharmaceutical composition. The hygroscopic material may be present in an amount of at least about 0.001%, 0.005%, 0.01%, 0.05%, 0.1%, 0.5%, 1%, 1.5%, 2%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 99% or more of the pharmaceutical composition. The hygroscopic material may be present in an amount up to about 0.001%, 0.005%, 0.01%, 0.05%, 0.1%, 0.5%, 1%, 1.5%, 2%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 99% or more of the pharmaceutical composition. The hygroscopic material may be present in an amount of about 0.001%-0.005%, 0.0051%-0.01%, 0.011%-0.05%, 0.05%-0.1%, 0.051%-0.1%, 0.11%-0.5%, 0.51%-1%, 1.1%-1.5%, 1.5%-2%, 2.1%-5%, or 5.1%-10% of the pharmaceutical composition. The percentage of hygroscopic material may be measured by weight, volume, weight / volume, or volume / weight of the pharmaceutical composition.

[0057] In some examples, SiO2 may be present in an amount of about 0.1% to about 10% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 0.2% to about 9% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 0.3% to about 8% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 0.4% to about 7% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 0.5% to about 6% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 0.6% to about 5% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 0.7% to about 4% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 0.8% to about 3% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 0.9% to about 2% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 0.91% to about 1.9% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 0.92% to about 1.8% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 0.93% to about 1.7% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 0.94% to about 1.6% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 0.95% to about 1.5% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 0.96% to about 1.4% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 0.97% to about 1.3% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 0.98% to about 1.2% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 0.99% to about 1.1% by weight of the pharmaceutical composition.In some cases, SiO2 may be present in an amount of about 0.08% to about 10% by weight, about 0.06% to about 10% by weight, about 0.04% to about 10% by weight, about 0.02% to about 10% by weight, about 0.01% to about 10% by weight, about 0.001% to about 10% by weight, about 0.0001% to about 10% by weight, about 0.1% to about 15% by weight, about 0.1% to about 20% by weight, about 0.1% to about 25% by weight, about 0.1% to about 30% by weight, about 0.1% to about 35% by weight, about 0.1% to about 40% by weight, about 0.1% to about 45% by weight, or about 0.1% to about 50% by weight of the pharmaceutical composition.

[0058] In some examples, SiO2 may be present in an amount of about 1% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 1.5% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 2% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 2.5% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 3% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 3.5% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 4% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 4.5% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 5% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 5.5% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 6% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 6.5% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 7% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 7.5% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 8% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 8.5% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 9% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 9.5% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 10% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 0.9% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 0.8% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 0.7% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 0.6% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 0.5% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 0.4% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 0.3% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 0.2% by weight of the pharmaceutical composition. In some cases, SiO2 may be present in an amount of about 0.1% by weight of the pharmaceutical composition.

[0059] In some cases, mannitol may be present in an amount of about 1% to about 90% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 1.25% to about 90% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 1.5% to about 90% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 1.75% to about 90% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 2% to about 90% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 2.25% to about 90% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 2.5% to about 90% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 2.75% to about 90% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 3% to about 90% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 3.25% to about 90% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 3.5% to about 90% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 3.75% to about 90% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 4% to about 90% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 4.25% to about 90% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 4.5% to about 90% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 4.75% to about 90% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 5% to about 90% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 5% to about 89.5% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 5% to about 89% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 5% to about 88.5% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 5% to about 88% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 5% to about 87.5% by weight of the pharmaceutical composition.In some cases, mannitol may be present in an amount of about 5% to about 87% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 5% to about 86.5% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 5% to about 86% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 5% to about 85.5% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 5% to about 85% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 5% to about 84.5% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 5% to about 84% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 5% to about 83.5% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 5% to about 83% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 5% to about 82.5% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 5% to about 82% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 5% to about 81.5% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 1% to about 91% by weight, about 1% to about 92% by weight, about 1% to about 93% by weight, about 1% to about 94% by weight, about 1% to about 95% by weight, about 1% to about 96% by weight, about 1% to about 97% by weight, about 1% to about 98% by weight, about 1% to about 99% by weight, about 0.1% to about 99% by weight, about 0.01% to about 99% by weight, or about 0.001% to about 99% by weight of the pharmaceutical composition.

[0060] In some cases, mannitol may be present in an amount of about 1% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 5% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 10% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 15% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 20% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 25% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 30% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 35% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 40% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 45% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 50% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 55% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 60% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 65% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 70% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 75% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 80% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 85% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 90% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 95% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 96% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 97% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 98% by weight of the pharmaceutical composition. In some cases, mannitol may be present in an amount of about 99% by weight of the pharmaceutical composition. In some cases, mannitol may be present in a quantity sufficient (QS) amount SP of the pharmaceutical composition. For example, if the pharmaceutical composition is N mg and other components of the pharmaceutical composition are x mg, mannitol may be Nx (mg).The proportion of hygroscopic material may be measured by weight, volume, weight / volume, or volume / weight of the pharmaceutical composition, any of which may be substituted for the units in the above formula depending on the units used.

[0061] In some cases, the anhydrous lactose may be present in an amount of about 1% to about 90% by weight of the pharmaceutical composition. In some cases, the anhydrous lactose may be present in an amount of about 1.25% to about 90% by weight of the pharmaceutical composition. In some cases, the anhydrous lactose may be present in an amount of about 1.5% to about 90% by weight of the pharmaceutical composition. In some cases, the anhydrous lactose may be present in an amount of about 1.75% to about 90% by weight of the pharmaceutical composition. In some cases, the anhydrous lactose may be present in an amount of about 2% to about 90% by weight of the pharmaceutical composition. In some cases, the anhydrous lactose may be present in an amount of about 2.25% to about 90% by weight of the pharmaceutical composition. In some cases, the anhydrous lactose may be present in an amount of about 2.5% to about 90% by weight of the pharmaceutical composition. In some cases, the anhydrous lactose may be present in an amount of about 2.75% to about 90% by weight of the pharmaceutical composition. In some cases, the anhydrous lactose may be present in an amount of about 3% to about 90% by weight of the pharmaceutical composition. In some cases, the anhydrous lactose may be present in an amount of about 3.25% to about 90% by weight of the pharmaceutical composition. In some cases, the anhydrous lactose may be present in an amount of about 3.5% to about 90% by weight of the pharmaceutical composition. In some cases, the anhydrous lactose may be present in an amount of about 3.75% to about 90% by weight of the pharmaceutical composition. In some cases, the anhydrous lactose may be present in an amount of about 4% to about 90% by weight of the pharmaceutical composition. In some cases, the anhydrous lactose may be present in an amount of about 4.25% to about 90% by weight of the pharmaceutical composition. In some cases, the anhydrous lactose may be present in an amount of about 4.5% to about 90% by weight of the pharmaceutical composition. In some cases, the anhydrous lactose may be present in an amount of about 4.75% to about 90% by weight of the pharmaceutical composition. In some cases, anhydrous lactose may be present in an amount of about 5% to about 90% by weight of the pharmaceutical composition. In some cases, anhydrous lactose may be present in an amount of about 5% to about 89.5% by weight of the pharmaceutical composition. In some cases, anhydrous lactose may be present in an amount of about 5% to about 89% by weight of the pharmaceutical composition. In some cases, anhydrous lactose may be present in an amount of about 5% to about 88.5% by weight of the pharmaceutical composition. In some cases, anhydrous lactose may be present in an amount of about 5% to about 88% by weight of the pharmaceutical composition.In some cases, the anhydrous lactose may be present in an amount of about 5% to about 87.5% by weight of the pharmaceutical composition. In some cases, the anhydrous lactose may be present in an amount of about 5% to about 87% by weight of the pharmaceutical composition. In some cases, the anhydrous lactose may be present in an amount of about 5% to about 86.5% by weight of the pharmaceutical composition. In some cases, the anhydrous lactose may be present in an amount of about 5% to about 86% by weight of the pharmaceutical composition. In some cases, the anhydrous lactose may be present in an amount of about 5% to about 85.5% by weight of the pharmaceutical composition. In some cases, the anhydrous lactose may be present in an amount of about 5% to about 85% by weight of the pharmaceutical composition. In some cases, the anhydrous lactose may be present in an amount of about 5% to about 84.5% by weight of the pharmaceutical composition. In some cases, the anhydrous lactose may be present in an amount of about 5% to about 84% by weight of the pharmaceutical composition. In some cases, the anhydrous lactose may be present in an amount of about 5% to about 83.5% by weight of the pharmaceutical composition. In some cases, anhydrous lactose may be present in an amount of about 5% to about 83% by weight of the pharmaceutical composition. In some cases, anhydrous lactose may be present in an amount of about 5% to about 82.5% by weight of the pharmaceutical composition. In some cases, anhydrous lactose may be present in an amount of about 5% to about 82% by weight of the pharmaceutical composition. In some cases, anhydrous lactose may be present in an amount of about 5% to about 81.5% by weight of the pharmaceutical composition. In some cases, anhydrous lactose may be present in an amount of about 1% to about 91%, about 1% to about 92%, about 1% to about 93%, about 1% to about 94%, about 1% to about 95%, about 1% to about 96%, about 1% to about 97%, about 1% to about 98%, about 1% to about 99%, about 0.1% to about 99%, about 0.01% to about 99%, or about 0.001% to about 99% by weight of the pharmaceutical composition.

[0062] In some cases, anhydrous lactose may be present in an amount of about 1% by weight of the pharmaceutical composition. In some cases, anhydrous lactose may be present in an amount of about 5% by weight of the pharmaceutical composition. In some cases, anhydrous lactose may be present in an amount of about / 10% by weight of the pharmaceutical composition. In some cases, anhydrous lactose may be present in an amount of about 15% by weight of the pharmaceutical composition. In some cases, anhydrous lactose may be present in an amount of about 20% by weight of the pharmaceutical composition. In some cases, anhydrous lactose may be present in an amount of about 25% by weight of the pharmaceutical composition. In some cases, anhydrous lactose may be present in an amount of about / 30% by weight of the pharmaceutical composition. In some cases, anhydrous lactose may be present in an amount of about 35% by weight of the pharmaceutical composition. In some cases, anhydrous lactose may be present in an amount of about 40% by weight of the pharmaceutical composition. In some cases, anhydrous lactose may be present in an amount of about 45% by weight of the pharmaceutical composition. In some cases, anhydrous lactose may be present in an amount of about / 50% by weight of the pharmaceutical composition. In some cases, anhydrous lactose may be present in an amount of about 55% by weight of the pharmaceutical composition. In some cases, anhydrous lactose may be present in an amount of about 60% by weight of the pharmaceutical composition. In some cases, anhydrous lactose may be present in an amount of about 65% by weight of the pharmaceutical composition. In some cases, anhydrous lactose may be present in an amount of about / 70% by weight of the pharmaceutical composition. In some cases, anhydrous lactose may be present in an amount of about 75% by weight of the pharmaceutical composition. In some cases, anhydrous lactose may be present in an amount of about 80% by weight of the pharmaceutical composition. In some cases, anhydrous lactose may be present in an amount of about 85% by weight of the pharmaceutical composition. In some cases, anhydrous lactose may be present in an amount of about / 90% by weight of the pharmaceutical composition. In some cases, anhydrous lactose may be present in an amount of about 95% by weight of the pharmaceutical composition. In some cases, anhydrous lactose may be present in an amount of about 96% by weight of the pharmaceutical composition. In some cases, anhydrous lactose may be present in an amount of about 97% by weight of the pharmaceutical composition. In some cases, anhydrous lactose may be present in an amount of about 98% by weight of the pharmaceutical composition. In some cases, anhydrous lactose may be present in an amount of about 99% by weight of the pharmaceutical composition. In some cases, anhydrous lactose may be present in a quantity sufficient (QS) amount of the pharmaceutical composition.For example, if the pharmaceutical composition is N mg and other components of the pharmaceutical composition are x mg, then the anhydrous lactose can be Nx (mg). The percentage of hygroscopic material can be measured by weight, volume, weight / volume, or volume / weight of the pharmaceutical composition. Any of these units can be substituted for the units in the above formula depending on the units used.

[0063] In some examples, the pharmaceutical composition may include mannitol and anhydrous lactose. In some cases, the mannitol and anhydrous lactose may be present in an amount of about 1% to about 90% by weight of the pharmaceutical composition. In some cases, the mannitol and anhydrous lactose may be present in an amount of about 1.25% to about 90% by weight of the pharmaceutical composition. In some cases, the mannitol and anhydrous lactose may be present in an amount of about 1.5% to about 90% by weight of the pharmaceutical composition. In some cases, the mannitol and anhydrous lactose may be present in an amount of about 1.75% to about 90% by weight of the pharmaceutical composition. In some cases, the mannitol and anhydrous lactose may be present in an amount of about 2% to about 90% by weight of the pharmaceutical composition. In some cases, the mannitol and anhydrous lactose may be present in an amount of about 2.25% to about 90% by weight of the pharmaceutical composition. In some cases, the mannitol and anhydrous lactose may be present in an amount of about 2.5% to about 90% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 2.75% to about 90% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 3% to about 90% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 3.25% to about 90% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 3.5% to about 90% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 3.75% to about 90% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 4% to about 90% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 4.25% to about 90% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 4.5% to about 90% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 4.75% to about 90% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 5% to about 90% by weight of the pharmaceutical composition.In some cases, mannitol and anhydrous lactose may be present in an amount of about 5% to about 89.5% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 5% to about 89% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 5% to about 88.5% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 5% to about 88% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 5% to about 87.5% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 5% to about 87% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 5% to about 86.5% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 5% to about 86% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 5% to about 85.5% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 5% to about 85% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 5% to about 84.5% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 5% to about 84% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 5% to about 83.5% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 5% to about 83% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 5% to about 82.5% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 5% to about 82% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 5% to about 81.5% by weight of the pharmaceutical composition.In some cases, mannitol and anhydrous lactose may be present in an amount of about 1% to about 91%, about 1% to about 92%, about 1% to about 93%, about 1% to about 94%, about 1% to about 95%, about 1% to about 96%, about 1% to about 97%, about 1% to about 98%, about 1% to about 99%, about 0.1% to about 99%, about 0.01% to about 99%, or about 0.001% to about 99% by weight of the pharmaceutical composition.

[0064] In some cases, mannitol and anhydrous lactose may be present in an amount of about 1% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 5% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 10% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 15% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 20% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 25% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 30% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 35% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 40% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 45% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 50% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 55% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 60% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 65% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 70% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 75% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 80% by weight of the pharmaceutical composition. In some cases, mannitol and anhydrous lactose may be present in an amount of about 85% by weight of the pharmaceutical composition. In some cases, the mannitol and anhydrous lactose may be present in an amount of about 90% by weight of the pharmaceutical composition. In some cases, the mannitol and anhydrous lactose may be present in an amount of about 95% by weight of the pharmaceutical composition. In some cases, the mannitol and anhydrous lactose may be present in an amount of about 96% by weight of the pharmaceutical composition.In some cases, the mannitol and anhydrous lactose may be present in an amount of about 97% by weight of the pharmaceutical composition. In some cases, the mannitol and anhydrous lactose may be present in an amount of about 98% by weight of the pharmaceutical composition. In some cases, the mannitol and anhydrous lactose may be present in an amount of about 99% by weight of the pharmaceutical composition. In some cases, the mannitol and anhydrous lactose may be present in an amount of a sufficient quantity (QS) of the pharmaceutical composition. For example, if the pharmaceutical composition is N mg and the other components of the pharmaceutical composition are x mg, the mannitol and anhydrous lactose may be Nx (mg). In some cases, when the pharmaceutical composition comprises mannitol and anhydrous lactose, the amount of mannitol and the amount of anhydrous lactose may be interchangeable. In some cases, the amount of mannitol and the amount of anhydrous lactose may vary and the total amount of mannitol and anhydrous lactose may be any amount of mannitol and anhydrous lactose described therein. The percentage of hygroscopic material may be measured by weight, volume, weight / volume, or volume / weight of the pharmaceutical composition. Any of these units can be substituted for the units in the above formula depending on the unit used.

[0065] In some examples, the pharmaceutical composition may include magnesium stearate. In some cases, the magnesium stearate may be present in an amount of about 0.1% to about 10% by weight of the pharmaceutical composition. In some cases, the magnesium stearate may be present in an amount of about 0.2% to about 9% by weight of the pharmaceutical composition. In some cases, the magnesium stearate may be present in an amount of about 0.3% to about 8% by weight of the pharmaceutical composition. In some cases, the magnesium stearate may be present in an amount of about 0.4% to about 7% by weight of the pharmaceutical composition. In some cases, the magnesium stearate may be present in an amount of about 0.5% to about 6% by weight of the pharmaceutical composition. In some cases, the magnesium stearate may be present in an amount of about 0.6% to about 5% by weight of the pharmaceutical composition. In some cases, the magnesium stearate may be present in an amount of about 0.7% to about 4% by weight of the pharmaceutical composition. In some cases, the magnesium stearate may be present in an amount of about 0.8% to about 3% by weight of the pharmaceutical composition. In some cases, magnesium stearate may be present in an amount of about 0.9% to about 2% by weight of the pharmaceutical composition. In some cases, magnesium stearate may be present in an amount of about 0.91% to about 1.9% by weight of the pharmaceutical composition. In some cases, magnesium stearate may be present in an amount of about 0.92% to about 1.8% by weight of the pharmaceutical composition. In some cases, magnesium stearate may be present in an amount of about 0.93% to about 1.7% by weight of the pharmaceutical composition. In some cases, magnesium stearate may be present in an amount of about 0.94% to about 1.6% by weight of the pharmaceutical composition. In some cases, magnesium stearate may be present in an amount of about 0.95% to about 1.5% by weight of the pharmaceutical composition. In some cases, magnesium stearate may be present in an amount of about 0.96% to about 1.4% by weight of the pharmaceutical composition. In some cases, magnesium stearate may be present in an amount of about 0.97% to about 1.3% by weight of the pharmaceutical composition. In some cases, magnesium stearate may be present in an amount of about 0.98% to about 1.2% by weight of the pharmaceutical composition. In some cases, magnesium stearate may be present in an amount of about 0.99% to about 1.1% by weight of the pharmaceutical composition.In some cases, magnesium stearate may be present in an amount of about 0.08% to about 10%, about 0.06% to about 10%, about 0.04% to about 10%, about 0.02% to about 10%, about 0.01% to about 10%, about 0.001% to about 10%, about 0.0001% to about 10%, about 0.1% to about 15%, about 0.1% to about 20%, about 0.1% to about 25%, about 0.1% to about 30%, about 0.1% to about 35%, about 0.1% to about 40%, about 0.1% to about 45%, or about 0.1% to about 50% by weight of the pharmaceutical composition.

[0066] In some examples, magnesium stearate may be present in an amount of about 1% by weight of the pharmaceutical composition. In some cases, magnesium stearate may be present in an amount of about 1.5% by weight of the pharmaceutical composition. In some cases, magnesium stearate may be present in an amount of about 2% by weight of the pharmaceutical composition. In some cases, magnesium stearate may be present in an amount of about 2.5% by weight of the pharmaceutical composition. In some cases, magnesium stearate may be present in an amount of about 3% by weight of the pharmaceutical composition. In some cases, magnesium stearate may be present in an amount of about 3.5% by weight of the pharmaceutical composition. In some cases, magnesium stearate may be present in an amount of about 4% by weight of the pharmaceutical composition. In some cases, magnesium stearate may be present in an amount of about 4.5% by weight of the pharmaceutical composition. In some cases, magnesium stearate may be present in an amount of about 5% by weight of the pharmaceutical composition. In some cases, magnesium stearate may be present in an amount of about 5.5% by weight of the pharmaceutical composition. In some cases, magnesium stearate may be present in an amount of about 6% by weight of the pharmaceutical composition. In some cases, magnesium stearate may be present in an amount of about 6.5% by weight of the pharmaceutical composition. In some cases, magnesium stearate may be present in an amount of about 7% by weight of the pharmaceutical composition. In some cases, magnesium stearate may be present in an amount of about 7.5% by weight of the pharmaceutical composition. In some cases, magnesium stearate may be present in an amount of about 8% by weight of the pharmaceutical composition. In some cases, magnesium stearate may be present in an amount of about 8.5% by weight of the pharmaceutical composition. In some cases, magnesium stearate may be present in an amount of about 9% by weight of the pharmaceutical composition. In some cases, magnesium stearate may be present in an amount of about 9.5% by weight of the pharmaceutical composition. In some cases, magnesium stearate may be present in an amount of about 10% by weight of the pharmaceutical composition. In some cases, magnesium stearate may be present in an amount of about 0.9% by weight of the pharmaceutical composition. In some cases, magnesium stearate may be present in an amount of about 0.8% by weight of the pharmaceutical composition. In some cases, magnesium stearate may be present in an amount of about 0.7% by weight of the pharmaceutical composition. In some cases, magnesium stearate may be present in an amount of about 0.6% by weight of the pharmaceutical composition.In some cases, magnesium stearate may be present in an amount of about 0.5% by weight of the pharmaceutical composition. In some cases, magnesium stearate may be present in an amount of about 0.4% by weight of the pharmaceutical composition. In some cases, magnesium stearate may be present in an amount of about 0.3% by weight of the pharmaceutical composition. In some cases, magnesium stearate may be present in an amount of about 0.2% by weight of the pharmaceutical composition. In some cases, magnesium stearate may be present in an amount of about 0.1% by weight of the pharmaceutical composition.

[0067] In some cases, the pharma- ceutically acceptable excipient comprises from about 0.0001% to about 10%, from about 0.001% to about 10%, from about 0.001% to about 99%, from about 0.01% to about 10%, from about 0.01% to about 99%, from about 0.02% to about 10%, from about 0.04% to about 10%, from about 0.06% to about 10%, from about 0.08% to about 10%, from about 0.1% to about 15%, from about 0.1% to about 20%, from about 0.1% to about 25%, from about 0.1% to about 30%, from about 0.1% to about 35%, from about 0.1% to about 40%, from about 0.1% to about 45%, from about 0. 1% to about 50%, about 0.1% to about 99%, about 0.1% to about 10%, about 0.2% to about 9%, about 0.3% to about 8%, about 0.4% to about 7%, about 0.5% to about 6%, about 0.6% to about 5%, about 0.7% to about 4%, about 0.8% to about 3%, about 0.9% to about 2%, about 0.91% to about 1.9%, about 0.92% to about 1.8%, about 0.93% to about 1.7%, about 0.94% to about 1.6%, about 0.95% to about 1.5%, about 0.96% to about 1.4%, about 0.97% to about 1.3%, about 0.98% to about 1.2%, about 0.99% to about 1.1%, about 1% to about 91%, about 1% to about 92%, about 1% to about 93%, about 1% to about 94%, about 1% to about 95%, about 1% to about 96%, about 1% to about 97%, about 1% to about 98%, about 1% to about 99%, about 1.25% to about 90%, about 1.5% to about 90%, about 1.75% to about 90%, about 2% to about 90%, about 2.25% to about 90%, about 2.5% to about 90%, about 2.75% to about 90%, about 3% to about 90%, about 3.25% to about 90%, about 3.5% to about 90%, about 3.75% to about 90%, about 4% to about 90%, about 4. It may be present in an amount of from 25% to about 90%, from about 4.5% to about 90%, from about 4.75% to about 90%, from about 5% to about 90%, from about 5% to about 89.5%, from about 5% to about 89%, from about 5% to about 88.5%, from about 5% to about 88%, from about 5% to about 87.5%, from about 5% to about 87%, from about 5% to about 86.5%, from about 5% to about 86%, from about 5% to about 85.5%, from about 5% to about 85%, from about 5% to about 84.5%, from about 5% to about 84%, from about 5% to about 83.5%, from about 5% to about 83%, from about 5% to about 82.5%, from about 5% to about 82%, or from about 5% to about 81.5%.In some cases, the pharma- ceutically acceptable excipient may comprise about 1%, about 1.5%, about 2%, about 2.5%, about 3%, about 3.5%, about 4%, about 4.5%, about 5%, about 5.5%, about 6%, about 6.5%, about 7%, about 7.5%, about 8%, about 8.5%, about 9%, about 9.5%, about 10%, about 0.9%, about 0.8%, about 0.7%, about 0.6%, about 0.5%, about 10% or about 10% of the pharmaceutical composition. %, about 0.4%, about 0.3%, about 0.2%, about 0.1%, about 1%, about 5%, about, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90%, about 95%, about 96%, about 97%, about 98%, or about 99%. In some cases, the pharma- ceutical acceptable excipient may be present in the QQS amount of the pharmaceutical composition. For example, if the pharmaceutical composition is N mg and other components of the pharmaceutical composition are x mg, then mannitol may be Nx (mg). The proportion of hygroscopic material may be measured by weight, volume, weight / volume, or volume / weight of the pharmaceutical composition. Any of these units may be substituted for the units in the above formula depending on the units used. Pharmaceutically acceptable excipients. In some cases, the pharma- ceutically acceptable excipients may also include maltodextrin, cellulose, methionine, ascorbic acid, magnesium stearate, beta-cyclodextrin, dextrin, 2-hydroxypropyl-β-cyclodextrin cysteine, riboflavin, starch, Glucidex, mannitol, saccharose, trehalose, anhydrous lactose, or combinations thereof. In some cases, the pharma-ceutically acceptable excipients may include maltodextrin. In some cases, the pharma-ceutically acceptable excipients may include cellulose. In some cases, the pharma-ceutically acceptable excipients may include methionine. In some cases, the pharma-ceutically acceptable excipients may include ascorbic acid. In some cases, the pharma-ceutically acceptable excipients may include magnesium stearate. In some cases, the pharma-ceutically acceptable excipients may include beta-cyclodextrin. In some cases, the pharma- ceutically acceptable excipient may include dextrin.In some cases, the pharma- ceutically acceptable excipient may include 2-hydroxypropyl-β-cyclodextrin.In some cases, the pharma- ceutically acceptable excipient may include cysteine. In some cases, the pharma-ceutically acceptable excipient may include riboflavin. In some cases, the pharma-ceutically acceptable excipient may include starch. In some cases, the pharma-ceutically acceptable excipient may include Glucidex. In some cases, the pharma-ceutically acceptable excipient may include mannitol. In some cases, the pharma-ceutically acceptable excipient may include sucrose. In some cases, the pharma-ceutically acceptable excipient may include trehalose. In some cases, the pharma-ceutically acceptable excipient may include anhydrous lactose. The pharma- ceutically acceptable excipient may be present in an amount of at least about 0.001%, 0.005%, 0.01%, 0.05%, 0.1%, 0.5%, 1%, 1.5%, 2%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 99% or more of the pharmaceutical composition. Pharmaceutically acceptable excipients may be present in an amount up to about 0.001%, 0.005%, 0.01%, 0.05%, 0.1%, 0.5%, 1%, 1.5%, 2%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, or 99% of the pharmaceutical composition.

[0068] In some cases, the hygroscopic material may comprise from about 0.0001% to about 10%, from about 0.001% to about 10%, from about 0.001% to about 99%, from about 0.01% to about 10%, from about 0.01% to about 99%, from about 0.02% to about 10%, from about 0.04% to about 10%, from about 0.06% to about 10%, from about 0.08% to about 10%, from about 0.1% to about 15%, from about 0.1% to about 20%, from about 0.1% to about 25%, from about 0.1% to about 30%, from about 0.1% to about 35%, from about 0.1% to about 40%, from about 0.1% to about 45%, from about 0.1% to about 50%, or ... %, about 0.1% to about 99%, about 0.1% to about 10%, about 0.2% to about 9%, about 0.3% to about 8%, about 0.4% to about 7%, about 0.5% to about 6%, about 0.6% to about 5%, about 0.7% to about 4%, about 0.8% to about 3%, about 0.9% to about 2%, about 0.91% to about 1.9%, about 0.92% to about 1.8%, about 0.93% to about 1.7%, about 0.94% to about 1.6%, about 0.95% to about 1.5%, about 0.96% to about 1.4%, about 0.97% to about 1.3%, about 0.98% to about 1.2%, about 0.99% to about 1.1% , about 1% to about 91%, about 1% to about 92%, about 1% to about 93%, about 1% to about 94%, about 1% to about 95%, about 1% to about 96%, about 1% to about 97%, about 1% to about 98%, about 1% to about 99%, about 1.25% to about 90%, about 1.5% to about 90%, about 1.75% to about 90%, about 2% to about 90%, about 2.25% to about 90%, about 2.5% to about 90%, about 2.75% to about 90%, about 3% to about 90%, about 3.25% to about 90%, about 3.5% to about 90%, about 3.75% to about 90%, about 4% to about 90%, about 4.25 % to about 90%, about 4.5% to about 90%, about 4.75% to about 90%, about 5% to about 90%, about 5% to about 89.5%, about 5% to about 89%, about 5% to about 88.5%, about 5% to about 88%, about 5% to about 87.5%, about 5% to about 87%, about 5% to about 86.5%, about 5% to about 86%, about 5% to about 85.5%, about 5% to about 85%, about 5% to about 84.5%, about 5% to about 84%, about 5% to about 83.5%, about 5% to about 83%, about 5% to about 82.5%, about 5% to about 82%, or about 5% to about 81.5%.In some cases, the hygroscopic material may comprise about 1%, about 1.5%, about 2%, about 2.5%, about 3%, about 3.5%, about 4%, about 4.5%, about 5%, about 5.5%, about 6%, about 6.5%, about 7%, about 7.5%, about 8%, about 8.5%, about 9%, about 9.5%, about 10%, about 0.9%, about 0.8%, about 0.7%, about 0.6%, about 0.5%, about 0.8 ... The range may include about 0.4%, about 0.3%, about 0.2%, about 0.1%, about 1%, about 5%, about, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90%, about 95%, about 96%, about 97%, about 98%, or about 99%.

[0069] In some examples, the pharmaceutical composition may comprise SiO2 in an amount of about 0.1% to about 10% by weight of the pharmaceutical composition, mannitol in an amount of about 1% to about 90% by weight of the pharmaceutical composition, and magnesium stearate in an amount of about 0.1% to about 10% by weight of the pharmaceutical composition. In some cases, the pharmaceutical composition may comprise SiO2 in an amount of about 0.1% to about 10% by weight of the pharmaceutical composition, and mannitol in an amount of about 1% to about 90% by weight of the pharmaceutical composition. In some examples, the pharmaceutical composition may comprise SiO2 in an amount of about 1% by weight of the pharmaceutical composition, mannitol in an amount of about 5% to about 81.5% by weight of the pharmaceutical composition, and magnesium stearate in an amount of 1.5% by weight of the pharmaceutical composition. In some cases, the pharmaceutical composition may comprise SiO2 in an amount of about 1% by weight of the pharmaceutical composition, and mannitol in an amount of about 5% to about 81.5% by weight of the pharmaceutical composition.

[0070] In some examples, the pharmaceutical composition may comprise SiO2 in an amount of about 0.1% to about 10% by weight of the pharmaceutical composition, anhydrous lactose in an amount of about 1% to about 90% by weight of the pharmaceutical composition, and magnesium stearate in an amount of about 0.1% to about 10% by weight of the pharmaceutical composition. In some cases, the pharmaceutical composition may comprise SiO2 in an amount of about 0.1% to about 10% by weight of the pharmaceutical composition, and anhydrous lactose in an amount of about 1% to about 90% by weight of the pharmaceutical composition. In some examples, the pharmaceutical composition may comprise SiO2 in an amount of about 1% by weight of the pharmaceutical composition, anhydrous lactose in an amount of about 5% to about 81.5% by weight of the pharmaceutical composition, and magnesium stearate in an amount of 1.5% by weight of the pharmaceutical composition. In some cases, the pharmaceutical composition may comprise SiO2 in an amount of about 1% by weight of the pharmaceutical composition, and anhydrous lactose in an amount of about 5% to about 81.5% by weight of the pharmaceutical composition.

[0071] In some examples, the pharmaceutical composition may comprise SiO2 in an amount of about 0.1% to about 10% by weight of the pharmaceutical composition, mannitol and anhydrous lactose in an amount of about 1% to about 90% by weight of the pharmaceutical composition, and magnesium stearate in an amount of about 0.1% to about 10% by weight of the pharmaceutical composition. In some cases, the pharmaceutical composition may comprise SiO2 in an amount of about 0.1% to about 10% by weight of the pharmaceutical composition, and mannitol and anhydrous lactose in an amount of about 1% to about 90% by weight of the pharmaceutical composition. In some examples, the pharmaceutical composition may comprise SiO2 in an amount of about 1% by weight of the pharmaceutical composition, mannitol and anhydrous lactose in an amount of about 5% to about 81.5% by weight of the pharmaceutical composition, and magnesium stearate in an amount of 1.5% by weight of the pharmaceutical composition. In some cases, the pharmaceutical composition may comprise SiO2 in an amount of about 1% by weight of the pharmaceutical composition, and mannitol and anhydrous lactose in an amount of about 5% to about 81.5% by weight of the pharmaceutical composition.

[0072] Bacterial populations In some examples, the bacterial population may comprise at least one strain of Lactobacillus species, at least one strain of Ackermansia species, or at least one strain of Faecalibacterium species. In some examples, the bacterial population may comprise at least one strain of Lactobacillaceae species, at least one strain of Ackermansia species, or at least one strain of Faecalibacterium species. In some examples, the bacterial population may comprise at least two of at least one strain of Lactobacillus species, at least one strain of Ackermansia species, or at least one strain of Faecalibacterium species. In some examples, the bacterial population may comprise at least one strain of Lactobacillaceae species, at least one strain of Ackermansia species, or at least one strain of Faecalibacterium species. In some cases, the bacterial population may comprise at least one strain of Lactobacillus species, at least one strain of Ackermansia species, or at least one strain of Faecalibacterium species. In some cases, the bacterial population may comprise at least one strain of Lactobacillaceae species, at least one strain of Ackermansia species, or at least one strain of Faecalibacterium species.In some cases, the bacterial population may comprise at least one strain of Lactobacillus species, at least one strain of Ackermansia species, and at least one strain of Faecalibacterium species.In some cases, the bacterial population may comprise at least one strain of Lactobacillaceae species, at least one strain of Ackermansia species, and at least one strain of Faecalibacterium species.

[0073] In some examples, the bacterial population may comprise at least one strain of Lactobacillus species or at least one strain of Ackermansia species. In some examples, the bacterial population may comprise at least one strain of Lactobacillaceae species or at least one strain of Ackermansia species. In some cases, the bacterial population may comprise at least one strain of Lactobacillus species or at least one strain of Faecalibacterium species. In some cases, the bacterial population may comprise at least one strain of Lactobacillaceae species or at least one strain of Faecalibacterium species. In some cases, the bacterial population may comprise at least one strain of Lactobacillus species or at least one strain of Ackermansia species. In some cases, the bacterial population may comprise at least one strain of Lactobacillus species and at least one strain of Ackermansia species. In some cases, the bacterial population may comprise at least one strain of Lactobacillaceae species and at least one strain of Ackermansia species. In some cases, the bacterial population may comprise at least one strain of Lactobacillus species and at least one strain of Faecalibacterium species. In some cases, the bacterial population may comprise at least one strain of Lactobacillaceae species and at least one strain of Faecalibacterium species. In some cases, the bacterial population may comprise at least one strain of Ackermansia species and at least one strain of Faecalibacterium species.

[0074] In some examples, the bacterial population may comprise at least two strains of Lactobacillus species, at least two strains of Ackermansia species, or at least two strains of Faecalibacterium species. In some examples, the bacterial population may comprise at least two strains of Lactobacillaceae species, at least two strains of Ackermansia species, or at least two strains of Faecalibacterium species. In some cases, the bacterial population may comprise at least three strains of Lactobacillus species, at least three strains of Ackermansia species, or at least three strains of Faecalibacterium species. In some cases, the bacterial population may comprise at least three strains of Lactobacillaceae species, at least three strains of Ackermansia species, or at least three strains of Faecalibacterium species. In some cases, the bacterial population may comprise at least four or more strains of Lactobacillus species, at least four or more strains of Ackermansia species, or at least four or more strains of Faecalibacterium species. In some cases, the bacterial population may include at least four or more strains of Lactobacillaceae species, at least four or more strains of Ackermansia species, or at least four or more strains of Faecalibacterium species. In some cases, the bacterial population may include at least one strain of Lactobacillus species. In some cases, the bacterial population may include at least one strain of Lactobacillaceae species. In some cases, the bacterial population may include at least one strain of Ackermansia species. In some cases, the bacterial population may include at least one strain of Faecalibacterium species. In some cases, the bacterial population may include at least two strains of Lactobacillus species. In some cases, the bacterial population may include at least two strains of Lactobacillaceae species. In some cases, the bacterial population may include at least two strains of Ackermansia species. In some cases, the bacterial population may include at least two strains of Faecalibacterium species. In some cases, the bacterial population may include at least three strains of Lactobacillus species. In some cases, the bacterial population may include at least three strains of Lactobacillus species. In some cases, the bacterial population may include at least three strains of Ackermansia spp. In some cases, the bacterial population may include at least three strains of Faecalibacterium spp.In some cases, the bacterial population may include at least four or more strains of Lactobacillus species. In some cases, the bacterial population may include at least four or more strains of Lactobacillaceae species. In some cases, the bacterial population may include at least four or more strains of Ackermansia species. In some cases, the bacterial population may include at least four or more strains of Faecalibacterium species.

[0075] In some examples, the pharmaceutical composition can include a bacterial population. Such a bacterial population can include one or more different bacterial species and / or strains. Such bacterial species and / or strains can belong to one or more different bacterial phyla. Such bacterial phyla can include Verrucomicrobia, Firmicutes, or a combination thereof. Such bacterial phyla can also include Verrucomicrobia, Firmicutes, Proteobacteria, Actinobacteria, and / or Bacteroidetes, or a combination thereof.

[0076] In some examples, species of the Lactobacillaceae family may include species of the genus Lactobacillus proposed in 1901, as described in Zheng, J., et.al. Int. J. Syst. Evol. Microbiol. 2020;70:2782-2858, which is fully incorporated herein by reference. The genus Lactobacillus may include gram-positive, fermentative, facultative anaerobic, and / or non-spore-forming microorganisms. In some cases, the definition of the 1901 classification may increase the number of microorganisms that can be classified into the genus Lactobacillus compared to those classified in 1901. The genus Lactobacillus may include approximately 261 species that include characteristic phenotypic, ecological, and / or genotypic characteristics. The number of species in the genus Lactobacillus and / or the level of diversity within the genus Lactobacillus may exceed the species of other bacterial genera and / or bacterial families. In this case, Lactobacillus may be reclassified. For example, to reclassify Lactobacillus classified using the 1901 definition, the average nucleotide identity (ANI), average amino acid identity (AAI), core gene average amino acid identity (cAAI), core genome phylogeny, signature genes, and metabolic and / or ecological criteria of bacterial species of the genus Lactobacillus and its sister taxa of the families Lactobacillaceae and Leuconostocacae are used.

[0077] In some cases, under the reclassification system, species of the Lactobacillaceae family are grouped into about 26 different genera (Lactobacillus, Paralactobacillus, Pediococcus, Holzapfelia, Amylolactobacillus, Bombilactobacillus, Companilactobacillus, Rapidilactobacillus, and others). Lapidilactobacillus, Agrilactobacillus, Schleiferilactobacillus, Loigolactobacillus, Latilactobacillus, Dellaglioa, Liquorilactobacillus, Ligilactobacillus, Lactipran Lactiplantibacillus, Furfurilactobacillus, Paucilactobacillus, Limosilactobacillus, Fructilactobacillus, Acetilactobacillus, Apilactobacillus, Levilactobacillus Lactobacillus, Secundilactobacillus, and Lentilactobacillus, and Leuconostocaceae may be merged into Lactobacillaceae. A comparison of the reclassified Lactobacillus species can be found using the Lactotax database, which can be found at the link http: / / Lactobacillus.ualberta.ca / , which is incorporated herein by reference in its entirety.The classification of Lactobacillus described herein is based on the findings of Parks,DH et.al.Nat Biotechnol.2018 Nov;36(10):996-1004;Salvetti,E,et.al.Appl Environ Microbio.2018 Aug 17;84(17).Print 2018 Sep.1 Erratum in:Appl Environ Microbio.2018 Oct.1;84(20);Markets and Markets:https: / / www.marketsandmarkets.com / Market-Reports / probiotic-market-advanced-technologies-and-global-market-69.html);Parker,CT,et.al.Int.J.Syst.Evol.Microbiol.68:1825-1829;Duar,DM,et.al.FEMS Microbiol Rev.2017 Aug 1;41(Supp_1):S27-S48; or Pane and Vinot 2019: https: / / www.microbiometimes.com / the-Lactobacillus-taxonomy-change-is-coming-why-and-how-to-make-the-most-of-it / , each of which is incorporated herein by reference in its entirety.

[0078] In some examples, the bacterial populations described herein may include one or more Lactobacillus species. The one or more Lactobacillus species may be selected from the group consisting of Lactobacillus johnsonii, Lactobacillus rhamnosus, Lactobacillus zeae, Lactobacillus acidipiscis, Lactobacillus acidophilus, Lactobacillus agilis, Lactobacillus aviarius, Lactobacillus brevis, Lactobacillus coleohominis, Lactobacillus crispatus, Lactobacillus crustrum, and the like. crustorum, Lactobacillus curvatus, Lactobacillus diolivorans, Lactobacillus farraginis, Lactobacillus fermentum, Lactobacillus fuchuensis, Lactobacillus harbinensis, Lactobacillus helveticus, Lactobacillus hilgardii, Lactobacillus intestinalis, Lactobacillus jensenii jensenii, Lactobacillus kefiranofaciens, Lactobacillus kefiri, Lactobacillus lindnerilindneri, Lactobacillus mali, Lactobacillus manihotivorans, Lactobacillus mucosae, Lactobacillus oeni, Lactobacillus oligofermentans, Lactobacillus panis, Lactobacillus pantheris, Lactobacillus parabrevis, Lactobacillus paracollinoides, Lactobacillus parakefiri, Lactobacillus paraplantarum paraplantarum, Lactobacillus pentosus, Lactobacillus pontis, Lactobacillus reuteri, Lactobacillus rossiae, Lactobacillus salivarius, Lactobacillus siliginis, Lactobacillus sucicola, Lactobacillus vaccinostercus, Lactobacillus vaginalis, Lactobacillus vini, Lactococcus garbiei, Lactococcus ... garvieae), or Lactococcus lactislactis), or any combination thereof. In some embodiments, the Lactobacillus species is Lactobacillus johnsonii or Lactobacillus crispatus. In such cases, the bacterial population herein may include one or more Lactobacillus johnsonii strains or Lactobacillus crispatus strains. Such one or more (one or more) Lactobacillus crispatus strains may include Lactobacillus crispatus (DSM 33187) (i.e., L. crispatus (DSM 33187)). In various examples, the bacterial population herein includes Lactobacillus crispatus (DSM 33187).

[0079] In some examples, the bacterial population described herein may include one or more Lactobacillus species. The one or more Lactobacillus species may include Lactobacillus acidophilus, Lactobacillus crispatus, Lactobacillus helveticus, Lactobacillus intestinalis, Lactobacillus jensenii, Lactobacillus johnsonii, or Lactobacillus kefiranofaciens. In some cases, the bacterial population of the pharmaceutical composition may include at least two or a combination of Lactobacillus species. The at least two or combinations of Lactobacillus species may include any one of Lactobacillus acidophilus, Lactobacillus crispatus, Lactobacillus helveticus, Lactobacillus intestinalis, Lactobacillus jensenii, Lactobacillus johnsonii, or Lactobacillus kefiranofaciens.

[0080] In some examples, the bacterial populations described herein may include one or more species of the family Lactobacillaceae. One or more species of the Lactobacillaceae family may include Lactobacillus johnsonii, Lactocaseibacillus rhamnosus, Lactocaseibacillus zeae, Ligilactobacillus acidipiscis, Lactobacillus acidophilus, Ligilactobacillus agilis, Ligilactobacillus aviarius, Levilactobacillus brevis, Limosilactobacillus koleohominis, coleohominis, Lactobacillus crispatus, Companilactobacillus crustorum, Latilactobacillus curvatus, Lentilactobacillus diolivorans, Lentilactobacillus farraginis, Limosilactobacillus fermentum, Latilactobacillus fuchuensis, Schleiferilactobacillus harbinensis, Lactobacillus helveticus, Lentilactobacillus hilgardii, Lactobacillus intestinalisintestinalis, Lactobacillus jensenii, Lactobacillus kefiranofaciens, Lentilactobacillus kefiri, Fructilactobacillus lindneri, Liquorilactobacillus mali, Lactocaseibacillus manihotivorans, Limosilactobacillus mucosae, Liquorilactobacillus oeni, Paucilactobacillus oligofermentans oligofermentans, Limosilactobacillus panis, Lactocaseibacillus pantheris, Levilactobacillus parabrevis, Secundilactobacillus paracollinoides, Lactoplantibacillus paraplantarum, Lactoplantibacillus pentosus, Limosiactobacillus pontis, Limosiactobacillus reuteri, Furfurilactobacillus rossiae, Ligilactobacillus salivarius, Furfurilactobacillus siliginisThe bacterial species may include Lactobacillus siliginis, Liquorilactobacillus sucicola, Paucilactobacillus vaccinostercus, Limosilactobacillus vaginalis, Liquorilactobacillus vini, Lactococcus garvieae, or Lactococcus lactis, or a combination thereof. In some embodiments, the Lactobacillaceae species is Lactobacillus johnsonii or Lactobacillus crispatus. In such cases, the bacterial population herein may include one or more Lactobacillus johnsonii or Lactobacillus crispatus strains. Such one or more (one or more) Lactobacillus crispatus strains may include Lactobacillus crispatus (DSM 33187) (i.e., L. crispatus (DSM 33187)). In various examples, the bacterial populations herein include Lactobacillus crispatus (DSM 33187).

[0081] In some examples, the bacterial population described herein may include one or more species of the Lactobacillaceae family. One or more species of the Lactobacillaceae family may include Lactobacillus acidophilus, Lactobacillus crispatus, Lactobacillus helveticus, Lactobacillus intestinalis, Lactobacillus jensenii, Lactobacillus johnsonii, and Lactobacillus kefiranofaciens. Table 39 below shows the names of various Lactobacillus species under the 1901 classification and reclassification. [Table 1] TIFF2024514811000003.tif177152 In some examples, the bacterial populations herein may include one or more Akkermansia species. Such one or more Akkermansia species may include Akkermansia muciniphila, Akkermansia glycaniphila, or a combination thereof. In some examples, the one or more Akkermansia species may be Akkermansia muciniphila. In such examples, the bacterial populations herein may include one or more Akkermansia muciniphila strains. Such one or more Akkermansia muciniphila strains may include Akkermansia muciniphila (DSM 33213). In various examples, the bacterial populations herein include Akkermansia muciniphila (DSM 33213).

[0082] In some examples, the bacterial population may include one or more Faecalibacterium species. The one or more Faecalibacterium species may include Faecalibacterium prausnitzii. In such cases, the bacterial population herein may include one or more Faecalibacterium prausnitzii strains. Such one or more Faecalibacterium prausnitzii strains may include Faecalibacterium prausnitzii (DSM 33185), Faecalibacterium prausnitzii (DSM 33191), Faecalibacterium prausnitzii (DSM 33186), or Faecalibacterium prausnitzii (DSM 33190), or combinations thereof. In various examples, the bacterial population herein includes Faecalibacterium prausnitzii (DSM 33185).

[0083] Further provided herein is a bacterial population which may comprise one or more strains of any one or more of Bacteroides sp., Blautia sp., Bifidobacterium sp., Coprococcus sp., or Dorea sp. In such examples, the bacterial populations herein may include one or more of Bacteroides faecis (DSM 22177), Bacteroides thetaiotaomicron (DSM 33178), Blautia producta (DSM 33180), Bifidobacterium longum (DSM 33179), Coprococcus comes (DSM 33176), or Dorea longicatena (DSM 33188). Exemplary strains for inclusion in the bacterial populations described herein are listed in Table 1. [Table 2] In some examples, the bacterial population may comprise one strain of Lactobacillus species, one strain of Ackermansia species, or one strain of Faecalibacterium species. In some examples, the bacterial population may comprise one strain of Lactobacillaceae species, one strain of Ackermansia species, or one strain of Faecalibacterium species. In some cases, the bacterial population may comprise one strain of Lactobacillus species, one strain of Ackermansia species, and one strain of Faecalibacterium species. In some cases, the bacterial population may comprise one strain of Lactobacillaceae species, one strain of Ackermansia species, and one strain of Faecalibacterium species. In some cases, the bacterial population may comprise one strain of Lactobacillus species, or one strain of Ackermansia species. In some cases, the bacterial population may comprise one strain of Lactobacillaceae species, or one strain of Ackermansia species. In some cases, the bacterial population may include one strain of Lactobacillus species or one strain of Faecalibacterium species. In some cases, the bacterial population may include one strain of Lactobacillaceae species or one strain of Faecalibacterium species. In some cases, the bacterial population may include one strain of Ackermansia species or one strain of Faecalibacterium species. In some cases, the bacterial population may include one strain of Lactobacillus species and one strain of Ackermansia species. In some cases, the bacterial population may include one strain of Lactobacillaceae species and one strain of Ackermansia species. In some cases, the bacterial population may include one strain of Lactobacillus species and one strain of Faecalibacterium species. In some cases, the bacterial population may include one strain of Lactobacillaceae species and one strain of Faecalibacterium species. In some cases, the bacterial population may include one strain of Ackermansia species and one strain of Faecalibacterium species.

[0084] In some examples, the bacterial population may include Lactobacillus crispatus (DSM 33187), Ackermansia muciniphila (DSM 33213), or Faecalibacterium prausnitzii (DSM 33185). In some cases, the bacterial population may include at least two of Lactobacillus crispatus (DSM 33187), Ackermansia muciniphila (DSM 33213), or Faecalibacterium prausnitzii (DSM 33185). In some cases, the bacterial population may include Lactobacillus crispatus (DSM 33187), Ackermansia muciniphila (DSM 33213), and Faecalibacterium prausnitzii (DSM 33185). In some cases, the bacterial population may include Lactobacillus crispatus (DSM 33187). In some cases, the bacterial population may include Ackermansia species. In some cases, the bacterial population may include Faecalibacterium prausnitzii (DSM 33185). In some cases, the bacterial population may include at least two strains of Lactobacillus crispatus (DSM 33187).

[0085] In some examples, the bacterial population may comprise, consist essentially of, or consist of 20, 19, 18, 17, 16, 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1 bacterial species and / or strain(s). In some examples, such bacterial populations may comprise at least one bacterial strain selected from Table 1. In some embodiments, the bacterial population may consist of up to three different bacterial strains. In some embodiments, the bacterial populations described herein comprise at least one, at least two, or all three bacterial strains listed in Table 2. In some examples, the bacterial population comprises or consists of the bacterial strains L. crispatus (DSM 33187), A. muciniphila (DSM 33213), and F. prausnitzii (DSM 33185). [Table 3] In some examples, the bacterial population may contain various numbers of colony forming units (CFU / dose) of each of the bacterial species and / or strains it contains. In some cases, the bacterial population may contain about 1 x 10^3 CFU / dose to about 1 x 10^12 CFU / dose of a bacterial species or strain. In some cases, the bacterial population may contain about 1 x 10^3 CFU / dose to about 1 x 10^11 CFU / dose of a bacterial species or strain. In some cases, the bacterial population may contain about 1 x 10^3 CFU / dose to about 1 x 10^10 CFU / dose of a bacterial species or strain. In some cases, the bacterial population may contain about 1 x 10^3 CFU / dose to about 1 x 10^9 CFU / dose of a bacterial species or strain. In some cases, the bacterial population may contain about 1 x 10^3 CFU / dose to about 1 x 10^8 CFU / dose of a bacterial species or strain. In some cases, the bacterial population may include about 1 x 10^4 CFU / dose to about 1 x 10^12 CFU / dose of a bacterial species or strain. In some cases, the bacterial population may include about 1 x 10^4 CFU / dose to about 1 x 10^11 CFU / dose of a bacterial species or strain. In some cases, the bacterial population may include about 1 x 10^4 CFU / dose to about 1 x 10^10 CFU / dose of a bacterial species or strain. In some cases, the bacterial population may include about 1 x 10^4 CFU / dose to about 1 x 10^9 CFU / dose of a bacterial species or strain. In some cases, the bacterial population may include about 1 x 10^4 CFU / dose to about 1 x 10^8 CFU / dose of a bacterial species or strain. In some cases, the bacterial population may include about 1 x 10^5 CFU / dose to about 1 x 10^12 CFU / dose of a bacterial species or strain. In some cases, the bacterial population may include about 1 x 10^5 CFU / dose to about 1 x 10^11 CFU / dose of a bacterial species or strain. In some cases, the bacterial population may include about 1 x 10^5 CFU / dose to about 1 x 10^10 CFU / dose of a bacterial species or strain. In some cases, the bacterial population may include about 1 x 10^5 CFU / dose to about 1 x 10^9 CFU / dose of a bacterial species or strain. In some cases, the bacterial population may include about 1 x 10^5 CFU / dose to about 1 x 10^8 CFU / dose of a bacterial species or strain. In some cases, the bacterial population may include about 1 x 10^6 CFU / dose to about 1 x 10^12 CFU / dose of a bacterial species or strain. In some cases, the bacterial population may include about 1 x 10^6 CFU / dose to about 1 x 10^11 CFU / dose of a bacterial species or strain.In some cases, the bacterial population may include about 1 x 10^6 CFU / dose to about 1 x 10^10 CFU / dose of a bacterial species or strain. In some cases, the bacterial population may include about 1 x 10^6 CFU / dose to about 1 x 10^9 CFU / dose of a bacterial species or strain. In some cases, the bacterial population may include about 1 x 10^6 CFU / dose to about 1 x 10^8 CFU / dose of a bacterial species or strain. In some cases, the bacterial population may include about 1 x 10^7 CFU / dose to about 1 x 10^12 CFU / dose of a bacterial species or strain. In some cases, the bacterial population may include about 1 x 10^7 CFU / dose to about 1 x 10^11 CFU / dose of a bacterial species or strain. In some cases, the bacterial population may include about 1 x 10^7 CFU / dose to about 1 x 10^10 CFU / dose of a bacterial species or strain. In some cases, the bacterial population may include about 1 x 10^7 CFU / dose to about 1 x 10^9 CFU / dose of a bacterial species or strain. In some cases, the bacterial population may include about 1 x 10^7 CFU / dose to about 1 x 10^8 CFU / dose of a bacterial species or strain. In some cases, the bacterial population may include about 1 x 10^8 CFU / dose to about 1 x 10^12 CFU / dose of a bacterial species or strain. In some cases, the bacterial population may include about 1 x 10^8 CFU / dose to about 1 x 10^11 CFU / dose of a bacterial species or strain. In some cases, the bacterial population may include about 1 x 10^8 CFU / dose to about 1 x 10^10 CFU / dose of a bacterial species or strain. In some cases, the bacterial population may include about 1 x 10^8 CFU / dose to about 1 x 10^9 CFU / dose of a bacterial species or strain. In some cases, the bacterial population may include about 1 x 10^9 CFU / dose to about 1 x 10^12 CFU / dose of a bacterial species or strain. In some cases, the bacterial population may include about 1 x 10^9 CFU / dose to about 1 x 10^11 CFU / dose of a bacterial species or strain. In some cases, the bacterial population may include about 1 x 10^9 CFU / dose to about 1 x 10^10 CFU / dose of a bacterial species or strain. In some cases, such bacterial population may also include about 1 x 10^7 CFU / dose to about 1 x 10^10 CFU / dose of a bacterial species or strain.In some examples, the bacterial population is at least about 1x10^3 CFU / dose, 5x10^3 CFU / dose, 1x10^4 CFU / dose, 5x10^4 CFU / dose, 1x10^5 CFU / dose, 5x10^5 CFU / dose, 1x10^6 CFU / dose, 5x10^6 CFU / dose, 1x10^7 CFU / dose, 5x10^7 CFU / dose, 1x1 The bacterial population may include a bacterial species or strain of 0^8 CFU / dose, 5x10^8 CFU / dose, 1x10^9 CFU / dose, 5x10^9 CFU / dose, 1x10^10 CFU / dose, 5x10^10 CFU / dose, 1x10^11 CFU / dose, 5x10^11 CFU / dose, or 1x10^12 CFU / dose, but not more than about 5x10^12 CFU / dose. The bacterial population may also include from about 1x10^6 to about 1x10^11 CFU / dose per bacterial species or strain. In some cases, the bacterial population may include from about 1x10^3 to about 1x10^12 CFU / dose per bacterial species or strain. In some examples, the bacterial population may include from about 1x10^8 to about 5x10^10 CFU / dose per bacterial species or strain. In some examples, the bacterial population may include about 1 x 10^7 to about 5 x 10^10 CFU / dose per bacterial species or strain. In various cases, the bacterial population may include about 5 x 10^8 CFU / dose per bacterial species or strain.

[0086] In some examples, the bacterial population may include various numbers of colony forming units (CFU / dose) of bacterial cells. In some cases, the bacterial population may include about 1 x 10^3 CFU / dose to about 1 x 10^12 CFU / dose of bacterial cells. In some cases, the bacterial population may include about 1 x 10^3 CFU / dose to about 1 x 10^11 CFU / dose of bacterial cells. In some cases, the bacterial population may include about 1 x 10^3 CFU / dose to about 1 x 10^10 CFU / dose of bacterial cells. In some cases, the bacterial population may include about 1 x 10^3 CFU / dose to about 1 x 10^9 CFU / dose of bacterial cells. In some cases, the bacterial population may include about 1 x 10^3 CFU / dose to about 1 x 10^8 CFU / dose of bacterial cells. In some cases, the bacterial population may include about 1 x 10^4 CFU / dose to about 1 x 10^12 CFU / dose of bacterial cells. In some cases, the bacterial population may include about 1 x 10^4 CFU / dose to about 1 x 10^11 CFU / dose of bacterial cells. In some cases, the bacterial population may include about 1 x 10^4 CFU / dose to about 1 x 10^10 CFU / dose of bacterial cells. In some cases, the bacterial population may include about 1 x 10^4 CFU / dose to about 1 x 10^9 CFU / dose of bacterial cells. In some cases, the bacterial population may include about 1 x 10^4 CFU / dose to about 1 x 10^8 CFU / dose of bacterial cells. In some cases, the bacterial population may include about 1 x 10^5 CFU / dose to about 1 x 10^12 CFU / dose of bacterial cells. In some cases, the bacterial population may include about 1 x 10^5 CFU / dose to about 1 x 10^11 CFU / dose of bacterial cells. In some cases, the bacterial population may include about 1 x 10^5 CFU / dose to about 1 x 10^10 CFU / dose of bacterial cells. In some cases, the bacterial population may include about 1 x 10^5 CFU / dose to about 1 x 10^9 CFU / dose of bacterial cells. In some cases, the bacterial population may include about 1 x 10^5 CFU / dose to about 1 x 10^8 CFU / dose of bacterial cells. In some cases, the bacterial population may include about 1 x 10^6 CFU / dose to about 1 x 10^12 CFU / dose of bacterial cells. In some cases, the bacterial population may include about 1 x 10^6 CFU / dose to about 1 x 10^11 CFU / dose of bacterial cells. In some cases, the bacterial population may include about 1 x 10^6 CFU / dose to about 1 x 10^10 CFU / dose of bacterial cells.In some cases, the bacterial population may include about 1 x 10^6 CFU / dose to about 1 x 10^9 CFU / dose of bacterial cells. In some cases, the bacterial population may include about 1 x 10^6 CFU / dose to about 1 x 10^8 CFU / dose of bacterial cells. In some cases, the bacterial population may include about 1 x 10^7 CFU / dose to about 1 x 10^12 CFU / dose of bacterial cells. In some cases, the bacterial population may include about 1 x 10^7 CFU / dose to about 1 x 10^11 CFU / dose of bacterial cells. In some cases, the bacterial population may include about 1 x 10^7 CFU / dose to about 1 x 10^10 CFU / dose of bacterial cells. In some cases, the bacterial population may include about 1 x 10^7 CFU / dose to about 1 x 10^9 CFU / dose of bacterial cells. In some cases, the bacterial population may include about 1 x 10^7 CFU / dose to about 1 x 10^8 CFU / dose of bacterial cells. In some cases, the bacterial population may include about 1 x 10^8 CFU / dose to about 1 x 10^12 CFU / dose of bacterial cells. In some cases, the bacterial population may include about 1 x 10^8 CFU / dose to about 1 x 10^11 CFU / dose of bacterial cells. In some cases, the bacterial population may include about 1 x 10^8 CFU / dose to about 1 x 10^10 CFU / dose of bacterial cells. In some cases, the bacterial population may include about 1 x 10^8 CFU / dose to about 1 x 10^9 CFU / dose of bacterial cells. In some cases, the bacterial population may include about 1 x 10^9 CFU / dose to about 1 x 10^12 CFU / dose of bacterial cells. In some cases, the bacterial population may comprise about 1 x 10^9 CFU / dose to about 1 x 10^11 CFU / dose of bacterial cells. In some cases, the bacterial population may comprise about 1 x 10^9 CFU / dose to about 1 x 10^10 CFU / dose of bacterial cells. In some cases, such bacterial population may also comprise about 1 x 10^7 CFU / dose to about 1 x 10^10 CFU / dose of bacterial cells.In some examples, the bacterial population may comprise at least about 1x10^3 CFU / dose, 5x10^3 CFU / dose, 1x10^4 CFU / dose, 5x10^4 CFU / dose, 1x10^5 CFU / dose, 5x10^5 CFU / dose, 1x10^6 CFU / dose, 5x10^6 CFU / dose, 1x10^7 CFU / dose, 5x10^7 CFU / dose, 1x10^8 CFU / dose, 5x10^8 CFU / dose, 1x10^9 CFU / dose, 5x10^9 CFU / dose, 1x10^10 CFU / dose, 5x10^10 CFU / dose, 1x10^11 CFU / dose, 5x10^11 CFU / dose, or 1x10^12 CFU / dose, but not more than about 5x10^12 CFU / dose of bacterial cells.

[0087] In some cases, the at least one strain of Ackermansia species of the pharmaceutical composition may comprise from about 1 x 10^6 CFU / dose to about 5 x 10^9 CFU / dose. In some cases, the at least one strain of Ackermansia species of the pharmaceutical composition may comprise from about 1 x 10^6 CFU / dose to about 4 x 10^9 CFU / dose. In some cases, the at least one strain of Ackermansia species of the pharmaceutical composition may comprise from about 1 x 10^6 CFU / dose to about 3 x 10^9 CFU / dose. In some cases, the at least one strain of Ackermansia species of the pharmaceutical composition may comprise from about 1 x 10^6 CFU / dose to about 2 x 10^9 CFU / dose. In some cases, the at least one strain of Ackermansia species of the pharmaceutical composition may comprise from about 1 x 10^6 CFU / dose to about 1 x 10^9 CFU / dose. In some cases, the at least one strain of Ackermansia spp. in the pharmaceutical composition may comprise from about 1 x 10^6 CFU / dose to about 9 x 10^8 CFU / dose. In some cases, the at least one strain of Ackermansia spp. in the pharmaceutical composition may comprise from about 1 x 10^6 CFU / dose to about 8 x 10^8 CFU / dose. In some cases, the at least one strain of Ackermansia spp. in the pharmaceutical composition may comprise from about 1 x 10^6 CFU / dose to about 7 x 10^8 CFU / dose. In some cases, the at least one strain of Ackermansia spp. in the pharmaceutical composition may comprise from about 1 x 10^6 CFU / dose to about 6 x 10^8 CFU / dose. In some cases, the at least one strain of Ackermansia spp. in the pharmaceutical composition may comprise from about 1 x 10^6 CFU / dose to about 5 x 10^8 CFU / dose. In some cases, the at least one strain of Ackermansia spp. in the pharmaceutical composition may comprise from about 1 x 10^6 CFU / dose to about 4 x 10^8 CFU / dose. In some cases, the at least one strain of Ackermansia spp. in the pharmaceutical composition may comprise from about 1 x 10^6 CFU / dose to about 3 x 10^8 CFU / dose. In some cases, the at least one strain of Ackermansia spp. in the pharmaceutical composition may comprise from about 1 x 10^6 CFU / dose to about 2 x 10^8 CFU / dose. In some cases, the at least one strain of Ackermansia spp. in the pharmaceutical composition may comprise from about 1 x 10^6 CFU / dose to about 1 x 10^8 CFU / dose.In some cases, the at least one strain of Ackermansia spp. in the pharmaceutical composition may comprise from about 1×10^6 CFU / dose to about 9×10^7 CFU / dose. In some cases, the at least one strain of Ackermansia spp. in the pharmaceutical composition may comprise from about 1×10^6 CFU / dose to about 8×10^7 CFU / dose. In some cases, the at least one strain of Ackermansia spp. in the pharmaceutical composition may comprise from about 1×10^6 CFU / dose to about 7×10^7 CFU / dose. In some cases, the at least one strain of Ackermansia spp. in the pharmaceutical composition may comprise from about 1×10^6 CFU / dose to about 6×10^7 CFU / dose. In some cases, the at least one strain of Ackermansia spp. in the pharmaceutical composition may comprise from about 1×10^6 CFU / dose to about 5×10^7 CFU / dose. In some cases, the at least one strain of Ackermansia spp. in the pharmaceutical composition may comprise from about 1 x 10^6 CFU / dose to about 4 x 10^7 CFU / dose. In some cases, the at least one strain of Ackermansia spp. in the pharmaceutical composition may comprise from about 1 x 10^6 CFU / dose to about 3 x 10^7 CFU / dose. In some cases, the at least one strain of Ackermansia spp. in the pharmaceutical composition may comprise from about 1 x 10^6 CFU / dose to about 2 x 10^7 CFU / dose. In some cases, the at least one strain of Ackermansia spp. in the pharmaceutical composition may comprise from about 1 x 10^6 CFU / dose to about 1 x 10^7 CFU / dose. In some cases, at least one strain of Ackermansia spp. may contain at least about 1x10^3, 1x10^4, 1x10^5, 1x10^6, 1x10^7, 1x10^8, 1x10^9, 1x10^10, 1x10^11, 1x10^12 or more CFU / dose. In some cases, at least one strain of Ackermansia spp. may contain up to about 1x10^3, 1x10^4, 1x10^5, 1x10^6, 1x10^7, 1x10^8, 1x10^9, 1x10^10, 1x10^11, or 1x10^12 CFU / dose. In some cases, at least one strain of Ackermansia spp. may contain about 5x10^9 CFU / dose. In some cases, the at least one strain of Ackermansia spp. may contain about 4 x 10^9 CFU / dose. In some cases, the at least one strain of Ackermansia spp. may contain about 3 x 10^9 CFU / dose.In some cases, at least one strain of Ackermansia species may comprise about 2x10^9 CFU / dose. In some cases, at least one strain of Ackermansia species may comprise about 1x10^9 CFU / dose. In some cases, at least one strain of Ackermansia species may comprise about 9x10^8 CFU / dose. In some cases, at least one strain of Ackermansia species may comprise about 8x10^8 CFU / dose. In some cases, at least one strain of Ackermansia species may comprise about 7x10^8 CFU / dose. In some cases, at least one strain of Ackermansia species may comprise about 6x10^8 CFU / dose. In some cases, at least one strain of Ackermansia species may comprise about 5x10^8 CFU / dose. In some cases, at least one strain of Ackermansia species may comprise about 4x10^8 CFU / dose. In some cases, at least one strain of Ackermansia species may comprise about 3x10^8 CFU / dose. In some cases, at least one strain of Ackermansia species may comprise about 2x10^8 CFU / dose. In some cases, at least one strain of Ackermansia species may comprise about 1x10^8 CFU / dose. In some cases, at least one strain of Ackermansia species may comprise about 9x10^7 CFU / dose. In some cases, at least one strain of Ackermansia species may comprise about 8x10^7 CFU / dose. In some cases, at least one strain of Ackermansia species may comprise about 7x10^7 CFU / dose. In some cases, at least one strain of Ackermansia species may comprise about 6x10^7 CFU / dose. In some cases, at least one strain of Ackermansia species may comprise about 5x10^7 CFU / dose. In some cases, at least one strain of Ackermansia spp. may contain about 4 x 10^7 CFU / dose. In some cases, at least one strain of Ackermansia spp. may contain about 3 x 10^7 CFU / dose. In some cases, at least one strain of Ackermansia spp. may contain about 2 x 10^7 CFU / dose. In some cases, at least one strain of Ackermansia spp. may contain about 1 x 10^7 CFU / dose.

[0088] In some cases, the pharmaceutical composition of A. muciniphila (DSM 33213) may include about 1 x 10^6 CFU / dose to about 5 x 10^9 CFU / dose. In some cases, the pharmaceutical composition of A. muciniphila (DSM 33213) may include about 1 x 10^6 CFU / dose to about 4 x 10^9 CFU / dose. In some cases, the pharmaceutical composition of A. muciniphila (DSM 33213) may include about 1 x 10^6 CFU / dose to about 3 x 10^9 CFU / dose. In some cases, the pharmaceutical composition of A. muciniphila (DSM 33213) may include about 1 x 10^6 CFU / dose to about 2 x 10^9 CFU / dose. In some cases, the pharmaceutical composition of A. muciniphila (DSM 33213) may include about 1 x 10^6 CFU / dose to about 1 x 10^9 CFU / dose. In some cases, the pharmaceutical composition of A. muciniphila (DSM 33213) may include about 1 x 10^6 CFU / dose to about 9 x 10^8 CFU / dose. In some cases, the pharmaceutical composition of A. muciniphila (DSM 33213) may include about 1 x 10^6 CFU / dose to about 8 x 10^8 CFU / dose. In some cases, the pharmaceutical composition of A. muciniphila (DSM 33213) may include about 1 x 10^6 CFU / dose to about 7 x 10^8 CFU / dose. In some cases, the pharmaceutical composition of A. muciniphila (DSM 33213) may include about 1 x 10^6 CFU / dose to about 6 x 10^8 CFU / dose. In some cases, the pharmaceutical composition of A. muciniphila (DSM 33213) may include about 1 x 10^6 CFU / dose to about 5 x 10^8 CFU / dose. In some cases, the pharmaceutical composition of A. muciniphila (DSM 33213) may include about 1 x 10^6 CFU / dose to about 4 x 10^8 CFU / dose. In some cases, the pharmaceutical composition of A. muciniphila (DSM 33213) may include about 1 x 10^6 CFU / dose to about 3 x 10^8 CFU / dose. In some cases, the A. muciniphila (DSM 33213) of the pharmaceutical composition may include from about 1 x 10^6 CFU / dose to about 2 x 10^8 CFU / dose. In some cases, the A. muciniphila (DSM 33213) of the pharmaceutical composition may include from about 1 x 10^6 CFU / dose to about 1 x 10^8 CFU / dose.In some cases, the pharmaceutical composition of A. muciniphila (DSM 33213) may include about 1 x 10^6 CFU / dose to about 9 x 10^7 CFU / dose. In some cases, the pharmaceutical composition of A. muciniphila (DSM 33213) may include about 1 x 10^6 CFU / dose to about 8 x 10^7 CFU / dose. In some cases, the pharmaceutical composition of A. muciniphila (DSM 33213) may include about 1 x 10^6 CFU / dose to about 7 x 10^7 CFU / dose. In some cases, the pharmaceutical composition of A. muciniphila (DSM 33213) may include about 1 x 10^6 CFU / dose to about 6 x 10^7 CFU / dose. In some cases, the pharmaceutical composition of A. muciniphila (DSM 33213) may include about 1 x 10^6 CFU / dose to about 5 x 10^7 CFU / dose. In some cases, the pharmaceutical composition of A. muciniphila (DSM 33213) may include about 1 x 10^6 CFU / dose to about 4 x 10^7 CFU / dose. In some cases, the pharmaceutical composition of A. muciniphila (DSM 33213) may include about 1 x 10^6 CFU / dose to about 3 x 10^7 CFU / dose. In some cases, the pharmaceutical composition of A. muciniphila (DSM 33213) may include about 1 x 10^6 CFU / dose to about 2 x 10^7 CFU / dose. In some cases, the A. muciniphila (DSM 33213) of the pharmaceutical composition may comprise about 1 x 10^6 CFU / dose to about 1 x 10^7 CFU / dose. In some cases, the A. muciniphila (DSM 33213) may comprise about 5 x 10^9 CFU / dose. In some cases, the A. muciniphila (DSM 33213) may comprise about 4 x 10^9 CFU / dose. In some cases, the A. muciniphila (DSM 33213) may comprise about 3 x 10^9 CFU / dose. In some cases, the A. muciniphila (DSM 33213) may comprise about 2 x 10^9 CFU / dose. In some cases, the A. muciniphila (DSM 33213) may comprise about 1 x 10^9 CFU / dose. In some cases, A. muciniphila (DSM 33213) may contain about 9 x 10^8 CFU / dose. In some cases, A. muciniphila (DSM 33213) may contain about 8 x 10^8 CFU / dose. In some cases, A. muciniphila (DSM 33213) may contain about 7 x 10^8 CFU / dose.In some cases, A. muciniphila (DSM 33213) may contain about 6 x 10^8 CFU / dose. In some cases, A. muciniphila (DSM 33213) may contain about 5 x 10^8 CFU / dose. In some cases, A. muciniphila (DSM 33213) may contain about 4 x 10^8 CFU / dose. In some cases, A. muciniphila (DSM 33213) may contain about 3 x 10^8 CFU / dose. In some cases, A. muciniphila (DSM 33213) may contain about 2 x 10^8 CFU / dose. In some cases, A. muciniphila (DSM 33213) may contain about 1 x 10^8 CFU / dose. In some cases, A. muciniphila (DSM 33213) may contain about 9 x 10^7 CFU / dose. In some cases, A. muciniphila (DSM 33213) may contain about 8 x 10^7 CFU / dose. In some cases, A. muciniphila (DSM 33213) may contain about 7 x 10^7 CFU / dose. In some cases, A. muciniphila (DSM 33213) may contain about 6 x 10^7 CFU / dose. In some cases, A. muciniphila (DSM 33213) may contain about 5 x 10^7 CFU / dose. In some cases, A. muciniphila (DSM 33213) may contain about 4 x 10^7 CFU / dose. In some cases, A. muciniphila (DSM 33213) may contain about 3 x 10^7 CFU / dose. In some cases, A. muciniphila (DSM 33213) may contain about 2 x 10^7 CFU / dose. In some cases, A. muciniphila (DSM 33213) may contain about 1 x 10^7 CFU / dose.

[0089] In some cases, the at least one strain of Faecalibacterium spp. of the pharmaceutical composition may comprise from about 1 x 10^6 CFU / dose to about 5 x 10^9 CFU / dose. In some cases, the at least one strain of Faecalibacterium spp. of the pharmaceutical composition may comprise from about 1 x 10^6 CFU / dose to about 4 x 10^9 CFU / dose. In some cases, the at least one strain of Faecalibacterium spp. of the pharmaceutical composition may comprise from about 1 x 10^6 CFU / dose to about 3 x 10^9 CFU / dose. In some cases, the at least one strain of Faecalibacterium spp. of the pharmaceutical composition may comprise from about 1 x 10^6 CFU / dose to about 2 x 10^9 CFU / dose. In some cases, the at least one strain of Faecalibacterium spp. of the pharmaceutical composition may comprise from about 1 x 10^6 CFU / dose to about 1 x 10^9 CFU / dose. In some cases, the at least one strain of Faecalibacterium spp. of the pharmaceutical composition may comprise from about 1 x 10^6 CFU / dose to about 9 x 10^8 CFU / dose. In some cases, the at least one strain of Faecalibacterium spp. of the pharmaceutical composition may comprise from about 1 x 10^6 CFU / dose to about 8 x 10^8 CFU / dose. In some cases, the at least one strain of Faecalibacterium spp. of the pharmaceutical composition may comprise from about 1 x 10^6 CFU / dose to about 7 x 10^8 CFU / dose. In some cases, the at least one strain of Faecalibacterium spp. of the pharmaceutical composition may comprise from about 1 x 10^6 CFU / dose to about 6 x 10^8 CFU / dose. In some cases, the at least one strain of Faecalibacterium spp. of the pharmaceutical composition may comprise from about 1 x 10^6 CFU / dose to about 5 x 10^8 CFU / dose. In some cases, the at least one strain of Faecalibacterium spp. of the pharmaceutical composition may comprise from about 1 x 10^6 CFU / dose to about 4 x 10^8 CFU / dose. In some cases, the at least one strain of Faecalibacterium spp. of the pharmaceutical composition may comprise from about 1 x 10^6 CFU / dose to about 3 x 10^8 CFU / dose. In some cases, the at least one strain of Faecalibacterium spp. of the pharmaceutical composition may comprise from about 1 x 10^6 CFU / dose to about 2 x 10^8 CFU / dose. In some cases, the at least one strain of Faecalibacterium spp. of the pharmaceutical composition may comprise from about 1 x 10^6 CFU / dose to about 1 x 10^8 CFU / dose.In some cases, the at least one strain of Faecalibacterium spp. of the pharmaceutical composition may comprise from about 1 x 10^6 CFU / dose to about 9 x 10^7 CFU / dose. In some cases, the at least one strain of Faecalibacterium spp. of the pharmaceutical composition may comprise from about 1 x 10^6 CFU / dose to about 8 x 10^7 CFU / dose. In some cases, the at least one strain of Faecalibacterium spp. of the pharmaceutical composition may comprise from about 1 x 10^6 CFU / dose to about 7 x 10^7 CFU / dose. In some cases, the at least one strain of Faecalibacterium spp. of the pharmaceutical composition may comprise from about 1 x 10^6 CFU / dose to about 6 x 10^7 CFU / dose. In some cases, the at least one strain of Faecalibacterium spp. of the pharmaceutical composition may comprise from about 1 x 10^6 CFU / dose to about 5 x 10^7 CFU / dose. In some cases, the at least one strain of Faecalibacterium spp. of the pharmaceutical composition may comprise from about 1 x 10^6 CFU / dose to about 4 x 10^7 CFU / dose. In some cases, the at least one strain of Faecalibacterium spp. of the pharmaceutical composition may comprise from about 1 x 10^6 CFU / dose to about 3 x 10^7 CFU / dose. In some cases, the at least one strain of Faecalibacterium spp. of the pharmaceutical composition may comprise from about 1 x 10^6 CFU / dose to about 2 x 10^7 CFU / dose. In some cases, the at least one strain of Faecalibacterium spp. of the pharmaceutical composition may comprise from about 1 x 10^6 CFU / dose to about 1 x 10^7 CFU / dose. In some cases, at least one strain of Faecalibacterium spp. may contain at least about 1x10^3, 1x10^4, 1x10^5, 1x10^6, 1x10^7, 1x10^8, 1x10^9, 1x10^10, 1x10^11, 1x10^12 or more CFU / dose. In some cases, at least one strain of Faecalibacterium spp. may contain up to about 1x10^3, 1x10^4, 1x10^5, 1x10^6, 1x10^7, 1x10^8, 1x10^9, 1x10^10, 1x10^11, or 1x10^12 CFU / dose. In some cases, at least one strain of Faecalibacterium spp. may contain about 5x10^9 CFU / dose. In some cases, at least one strain of Faecalibacterium spp. may contain about 4 x 10^9 CFU / dose.In some cases, at least one strain of Faecalibacterium spp. may comprise about 3x10^9 CFU / dose. In some cases, at least one strain of Faecalibacterium spp. may comprise about 2x10^9 CFU / dose. In some cases, at least one strain of Faecalibacterium spp. may comprise about 1x10^9 CFU / dose. In some cases, at least one strain of Faecalibacterium spp. may comprise about 9x10^8 CFU / dose. In some cases, at least one strain of Faecalibacterium spp. may comprise about 8x10^8 CFU / dose. In some cases, at least one strain of Faecalibacterium spp. may comprise about 7x10^8 CFU / dose. In some cases, at least one strain of Faecalibacterium spp. may comprise about 6x10^8 CFU / dose. In some cases, at least one strain of Faecalibacterium spp. may comprise about 5x10^8 CFU / dose. In some cases, at least one strain of Faecalibacterium spp. may comprise about 4x10^8 CFU / dose. In some cases, at least one strain of Faecalibacterium spp. may comprise about 3x10^8 CFU / dose. In some cases, at least one strain of Faecalibacterium spp. may comprise about 2x10^8 CFU / dose. In some cases, at least one strain of Faecalibacterium spp. may comprise about 1x10^8 CFU / dose. In some cases, at least one strain of Faecalibacterium spp. may comprise about 9x10^7 CFU / dose. In some cases, at least one strain of Faecalibacterium spp. may comprise about 8x10^7 CFU / dose. In some cases, at least one strain of Faecalibacterium spp. may comprise about 7x10^7 CFU / dose. In some cases, at least one strain of Faecalibacterium spp. may comprise about 6x10^7 CFU / dose. In some cases, at least one strain of Faecalibacterium spp. may contain about 5 x 10^7 CFU / dose. In some cases, at least one strain of Faecalibacterium spp. may contain about 4 x 10^7 CFU / dose. In some cases, at least one strain of Faecalibacterium spp. may contain about 3 x 10^7 CFU / dose.In some cases, at least one strain of Faecalibacterium spp. may contain about 2 x 10^7 CFU / dose. In some cases, at least one strain of Faecalibacterium spp. may contain about 1 x 10^7 CFU / dose.

[0090] In some cases, the pharmaceutical composition of F. prausnitzii (DSM 33185) may contain about 1 x 10^6 CFU / dose to about 5 x 10^9 CFU / dose. In some cases, the pharmaceutical composition of F. prausnitzii (DSM 33185) may contain about 1 x 10^6 CFU / dose to about 4 x 10^9 CFU / dose. In some cases, the pharmaceutical composition of F. prausnitzii (DSM 33185) may contain about 1 x 10^6 CFU / dose to about 3 x 10^9 CFU / dose. In some cases, the pharmaceutical composition of F. prausnitzii (DSM 33185) may contain about 1 x 10^6 CFU / dose to about 2 x 10^9 CFU / dose. In some cases, the pharmaceutical composition of F. prausnitzii (DSM 33185) may contain about 1 x 10^6 CFU / dose to about 1 x 10^9 CFU / dose. In some cases, the pharmaceutical composition of F. prausnitzii (DSM 33185) may contain about 1 x 10^6 CFU / dose to about 9 x 10^8 CFU / dose. In some cases, the pharmaceutical composition of F. prausnitzii (DSM 33185) may contain about 1 x 10^6 CFU / dose to about 8 x 10^8 CFU / dose. In some cases, the pharmaceutical composition of F. prausnitzii (DSM 33185) may contain about 1 x 10^6 CFU / dose to about 7 x 10^8 CFU / dose. In some cases, the pharmaceutical composition of F. prausnitzii (DSM 33185) may contain about 1 x 10^6 CFU / dose to about 6 x 10^8 CFU / dose. In some cases, the pharmaceutical composition of F. prausnitzii (DSM 33185) may contain about 1 x 10^6 CFU / dose to about 5 x 10^8 CFU / dose. In some cases, the pharmaceutical composition of F. prausnitzii (DSM 33185) may contain about 1 x 10^6 CFU / dose to about 4 x 10^8 CFU / dose. In some cases, the pharmaceutical composition of F. prausnitzii (DSM 33185) may contain about 1 x 10^6 CFU / dose to about 3 x 10^8 CFU / dose. In some cases, the F. prausnitzii (DSM 33185) of the pharmaceutical composition may contain about 1 x 10^6 CFU / dose to about 2 x 10^8 CFU / dose. In some cases, the F. prausnitzii (DSM 33185) of the pharmaceutical composition may contain about 1 x 10^6 CFU / dose to about 1 x 10^8 CFU / dose.In some cases, the pharmaceutical composition of F. prausnitzii (DSM 33185) may contain about 1 x 10^6 CFU / dose to about 9 x 10^7 CFU / dose. In some cases, the pharmaceutical composition of F. prausnitzii (DSM 33185) may contain about 1 x 10^6 CFU / dose to about 8 x 10^7 CFU / dose. In some cases, the pharmaceutical composition of F. prausnitzii (DSM 33185) may contain about 1 x 10^6 CFU / dose to about 7 x 10^7 CFU / dose. In some cases, the pharmaceutical composition of F. prausnitzii (DSM 33185) may contain about 1 x 10^6 CFU / dose to about 6 x 10^7 CFU / dose. In some cases, the pharmaceutical composition of F. prausnitzii (DSM 33185) may contain about 1 x 10^6 CFU / dose to about 5 x 10^7 CFU / dose. In some cases, the pharmaceutical composition of F. prausnitzii (DSM 33185) may contain about 1 x 10^6 CFU / dose to about 4 x 10^7 CFU / dose. In some cases, the pharmaceutical composition of F. prausnitzii (DSM 33185) may contain about 1 x 10^6 CFU / dose to about 3 x 10^7 CFU / dose. In some cases, the pharmaceutical composition of F. prausnitzii (DSM 33185) may contain about 1 x 10^6 CFU / dose to about 2 x 10^7 CFU / dose. In some cases, the F. prausnitzii (DSM 33185) of the pharmaceutical composition may comprise about 1 x 10^6 CFU / dose to about 1 x 10^7 CFU / dose. In some cases, the F. prausnitzii (DSM 33185) may comprise about 5 x 10^9 CFU / dose. In some cases, the F. prausnitzii (DSM 33185) may comprise about 4 x 10^9 CFU / dose. In some cases, the F. prausnitzii (DSM 33185) may comprise about 3 x 10^9 CFU / dose. In some cases, the F. prausnitzii (DSM 33185) may comprise about 2 x 10^9 CFU / dose. In some cases, the F. prausnitzii (DSM 33185) may comprise about 1 x 10^9 CFU / dose. In some cases, F. prausnitzii (DSM 33185) may contain about 9 x 10^8 CFU / dose. In some cases, F. prausnitzii (DSM 33185) may contain about 8 x 10^8 CFU / dose.In some cases, F. prausnitzii (DSM 33185) may contain about 7x10^8 CFU / dose. In some cases, F. prausnitzii (DSM 33185) may contain about 6x10^8 CFU / dose. In some cases, F. prausnitzii (DSM 33185) may contain about 5x10^8 CFU / dose. In some cases, F. prausnitzii (DSM 33185) may contain about 4x10^8 CFU / dose. In some cases, F. prausnitzii (DSM 33185) may contain about 3x10^8 CFU / dose. In some cases, F. prausnitzii (DSM 33185) may contain about 2x10^8 CFU / dose. In some cases, F. prausnitzii (DSM 33185) may contain about 1x10^8 CFU / dose. In some cases, F. prausnitzii (DSM 33185) may contain about 9x10^7 CFU / dose. In some cases, F. prausnitzii (DSM 33185) may contain about 8x10^7 CFU / dose. In some cases, F. prausnitzii (DSM 33185) may contain about 7x10^7 CFU / dose. In some cases, F. prausnitzii (DSM 33185) may contain about 6x10^7 CFU / dose. In some cases, F. prausnitzii (DSM 33185) may contain about 5x10^7 CFU / dose. In some cases, F. prausnitzii (DSM 33185) may contain about 4x10^7 CFU / dose. In some cases, F. prausnitzii (DSM 33185) may contain about 3x10^7 CFU / dose. In some cases, F. prausnitzii (DSM 33185) may contain about 2x10^7 CFU / dose. In some cases, F. prausnitzii (DSM 33185) may contain about 1x10^7 CFU / dose.

[0091] In some cases, the at least one strain of Lactobacillus species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 5 x 10^10 CFU / dose. In some cases, the at least one strain of Lactobacillaceae species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 5 x 10^10 CFU / dose. In some cases, the at least one strain of Lactobacillus species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 4 x 10^10 CFU / dose. In some cases, the at least one strain of Lactobacillaceae species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 4 x 10^10 CFU / dose. In some cases, the at least one strain of Lactobacillus species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 3 x 10^10 CFU / dose. In some cases, the at least one strain of the Lactobacillaceae species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 3 x 10^10 CFU / dose. In some cases, the at least one strain of the Lactobacillaceae species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 2 x 10^10 CFU / dose. In some cases, the at least one strain of the Lactobacillaceae species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 2 x 10^10 CFU / dose. In some cases, the at least one strain of the Lactobacillaceae species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 1 x 10^10 CFU / dose. In some cases, the at least one strain of the Lactobacillaceae species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 1 x 10^10 CFU / dose. In some cases, the at least one strain of Lactobacillus species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 9 x 10^9 CFU / dose. In some cases, the at least one strain of Lactobacillaceae species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 9 x 10^9 CFU / dose. In some cases, the at least one strain of Lactobacillus species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 8 x 10^9 CFU / dose. In some cases, the at least one strain of Lactobacillaceae species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 8 x 10^9 CFU / dose.In some cases, the at least one strain of Lactobacillus species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 7 x 10^9 CFU / dose. In some cases, the at least one strain of Lactobacillaceae species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 7 x 10^9 CFU / dose. In some cases, the at least one strain of Lactobacillus species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 6 x 10^9 CFU / dose. In some cases, the at least one strain of Lactobacillus species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 6 x 10^9 CFU / dose. In some cases, the at least one strain of Lactobacillus species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 5 x 10^9 CFU / dose. In some cases, the at least one strain of the Lactobacillaceae species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 5 x 10^9 CFU / dose. In some cases, the at least one strain of the Lactobacillus species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 4 x 10^9 CFU / dose. In some cases, the at least one strain of the Lactobacillus species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 4 x 10^9 CFU / dose. In some cases, the at least one strain of the Lactobacillus species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 3 x 10^9 CFU / dose. In some cases, the at least one strain of the Lactobacillus species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 3 x 10^9 CFU / dose. In some cases, the at least one strain of Lactobacillus species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 2 x 10^9 CFU / dose. In some cases, the at least one strain of Lactobacillaceae species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 2 x 10^9 CFU / dose. In some cases, the at least one strain of Lactobacillus species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 1 x 10^9 CFU / dose. In some cases, the at least one strain of Lactobacillaceae species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 1 x 10^9 CFU / dose.In some cases, the at least one strain of Lactobacillus species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 9 x 10^8 CFU / dose. In some cases, the at least one strain of Lactobacillaceae species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 9 x 10^8 CFU / dose. In some cases, the at least one strain of Lactobacillus species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 8 x 10^8 CFU / dose. In some cases, the at least one strain of Lactobacillus species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 8 x 10^8 CFU / dose. In some cases, the at least one strain of Lactobacillus species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 7 x 10^8 CFU / dose. In some cases, the at least one strain of the Lactobacillaceae species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 7 x 10^8 CFU / dose. In some cases, the at least one strain of the Lactobacillus species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 6 x 10^8 CFU / dose. In some cases, the at least one strain of the Lactobacillus species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 6 x 10^8 CFU / dose. In some cases, the at least one strain of the Lactobacillus species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 5 x 10^8 CFU / dose. In some cases, the at least one strain of the Lactobacillus species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 5 x 10^8 CFU / dose. In some cases, the at least one strain of Lactobacillus species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 4 x 10^8 CFU / dose. In some cases, the at least one strain of Lactobacillaceae species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 4 x 10^8 CFU / dose. In some cases, the at least one strain of Lactobacillus species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 3 x 10^8 CFU / dose. In some cases, the at least one strain of Lactobacillaceae species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 3 x 10^8 CFU / dose.In some cases, the at least one strain of Lactobacillus species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 2 x 10^8 CFU / dose. In some cases, the at least one strain of Lactobacillaceae species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 2 x 10^8 CFU / dose. In some cases, the at least one strain of Lactobacillus species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 1 x 10^8 CFU / dose. In some cases, the at least one strain of Lactobacillaceae species of the pharmaceutical composition may comprise about 1 x 10^7 CFU / dose to about 1 x 10^8 CFU / dose. In some cases, at least one strain of Lactobacillus species may contain at least about 1x10^3, 1x10^4, 1x10^5, 1x10^6, 1x10^7, 1x10^8, 1x10^9, 1x10^10, 1x10^11, 1x10^12 or more CFU / dose. In some cases, at least one strain of Lactobacillus species may contain up to about 1x10^3, 1x10^4, 1x10^5, 1x10^6, 1x10^7, 1x10^8, 1x10^9, 1x10^10, 1x10^11, or 1x10^12 CFU / dose. In some cases, at least one strain of a Lactobacillaceae species may contain at least about 1x10^3, 1x10^4, 1x10^5, 1x10^6, 1x10^7, 1x10^8, 1x10^9, 1x10^10, 1x10^11, 1x10^12 or more CFU / dose. In some cases, at least one strain of a Lactobacillaceae species may contain up to about 1x10^3, 1x10^4, 1x10^5, 1x10^6, 1x10^7, 1x10^8, 1x10^9, 1x10^10, 1x10^11 or 1x10^12 CFU / dose. In some cases, at least one strain of a Lactobacillus species may contain about 5x10^9 CFU / dose. In some cases, at least one strain of Lactobacillaceae species may contain about 5x10^9 CFU / dose. In some cases, at least one strain of Lactobacillus species may contain about 4x10^9 CFU / dose. In some cases, at least one strain of Lactobacillus species may contain about 4x10^9 CFU / dose. In some cases, at least one strain of Lactobacillus species may contain about 3x10^9 CFU / dose.In some cases, at least one strain of Lactobacillaceae species may contain about 3x10^9 CFU / dose. In some cases, at least one strain of Lactobacillus species may contain about 2x10^9 CFU / dose. In some cases, at least one strain of Lactobacillaceae species may contain about 2x10^9 CFU / dose. In some cases, at least one strain of Lactobacillus species may contain about 1x10^9 CFU / dose. In some cases, at least one strain of Lactobacillaceae species may contain about 1x10^9 CFU / dose. In some cases, at least one strain of Lactobacillus species may contain about 9x10^8 CFU / dose. In some cases, at least one strain of Lactobacillaceae species may contain about 9x10^8 CFU / dose. In some cases, at least one strain of Lactobacillus species may contain about 8x10^8 CFU / dose. In some cases, at least one strain of Lactobacillaceae species may contain about 8 x 10^8 CFU / dose. In some cases, at least one strain of Lactobacillus species may contain about 7 x 10^8 CFU / dose. In some cases, at least one strain of Lactobacillaceae species may contain about 7 x 10^8 CFU / dose. In some cases, at least one strain of Lactobacillus species may contain about 6 x 10^8 CFU / dose. In some cases, at least one strain of Lactobacillaceae species may contain about 6 x 10^8 CFU / dose. In some cases, at least one strain of Lactobacillus species may contain about 5 x 10^8 CFU / dose. In some cases, at least one strain of Lactobacillaceae species may contain about 5 x 10^8 CFU / dose. In some cases, at least one strain of Lactobacillus species may contain about 4 x 10^8 CFU / dose. In some cases, at least one strain of Lactobacillaceae species may contain about 4 x 10^8 CFU / dose. In some cases, at least one strain of Lactobacillus species may contain about 3 x 10^8 CFU / dose. In some cases, at least one strain of Lactobacillus species may contain about 3 x 10^8 CFU / dose. In some cases, at least one strain of Lactobacillus species may contain about 2 x 10^8 CFU / dose.In some cases, at least one strain of a Lactobacillaceae species may comprise about 2x10^8 CFU / dose. In some cases, at least one strain of a Lactobacillaceae species may comprise about 1x10^8 CFU / dose. In some cases, at least one strain of a Lactobacillaceae species may comprise about 1x10^8 CFU / dose. In some cases, at least one strain of a Lactobacillaceae species may comprise about 9x10^7 CFU / dose. In some cases, at least one strain of a Lactobacillaceae species may comprise about 9x10^7 CFU / dose. In some cases, at least one strain of a Lactobacillaceae species may comprise about 8x10^7 CFU / dose. How many. In some cases, at least one strain of Lactobacillaceae species may contain about 8 x 10^7 CFU / dose. In some cases, at least one strain of Lactobacillaceae species may contain about 7 x 10^7 CFU / dose. In some cases, at least one strain of Lactobacillaceae species may contain about 7 x 10^7 CFU / dose. In some cases, at least one strain of Lactobacillaceae species may contain about 6 x 10^7 CFU / dose. In some cases, at least one strain of Lactobacillaceae species may contain about 6 x 10^7 CFU / dose. In some cases, at least one strain of Lactobacillaceae species may contain about 5 x 10^7 CFU / dose. In some cases, at least one strain of Lactobacillaceae species may contain about 5 x 10^7 CFU / dose. In some cases, at least one strain of Lactobacillus species may contain about 4 x 10^7 CFU / dose. In some cases, at least one strain of Lactobacillaceae species may contain about 4 x 10^7 CFU / dose. In some cases, at least one strain of Lactobacillus species may contain about 3 x 10^7 CFU / dose. In some cases, at least one strain of Lactobacillaceae species may contain about 3 x 10^7 FU / dose. In some cases, at least one strain of Lactobacillaceae species may contain about 2 x 10^7 CFU / dose. In some cases, at least one strain of Lactobacillaceae species may contain about 2 x 10^7 CFU / dose. In some cases, at least one strain of Lactobacillus species may contain about 1 x 10^7 CFU / dose. In some cases, at least one strain of Lactobacillaceae species may contain about 1 x 10^7 CFU / dose.

[0092] In some cases, the L. crispatus (DSM 33187) of the pharmaceutical composition may include from about 1 x 10^7 CFU / dose to about 5 x 10^10 CFU / dose. In some cases, the L. crispatus (DSM 33187) of the pharmaceutical composition may include from about 1 x 10^7 CFU / dose to about 4 x 10^10 CFU / dose. In some cases, the L. crispatus (DSM 33187) of the pharmaceutical composition may include from about 1 x 10^7 CFU / dose to about 3 x 10^10 CFU / dose. In some cases, the L. crispatus (DSM 33187) of the pharmaceutical composition may include from about 1 x 10^7 CFU / dose to about 2 x 10^10 CFU / dose. In some cases, the pharmaceutical composition of L. crispatus (DSM 33187) may include from about 1 x 10^7 CFU / dose to about 1 x 10^10 CFU / dose. In some cases, the pharmaceutical composition of L. crispatus (DSM 33187) may include from about 1 x 10^7 CFU / dose to about 9 x 10^9 CFU / dose. In some cases, the pharmaceutical composition of L. crispatus (DSM 33187) may include from about 1 x 10^7 CFU / dose to about 8 x 10^9 CFU / dose. In some cases, the pharmaceutical composition of L. crispatus (DSM 33187) may include from about 1 x 10^7 CFU / dose to about 7 x 10^9 CFU / dose. In some cases, the pharmaceutical composition of L. crispatus (DSM 33187) may include from about 1 x 10^7 CFU / dose to about 6 x 10^9 CFU / dose. In some cases, the pharmaceutical composition of L. crispatus (DSM 33187) may include about 1 x 10^7 CFU / dose to about 5 x 10^9 CFU / dose. In some cases, the pharmaceutical composition of L. crispatus (DSM 33187) may include about 1 x 10^7 CFU / dose to about 4 x 10^9 CFU / dose. In some cases, the pharmaceutical composition of L. crispatus (DSM 33187) may include about 1 x 10^7 CFU / dose to about 3 x 10^9 CFU / dose. In some cases, the pharmaceutical composition of L. crispatus (DSM 33187) may include about 1 x 10^7 CFU / dose to about 2 x 10^9 CFU / dose. In some cases, the pharmaceutical composition of L. crispatus (DSM 33187) may include about 1 x 10^7 CFU / dose to about 1 x 10^9 CFU / dose.In some cases, the pharmaceutical composition of L. crispatus (DSM 33187) may include about 1 x 10^7 CFU / dose to about 9 x 10^8 CFU / dose. In some cases, the pharmaceutical composition of L. crispatus (DSM 33187) may include about 1 x 10^7 CFU / dose to about 8 x 10^8 CFU / dose. In some cases, the pharmaceutical composition of L. crispatus (DSM 33187) may include about 1 x 10^7 CFU / dose to about 7 x 10^8 CFU / dose. In some cases, the pharmaceutical composition of L. crispatus (DSM 33187) may include about 1 x 10^7 CFU / dose to about 6 x 10^8 CFU / dose. In some cases, the pharmaceutical composition of L. crispatus (DSM 33187) may include about 1 x 10^7 CFU / dose to about 5 x 10^8 CFU / dose. In some cases, the L. crispatus (DSM 33187) of the pharmaceutical composition may include about 1 x 10^7 CFU / dose to about 4 x 10^8 CFU / dose. In some cases, the L. crispatus (DSM 33187) of the pharmaceutical composition may include about 1 x 10^7 CFU / dose to about 3 x 10^8 CFU / dose. In some cases, the L. crispatus (DSM 33187) of the pharmaceutical composition may include about 1 x 10^7 CFU / dose to about 2 x 10^8 CFU / dose. In some cases, the L. crispatus (DSM 33187) of the pharmaceutical composition may include about 1 x 10^7 CFU / dose to about 1 x 10^8 CFU / dose. In some cases, the L. crispatus (DSM 33187) of the pharmaceutical composition may include about 5 x 10^9 CFU / dose. In some cases, L. crispatus (DSM 33187) may contain about 4x10^9 CFU / dose. In some cases, L. crispatus (DSM 33187) may contain about 3x10^9 CFU / dose. In some cases, L. crispatus (DSM 33187) may contain about 2x10^9 CFU / dose. In some cases, L. crispatus (DSM 33187) may contain about 1x10^9 CFU / dose. In some cases, L. crispatus (DSM 33187) may contain about 9x10^8 CFU / dose. In some cases, L. crispatus (DSM 33187) may contain about 8x10^8 CFU / dose. In some cases, L. crispatus (DSM 33187) may contain about 7x10^8 CFU / dose.In some cases, L. crispatus (DSM 33187) may contain about 6x10^8 CFU / dose. In some cases, L. crispatus (DSM 33187) may contain about 5x10^8 CFU / dose. In some cases, L. crispatus (DSM 33187) may contain about 4x10^8 CFU / dose. In some cases, L. crispatus (DSM 33187) may contain about 3x10^8 CFU / dose. In some cases, L. crispatus (DSM 33187) may contain about 2x10^8 CFU / dose. In some cases, L. crispatus (DSM 33187) may contain about 1x10^8 CFU / dose. In some cases, L. crispatus (DSM 33187) may contain about 9x10^7 CFU / dose. In some cases, L. crispatus (DSM 33187) may contain about 8 x 10^7 CFU / dose. In some cases, L. crispatus (DSM 33187) may contain about 7 x 10^7 CFU / dose. In some cases, L. crispatus (DSM 33187) may contain about 6 x 10^7 CFU / dose. In some cases, L. crispatus (DSM 33187) may contain about 5 x 10^7 CFU / dose. In some cases, L. crispatus (DSM 33187) may contain about 4 x 10^7 CFU / dose. In some cases, L. crispatus (DSM 33187) may contain about 3 x 10^7 CFU / dose. In some cases, L. crispatus (DSM 33187) may contain about 2 x 10^7 CFU / dose. In some cases, L. crispatus (DSM 33187) may contain about 1 x 10^7 CFU / dose.

[0093] In some cases herein, the bacterial population for use in the pharmaceutical compositions of the present disclosure may comprise or consist of about 5×10^8 CFU / mL of any of the bacterial strains L. crispatus (DSM 33187), A. muciniphila (DSM 33213), and / or F. prausnitzii (DSM 33185). In such cases, the bacterial population may consist of about 5×10^8 CFU / mL of the bacterial strains L. crispatus (DSM 33187), A. muciniphila (DSM 33213), and F. prausnitzii (DSM 33185).

[0094] When the pharmaceutical composition is formulated into a unit dose for administration, such CFU / dose value may be per mass unit (e.g., 5×10^8 CFU / dose / g) or volume unit (e.g., 5×10^8 CFU / dose / mL) of such dosage form. In other cases, the CFU / dose value may be equivalent to CFU / capsule when one dose is administered as one capsule or when one capsule contains the dose. In some cases, the dose may be in other forms as described elsewhere in this disclosure.

[0095] In some examples, the bacterial population for use in the pharmaceutical compositions described herein is at least about 1 x 10^3 CFU / gram of bacterial cells, 5 x 10^3 CFU / gram of bacterial cells, 1 x 10^4 CFU / gram of bacterial cells, 5 x 10^4 CFU / gram of bacterial cells, 1 x 10^5 CFU / gram of bacterial cells, 5 x 10^5 CFU / gram of bacterial cells, 1 x 10^6 CFU / gram of bacterial cells, 5 x 10^6 CFU / gram of bacterial cells, 1 x 10^7 CFU / gram of bacterial cells, 5 x 10^7 CFU / gram of bacterial cells, 1 x 10^8 CFU / gram of bacterial cells, 5 x 10^8 CFU / gram of bacterial cells, 1 x 10^9 CFU / gram of bacterial cells, 5 ... U / gram of bacterial cells, 5x10^9 CFU / gram of bacterial cells, 1x10^10 CFU / gram of bacterial cells, 5x10^10 CFU / gram of bacterial cells, 1x10^11 CFU / gram of bacterial cells, 5x10^11 CFU / gram of bacterial cells, 1x10^12 CFU / gram of bacterial cells, 5x10^12 CFU / gram of bacterial cells, 1x10^13 CFU / gram of bacterial cells, 5x10^13 CFU / gram of bacterial cells, 1x10^14 CFU / gram of bacterial cells, 5x10^14 CFU / gram of bacterial cells, 1x10^15 CFU / gram of bacterial cells, 5x10^15 CFU / gram of bacterial cells or more.In some examples, the bacterial population for use in the pharmaceutical compositions described herein is at most about 1 x 10^3 CFU / gram of bacterial cells, 5 x 10^3 CFU / gram of bacterial cells, 1 x 10^4 CFU / gram of bacterial cells, 5 x 10^4 CFU / gram of bacterial cells, 1 x 10^5 CFU / gram of bacterial cells, 5 x 10^5 CFU / gram of bacterial cells, 1 x 10^6 CFU / gram of bacterial cells, 5 x 10^6 CFU / gram of bacterial cells, 1 x 10^7 CFU / gram of bacterial cells, 5 x 10^7 CFU / gram of bacterial cells, 1 x 10^8 CFU / gram of bacterial cells, 5 x 10^8 CFU / gram of bacterial cells, 1 x 10^9 CFU / gram of bacterial cells, 5 ... FU / gram of bacterial cells, 5x10^9 CFU / gram of bacterial cells, 1x10^10 CFU / gram of bacterial cells, 5x10^10 CFU / gram of bacterial cells, 1x10^11 CFU / gram of bacterial cells, 5x10^11 CFU / gram of bacterial cells, 1x10^12 CFU / gram of bacterial cells, 5x10^12 CFU / gram of bacterial cells, 1x10^13 CFU / gram of bacterial cells, 5x10^13 CFU / gram of bacterial cells, 1x10^14 CFU / gram of bacterial cells, 5x10^14 CFU / gram of bacterial cells, 1x10^15 CFU / gram of bacterial cells, or 5x10^15 CFU / gram of bacterial cells.

[0096] In some examples, at least one strain of Ackermansia species in the pharmaceutical compositions described herein is at least about 1 x 10^3 CFU / gram of bacterial cells, 5 x 10^3 CFU / gram of bacterial cells, 1 x 10^4 CFU / gram of bacterial cells, 5 x 10^4 CFU / gram of bacterial cells, 1 x 10^5 CFU / gram of bacterial cells, 5 x 10^5 CFU / gram of bacterial cells, 1 x 10^6 CFU / gram of bacterial cells, 5 x 10^6 CFU / gram of bacterial cells, 1 x 10^7 CFU / gram of bacterial cells, 5 x 10^7 CFU / gram of bacterial cells, 1 x 10^8 CFU / gram of bacterial cells, 5 x 10^8 CFU / gram of bacterial cells, 1 x 10 ^9 CFU / gram of bacterial cells, 5x10^9 CFU / gram of bacterial cells, 1x10^10 CFU / gram of bacterial cells, 5x10^10 CFU / gram of bacterial cells, 1x10^11 CFU / gram of bacterial cells, 5x10^11 CFU / gram of bacterial cells, 1x10^12 CFU / gram of bacterial cells, 5x10^12 CFU / gram of bacterial cells, 1x10^13 CFU / gram of bacterial cells, 5x10^13 CFU / gram of bacterial cells, 1x10^14 CFU / gram of bacterial cells, 5x10^14 CFU / gram of bacterial cells, 1x10^15 CFU / gram of bacterial cells, 5x10^15 CFU / gram of bacterial cells or more.In some examples, at least one strain of Ackermansia species in the pharmaceutical compositions described herein is at most about 1x10^3 CFU / gram of bacterial cells, 5x10^3 CFU / gram of bacterial cells, 1x10^4 CFU / gram of bacterial cells, 5x10^4 CFU / gram of bacterial cells, 1x10^5 CFU / gram of bacterial cells, 5x10^5 CFU / gram of bacterial cells, 1x10^6 CFU / gram of bacterial cells, 5x10^6 CFU / gram of bacterial cells, 1x10^7 CFU / gram of bacterial cells, 5x10^7 CFU / gram of bacterial cells, 1x10^8 CFU / gram of bacterial cells, 5x10^8 CFU / gram of bacterial cells, 1x10^ 9 CFU / gram of bacterial cells, 5x10^9 CFU / gram of bacterial cells, 1x10^10 CFU / gram of bacterial cells, 5x10^10 CFU / gram of bacterial cells, 1x10^11 CFU / gram of bacterial cells, 5x10^11 CFU / gram of bacterial cells, 1x10^12 CFU / gram of bacterial cells, 5x10^12 CFU / gram of bacterial cells, 1x10^13 CFU / gram of bacterial cells, 5x10^13 CFU / gram of bacterial cells, 1x10^14 CFU / gram of bacterial cells, 5x10^14 CFU / gram of bacterial cells, 1x10^15 CFU / gram of bacterial cells, 5x10^15 CFU / gram of bacterial cells or more.

[0097] In some examples, at least one strain of Faecalibacterium species in the pharmaceutical compositions described herein has a bacterial cell density of at least about 1 x 10^3 CFU / gram, 5 x 10^3 CFU / gram, 1 x 10^4 CFU / gram, 5 x 10^4 CFU / gram, 1 x 10^5 CFU / gram, 5 x 10^5 CFU / gram, 1 x 10^6 CFU / gram, 5 x 10^6 CFU / gram, 1 x 10^7 CFU / gram, 5 x 10^7 CFU / gram, 1 x 10^8 CFU / gram, 5 x 10^8 CFU / gram, 1 x The bacterial cells may include 10^9 CFU / gram, 5x10^9 CFU / gram, 1x10^10 CFU / gram, 5x10^10 CFU / gram, 1x10^11 CFU / gram, 5x10^11 CFU / gram, 1x10^12 CFU / gram, 5x10^12 CFU / gram, 1x10^13 CFU / gram, 5x10^13 CFU / gram, 1x10^14 CFU / gram, 5x10^14 CFU / gram, 1x10^15 CFU / gram, 5x10^15 CFU / gram or more.In some examples, at least one strain of Faecalibacterium species in the pharmaceutical compositions described herein has a bacterial cell density of at most about 1 x 10^3 CFU / gram, 5 x 10^3 CFU / gram, 1 x 10^4 CFU / gram, 5 x 10^4 CFU / gram, 1 x 10^5 CFU / gram, 5 x 10^5 CFU / gram, 1 x 10^6 CFU / gram, 5 x 10^6 CFU / gram, 1 x 10^7 CFU / gram, 5 x 10^7 CFU / gram, 1 x 10^8 CFU / gram, 5 x 10^8 CFU / gram, 1 ... The bacterial cells may include 0^9 CFU / gram, 5x10^9 CFU / gram, 1x10^10 CFU / gram, 5x10^10 CFU / gram, 1x10^11 CFU / gram, 5x10^11 CFU / gram, 1x10^12 CFU / gram, 5x10^12 CFU / gram, 1x10^13 CFU / gram, 5x10^13 CFU / gram, 1x10^14 CFU / gram, 5x10^14 CFU / gram, 1x10^15 CFU / gram, 5x10^15 CFU / gram or more.

[0098] In some examples, at least one strain of Lactobacillus species in a pharmaceutical composition described herein has a bacterial cell density of at least about 1 x 10^3 CFU / gram, 5 x 10^3 CFU / gram, 1 x 10^4 CFU / gram, 5 x 10^4 CFU / gram, 1 x 10^5 CFU / gram, 5 x 10^5 CFU / gram, 1 x 10^6 CFU / gram, 5 x 10^6 CFU / gram, 1 x 10^7 CFU / gram, 5 x 10^7 CFU / gram, 1 x 10^8 CFU / gram, 5 x 10^8 CFU / gram, 1 x 10 ^9 CFU / gram of bacterial cells, 5x10^9 CFU / gram of bacterial cells, 1x10^10 CFU / gram of bacterial cells, 5x10^10 CFU / gram of bacterial cells, 1x10^11 CFU / gram of bacterial cells, 5x10^11 CFU / gram of bacterial cells, 1x10^12 CFU / gram of bacterial cells, 5x10^12 CFU / gram of bacterial cells, 1x10^13 CFU / gram of bacterial cells, 5x10^13 CFU / gram of bacterial cells, 1x10^14 CFU / gram of bacterial cells, 5x10^14 CFU / gram of bacterial cells, 1x10^15 CFU / gram of bacterial cells, 5x10^15 CFU / gram of bacterial cells or more.In some examples, at least one strain of Lactobacillus species in the pharmaceutical compositions described herein has a bacterial cell density of at most about 1x10^3 CFU / gram, 5x10^3 CFU / gram, 1x10^4 CFU / gram, 5x10^4 CFU / gram, 1x10^5 CFU / gram, 5x10^5 CFU / gram, 1x10^6 CFU / gram, 5x10^6 CFU / gram, 1x10^7 CFU / gram, 5x10^7 CFU / gram, 1x10^8 CFU / gram, 5x10^8 CFU / gram, 1x10^ 9 CFU / gram of bacterial cells, 5x10^9 CFU / gram of bacterial cells, 1x10^10 CFU / gram of bacterial cells, 5x10^10 CFU / gram of bacterial cells, 1x10^11 CFU / gram of bacterial cells, 5x10^11 CFU / gram of bacterial cells, 1x10^12 CFU / gram of bacterial cells, 5x10^12 CFU / gram of bacterial cells, 1x10^13 CFU / gram of bacterial cells, 5x10^13 CFU / gram of bacterial cells, 1x10^14 CFU / gram of bacterial cells, 5x10^14 CFU / gram of bacterial cells, 1x10^15 CFU / gram of bacterial cells, 5x10^15 CFU / gram of bacterial cells or more.

[0099] In some examples, at least one strain of a Lactobacillaceae species in a pharmaceutical composition described herein has a bacterial cell density of at least about 1 x 10^3 CFU / gram, 5 x 10^3 CFU / gram, 1 x 10^4 CFU / gram, 5 x 10^4 CFU / gram, 1 x 10^5 CFU / gram, 5 x 10^5 CFU / gram, 1 x 10^6 CFU / gram, 5 x 10^6 CFU / gram, 1 x 10^7 CFU / gram, 5 x 10^7 CFU / gram, 1 x 10^8 CFU / gram, 5 x 10^8 CFU / gram, 1 ... The bacterial cells may include 0^9 CFU / gram, 5x10^9 CFU / gram, 1x10^10 CFU / gram, 5x10^10 CFU / gram, 1x10^11 CFU / gram, 5x10^11 CFU / gram, 1x10^12 CFU / gram, 5x10^12 CFU / gram, 1x10^13 CFU / gram, 5x10^13 CFU / gram, 1x10^14 CFU / gram, 5x10^14 CFU / gram, 1x10^15 CFU / gram, 5x10^15 CFU / gram or more.In some examples, at least one strain of a species of the Lactobacillaceae family in a pharmaceutical composition described herein has a bacterial cell density of at most about 1 x 10^3 CFU / gram, 5 x 10^3 CFU / gram, 1 x 10^4 CFU / gram, 5 x 10^4 CFU / gram, 1 x 10^5 CFU / gram, 5 x 10^5 CFU / gram, 1 x 10^6 CFU / gram, 5 x 10^6 CFU / gram, 1 x 10^7 CFU / gram, 5 x 10^7 CFU / gram, 1 x 10^8 CFU / gram, 5 x 10^8 CFU / gram, 1 x 10 ^9 CFU / gram of bacterial cells, 5x10^9 CFU / gram of bacterial cells, 1x10^10 CFU / gram of bacterial cells, 5x10^10 CFU / gram of bacterial cells, 1x10^11 CFU / gram of bacterial cells, 5x10^11 CFU / gram of bacterial cells, 1x10^12 CFU / gram of bacterial cells, 5x10^12 CFU / gram of bacterial cells, 1x10^13 CFU / gram of bacterial cells, 5x10^13 CFU / gram of bacterial cells, 1x10^14 CFU / gram of bacterial cells, 5x10^14 CFU / gram of bacterial cells, 1x10^15 CFU / gram of bacterial cells, 5x10^15 CFU / gram of bacterial cells or more.

[0100] Pharmaceutical Composition Forms and Administration In some examples, the pharmaceutical composition may be formulated into a suspension. In some cases, the pharmaceutical composition may be formulated into an oral dosage form. The oral dosage form of the pharmaceutical composition may include, in some cases, a capsule, a tablet, an emulsion, a suspension, a syrup, a gel, a gum, a paste, herbal tea, a drop, a dissolving granule, a powder, a tablet, a lyophilisate, a popsicle, a foam, or an ice cream. In some cases, the oral dosage form of the pharmaceutical composition may include a capsule. In some cases, the oral dosage form of the pharmaceutical composition may include a dissolving granule. In some cases, the oral dosage form of the pharmaceutical composition may include a drop. In some cases, the oral dosage form of the pharmaceutical composition may include an emulsion. In some cases, the oral dosage form of the pharmaceutical composition may include a foam. In some cases, the oral dosage form of the pharmaceutical composition may include a gel. In some cases, the oral dosage form of the pharmaceutical composition may include a gum. In some cases, the oral dosage form of the pharmaceutical composition may include an herbal tea. In some cases, the oral dosage form of the pharmaceutical composition may include an ice cream. In some cases, the oral dosage form of the pharmaceutical composition may include a lyophilisate. In some cases, the oral dosage form of the pharmaceutical composition may include a paste. In some cases, the oral dosage form of the pharmaceutical composition may include a popsicle. In some cases, the oral dosage form of the pharmaceutical composition may include a powder. In some cases, the oral dosage form of the pharmaceutical composition may include a suspension. In some cases, the oral dosage form of the pharmaceutical composition may include a syrup. In some cases, the oral dosage form of the pharmaceutical composition may include a tablet. In some cases, the oral dosage form of the pharmaceutical composition may include a pill, a gel tab, a sachet, a lozenge, or any other suitable oral dosage form. In some cases, the oral dosage form or suspension form of the pharmaceutical composition may be administered alone. In other cases, the oral dosage form or suspension form of the pharmaceutical composition may be mixed with food for administration to a subject. Such food may include powdered milk, milk, or any derivative thereof. In some cases, the pharmaceutical composition may be formulated into a parenteral dosage form. The parenteral dosage form may be in the form of a suppository in some cases, for example, and may include various parenteral routes.

[0101] In some cases, the pharmaceutical composition may be contained in a primary container. In some examples, the pharmaceutical composition may be contained in a capsule. In some cases, the capsule containing the pharmaceutical composition may include a plant-based capsule. In some cases, the capsule containing the pharmaceutical composition may include a vegan capsule. In some cases, the plant-based capsule may include a plant-derived material. The plant-derived material may include, in some cases, a cellulosic polymer. In some cases, the plant-based capsule may include a hypromellose capsule. In some cases, the plant-based capsule may include a hydroxypropyl methylcellulose (HPMC) capsule. In some cases, the plant-based capsule may include a starch capsule. In some cases, the plant-based capsule may include a hydrolyzed plant-based collagen capsule. In some cases, the plant-based capsule may include a pullulan capsule. In some cases, the plant-based capsule may include a tapioca capsule. In some cases, the plant-based capsule may include any combination of plant-based materials described. The primary container may include, in some cases, any capsule described herein and its derivatives.

[0102] In some cases, the capsule may not be administered to the subject. In some cases, the capsule may not be administered to the subject together with a pharmaceutical composition. In other cases, the capsule may be administered to the subject.

[0103] The capsule may be enterically coated. The enterically coated capsule may include fatty acids, waxes, shellac, plastics, vegetable fibers, or any combination thereof. The capsule may have a size of 000, 00, 0, 1, 2, 3, 4, or 5 empty pill capsule size. In some cases, the capsule may include gelatin.

[0104] The capsules may be starch-free, gluten-free, and preservative-free. When the capsules are filled with unformulated acetaminophen, greater than 90% of the capsules dissolve within 60 minutes as measured by acetaminophen dissolution in water, pH=1.2 solution, sodium acetate buffer USP (pH=4.5), or sodium phosphate buffer (pH=7.2). The capsules may have a disintegration endpoint of about 1.6 minutes as measured at 37° C. with deionized water. The capsules may have a disintegration endpoint of about 0.1, 0.5, 0.6, 0.7, 1.9, 0.9, 1, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 2.9, 2.0, 2.1, 2.2, 2.3, 3.4, 2.5, 2.6, 2.7, 2.8, 37, 3, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.9, or 4 minutes when measured at 37° C. using deionized water. When measured at 37°C using deionized water, the capsules showed the following peak times: 0.1-0.5 min, 0.51-0.6 min, 0.61-0.7 min, 0.71-0.8 min, 0.81-0.9 min, 0.91-1 min, 1.01-1.1 min, 1.11-1.2 min, 1.21-1.3 min, 1.31-1.4 min, 1.41-1.5 min, 1.51-1.6 min, 1.61-1.7 min, 1.71-1.8 min, 1.81-1.9 min, 1.91-2 min, 2.01-2.1 min, 2.1 The capsule may have a collapse endpoint of 1 to 2.2 minutes, 2.21 to 2.3 minutes, 2.31 to 2.4 minutes, 2.41 to 2.5 minutes, 2.51 to 2.6 minutes, 2.61 to 2.7 minutes, 2.71 to 2.8 minutes, 2.81 to 2.9 minutes, 2.91 to 3 minutes, 3.01 to 3.1 minutes, 3.11 to 3.2 minutes, 3.21 to 3.3 minutes, 3.31 to 3.4 minutes, 3.41 to 3.5 minutes, 3.51 to 3.6 minutes, 3.61 to 3.7 minutes, 3.71 to 3.8 minutes, 3.81 to 3.9 minutes, or 3.91 to 4 minutes. The capsule may have an oxygen permeability (cm) of 0.5 or less as measured by the gas composition within the capsule. 3 / m 2 The capsule may have an oxygen transmission rate (cm) of 0.0001 or less, 0.0005 or less, 0.001 or less, 0.005 or less, 0.01 or less, 0.05 or less, 0.1 or less, 0.5 or less, 1 or less, 1.5 or less, 2 or less, 5 or less, or 10 or less, as measured by the gas composition within the capsule. 3 / m2 / day).

[0105] In some cases, the pharmaceutical composition may be lyophilized. In some cases, the pharmaceutical composition may be frozen. Such frozen formulations or lyophilized formulations may be administered to a subject in a frozen or lyophilized state. In some examples, such frozen formulations may be popsicles, ice cream, or other frozen formulations.

[0106] In some cases, the liquid suspension may be dispensed into a specific volume to provide a unit dose of such oral dosage form. Such a unit dose may have a volume of about 0.25, 0.5, 1, 2, 3, 5 or 10 mL. In some examples, a unit dose of the pharmaceutical composition herein has a volume of about 1 mL. Such pharmaceutical compositions may include a bacterial population, a cryoprotectant, an antioxidant, a buffered aqueous solution that may be derived from the liquid cell suspension. Such cell suspensions may be tested for quality control to ensure that they contain a certain number of metabolically active cells per bacterial strain described herein.

[0107] In some examples, the pharmaceutical compositions described herein are lyophilized or frozen. The bacterial cells in the lyophilized or frozen pharmaceutical compositions can be stored at -70°C. In some embodiments, the bacterial cells can be stored at 10°C, 4°C, 0°C, -5°C, -10°C, -15°C, -20°C, -25°C, -30°C, -35°C, -40°C, -45°C, -50°C, -55°C, -60°C, -65°C, -70°C, -75°C, or -80°C. In other cases, the bacterial cells can be stored at -80°C to -70°C, -70°C to -60°C, -60°C to -50°C, -50°C to -40°C, -40°C to -30°C, -30°C to -20°C, -20°C to -10°C, -10°C to 0°C, or 0°C to 10°C. In some embodiments, at least 70% of the stored lyophilized or frozen bacterial cells may remain viable after 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, 12 months, 13 months, 14 months, 15 months, 16 months, 17 months, 18 months, 19 months, 20 months, 21 months, 22 months, 23 months, 24 months, 25 months, 26 months, 27 months, 28 months, 29 months, 30 months, 31 months, 32 months, 33 months, 34 months, 35 months, or 36 months. In some cases, at least 75% of the stored lyophilized or frozen bacterial cells may remain viable after 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, 12 months, 13 months, 14 months, 15 months, 16 months, 17 months, 18 months, 19 months, 20 months, 21 months, 22 months, 23 months, 24 months, 25 months, 26 months, 27 months, 28 months, 29 months, 30 months, 31 months, 32 months, 33 months, 34 months, 35 months, or 36 months. In other cases, at least 80% of the stored lyophilized or frozen bacterial cells may remain viable after 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, 12 months, 13 months, 14 months, 15 months, 16 months, 17 months, 18 months, 19 months, 20 months, 21 months, 22 months, 23 months, 24 months, 25 months, 26 months, 27 months, 28 months, 29 months, 30 months, 31 months, 32 months, 33 months, 34 months, 35 months, or 36 months.In some embodiments, at least 85% of the stored lyophilized or frozen bacterial cells may remain viable after 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, 12 months, 13 months, 14 months, 15 months, 16 months, 17 months, 18 months, 19 months, 20 months, 21 months, 22 months, 23 months, 24 months, 25 months, 26 months, 27 months, 28 months, 29 months, 30 months, 31 months, 32 months, 33 months, 34 months, 35 months, or 36 months. In other embodiments, at least 90% of the stored lyophilized or frozen bacterial cells may remain viable after 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, 12 months, 13 months, 14 months, 15 months, 16 months, 17 months, 18 months, 19 months, 20 months, 21 months, 22 months, 23 months, 24 months, 25 months, 26 months, 27 months, 28 months, 29 months, 30 months, 31 months, 32 months, 33 months, 34 months, 35 months, or 36 months. At least 95% of the stored lyophilized or frozen bacterial cells may also remain viable after 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, 12 months, 13 months, 14 months, 15 months, 16 months, 17 months, 18 months, 19 months, 20 months, 21 months, 22 months, 23 months, 24 months, 25 months, 26 months, 27 months, 28 months, 29 months, 30 months, 31 months, 32 months, 33 months, 34 months, 35 months, or 36 months. In some embodiments, at least 99% of the stored lyophilized or frozen bacterial cells may remain viable after 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, 12 months, 13 months, 14 months, 15 months, 16 months, 17 months, 18 months, 19 months, 20 months, 21 months, 22 months, 23 months, 24 months, 25 months, 26 months, 27 months, 28 months, 29 months, 30 months, 31 months, 32 months, 33 months, 34 months, 35 months, or 36 months.

[0108] In some examples, the pharmaceutical composition has storage stability. The storage stability of the pharmaceutical composition may include maintaining the stability of the pharmaceutical composition. The storage stability of the pharmaceutical composition may include maintaining the pharmaceutical activity or pharmacological stability of the pharmaceutical composition. The storage stability of the pharmaceutical composition may also include maintaining the biological or physiological activity that the pharmaceutical composition induces in a subject (e.g., the ability to treat or prevent the risk of a disease in a subject). In some cases, the storage stability may include a measurable variable that indicates or correlates with the stability of the pharmaceutical composition, the pharmaceutical activity of the pharmaceutical composition, the pharmacological stability of the pharmaceutical composition, the biological or physiological activity of the pharmaceutical composition that it induces in a subject, or any combination thereof. In some cases, the storage stability of the pharmaceutical composition may include the viability of the strain(s) of the pharmaceutical composition.

[0109] In some examples, storage stability can be evaluated after the pharmaceutical composition is stored in an environment. In some examples, storage stability can be evaluated while the pharmaceutical composition is stored in an environment. In some examples, storage stability can be evaluated before the pharmaceutical composition is stored in an environment. Storage stability can be evaluated in some cases at any time after the production or manufacture of the pharmaceutical composition. Storage stability can be evaluated for the pharmaceutical composition as a whole. Storage stability can be evaluated for individual bacterial strains in the bacterial population. Storage stability can be evaluated for combinations of bacterial strains in the bacterial population. In some examples, storage stability is evaluated at a time after the pharmaceutical composition is manufactured. In some examples, storage stability is evaluated at a time before the pharmaceutical composition is manufactured. In some examples, storage stability is evaluated at a time while the pharmaceutical composition is manufactured. To achieve storage stability, the pharmaceutical composition can include a cryoprotectant, a pharma- ceutically acceptable excipient, be stored in a capsule, or a combination thereof.

[0110] In some examples, the storage stability of the pharmaceutical composition can be evaluated by measuring the viability of the bacterial population of the pharmaceutical composition. The viability of the bacterial population of the pharmaceutical can be measured as the number of bacterial cells in the pharmaceutical composition. The viability of the bacterial population can be measured in CFU. The viability of the bacterial population can also be measured by other means, including but not limited to optical density, which can measure the number of bacterial cells.

[0111] In some examples, the storage stability of a pharmaceutical composition can be represented by the ratio of the viability of the number of bacterial cells of the bacterial population of the pharmaceutical composition after the pharmaceutical composition is stored in an environment to the number of bacterial cells of the bacterial population of the equivalent pharmaceutical composition before the equivalent pharmaceutical composition is stored in the environment. In some examples, the storage stability of a pharmaceutical composition can be represented by the ratio of the viability of the number of bacterial cells of the bacterial population of the pharmaceutical composition after the pharmaceutical composition is stored in an environment to the number of bacterial cells of the bacterial population of the equivalent pharmaceutical composition not stored in the environment. The environment can be an anaerobic environment or an aerobic environment. The environment can be an anaerobic environment. The environment can be an aerobic environment. An equivalent pharmaceutical composition of a pharmaceutical composition can include a pharmaceutical composition having the same or substantially the same composition of the pharmaceutical composition. The composition of the pharmaceutical composition (or equivalent) can include any one or all strains of the bacterial population, the number or percentage of bacterial cells of the bacterial strain, the amount of pharma- ceutically acceptable excipients or cryoprotectants, the manufacturing method used, or any combination thereof.

[0112] For example, the storage stability of a pharmaceutical composition can be calculated by comparing the viability of the bacterial population of the pharmaceutical composition at a time point after the pharmaceutical composition is stored in the environment. In some cases, the storage stability can be measured from about 0 to about 500 days after storage in the environment. In some cases, the storage stability can be measured after about 3 days after storage in the environment. In some cases, the storage stability can be measured after about 10 days after storage in the environment. In some cases, the storage stability can be measured after about 100 days after storage in the environment.

[0113] In some examples, the pharmaceutical composition can have a storage stability of about 1×10^-8% to about 100% after storage in the environment. In some cases, the pharmaceutical composition can have a storage stability of at least about 1×10^-8%, at least about 1×10^-7%, at least about 1×10^-6%, at least about 1×10^-5%, at least about 1×10^-4%, at least about 1×10^-3%, at least about 1×10^-2%, at least about 0.1%, at least about 1%, at least about 5%, at least about 10%, at least about 20%, at least about 25%, at least about 30%, at least about 40%, at least about 50%, at least about 60%, at least about 70%, at least about 80%, at least about 90%, at least about 100%, or more after storage in the environment. In some cases, the pharmaceutical composition may have a storage stability of up to about 100%, up to about 90%, up to about 80%, up to about 70%, up to about 60%, up to about 50%, up to about 40%, up to about 30%, up to about 25%, up to about 20%, up to about 10%, up to about 5%, up to about 1%, up to about 0.1%, up to about 1x10^-2%, up to about 1x10^-3%, up to about 1x10^-4%, up to about 1x10^-5%, up to about 1x10^-6%, up to about 1x10^-7%, up to about 1x10^-8%, or less, after being stored in an environment. In some cases, the pharmaceutical composition may have a storage stability of at least about 1x10^-6%, at least about 1x10^-5%, at least about 1x10^-4%, at least about 1x10^-2%, at least about 1%, at least about 10%, at least about 25%, or at least about 50%.

[0114] In some examples, the pharmaceutical composition can have a storage stability of about 1×10^-8% to about 100% after storage in an anaerobic environment. In some cases, the pharmaceutical composition can have a storage stability of at least about 1×10^-8%, at least about 1×10^-7%, at least about 1×10^-6%, at least about 1×10^-5%, at least about 1×10^-4%, at least about 1×10^-3%, at least about 1×10^-2%, at least about 0.1%, at least about 1%, at least about 5%, at least about 10%, at least about 20%, at least about 25%, at least about 30%, at least about 40%, at least about 50%, at least about 60%, at least about 70%, at least about 80%, at least about 90%, at least about 100%, or more after storage in an anaerobic environment. In some cases, the pharmaceutical composition may have a storage stability of up to about 100%, up to about 90%, up to about 80%, up to about 70%, up to about 60%, up to about 50%, up to about 40%, up to about 30%, up to about 25%, up to about 20%, up to about 10%, up to about 5%, up to about 1%, up to about 0.1%, up to about 1x10^-2%, up to about 1x10^-3%, up to about 1x10^-4%, up to about 1x10^-5%, up to about 1x10^-6%, up to about 1x10^-7%, up to about 1x10^-8%, or less, after being stored in an anaerobic environment. In some cases, the pharmaceutical composition may have a storage stability of at least about 1x10^-6%, at least about 1x10^-5%, at least about 1x10^-4%, at least about 1x10^-2%, at least about 1%, at least about 10%, at least about 25%, or at least about 50%.

[0115] In some examples, the pharmaceutical composition can have storage stability after being stored in the environment for about 1 day to about 500 days. In some cases, the pharmaceutical composition can have storage stability after being stored in the environment for at least about 1 day, at least about 2 days, at least about 3 days, at least about 4 days, at least about 5 days, at least about 6 days, at least about 7 days, at least about 8 days, at least about 9 days, at least about 10 days, at least about 20 days, at least about 30 days, at least about 40 days, at least about 50 days, at least about 60 days, at least about 70 days, at least about 80 days, at least about 90 days, at least about 100 days, at least about 110 days, at least about 120 days, at least about 130 days, at least about 140 days, at least about 150 days, at least about 200 days, at least about 250 days, at least about 300 days, at least about 350 days, at least about 400 days, at least about 450 days, at least about 500 days, In some cases, the pharmaceutical composition may have shelf stability after being stored in the environment for up to about 500 days, up to about 450 days, up to about 400 days, up to about 350 days, up to about 300 days, up to about 250 days, up to about 200 days, up to about 150 days, up to about 140 days, up to about 130 days, up to about 120 days, up to about 110 days, up to about 100 days, up to about 200 days, up to about 250 days, up to about 300 days, up to about 350 days, up to about 400 days, up to about 500 days, up to about 600 days, up to about 700 days, up to about 800 days, up to about 900 days, up to about 100 days, up to about 120 days, up to about 130 days, up to about 140 days, up to about 150 days, up to about 160 days, up to about 170 days, up to about 180 days, up to about 190 days, up to about 210 days, up to about 220 days, up to about 230 days, up to about 240 days, up to about 250 days, up to about 260 days, up to about 270 days, up to about 280 days, up to about 300 days, up to about 310 days, up to about 320 days, up to about 330 days, up to about 340 days, up to about 350 days, up to about 360 days, up to about 370 days, up to about 380 days, up to about 390 days, up to about 400 days, up to about 400 days, up to about 450 days, up to about 400 days, up to about 450 The composition may be shelf stable after storage for up to about 90 days, up to about 80 days, up to about 70 days, up to about 60 days, up to about 50 days, up to about 40 days, up to about 30 days, up to about 20 days, up to about 10 days, up to about 9 days, up to about 8 days, up to about 7 days, up to about 6 days, up to about 5 days, up to about 4 days, up to about 3 days, up to about 2 days, up to about 1 day, or less. In some examples, the pharmaceutical composition can have storage stability after storage in an anaerobic environment for about 1 day to about 500 days. In some cases, the pharmaceutical composition can have storage stability after storage in an anaerobic environment for at least about 1 day, at least about 2 days, at least about 3 days, at least about 4 days, at least about 5 days, at least about 6 days, at least about 7 days, at least about 8 days, at least about 9 days, at least about 10 days, at least about 20 days, at least about 30 days, at least about 40 days, at least about 50 days, at least about 60 days, at least about 70 days, at least about 80 days, at least about 90 days, at least about 100 days, at least about 110 days, at least about 120 days, at least about 130 days, at least about 140 days, at least about 150 days, at least about 200 days, at least about 250 days, at least about 300 days, at least about 350 days, at least about 400 days, at least about 450 days, at least about 500 days. In some cases, the pharmaceutical composition may have shelf stability after being stored in an anaerobic environment for up to about 500 days, up to about 450 days, up to about 400 days, up to about 350 days, up to about 300 days, up to about 250 days, up to about 200 days, up to about 150 days, up to about 140 days, up to about 130 days, up to about 120 days, up to about 110 days, up to about 100 days, The composition may be storage stable after storage for up to about 90 days, up to about 80 days, up to about 70 days, up to about 60 days, up to about 50 days, up to about 40 days, up to about 30 days, up to about 20 days, up to about 10 days, up to about 9 days, up to about 8 days, up to about 7 days, up to about 6 days, up to about 5 days, up to about 4 days, up to about 3 days, up to about 2 days, up to about 1 day, or less. In some examples, the pharmaceutical composition can be storage stable after storage in an environment at a temperature of about −80° C. to about 42° C. In some cases, the pharmaceutical composition can be storage stable after storage in an environment at a temperature of at least about −80° C., at least about −20° C., at least about −10° C., at least about −4° C., at least about 0° C., at least about 5° C., at least about 10° C., at least about 15° C., at least about 20° C., at least about 25° C., at least about 30° C., at least about 35° C., at least about 40° C., at least about 42° C., or greater. In some cases, the pharmaceutical composition may have storage stability after being stored in an environment at a temperature of up to about 42°C, up to about 40°C, up to about 35°C, up to about 30°C, up to about 25°C, up to about 20°C, up to about 15°C, up to about 10°C, up to about 5°C, up to about 0°C, up to about -4°C, up to about -10°C, up to about -20°C, up to about -80°C or less.

[0116] In some examples, the pharmaceutical composition can be storage stable after storage in an anaerobic environment at a temperature of about −80° C. to about 42° C. In some cases, the pharmaceutical composition can be storage stable after storage in an anaerobic environment at a temperature of at least about −80° C., at least about −20° C., at least about −10° C., at least about −4° C., at least about 0° C., at least about 5° C., at least about 10° C., at least about 15° C., at least about 20° C., at least about 25° C., at least about 30° C., at least about 35° C., at least about 40° C., at least about 42° C., or greater. In some cases, the pharmaceutical composition may have storage stability after storage in an anaerobic environment at temperatures up to about 42° C., up to about 40° C., up to about 35° C., up to about 30° C., up to about 25° C., up to about 20° C., up to about 15° C., up to about 10° C., up to about 5° C., up to about 0° C., up to about −4° C., up to about −10° C., up to about −20° C., up to about −80° C. or less.

[0117] Pharmaceutical Composition Pack In some examples, the botanical capsule containing the pharmaceutical composition may be contained in a blister pack. In some examples, the botanical capsule containing the pharmaceutical composition may be contained in a sachet pack. In some cases, the botanical capsule containing the pharmaceutical composition may be contained in a secondary container. The secondary container may be a blister pack, a vial, a bottle, an ampoule, or a combination thereof. The secondary container may be a blister pack. The secondary container may be a vial. The secondary container may be a bottle. The secondary container may be an ampoule. In some cases, the blister pack containing the botanical capsule containing the pharmaceutical composition may comprise an aluminum blister pack. In some cases, the blister pack may comprise polyethylene terephthalate (PET), polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), polychlorotrifluoroethylene (PCTFE), cyclic olefin polymer (COP), oriented polyamide (OPA), aluminum foil, or a plastic film. In some cases, the sachet pack may comprise metal foil, cloth, plastic, paper, polyethylene terephthalate (PET), polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), polychlorotrifluoroethylene (PCTFE), cyclic olefin polymer (COP), oriented polyamide (OPA), or a combination thereof. In some cases, the blister pack containing the plant-based capsule containing the pharmaceutical composition may comprise polyethylene terephthalate (PET), polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), polychlorotrifluoroethylene (PCTFE), cyclic olefin polymer (COP), oriented polyamide (OPA), aluminum foil, or plastic film. In some cases, the blister pack containing the plant-based capsule containing the pharmaceutical composition may comprise a derivative or combination of the listed materials. In some cases, the blister pack containing the plant-based capsule containing the pharmaceutical composition may comprise PET. In some cases, the blister pack containing the plant-based capsule containing the pharmaceutical composition may comprise PVC. In some cases, the blister pack containing the plant-based capsule containing the pharmaceutical composition may comprise PVDC.In some cases, the blister pack containing the plant-based capsule containing the pharmaceutical composition may comprise PCTFE. In some cases, the blister pack containing the plant-based capsule containing the pharmaceutical composition may comprise COP. In some cases, the blister pack containing the plant-based capsule containing the pharmaceutical composition may comprise OPA. In some cases, the blister pack containing the plant-based capsule containing the pharmaceutical composition may comprise aluminum foil. In some cases, the blister pack containing the plant-based capsule containing the pharmaceutical composition may comprise plastic film. In some cases, the secondary container containing the plant-based capsule containing the pharmaceutical composition may comprise any material described for the blister pack. In some cases, the pharmaceutical composition may be contained in a blister pack, vial, bottle, ampoule, or secondary container without being contained in a capsule. In some cases, the pharmaceutical composition may be contained in a blister pack, vial, bottle, ampoule, or secondary container without being contained in a primary container.

[0118] In some cases, the blister pack may be filled with nitrogen gas. In some cases, the blister pack may be filled with pure nitrogen gas. In some cases, the blister pack may be filled with about 100% of the atmosphere by volume of nitrogen gas. In some cases, the blister pack containing the pharmaceutical composition may be filled with 99% of the atmosphere by volume of nitrogen gas. In some cases, the blister pack containing the pharmaceutical composition may be filled with 98% of the atmosphere by volume of nitrogen gas. In some cases, the blister pack containing the pharmaceutical composition may be filled with 97% of the atmosphere by volume of nitrogen gas. In some cases, the blister pack containing the pharmaceutical composition may be filled with 96% of the atmosphere by volume of nitrogen gas. In some cases, the blister pack containing the pharmaceutical composition may be filled with 95% of the atmosphere by volume of nitrogen gas. In some cases, the blister pack containing the pharmaceutical composition may be filled with 94% of the atmosphere by volume of nitrogen gas. In some cases, the blister pack containing the pharmaceutical composition may be filled with 93% of the atmosphere by volume of nitrogen gas. In some cases, the blister pack containing the pharmaceutical composition may be filled with 92% of the atmosphere by volume of nitrogen gas. In some cases, the blister pack containing the pharmaceutical composition may be filled with 91% by volume of the atmosphere of nitrogen gas. In some cases, the blister pack containing the pharmaceutical composition may be filled with 90% by volume of the atmosphere of nitrogen gas. In some cases, the blister pack containing the pharmaceutical composition may be filled with 89% by volume of the atmosphere of nitrogen gas. In some cases, the blister pack containing the pharmaceutical composition may be filled with 88% by volume of the atmosphere of nitrogen gas. In some cases, the blister pack containing the pharmaceutical composition may be filled with 87% by volume of the atmosphere of nitrogen gas. In some cases, the blister pack containing the pharmaceutical composition may be filled with 86% by volume of the atmosphere of nitrogen gas. In some cases, the blister pack containing the pharmaceutical composition may be filled with 85% by volume of the atmosphere of nitrogen gas. In some cases, the blister pack containing the pharmaceutical composition may be filled with 84% by volume of the atmosphere of nitrogen gas. In some cases, the blister pack containing the pharmaceutical composition may be filled with 83% by volume of the atmosphere of nitrogen gas.In some cases, the blister pack containing the pharmaceutical composition may be filled with 82% by volume of the atmosphere of nitrogen gas. In some cases, the blister pack containing the pharmaceutical composition may be filled with 81% by volume of the atmosphere of nitrogen gas. In some cases, the blister pack containing the pharmaceutical composition may be filled with 80% by volume of the atmosphere of nitrogen gas. In some cases, the blister pack containing the pharmaceutical composition may be filled with 80% by volume to about 99% by volume of the atmosphere of nitrogen gas. In some cases, the blister pack containing the pharmaceutical composition may be filled with 85% by volume to about 99% by volume of the atmosphere of nitrogen gas. In some cases, the blister pack containing the pharmaceutical composition may be filled with 90% by volume to about 99% by volume of the atmosphere of nitrogen gas. In some cases, the blister pack containing the pharmaceutical composition may be filled with 95% by volume to about 99% by volume of the atmosphere of nitrogen gas. In some cases, the blister pack containing the pharmaceutical composition may be filled with 96% by volume to about 99% by volume of the atmosphere of nitrogen gas. In some cases, the blister pack containing the pharmaceutical composition may be filled with 97% to about 99% by volume of the atmosphere of nitrogen gas. In some cases, the blister pack containing the pharmaceutical composition may be filled with 98% to about 99% by volume of the atmosphere of nitrogen gas.

[0119] In some cases, the blister pack containing the plant-based capsule containing the pharmaceutical composition may contain about 100% nitrogen gas by volume of the atmosphere. In some cases, the blister pack containing the plant-based capsule containing the pharmaceutical composition may contain about 99% nitrogen gas by volume of the atmosphere. In some cases, the blister pack containing the plant-based capsule containing the pharmaceutical composition may contain about 98% nitrogen gas by volume of the atmosphere. In some cases, the blister pack containing the plant-based capsule containing the pharmaceutical composition may contain about 97% nitrogen gas by volume of the atmosphere. In some cases, the blister pack containing the plant-based capsule containing the pharmaceutical composition may contain about 96% nitrogen gas by volume of the atmosphere. In some cases, the blister pack containing the plant-based capsule containing the pharmaceutical composition may contain about 95% nitrogen gas by volume of the atmosphere. In some cases, the blister pack containing the plant-based capsule containing the pharmaceutical composition may contain about 94% nitrogen gas by volume of the atmosphere. In some cases, the blister pack containing the plant-based capsule containing the pharmaceutical composition may contain about 93% nitrogen gas by volume of the atmosphere. In some cases, the blister pack containing the plant-based capsule containing the pharmaceutical composition may contain about 92% nitrogen gas by volume of the atmosphere. In some cases, the blister pack containing the plant-based capsule containing the pharmaceutical composition may contain about 91% nitrogen gas by volume of the atmosphere. In some cases, the blister pack containing the plant-based capsule containing the pharmaceutical composition may contain about 90% nitrogen gas by volume of the atmosphere. In some cases, the blister pack containing the plant-based capsule containing the pharmaceutical composition may contain about 89% nitrogen gas by volume of the atmosphere. In some cases, the blister pack containing the plant-based capsule containing the pharmaceutical composition may contain about 88% nitrogen gas by volume of the atmosphere. In some cases, the blister pack containing the plant-based capsule containing the pharmaceutical composition may contain about 87% nitrogen gas by volume of the atmosphere. In some cases, the blister pack containing the plant-based capsule containing the pharmaceutical composition may contain about 86% nitrogen gas by volume of the atmosphere. In some cases, the blister pack containing the plant-based capsule containing the pharmaceutical composition may contain about 85% nitrogen gas by volume of the atmosphere.In some cases, the blister pack containing the plant-based capsule containing the pharmaceutical composition may contain about 84% by volume of the atmosphere of nitrogen gas. In some cases, the blister pack containing the plant-based capsule containing the pharmaceutical composition may contain about 83% by volume of the atmosphere of nitrogen gas. In some cases, the blister pack containing the plant-based capsule containing the pharmaceutical composition may contain about 82% by volume of the atmosphere of nitrogen gas. In some cases, the blister pack containing the plant-based capsule containing the pharmaceutical composition may contain about 81% by volume of the atmosphere of nitrogen gas. In some cases, the blister pack containing the plant-based capsule containing the pharmaceutical composition may contain about 80% by volume of the atmosphere of nitrogen gas. In some cases, the blister pack containing the plant-based capsule containing the pharmaceutical composition may contain about 80% to about 99% by volume of the atmosphere of nitrogen gas. In some cases, the blister pack containing the plant-based capsule containing the pharmaceutical composition may contain about 85% to about 99% by volume of the atmosphere of nitrogen gas. In some cases, the blister pack containing the plant-based capsule containing the pharmaceutical composition may contain about 90% to about 99% by volume of the atmosphere of nitrogen gas. In some cases, the blister pack containing the botanical capsule containing the pharmaceutical composition may contain about 95% to about 99% by volume of the atmosphere of nitrogen gas. In some cases, the blister pack containing the botanical capsule containing the pharmaceutical composition may contain about 96% to about 99% by volume of the atmosphere of nitrogen gas. In some cases, the blister pack containing the botanical capsule containing the pharmaceutical composition may contain about 97% to about 99% by volume of the atmosphere of nitrogen gas. In some cases, the blister pack containing the botanical capsule containing the pharmaceutical composition may contain about 98% to about 99% by volume of the atmosphere of nitrogen gas.

[0120] In some cases, the sachet pack may be filled with nitrogen gas. In some cases, the sachet pack may be filled with pure nitrogen gas. In some cases, the sachet pack may be filled with about 100% by volume of the atmosphere of nitrogen gas. In some cases, the sachet pack containing the pharmaceutical composition may be filled with 99% by volume of the atmosphere of nitrogen gas. In some cases, the sachet pack containing the pharmaceutical composition may be filled with 98% by volume of the atmosphere of nitrogen gas. In some cases, the sachet pack containing the pharmaceutical composition may be filled with 97% by volume of the atmosphere of nitrogen gas. In some cases, the sachet pack containing the pharmaceutical composition may be filled with 96% by volume of the atmosphere of nitrogen gas. In some cases, the sachet pack containing the pharmaceutical composition may be filled with 95% by volume of the atmosphere of nitrogen gas. In some cases, the sachet pack containing the pharmaceutical composition may be filled with 94% by volume of the atmosphere of nitrogen gas. In some cases, the sachet pack containing the pharmaceutical composition may be filled with 93% by volume of the atmosphere of nitrogen gas. In some cases, the sachet pack containing the pharmaceutical composition may be filled with 92% by volume of the atmosphere of nitrogen gas. In some cases, the sachet pack containing the pharmaceutical composition may be filled with 91% by volume of the atmosphere of nitrogen gas. In some cases, the sachet pack containing the pharmaceutical composition may be filled with 90% by volume of the atmosphere of nitrogen gas. In some cases, the sachet pack containing the pharmaceutical composition may be filled with 89% by volume of the atmosphere of nitrogen gas. In some cases, the sachet pack containing the pharmaceutical composition may be filled with 88% by volume of the atmosphere of nitrogen gas. In some cases, the sachet pack containing the pharmaceutical composition may be filled with 87% by volume of the atmosphere of nitrogen gas. In some cases, the sachet pack containing the pharmaceutical composition may be filled with 86% by volume of the atmosphere of nitrogen gas. In some cases, the sachet pack containing the pharmaceutical composition may be filled with 85% by volume of the atmosphere of nitrogen gas. In some cases, the sachet pack containing the pharmaceutical composition may be filled with 84% by volume of the atmosphere of nitrogen gas. In some cases, the sachet pack containing the pharmaceutical composition may be filled with 83% by volume of the atmosphere of nitrogen gas. In some cases, the sachet pack containing the pharmaceutical composition may be filled with 82% by volume of the atmosphere of nitrogen gas.In some cases, the sachet pack containing the pharmaceutical composition may be filled with 81% by volume of the atmosphere of nitrogen gas. In some cases, the sachet pack containing the pharmaceutical composition may be filled with 80% by volume of the atmosphere of nitrogen gas. In some cases, the sachet pack containing the pharmaceutical composition may be filled with 80% by volume to about 99% by volume of the atmosphere of nitrogen gas. In some cases, the sachet pack containing the pharmaceutical composition may be filled with 85% by volume to about 99% by volume of the atmosphere of nitrogen gas. In some cases, the sachet pack containing the pharmaceutical composition may be filled with 90% by volume to about 99% by volume of the atmosphere of nitrogen gas. In some cases, the sachet pack containing the pharmaceutical composition may be filled with 95% by volume to about 99% by volume of the atmosphere of nitrogen gas. In some cases, the sachet pack containing the pharmaceutical composition may be filled with 96% by volume to about 99% by volume of the atmosphere of nitrogen gas. In some cases, the sachet pack containing the pharmaceutical composition may be filled with 97% by volume to about 99% by volume of the atmosphere of nitrogen gas. In some cases, the sachet pack containing the pharmaceutical composition may be filled with 98% to about 99% by volume of the atmosphere of nitrogen gas.

[0121] In some cases, the sachet pack containing the botanical capsule containing the pharmaceutical composition may comprise about 100% nitrogen gas by volume of the atmosphere. In some cases, the sachet pack containing the botanical capsule containing the pharmaceutical composition may comprise about 99% nitrogen gas by volume of the atmosphere. In some cases, the sachet pack containing the botanical capsule containing the pharmaceutical composition may comprise about 98% nitrogen gas by volume of the atmosphere. In some cases, the sachet pack containing the botanical capsule containing the pharmaceutical composition may comprise about 97% nitrogen gas by volume of the atmosphere. In some cases, the sachet pack containing the botanical capsule containing the pharmaceutical composition may comprise about 96% nitrogen gas by volume of the atmosphere. In some cases, the sachet pack containing the botanical capsule containing the pharmaceutical composition may comprise about 95% nitrogen gas by volume of the atmosphere. In some cases, the sachet pack containing the botanical capsule containing the pharmaceutical composition may comprise about 94% nitrogen gas by volume of the atmosphere. In some cases, the sachet pack containing the botanical capsule containing the pharmaceutical composition may comprise about 93% nitrogen gas by volume of the atmosphere. In some cases, the sachet pack containing the botanical capsule containing the pharmaceutical composition may comprise about 92% nitrogen gas by volume of the atmosphere. In some cases, the sachet pack containing the botanical capsule containing the pharmaceutical composition may comprise about 91% nitrogen gas by volume of the atmosphere. In some cases, the sachet pack containing the botanical capsule containing the pharmaceutical composition may comprise about 90% nitrogen gas by volume of the atmosphere. In some cases, the sachet pack containing the botanical capsule containing the pharmaceutical composition may comprise about 89% nitrogen gas by volume of the atmosphere. In some cases, the sachet pack containing the botanical capsule containing the pharmaceutical composition may comprise about 88% nitrogen gas by volume of the atmosphere. In some cases, the sachet pack containing the botanical capsule containing the pharmaceutical composition may comprise about 87% nitrogen gas by volume of the atmosphere. In some cases, the sachet pack containing the botanical capsule containing the pharmaceutical composition may comprise about 86% nitrogen gas by volume of the atmosphere. In some cases, the sachet pack containing the botanical capsule containing the pharmaceutical composition may comprise about 85% nitrogen gas by volume of the atmosphere.In some cases, the sachet pack containing the botanical capsule containing the pharmaceutical composition may comprise about 84% by volume of the atmosphere of nitrogen gas. In some cases, the sachet pack containing the botanical capsule containing the pharmaceutical composition may comprise about 83% by volume of the atmosphere of nitrogen gas. In some cases, the sachet pack containing the botanical capsule containing the pharmaceutical composition may comprise about 82% by volume of the atmosphere of nitrogen gas. In some cases, the sachet pack containing the botanical capsule containing the pharmaceutical composition may comprise about 81% by volume of the atmosphere of nitrogen gas. In some cases, the sachet pack containing the botanical capsule containing the pharmaceutical composition may comprise about 80% by volume of the atmosphere of nitrogen gas. In some cases, the sachet pack containing the botanical capsule containing the pharmaceutical composition may comprise about 80% to about 99% by volume of the atmosphere of nitrogen gas. In some cases, the sachet pack containing the botanical capsule containing the pharmaceutical composition may comprise about 85% to about 99% by volume of the atmosphere of nitrogen gas. In some cases, the sachet pack containing the botanical capsule containing the pharmaceutical composition may comprise about 90% to about 99% by volume of the atmosphere of nitrogen gas. In some cases, the sachet pack containing the botanical capsule containing the pharmaceutical composition may comprise about 95% to about 99% by volume of the atmosphere of nitrogen gas. In some cases, the sachet pack containing the botanical capsule containing the pharmaceutical composition may comprise about 96% to about 99% by volume of the atmosphere of nitrogen gas. In some cases, the sachet pack containing the botanical capsule containing the pharmaceutical composition may comprise about 97% to about 99% by volume of the atmosphere of nitrogen gas. In some cases, the sachet pack containing the botanical capsule containing the pharmaceutical composition may comprise about 98% to about 99% by volume of the atmosphere of nitrogen gas.

[0122] Botanical medicinal compositions In some examples, the pharmaceutical compositions described in this disclosure may be plant-based. In some cases, the pharmaceutical compositions described in this disclosure may be vegan. In some cases, the pharmaceutical compositions may be plant-based if they do not contain any substances or products derived from slaughter. In some cases, the pharmaceutical compositions may be vegan if they do not contain any substances or products derived from animals. A substance may be derived from an animal if it is synthesized by or isolated from an animal. A substance may also be derived from an animal if it is directly derived from a product synthesized by or isolated from an animal. A substance may be synthesized by or isolated from an animal if a significant portion of the population of molecules of the substance is synthesized by an animal. A product may be synthesized by or isolated from an animal if a significant portion of the population of molecules of the product is synthesized by an animal. A substantial portion can include an amount of at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 55%, at least about 60%, at least about 65%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, at least about 90%, at least about 95%, at least about 96%, at least about 97%, at least about 98%, or at least about 99%.

[0123] Cryoprotectants and antioxidants Provided herein are pharmaceutical compositions that can include one or more cryoprotectants. The cryoprotectants can have a composition as described in Table 5 or Example 1. Such cryoprotectants can be used to maintain the viability of bacterial cells in pharmaceutical compositions when such compositions are frozen or lyophilized, for example, during transportation and / or storage prior to use. In some examples, the one or more cryoprotectants can be glycerol, dimethyl sulfoxide (DMSO), ethylene glycol, propylene glycol, 2-methyl-2,4-pentanediol, trehalose, sucrose, diethyl glycol, triethylene glycol, polyvinylpyrrolidone (PVP), polyethylene glycol (PEG), saccharose, formamide, glycerol 3-phosphate, proline, methyl alcohol, glucose, bovine serum albumin, polyvinyl alcohol, hydroxyethyl starch, sorbitol, or combinations thereof. The cryoprotectant can include an ice blocker. The ice blocker can include polyglycerol, polyvinyl alcohol, X-1000, and Z-1000. Such cryoprotectants can be used in the pharmaceutical composition in an amount of about 5, 10, 15, 20, 25, or 30 volume percent (% v / v) or weight percent (% w / w), depending on whether the pharmaceutical composition is a solid dosage form (e.g., from a capsule or tablet) or a liquid dosage form (e.g., from a suspension or gel). The cryoprotectant can also include a carbohydrate or an antioxidant. The carbohydrate can include trehalose, sucrose, sorbitol, glucose, fructose, saccharose, or a combination thereof.

[0124] In some embodiments, the pharmaceutical compositions described herein further comprise an antioxidant. The cryoprotectant may comprise an antioxidant. The cryoprotectant may be present in an amount of at least about 0.001%, 0.005%, 0.01%, 0.05%, 0.1%, 0.5%, 1%, 1.5%, 2%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 99% or more of the pharmaceutical composition. The cryoprotectant may be present in an amount up to about 0.001%, 0.005%, 0.01%, 0.05%, 0.1%, 0.5%, 1%, 1.5%, 2%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 99% or more of the pharmaceutical composition. The cryoprotectant may be present in an amount of about 0.001%-0.005%, 0.0051%-0.01%, 0.011%-0.05%, 0.05%-0.1%, 0.051%-0.1%, 0.11%-0.5%, 0.51%-1%, 1.1%-1.5%, 1.5%-2%, 2.1%-5%, or 5.1%-10% of the pharmaceutical composition. The percentage of the cryoprotectant may be measured by weight or volume of the pharmaceutical composition.

[0125] In some embodiments, the antioxidant is L-cysteine, in some embodiments, the L-cysteine ​​is present in an amount of about 0.001%, 0.005%, 0.01%, 0.05%, 0.1%, 0.5%, 1%, 1.5%, 2%, 5%, 10%, 0.001%-0.005%, 0.0051%-0.01%, 0.011%-0.05%, 0.05%-0.1%, 0.051%-0.1%, 0.11%-0.5%, 0.51%-1%, 1.1%-1.5%, 1.5%-2%, 2.1%-5%, or 5.1%-10%. Sucrose may be about 0.1%, 0.5%, 1%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 51%, 52%, 53%, 54%, 55%, 56%, 57%, 58%, 59%, 60%, 61%, 62%, 63%, 64%, 65%, 66%, 67%, 68%, 69%, 70%, 71%, 72%, 73%, 74%, 75%, 76%, 77%, 78%, 79%, 80%, 0.1% to 10% of the pharmaceutical composition. It may be present in an amount of 1%, 1%-5%, 5%-10%, 10-15%, 15-20%, 20-25%, 25-30%, 30-35%, 35-40%, 40-45%, 45-50%, 50-55%, 55-60%, 60-65%, 65-70%, 70-75%, 75-80%, 51-61%, 52-62%, 53-63%, 54-64%, 55-65%, 56-66%, 57-67%, 58-68%, or 59-69%.Trehalose may be present in an amount of about 0.01%, 0.05%, 0.1%, 0.5%, 1%, 1.5%, 2%, 2.5%, 3%, 3.5%, 4%, 4.5%, 5%, 5.5%, 6%, 6.5%, 7%, 7.5%, 8%, 8.5%, 9%, 9.5%, 10%, 10.5%, 11%, 11.5%, 12%, 12.5%, 13%, 13.5%, 14%, 14.5%, 15%, 15.5%, 16%, 16.5%, 17%, 17.5%, 18%, 18.5%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%, 41%, 42%, 43%, 44%, 45%, 46%, 47%, 48%, 49%, 50%, 51%, 52%, 53%, 54%, 55%, 56%, 57%, 58%, 59%, 60%, 61%, 62%, 63%, 64%, 65%, 66%, 67%, 68%, 69%, 70%, 71%, 72%, 73%, 74%, 75%, 76%, 77%, 78%, 79%, 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, It may be present in an amount of 5%, 20%, 20.5%, 21%, 21.5%, 22%, 22.5%, 23%, 23.5%, 24%, 24.5%, 25%, 0.01%-15%, 0.1%-20%, 0.01%-0.1%, 0.11%-1%, 1-11%, 2-12%, 3-13%, 4-14%, 5-15%, 6-16%, 7-17%, 8-18%, 9-19%, 10-20%, 11-21%, 12-22%, 13-23%, 14-24%, or 15-25%. Glycerol may represent approximately 0.1%, 0.5%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%, 41%, 42%, 43%, 44%, 45%, 46%, 47%, 48%, 49%, 50%, 51%, 52%, 53%, 54%, 55%, 56%, 57%, 58%, 59%, 60%, 61%, 62%, 63%, 64%, 65%, 66%, 67%, 68%, 69%, 70%, 71%, 72%, 73%, 74%, 75%, 76%, 77%, 78%, 79%, 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, 100%, 101%, 102%, 103%, 104%, 105%, 106%, 107%, 108%, 109%, 109%, 109%, 108%. It may be present in an amount of 7%, 38%, 39%, 40%, 1-21%, 2-22%, 3-23%, 4-24%, 5-25%, 6-26%, 7-27%, 8-28%, 9-29%, 10-30%, 11-31%, 12-32%, 13-33%, 14-34%, 15-35%, 16-36%, 17-37%, 18-38%, 19-39%, or 20-40%, which percentage may be measured by weight or volume of the pharmaceutical composition.

[0126] In some embodiments herein, the cryoprotectant of the pharmaceutical composition herein is glycerol. Such glycerol can be used in an amount of about 20% v / v in a pharmaceutical composition that can include a bacterial consortium of one or more, two or more, or three or more bacterial strains selected from Table 1. In some embodiments, the bacterial population can be lyophilized. The lyophilization process can include low-temperature dehydration of the bacterial population. In some embodiments, the lyophilization process can include subjecting the bacterial population to low temperature and low pressure.

[0127] Pharmaceutical compositions are provided herein that may include one or more antioxidants. In some instances, such antioxidants can be used to protect anaerobic bacterial species and / or strain(s) that may be present in the pharmaceutical composition. In such cases, one or more antioxidants can be used to provide anaerobic conditions during storage and / or transportation and / or to protect bacterial cells from reactive oxygen species. In some embodiments herein, the antioxidant is selected from the group consisting of ascorbic acid, dithiothreitol, glutathione, phenolic acids (e.g., gallic acid, protocatechuic acid, caffeic acid, and rosmarinic acid), phenolic diterpenes (e.g., carnosol and carnosic acid), flavonoids (e.g., quercetin and catechin), volatile oils (e.g., eugenol, carvacrol, thymol, and menthol), α-tocopherol (e.g., vitamin E), trolox, ascorbic acid, vitamin A, vitamin C, coenzyme Q10, manganese, iodide, melatonin, alpha-carotene, astaxanthin, beta-carotene, canthaxanthin, cryptoxanthin, lutein, lycopene, zeaxanthin, flavonoids (e.g., flavones such as apigentin), luteolin, tangiertin, flavonols, isorhamnetin, kaempferol, myricetin, proanthocyanidins, ketamine ... Lucetin, eriodictyol, hesperetin, naringenin, catechin, gallocatechin, epicatechin, epigallocatechin, theaflavin, thearubigin, isoflavone phytoestrogens, daidzein, genistein, glycitein, stilbenoids such as resveratrol, pterostilbene, anthocyanins, cyanidin, delphinidin, malvidin, pelargonidin, peonidin, petunidin, chicoric acid, The fatty acid may be hydroxypropyl ester, ...Such one or more antioxidant(s) may be present in the pharmaceutical composition in an amount of at least about 0.001%, 0.005%, 0.01%, 0.05%, 0.1%, 0.5%, 1%, 1.5%, 2%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, 99% or more of the pharmaceutical composition. The antioxidant may be present in an amount of about 0.001%, 0.005%, 0.01%, 0.05%, 0.1%, 0.5%, 1%, 1.5%, 2%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, or 99% of the pharmaceutical composition. The antioxidant may be present in an amount of about 0.001%-0.005%, 0.0051%-0.01%, 0.011%-0.05%, 0.05%-0.1%, 0.051%-0.1%, 0.11%-0.5%, 0.51%-1%, 1.1%-1.5%, 1.5%-2%, 2.1%-5%, or 5.1%-10% of the pharmaceutical composition. The percentage of the antioxidant may be measured by weight or volume of the pharmaceutical composition.L-glutamate may comprise approximately 0.01%, 0.05%, 0.1%, 0.5%, 1%, 1.5%, 2%, 2.1%, 2.2%, 2.3%, 2.4%, 2.5%, 2.6%, 2.7%, 2.8%, 2.9%, 3%, 3.1%, 3.2%, 3.3%, 3.4%, 3.5%, 3.6%, 3.7%, 3.8%, 3.9%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%, 41%, 42%, 43%, 44%, 45%, 46%, 47%, 48%, 49%, 50%, 51%, 52%, 53%, 54%, 55%, 56%, 57%, 58%, 59%, 60%, 61%, 62%, 63%, 64%, 65%, 66%, 67%, 68%, 69%, 70%, 71%, 72%, 73%, 74%, 75%, 76%, 77%, 78%, 79%, 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 9 %,4.1%,4.2%,4.3%,4.4%,4.5%,4.6%,4.7%,4.8%,4.9%,5%,5.1%,5.2%,5.3%,5.4%,5.5%,5.6%,5.7%,5.8%,5.9%,6%,6.1%,6.2%,6.3%,6.4%,6.5%,6.6%,6.7%,6.8%,6.9%,7% ,8%,9%,10%,1-5%,1.1-5.1%,1.2-5.2%,1.3-5.3%,1.4-5.4%,1.5-5.5%,1.6-5.6%,1.7-5.7%,1.8-5.8%,1.9-5.9%,2-6%,2.1-6.1%,2.2-6.2%,2.3-6.3%,2.4-6.4%,2.5-6.5 %, 2.6-6.6%, 2.7-6.7%, 2.8-6.8%, 2.9-6.9%, 3-7%, 3.1-7.1%, 3.2-7.2%, 3.3-7.3%, 3.4-7.4%, 3.5-7.5%, 3.6-7.6%, 3.7-7.7%, 3.8-7.8%, 3.9-7.9%, or 4-8%. The percentage of L-glutamate may be measured by weight or volume of the pharmaceutical composition. In some cases, the cryoprotectant may comprise about 60% sucrose, about 10% trehalose, about 1% L-cysteine, and about 4% L-glutamate by weight of the pharmaceutical composition.

[0128] Provided herein is a pharmaceutical composition that can include an aqueous buffer. Such an aqueous medium can be used as a primary storage and transport medium for bacterial cells. Thus, the buffer can include any one or more of a dissolved or suspended bacterial consortium, a cryoprotectant, and an antioxidant to form a pharmaceutical composition described herein. In some examples, the aqueous buffer can be phosphate buffered saline (PBS), HEPES or Tris buffer, any other suitable buffer, or any combination thereof. In some embodiments, the buffer is PBS and includes 137 mM NaCl, 2.7 mM KCl, 10 mM Na2HPO4, and 1.8 mM KH2PO4. In other cases, the buffer can be PBS and can have a pH of about 6, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7, 7.1, 7.2, 7.3, 7.4, 7.5, 7.6, 7.7, 7.8, 7.9, 8, 8.1, 8.2, 8.3, 8.4, 8.5, 8.6, 8.7, 8.8, 8.9 or 9.

[0129] Thus, in some embodiments herein, a pharmaceutical composition comprises a bacterial consortium of about 5×10^8 CFU of each of the bacterial strains A. muciniphila (DSM 33213), F. prausnitzii (DSM 33185), and L. crispatus (DSM 33187), about 20% v / v glycerol as a cryoprotectant, 0.1% w / w L-cysteine ​​as an antioxidant, and PBS buffer containing 137 mM NaCl, 2.7 mM KCl, 10 mM Na2HPO4, and 1.8 mM KH2PO4. Such pharmaceutical compositions can be manufactured using the methods and compositions described herein and formulated into an orally administrable dosage form.

[0130] Provided herein are pharmaceutical compositions that can be designed and manufactured to allow for storage and / or transport of the pharmaceutical composition. In some examples, the pharmaceutical compositions herein that include a bacterial consortium can be designed such that the viability of the bacterial cells in the pharmaceutical composition is not affected or is only minimally affected by storage and / or transport. In such cases, at least about 80%, 85%, 90%, 95%, 97% or 99% viability of the bacterial cells in the pharmaceutical composition is maintained during storage and / or transport.

[0131] In some examples, the pharmaceutical compositions herein include a cryoprotectant to allow storage at low temperatures of about -70°C or -80°C to preserve the viability of the bacterial cells. In such cases, the pharmaceutical composition may include about 20% v / v glycerol as a cryoprotectant. The pharmaceutical compositions herein may further include an antioxidant that can preserve an anaerobic environment in the storage or shipping vial and protect the bacterial cells from reactive oxygen species.

[0132] In one example, in the pharmaceutical compositions herein, live vegetative bacteria can be stored frozen in phosphate buffered saline (PBS) containing 20% ​​v / v glycerol and 0.1% w / w cysteine ​​to maintain their viability. In such cases, the live bacteria can belong to any one or more of the strains shown in Table 1.

[0133] In some examples, the cryoprotectant or antioxidant described herein and therein can be used with the bacterial population, pharmaceutical composition, method for producing pharmaceutical composition, or method for large-scale growth of Lactobacillus species described herein.In some examples, the cryoprotectant or antioxidant described herein and therein can be used with the bacterial population, pharmaceutical composition, method for producing pharmaceutical composition, or method for large-scale growth of Lactobacillus species described herein.In some cases, the cryoprotectant or antioxidant described herein and therein can be used with the growth medium or excipient described in this disclosure.In other cases, the cryoprotectant or antioxidant described herein and therein can be used in any embodiment or example described in this disclosure.

[0134] Growth media for bacterial populations Provided herein is a method for producing a batch of L. crispatus (DSM 33187) cells that can be used in the pharmaceutical compositions described herein. Such a method can include preparing a L. crispatus (DSM 33187) cell culture medium. Such a medium can be vMRS medium or Boullion vMRS broth. In some cases, such a medium can include a medium described elsewhere in this disclosure. In some cases, the medium for growing L. crispatus (DSM 33187) can be described in Tables 3 and 4 or Example 1. The medium for growing L. crispatus (DSM 33187) can also be used to grow any bacterial strain or species of the Lactobacillus species. The medium for growing L. crispatus (DSM 33187) can also be used to grow any bacterial strain or species of the Lactobacillaceae species.

[0135] In some instances, such a culture medium is not HiMedia vMRS broth. Such a culture medium may be specific to the L. crispatus (DSM 33187) strain and may include vMRS powder and dipotassium phosphate (K2HPO4). In such a case, a medium for growing and culturing L. crispatus (DSM 33187) cells may include about 250-300 g of vMRS powder and dipotassium phosphate (K2HPO4). In certain cases, such a medium may include about 273 g of vMRS powder and about 12.5 g of dipotassium phosphate (K2HPO4) and about 4.9 L of water. The pH of such a vMRS medium may be adjusted to about 6.5±0.1 using, for example, 5 M hydrochloride solution or glacial acetic acid. The medium can then be filtered, reduced to anaerobic conditions, transferred to a starter culture tube containing, for example, a stock L. crispatus (DSM 33187) solution, and incubated at 37 °C for about 16-20 hours. After incubation and growth, the absorbance of the cell culture at 600 nm can be determined and repeated in triplicate to ensure that the absorbance of the cell suspension falls within the range of about 0.8 to about 1.6, preferably about 1.0 to 1.4. The contents of the culture flask can be centrifuged and the residual cell pellet resuspended in 25 mL of sterile PBS containing antioxidants and a cryoprotectant such as 20% v / v glycerol, then combined to obtain a homogenous cell suspension.

[0136] Further provided herein is a method for producing a batch of A. muciniphila (DSM 33213) cells that can be used in the pharmaceutical compositions described herein. Such a method may comprise preparing an A. muciniphila (DSM 33213) cell culture medium. The medium for growing A. muciniphila (DSM 33213) may also be used to grow any bacterial strain or species of the Ackermansia species.

[0137] In some examples, such A. muciniphila (DSM 33213) culture medium can be a modified NAGT medium. Such modified NAGT medium can contain soybean or N-acetylglucosamine (NAG), or both soybean and NAG. In some cases, such modified NAGT medium can be free of magnesium, calcium, glucose, or combinations thereof. In some examples, modified NAGT medium can provide improved cell growth. Such improved cell growth can be about 30%, 35%, 40%, 45%, or 50% higher compared to cell growth in unmodified NAGT medium.

[0138] Thus, in some examples, such NAGT culture medium may be specific for A. muciniphila strain (DSM 33213) and may include any one or more of the following ingredients: soy, pea peptone, yeast extract, sodium bicarbonate (NaHCO3), dipotassium phosphate (K2HPO4), sodium chloride (NaCl), magnesium sulfate (e.g., MgSO4 x 7H2O), calcium chloride (CaCl2), glucose, N-acetylglucosamine, L-threonine, and / or L-cysteine. In such a case, a volume of about 5 L of modified NAGT medium for growing and culturing A. muciniphila (DSM 33213) cells may include about 75 g to about 100 g of SOLABIA Pea Peptone, about 75 g to about 85 g of Difco™ Select soytone, about 10 g to about 15 g Bacto™ yeast extract, about 2 g to about 8 g sodium bicarbonate (NaHCO3), about 10 g to about 15 g dibasic potassium phosphate (K2HPO4), about 0.5 g to about 5 g sodium chloride (NaCl), about 0.5 g to about 5 g magnesium sulfate heptahydrate (MgSO4 x 7H2O), about 0.5 g to about 5 g calcium chloride (CaCl2), about 20 g to about 25 g glucose (dextrose), about 25 g to about 30 g N-acetylglucosamine, about 15 g to about 25 g L-threonine, and / or about 2 g to about 8 g L-cysteine. In one example, a volume of about 5 L of modified NAGT medium for growing and culturing A. muciniphila (DSM 33213) cells may contain about 82.5 g SOLABIA Pea Peptone, 82.5 g Difco™ Select Soytone, about 12.5 g Bacto™ Yeast Extract, about 5 g Sodium Bicarbonate (NaHCO3), about 12.5 g Dibasic Potassium Phosphate (K2HPO4), about 1.5 g Sodium Chloride (NaCl), about 0.5 g Magnesium Sulfate Heptahydrate (MgSO4×7H2O), about 0.5 g Calcium Chloride (CaCl2), about 22.6 g Glucose (Dextrose), about 27.7 g N-Acetylglucosamine, about 20 g L-Threonine and / or about 5 g L-Cysteine.

[0139] The pH of such a NAGT medium may be adjusted, for example, to about 6.5±0.1, for example, using a 5M hydrochloride solution. The pH of such a NAGT medium may also be adjusted to about 7. A. muciniphila (DSM 33213) bacterial cells may be added to a prepared vial containing such a NAGT growth medium. After a period of incubation that may be specific for the A. muciniphila (DSM 33213) strain, the absorbance of the cell culture at 600 nm may be measured and recorded to achieve an absorbance value of about 0.5 to about 1.2, preferably about 0.7 to 1.1. The contents of the culture flask may then be centrifuged, the supernatant removed, and the remaining cell pellet resuspended in sterile PBS containing an antioxidant and a cryoprotectant, such as 20% v / v glycerol.

[0140] Further provided herein is a method for producing a batch of F. prausnitzii (DSM 33185) cells that can be used in the bacterial consortium of the pharmaceutical compositions described herein. The medium for growing F. prausnitzii (DSM 33185) can also be used for growing any bacterial strain or species of Faecalibacterium spp.

[0141] Such a method may include preparing a complete vitamin mix solution (e.g., YFAP vitamin mix) and F. prausnitzii (DSM 33185) cell culture medium. The YFAP vitamin mix may be specific to the F. prausnitzii (DSM 33185) strain and may include any one or more of biotin, cobalamin, p-aminobenzoic acid, folic acid, pyridoxamine, thiamine, and / or riboflavin. In such a case, a 1 L volume of the YFAP vitamin mix may include about 10 mg biotin, about 10 mg cobalamin, about 30 mg p-aminobenzoic acid, about 50 mg folic acid, about 150 mg pyridoxamine, about 50 mg thiamine, and about 50 mg riboflavin. All medium components may be dissolved to obtain a clear, solid- and precipitate-free solution. YFAP Vitamin Mix Medium can be filtered and sterilized for use in F. prausnitzii (DSM 33185) culture, as described below.

[0142] Such F. prausnitzii (DSM 33185) culture media may be prepared, for example, as described above, to include any one or more of BBL (Phytone Peptone brand), Difco™ Select Soytone, Bacto™ Yeast Extract, sodium bicarbonate (NaHCO3), dibasic potassium phosphate (K2HPO4), sodium chloride (NaCl), magnesium sulfate heptahydrate (MgSO4 x 7H2O), sodium acetate (NaOAc), glucose (dextrose), sodium propionate, L-cysteine, and / or YFAP vitamin mix solution. In such a case, a volume of about 5 L of F. prausnitzii (DSM 33185) medium is prepared, for example, as described above, containing about 75 g to about 100 g of SOLABIA Pea Peptone, about 45 g to about 55 g of BBL™ Phytone Peptone, about 45 g to about 55 g of Difco™ Select soytone, about 20 g to about 30 g of Bacto™ yeast extract, about 2 g to about 8 g of sodium bicarbonate (NaHCO3), about 10 g to about 15 g of dibasic potassium phosphate (K2HPO4), about 2 g to about 8 g of sodium chloride, about 0.5 g to about 2 g of magnesium sulfate heptahydrate (MgSO4 x 7H2O), about 20 g to about 30 g of sodium acetate (NaOAc), about 40 g to about 60 g of glucose (dextrose), about 2 g to about 8 g of sodium propionate, about 2 g to about 8 g of L-cysteine, and about 0.5 to about 3 mL of YFAP vitamin mix solution.Thus, in one example, a volume of about 5 L of F. prausnitzii (DSM 33185) medium may contain about 100 g SOLABIA Pea Peptone, 50 g BBL™ Phytone Peptone, about 50 g Difco™ Select Soytone, about 25 g Bacto™ Yeast Extract, about 5 g sodium bicarbonate (NaHCO3), about 12.5 g dibasic potassium phosphate (K2HPO4), about 5 g sodium chloride, about 1 g magnesium sulfate heptahydrate (MgSO4 x 7H2O), about 25 g sodium acetate (NaOAc), about 50 g glucose (dextrose), about 5 g sodium propionate, about 5 g L-cysteine, and about 1 mL of YFAP vitamin mix solution, for example, prepared as described above.

[0143] F. prausnitzii (DSM 33185) medium, YFAP-NU, may also be prepared to contain any one or more of pea peptone, NuCel® 783 yeast extract, sodium bicarbonate (NaHCO3), dipotassium phosphate (K2HPO4), sodium chloride (NaCl), magnesium sulfate heptahydrate (MgSO4×7H2O), sodium acetate (NaOAc), glucose (dextrose), L-cysteine, and / or cobalamin. In such a case, a volume of about 5 L of F. prausnitzii (DSM 33185) medium may contain about 75 g to 100 g of pea peptone, about 50 g of NuCel® 783 yeast extract, 5 g of sodium bicarbonate (NaHCO3), about 12.5 g of dibasic potassium phosphate (K2HPO4), about 5 g of sodium chloride (NaCl), about 1 g of magnesium sulfate heptahydrate (MgSO4 x 7H2O), about 25 g of sodium acetate (NaOAc), about 50 g of glucose (dextrose), about 5 g of L-cysteine, and about 5 g of cobalamin.

[0144] The pH of such cell culture media can be adjusted to about 6.5±0.1 using, for example, glacial acetic acid. Such pH can vary from about 6.2 to about 6.8, depending on the bacterial strain used. In some cases, the pH of the cell culture media may not be adjusted. Such pH can vary from about 4.5 to about 7.5. In some embodiments, the pH of such media can be about 5, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 6, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7, 7.1, 7.2, 7.3, 7.4, or 7.5. After reduction to anaerobic conditions, a starter culture of F. prausnitzii (DSM 33185) may be prepared by adding a certain amount of F. prausnitzii (DSM 33185) stock solution, for example approximately 500 μL of cell bank stock solution, to a starter culture tube containing reduced medium, followed by incubation at 37° C. for about 12-16 hours. After growth of the starter culture (e.g., after further incubation for about 12-24 hours), the absorbance of the cell culture at 600 nm may be determined and repeated in triplicate to ensure that the absorbance is in a particular range. Such absorbance range may be about 1.2 to about 2.0, preferably about 1.4 to about 1.8. The culture flask may then be centrifuged, the supernatant removed, and the remaining cell pellet resuspended in sterile PBS to obtain a homogenous solution.

[0145] Methods for the preparation of pharmaceutical compositions A method for producing a pharmaceutical composition.

[0146] Disclosed herein are pharmaceutical compositions and methods for producing the same. In some examples, the method includes 1) providing a mixture comprising a purified bacterial population; 2) filling the blended pharmaceutical composition into a capsule; and 3) packaging the capsule into a blister pack. In some cases, the purified bacterial population may comprise any of the purified bacterial populations described herein. In some cases, the providing and packaging may be in an oxygen-free atmosphere. In some cases, the providing may be in an oxygen-free atmosphere. In some cases, the packaging may be in an oxygen-free atmosphere. In some cases, the providing or packaging may be in an oxygen-free atmosphere. In some cases, the oxygen-free atmosphere may have no oxygen in the atmosphere. In some cases, the oxygen-free atmosphere may have less than about 10% oxygen by volume in the atmosphere. In some cases, the oxygen-free atmosphere may have less than about 9% oxygen by volume in the atmosphere. In some cases, the oxygen-free atmosphere may have less than about 8% oxygen by volume in the atmosphere. In some cases, the oxygen-free atmosphere may have less than about 7% oxygen by volume in the atmosphere. In some cases, the oxygen-free atmosphere may have less than about 6% oxygen by volume in the atmosphere. In some cases, the oxygen-free atmosphere may have less than about 5% oxygen by volume in the atmosphere. In some cases, the oxygen-free atmosphere may have less than about 4% oxygen by volume in the atmosphere. In some cases, the oxygen-free atmosphere may have less than about 3% oxygen by volume in the atmosphere. In some cases, the oxygen-free atmosphere may have less than about 2% oxygen by volume in the atmosphere. In some cases, the oxygen-free atmosphere may have less than about 1% oxygen by volume in the atmosphere. In some cases, the oxygen-free atmosphere may have less than about 1x10^-1% oxygen by volume in the atmosphere. In some cases, the oxygen-free atmosphere may have less than about 1x10^-2% oxygen by volume in the atmosphere. In some cases, the oxygen-free atmosphere may have less than about 1x10^-3% oxygen by volume in the atmosphere. In some cases, the oxygen-free atmosphere may have less than about 1x10^-4% oxygen by volume in the atmosphere. In some cases, the oxygen-free atmosphere may have less than about 1x10^-5% oxygen by volume in the atmosphere. In some cases, the oxygen-free atmosphere may have less than about 1x10^-6% oxygen by volume in the atmosphere.In some cases, the oxygen-free atmosphere may have less than about 1x10^-7% oxygen by volume in the atmosphere. In some cases, the oxygen-free atmosphere may have less than about 1x10^-8% oxygen by volume in the atmosphere. In some cases, the oxygen-free atmosphere may have less than about 1x10^-9% oxygen by volume in the atmosphere. In some cases, the oxygen-free atmosphere may have less than about 1x10^-10% oxygen by volume in the atmosphere. In some cases, the oxygen-free atmosphere may have less than about 21%, 20%, 19%, 18%, 17%, 16%, 15%, 14%, 13%, 12%, or 11% oxygen by volume in the atmosphere. In some examples, the pharmaceutical composition may include any of the bacterial populations described herein and therein.

[0147] In some examples, the method for producing the pharmaceutical composition may include storing the capsule in a bag before packaging. In some cases, the method for producing the pharmaceutical composition may include storing the capsule in a bag in an oxygen-free atmosphere before packaging. In some cases, the oxygen-free atmosphere is achieved by injecting nitrogen gas or an oxygen scrubber into the atmosphere. In some cases, the injected nitrogen gas may include pure nitrogen gas. In some cases, the injected nitrogen gas may include 100%, 99%, 98%, 97%, 96%, 95%, 94%, 93%, 92%, 91%, 90%, 89%, 88%, 87%, 86%, 85%, 84%, 83%, 82%, 81%, or 80% of the atmosphere by volume of nitrogen gas. In some cases, the injected nitrogen gas may include pure nitrogen gas. In some cases, the nitrogen gas injected may comprise 80% to about 99%, 85% to about 99%, 90% to about 99%, 95% to about 99%, 96% to about 99%, 97% to about 99%, or 98% to about 99% of the atmosphere by volume. In some cases, the oxygen scrubber injected may comprise pure nitrogen gas. In some cases, the oxygen scrubber injected may comprise 100%, 99%, 98%, 97%, 96%, 95%, 94%, 93%, 92%, 91%, 90%, 89%, 88%, 87%, 86%, 85%, 84%, 83%, 82%, 81%, or 80% of the atmosphere by volume. In some cases, the injected oxygen scrubber may include pure nitrogen gas. In some cases, the injected oxygen scrubber may include 80% to about 99% by volume, 85% to about 99% by volume, 90% to about 99% by volume, 95% to about 99% by volume, 96% to about 99% by volume, 97% to about 99% by volume, or 98% to about 99% by volume of the atmosphere.

[0148] In some examples, the oxygen scrubber may include an inert gas. In some cases, the oxygen scrubber may include carbon dioxide. In other cases, the oxygen scrubber may include a noble gas. The noble gas may include helium, neon, argon, krypton, xenon, radon, or oganesson. In some cases, the oxygen scrubber may include a N2H2CO2 (90:5:5) gas mixture. In some cases, the filling may be accomplished by a capsule filling machine. In other cases, the filling may be accomplished manually. In some cases, the filling may be accomplished in an anaerobic chamber. In some examples, the capsule may include any capsule and capsules thereof described herein. In some cases, the filling may also fill any primary container described herein and therein with a pharmaceutical composition. In some examples, the pack may include any blister pack described herein and therein. In some cases, the pack may include any secondary container described herein and therein.

[0149] Methods for large-scale growth of Lactobacillus species Disclosed herein is a method for large-scale growth of Lactobacillus species. The method may include performing multiple inoculation rounds with increasing amounts of growth medium. The Lactobacillus species may, in some instances, include Lactobacillus crispatus. In some cases, the Lactobacillus species may include Lactobacillus crispatus (DSM 33187). In some cases, the Lactobacillus species may include any bacterial species or strain of the Lactobacillus species described herein and therein.

[0150] In some cases, an inoculation round of a large scale propagation of a Lactobacillus species may comprise at least about 0.001%, 0.002%, 0.005%, 0.01%, 0.02%, 0.05%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, 1.5%, 2%, 2.5%, 3%, 3.5%, 4%, 4.5%, 5%, 5.5%, 6%, 6.5%, 7%, 7.5%, 8%, 8.5%, 9%, 9.5%, 10%, 20%, 50% or more by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of a large-scale propagation of a Lactobacillus species may contain up to about 0.001%, 0.002%, 0.005%, 0.01%, 0.02%, 0.05%, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, 1.5%, 2%, 2.5%, 3%, 3.5%, 4%, 4.5%, 5%, 5.5%, 6%, 6.5%, 7%, 7.5%, 8%, 8.5%, 9%, 9.5%, 10%, 20%, or 50% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of a large-scale propagation of a Lactobacillus species may comprise at least about 5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of a large-scale propagation of a Lactobacillus species may comprise at least about 0.5% by volume of the total batch material of the preceding inoculation.

[0151] In some cases, an inoculation round of a large-scale propagation of a Lactobacillus species may comprise at least about 0.1% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the present method may comprise at least about 0.2% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the present method may comprise at least about 0.3% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the present method may comprise at least about 0.4% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the present method may comprise at least about 0.5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the present method may comprise at least about 0.6% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the present method may comprise at least about 0.7% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the present method may comprise at least about 0.8% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the present method may comprise at least about 0.9% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise at least about 1% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise at least about 1.5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise at least about 2% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise at least about 2.5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise at least about 3% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise at least about 3.5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise at least about 4% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise at least about 4.5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise at least about 5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise at least about 5.5% by volume of the total batch material of the preceding inoculation.In some cases, an inoculation round of the method may comprise at least about 6% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise at least about 6.5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise at least about 7% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise at least about 7.5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise at least about 8% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise at least about 8.5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise at least about 9% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise at least about 9.5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise at least about 10% by volume of the total batch material of the preceding inoculation.

[0152] In some cases, an inoculation round of a large-scale propagation of a Lactobacillus species may comprise less than about 0.1% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the present method may comprise less than about 0.2% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the present method may comprise less than about 0.3% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the present method may comprise less than about 0.4% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the present method may comprise less than about 0.5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the present method may comprise less than about 0.6% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the present method may comprise less than about 0.7% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the present method may comprise less than about 0.8% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the present method may comprise less than about 0.9% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may include less than about 1% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may include less than about 1.5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may include less than about 2% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may include less than about 2.5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may include less than about 3% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may include less than about 3.5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may include less than about 4% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may include less than about 4.5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may include less than about 5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may include less than about 5.5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may include less than about 6% by volume of the total batch material of the preceding inoculation.In some cases, an inoculation round of the method may include less than about 6.5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may include less than about 7% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may include less than about 7.5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may include less than about 8% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may include less than about 8.5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may include less than about 9% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may include less than about 9.5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may include less than about 10% by volume of the total batch material of the preceding inoculation.

[0153] In some cases, an inoculation round of a large-scale propagation of a Lactobacillus species may comprise at least about 0.1% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the present method may comprise at least about 0.2% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the present method may comprise at least about 0.3% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the present method may comprise at least about 0.4% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the present method may comprise at least about 0.5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the present method may comprise at least about 0.6% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the present method may comprise at least about 0.7% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the present method may comprise at least about 0.8% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the present method may comprise at least about 0.9% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise at least about 1% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise at least about 1.5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise at least about 2% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise at least about 2.5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise at least about 3% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise at least about 3.5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise at least about 4% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise at least about 4.5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise at least about 5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise at least about 5.5% by volume of the total batch material of the preceding inoculation.In some cases, an inoculation round of the method may comprise at least about 6% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise at least about 6.5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise at least about 7% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise at least about 7.5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise at least about 8% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise at least about 8.5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise at least about 9% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise at least about 9.5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise at least about 10% by volume of the total batch material of the preceding inoculation.

[0154] In some cases, an inoculation round of a large-scale propagation of a Lactobacillus species may comprise less than about 0.1% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the present method may comprise less than about 0.2% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the present method may comprise less than about 0.3% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the present method may comprise less than about 0.4% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the present method may comprise less than about 0.5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the present method may comprise less than about 0.6% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the present method may comprise less than about 0.7% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the present method may comprise less than about 0.8% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the present method may comprise less than about 0.9% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may include less than about 1% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may include less than about 1.5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may include less than about 2% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may include less than about 2.5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may include less than about 3% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may include less than about 3.5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may include less than about 4% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may include less than about 4.5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may include less than about 5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may include less than about 5.5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may include less than about 6% by volume of the total batch material of the preceding inoculation.In some cases, an inoculation round of the method may comprise less than about 6.5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise less than about 7% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise less than about 7.5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise less than about 8% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise less than about 8.5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise less than about 9% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise less than about 9.5% by volume of the total batch material of the preceding inoculation. In some cases, an inoculation round of the method may comprise less than about 10% by volume of the total batch material of the preceding inoculation. In some cases, the percentages of the inoculation rounds described herein may also be measured by weight or weight / volume. For example, in the case of an inoculation round of the process that may include at least about 0.5% by volume of the total batch material of the preceding inoculation, the inoculation round of the process may also include at least about 0.5% by weight and / or at least about 0.5% (weight / volume) of the total batch material of the preceding inoculation.

[0155] In some examples, at least one of the inoculation rounds of the method may comprise at least about 1 L, 5 L, 10 L, 20 L, 30 L, 40 L, 50 L, 60 L, 70 L, 80 L, 90 L, 100 L, 150 L, 200 L, 250 L, 300 L, 350 L, 400 L, 450 L, 500 L, 1000 L, 1500 L, 2000 L, 2500 L, 3000 L, 3500 L, 4000 L, 4500 L, 5000 L, 7500 L, 10000 L, 50000 L or more of growth medium. In some cases, at least one of the inoculation rounds of the method may include up to about 1 L, 5 L, 10 L, 20 L, 30 L, 40 L, 50 L, 60 L, 70 L, 80 L, 90 L, 100 L, 150 L, 200 L, 250 L, 300 L, 350 L, 400 L, 450 L, 500 L, 1000 L, 1500 L, 2000 L, 2500 L, 3000 L, 3500 L, 4000 L, 4500 L, 5000 L, 7500 L, 10000 L, or 50000 L of growth medium. In some cases, the growth medium for large-scale growth of Lactobacillus species may be about 100 ml to about 4000 L. In some cases, the growth medium may be about 500 mL. In some cases, at least one of the inoculation rounds of the method may include about 4000 L of growth medium. In some cases, at least one of the inoculation rounds of the method may include about 3900 L of growth medium. In some cases, at least one of the inoculation rounds of the method may include about 3800 L of growth medium. In some cases, at least one of the inoculation rounds of the method may include about 3700 L of growth medium. In some cases, at least one of the inoculation rounds of the method may include about 3600 L of growth medium. In some cases, at least one of the inoculation rounds of the method may include about 3500 L of growth medium. In some cases, at least one of the inoculation rounds of the method may include about 3400 L of growth medium. In some cases, at least one of the inoculation rounds of the method may include about 3300 L of growth medium. In some cases, at least one of the inoculation rounds of the method may include about 3200 L of growth medium. In some cases, at least one of the inoculation rounds of the method may include about 3100 L of growth medium. In some cases, at least one of the inoculation rounds of the method may include about 3000 L of growth medium.In some cases, at least one of the inoculation rounds of the method may include about 2500 L of growth medium. In some cases, at least one of the inoculation rounds of the method may include about 2000 L of growth medium. In some cases, at least one of the inoculation rounds of the method may include about 1500 L of growth medium. In some cases, at least one of the inoculation rounds of the method may include about 1000 L of growth medium. In some cases, at least one of the inoculation rounds of the method may include about 500 L of growth medium. In some cases, at least one of the inoculation rounds of the method may include about 500 L of growth medium. In some cases, at least one of the inoculation rounds of the method may include about 450 L of growth medium. In some cases, at least one of the inoculation rounds of the method may include about 400 L of growth medium. In some cases, at least one of the inoculation rounds of the method may include about 350 L of growth medium. In some cases, at least one of the inoculation rounds of the method may include about 300 L of growth medium. In some cases, at least one of the inoculation rounds of the method may include about 250 L of growth medium. In some cases, at least one of the inoculation rounds of the method may include about 200 L of growth medium. In some cases, at least one of the inoculation rounds of the method may include about 150 L of growth medium. In some cases, at least one of the inoculation rounds of the method may include about 100 L of growth medium. In some cases, at least one of the inoculation rounds of the method may include about 90 L of growth medium. In some cases, at least one of the inoculation rounds of the method may include about 80 L of growth medium. In some cases, at least one of the inoculation rounds of the method may include about 70 L of growth medium. In some cases, at least one of the inoculation rounds of the method may include about 60 L of growth medium. In some cases, at least one of the inoculation rounds of the method may include about 50 L of growth medium. In some cases, at least one of the inoculation rounds of the method may include about 40 L of growth medium. In some cases, at least one of the inoculation rounds of the method may include about 30 L of growth medium. In some cases, at least one of the inoculation rounds of the method may include about 20 L of growth medium.In some cases, at least one of the inoculation rounds of the method may include about 10 L of growth medium. In some cases, at least one of the inoculation rounds of the method ma...

Claims

1. (a) a purified bacterial population comprising at least one strain of Ackermansia sp., at least one strain of Faecalibacterium sp., or at least one strain of Lactobacillus sp.; (b) a pharma- ceutically acceptable excipient, the excipient comprising a moisture adsorbent material and / or a moisture absorbent material; 13. A pharmaceutical composition comprising:

2. The pharma- ceutically acceptable excipients are microcrystalline cellulose (MCC), hydroxypropyl methylcellulose, silicon dioxide (SiO ２ ), polyethylene glycol 8000, lactose, D-trehalose dihydrate, mannitol, tribasic calcium phosphate, calcium sulfate, corn starch, fructose, xylitol, maltitol, lactose anhydrous, and dicalcium phosphate (DCP).

3. The pharma- ceutically acceptable excipient is SiO ２ The pharmaceutical composition of claim 2 , comprising:

4. The SiO ２ The pharmaceutical composition of claim 3, wherein is present in an amount of 0.1% to 10% by weight of the pharmaceutical composition.

5. The SiO ２ The pharmaceutical composition of claim 3 , wherein is present in an amount of at least 1% by weight of the pharmaceutical composition.

6. 2. The pharmaceutical composition of claim 1, wherein the pharma- ceutically acceptable excipient comprises mannitol.

7. 7. The pharmaceutical composition of claim 6, wherein the mannitol is present in an amount of 1% to 90% by weight of the pharmaceutical composition.

8. 8. The pharmaceutical composition of claim 7, wherein the mannitol is present in an amount of 5% to 81.5% by weight of the pharmaceutical composition.

9. 10. The pharmaceutical composition of claim 1, wherein the pharma- ceutically acceptable excipient comprises anhydrous lactose.

10. 10. The pharmaceutical composition of claim 9, wherein the anhydrous lactose is present in an amount of 1% to 90% by weight of the pharmaceutical composition.

11. 11. The pharmaceutical composition of claim 10, wherein the anhydrous lactose is present in an amount of 5% to 81.5% by weight of the pharmaceutical composition.

12. 10. The pharmaceutical composition of claim 1, wherein the pharma- ceutically acceptable excipient further comprises magnesium stearate.

13. 13. The pharmaceutical composition of claim 12, wherein the magnesium stearate is present in an amount of 0.1% to 10% by weight of the pharmaceutical composition.

14. 13. The pharmaceutical composition of claim 12, wherein the magnesium stearate is present in an amount of at least 1.5% by weight of the pharmaceutical composition.

15. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is formulated as an oral dosage form.

16. 16. The pharmaceutical composition of claim 15, wherein the oral dosage form is a capsule, tablet, emulsion, suspension, syrup, gel, gum, paste, herbal tea, drops, dissolving granules, powder, pill, lyophilisate, popsicle, foam, or ice cream or a combination thereof.

17. 17. The pharmaceutical composition of claim 1, wherein the pharma- ceutically acceptable excipient further comprises microcrystalline cellulose.

18. 17. A pharmaceutical composition according to any one of claims 1 to 16, wherein the purified bacterial population comprises at least two of at least one strain of the genus Ackermansia, at least one strain of the genus Faecalibacterium, and at least one strain of the genus Lactobacillus.

19. 17. The pharmaceutical composition of any one of claims 1 to 16, wherein the purified bacterial population comprises at least one strain of the genus Ackermansia, at least one strain of the genus Faecalibacterium, and at least one strain of the genus Lactobacillus.

20. 17. The pharmaceutical composition of any one of claims 1 to 16, wherein the purified bacterial population is lyophilized.

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