WO2022187578A1 - Formes posologiques solides - Google Patents

Formes posologiques solides Download PDF

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Publication number
WO2022187578A1
WO2022187578A1 PCT/US2022/018842 US2022018842W WO2022187578A1 WO 2022187578 A1 WO2022187578 A1 WO 2022187578A1 US 2022018842 W US2022018842 W US 2022018842W WO 2022187578 A1 WO2022187578 A1 WO 2022187578A1
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WIPO (PCT)
Prior art keywords
bacteria
solid dosage
dosage form
mevs
total
Prior art date
Application number
PCT/US2022/018842
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English (en)
Inventor
Syed Altaf
Ruiming HUANG
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Evelo Biosciences, Inc.
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Publication date
Application filed by Evelo Biosciences, Inc. filed Critical Evelo Biosciences, Inc.
Publication of WO2022187578A1 publication Critical patent/WO2022187578A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0007—Effervescent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/74—Bacteria
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—Poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/02—Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Definitions

  • the solid dosage forms provided herein comprise about 5% to about 40% pharmaceutical agent (e.g., a powder comprising bacteria and/or an agent of bacterial origin, such as mEVs); about 43% to about 77% silicified microcrystalline cellulose (e.g., HD90); about 15% crospovidone (e.g., PVPP); about 1% magnesium stearate; and about 1% colloidal silica (e.g., Aerosil 200).
  • pharmaceutical agent e.g., a powder comprising bacteria and/or an agent of bacterial origin, such as mEVs
  • silicified microcrystalline cellulose e.g., HD90
  • crospovidone e.g., PVPP
  • magnesium stearate e.g., Aerosil 200
  • the solid dosage forms provided herein comprise about 74.5% pharmaceutical agent (e.g., a powder comprising bacteria and/or an agent of bacterial origin, such as mEVs); about 16% silicified microcrystalline cellulose (e.g., HD90); about 7% crospovidone (e.g., PVPP); about 1.5% magnesium stearate; and about 1% colloidal silica (e.g., Aerosil 200).
  • pharmaceutical agent e.g., a powder comprising bacteria and/or an agent of bacterial origin, such as mEVs
  • about 16% silicified microcrystalline cellulose e.g., HD90
  • about 7% crospovidone e.g., PVPP
  • magnesium stearate e.g., Aerosil 200
  • the solid dosage forms provided herein comprise about 23% pharmaceutical agent (e.g., a powder comprising bacteria and/or an agent of bacterial origin, such as mEVs); about 27% silicified microcrystalline cellulose (e.g., grade HD90); about 27% low-substituted hydroxypropyl ether of cellulose (e.g. L-HPC grade LH-B1); about 6% croscarmellose sodium (e.g. AcDiSol); about 15% crospovidone (PVPP, e.g., Kollidon CL- F); about 1% silicon dioxide; and about 1% magnesium stearate.
  • pharmaceutical agent e.g., a powder comprising bacteria and/or an agent of bacterial origin, such as mEVs
  • about 27% silicified microcrystalline cellulose e.g., grade HD90
  • about 27% low-substituted hydroxypropyl ether of cellulose e.g. L-HPC grade LH-B1
  • the solid dosage form comprises a minitablet.
  • the minitablet e.g., enterically coated minitablet
  • the minitablet is a 1 mm minitablet, 1.5 mm minitablet, 2 mm minitablet, 3 mm minitablet, or 4 mm minitablet.
  • a plurality of enterically coated minitablets are contained in a capsule (e.g., a size 0 capsule can contain about 31 to about 35 (e.g., 33) minitablets, wherein the minitablets are 3mm in size).
  • the capsule is a size 00, size 0, size 1, size 2, size 3, size 4, or size 5 capsule.
  • the capsule comprises HPMC (hydroxyl propyl methyl cellulose) or gelatin.
  • the bacteria of the genus Megasphaera, Selenomonas, Propionospora, or Acidaminococcus are provided.
  • the bacteria are Prevotella bacteria.
  • the Prevotella bacteria are a strain comprising at least 90% (or at least 97%) genomic, 16S and/or CRISPR sequence identity to the nucleotide sequence of the Prevotella Strain B 50329 (NRRL accession number B 50329).
  • the Prevotella bacteria are a strain comprising at least 99% genomic, 16S and/or CRISPR sequence identity to the nucleotide sequence of the Prevotella Strain B 50329 (NRRL accession number B 50329).
  • the Prevotella bacteria are Prevotella Strain B 50329 (NRRL accession number B 50329).
  • the bacteria are Bifidobacterium bacteria.
  • the Bifidobacterium bacteria are from a strain comprising at least 90% (or at least 97%) genomic, 16S and/or CRISPR sequence identity to the nucleotide sequence of the Bifidobacterium bacteria deposited as ATCC designation number PTA- 125097.
  • the Bifidobacterium bacteria are a strain comprising at least 99% genomic,
  • the bacteria are Bacteroides thetaiotaomicron bacteria.
  • the bacteria are of the Megasphaera genus.
  • the bacteria are from the species Dysosmobacter welbionis.
  • the bacteria are from the species Cupriavidus metallidurans or Streptococcus pyogenes.
  • the bacteria are from Megasphaera massiliensis bacteria (for example, from the strain with accession number DSM 26228).
  • th Q Megasphaera massiliensis bacteria is a strain comprising at least 80%, at least 85%, at least 90%, at least 95%, at least 96%, at least 97%, at least 98%, or at least 99% sequence identity (for example, at least 99.5% sequence identity, at least 99.6% sequence identity, at least 99.7% sequence identity, at least 99.8% sequence identity, at least 99.9% sequence identity) to the nucleotide sequence (for example, genomic sequence, 16S sequence, and/or CRISPR sequence) of the Megasphaera massiliensis bacteria strain deposited under accession number NCIMB 42787.
  • the Megasphaera massiliensis bacteria is the strain deposited under accession number NCIMB 42787.
  • th Q Megasphaera massiliensis bacteria is a strain comprising at least 80%, at least 85%, at least 90%, at least 95%, at least 96%, at least 97%, at least 98%, or at least 99% sequence identity (for example, at least 99.5% sequence identity, at least 99.6% sequence identity, at least 99.7% sequence identity, at least 99.8% sequence identity, at least 99.9% sequence identity) to the nucleotide sequence (for example, genomic sequence, 16S sequence, and/or CRISPR sequence) of Megasphaera massiliensis bacteria deposited under accession number DSM 26228.
  • the Megasphaera massiliensis bacteria is the strain deposited under accession number DSM 26228.
  • the mEVs are from anaerobic bacteria.
  • the anaerobic bacteria comprise obligate anaerobes.
  • the anaerobic bacteria comprise facultative anaerobes.
  • the mEVs are from Harryflintia acetispora bacteria.
  • the Harryflintia acetispora bacteria are from a strain comprising at least 90% (or at least 97%) genomic, 16S and/or CRISPR sequence identity to the nucleotide sequence of the Harryflintia acetispora bacteria deposited as ATCC designation number PTA-126694.
  • the mEVs are from Bacteroides thetaiotaomicron bacteria.
  • the mEVs are from Erysipelatoclostridium ramosum bacteria.
  • the mEVs are from Selenomonas felix bacteria. [284] In some embodiments, the mEVs are from Acidaminococcus intestini bacteria.
  • purified pmEV composition or “pmEV composition” refers to a preparation of pmEVs that have been separated from at least one associated substance found in a source material (e.g., separated from at least one other microbial component) or any material associated with the pmEVs in any process used to produce the preparation. It can also refer to a composition that has been significantly enriched for specific components.
  • an “oncobiome” as used herein comprises tumorigenic and/or cancer-associated microbiota, wherein the microbiota comprises one or more of a virus, a bacterium, a fungus, a protist, a parasite, or another microbe.
  • a “systemic effect” in a subject treated with a pharmaceutical composition containing bacteria or mEVs means a physiological effect occurring at one or more sites outside the gastrointestinal tract.
  • Systemic effect(s) can result from immune modulation (e.g., via an increase and/or a reduction of one or more immune cell types or subtypes (e.g., CD8+ T cells) and/or one or more cytokines).
  • the Oscillospriraceae family within the Clostridia class of microorganisms are common commensal organisms of vertebrates.
  • the bacteria of the pharmaceutical agent or from which the mEVs of the pharmaceutical agent are obtained are of the Negativicutes class.
  • pellets are resuspended in 10 mM Tris-HCl, pH 8.0, 2% Triton X-100 and incubated 30-60 min with mixing at room temperature. In some embodiments, samples are centrifuged at 110,000 x g for 15 min at 4°C. In some embodiments, pellets are resuspended in PBS and stored at -20°C.
  • pmEVs are gamma irradiated (e.g., at 17.5 or 25 kGy).
  • pmEVs are UV irradiated.
  • the smEVs can be analyzed, e.g., as described in Jeppesen, et al. Cell 177:428 (2019).
  • smEVs are UV irradiated.
  • the solid dosage forms provided herein comprise: (i) a pharmaceutical agent having a total pharmaceutical agent mass that is at least 5% and no more than 75% of the total mass of the pharmaceutical composition, and (ii) silicified microcrystalline cellulose having a total silicified microcrystalline cellulose mass that is at least 5% (e.g., at least 5%, 7%, 10%, 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%,
  • the total silicified microcrystalline cellulose mass plus the total the total crospovidone mass is at least 60%, 70%, 80% or 90% of the total mass of the pharmaceutical composition.
  • the solid dosage form comprises: a total L-HPC mass is about 50% of the total mass of the pharmaceutical composition and a total crospovidone mass is about 15% of the total mass of the pharmaceutical composition.
  • the solid dosage form comprises: a total L-HPC mass is about 76.4% of the total mass of the pharmaceutical composition and a total crospovidone mass is about 15% of the total mass of the pharmaceutical composition.
  • the solid dosage forms provided herein comprise colloidal silica (also referred to as colloidal silicon dioxide or SiC ).
  • the colloidal silica is Aerosil 200.
  • the total colloidal silica mass is at least 0.01%, 0.1%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, or 11% of the total mass of the pharmaceutical composition.
  • the total colloidal silica mass is no more than 0.01%, 0.1%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, or 11% of the total mass of the pharmaceutical composition.
  • the solid dosage forms provided herein comprise citric acid.
  • the total citric acid mass is at least 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21% or 22% of the total mass of the pharmaceutical composition.
  • the total citric acid is no more than 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21% or 22% of the total mass of the pharmaceutical composition.
  • the solid dosage forms provided herein comprise about 50% pharmaceutical agent (e.g., a powder or granule comprising bacteria and/or an agent of bacterial origin, such as mEVs); about 5% silicified microcrystalline cellulose (e.g., grade HD90); about 22% low-substituted hydroxypropyl ether of cellulose (e.g. L-HPC grade LH- Bl); about 6% croscarmellose sodium (e.g., AcDiSol); about 15% crospovidone (PVPP, e.g., Kollidon CL-F); about 1% silicon dioxide; and about 1% magnesium stearate.
  • pharmaceutical agent e.g., a powder or granule comprising bacteria and/or an agent of bacterial origin, such as mEVs
  • silicified microcrystalline cellulose e.g., grade HD90
  • L-HPC grade LH- Bl low-substituted hydroxypropyl ether of cellulose
  • the solid dosage form comprises a tablet (> 4mm) (e.g., 5mm- 17mm).
  • the tablet is a 5 mm, 5.5 mm, 6 mm, 6.5 mm, 7 mm, 7.5 mm, 8 mm,
  • EUDRAGIT is the brand name for a diverse range of polymethacrylate-based copolymers. It includes anionic, cationic, and neutral copolymers based on methacrylic acid and methacrylic/acrylic esters or their derivatives.
  • Examples of other materials that can be used in the enteric coating include cellulose acetate phthalate (CAP), cellulose acetate trimellitate (CAT), poly(vinyl acetate phthalate) (PYAP), hydroxypropyl methylcellulose phthalate (HPMCP), fatty acids, waxes, shellac (esters of aleurtic acid), plastics, plant fibers, zein, AQUA-ZEIN® (an aqueous zein formulation containing no alcohol), amylose starch, starch derivatives, dextrins, methyl acrylate-methacrylic acid copolymers, cellulose acetate succinate, hydroxypropyl methyl cellulose acetate succinate (hypromellose acetate succinate), methyl methacrylate- methacrylic acid copolymers, and/or sodium alginate.
  • CAP cellulose acetate phthalate
  • CAT cellulose acetate trimellitate
  • PYAP poly(vinyl acetate phthalate)
  • the one enteric coating can include a Eudragit copolymer, e.g., a Eudragit L (e.g., Eudragit L 100-55; Eudragit L 30 D-55), a Eudragit S, a Eudragit RL, a Eudragit RS, a Eudragit E, or a Eudragit FS (e.g., Eudragit FS 30 D).
  • a Eudragit copolymer e.g., a Eudragit L (e.g., Eudragit L 100-55; Eudragit L 30 D-55), a Eudragit S, a Eudragit RL, a Eudragit RS, a Eudragit E, or a Eudragit FS (e.g., Eudragit FS 30 D).
  • the pharmaceutical agent comprises mEVs and the dose of mEVs is about 1 x 10 5 to about 7 x 10 13 particles (e.g., wherein particle count is determined by NTA (nanoparticle tracking analysis)), wherein the dose is per capsule or tablet or per total number of minitablets in a capsule.
  • the pharmaceutical agent comprises mEVs and the dose of mEVs is about 1 x 10 10 to about 7 x 10 13 particles (e.g., wherein particle count is determined by NTA (nanoparticle tracking analysis)), wherein the dose is per capsule or tablet or per total number of minitablets in a capsule.
  • the disclosure provides use of a solid dosage form provided herein for the preparation of a medicament for treating a subject (e.g., human) (e.g., a subject in need of treatment).
  • a subject e.g., human
  • a subject in need of treatment e.g., a subject in need of treatment.
  • the dose can be about 3 mg to about 125 mg of the pharmaceutical agent, per capsule or tablet or per total number of minitablets, e.g., in a capsule.
  • the total pharmaceutical agent mass is no more than 70%, 65%, 60%, 55%, 50%, 45%, 40%, 35%, 30%, or 25% of the total mass of the pharmaceutical composition.
  • the total mass of the one or more excipients is at least 5%, at least 10%, at least 20%, at least 30%, at least 35%, at least 40%, at least 45%, or at least 50% of the total mass of the pharmaceutical composition.
  • the total mass of the one or more excipients is no more than 90%, 85%, 80%, 75%, 70%, 65%, 60%, or 55% of the total mass of the pharmaceutical composition.
  • the solid dosage forms e.g., as described herein, comprising a pharmaceutical agent (e.g., a therapeutically effective amount thereof), wherein the pharmaceutical agent comprises bacteria and/or microbial extracellular vesicles (mEVs), and wherein the solid dosage form further comprises the described excipients, can bring about one or more changes to a subject, e.g., human, e.g., to treat or prevent a disease or a health disorder.
  • a pharmaceutical agent e.g., a therapeutically effective amount thereof
  • the pharmaceutical agent comprises bacteria and/or microbial extracellular vesicles (mEVs)
  • mEVs extracellular vesicles
  • the additional therapeutic is an antibiotic.
  • antibiotics can be administered, e.g., to eliminate the disease-associated bacteria from the subject.
  • the cancer therapeutic is an antibiotic.
  • antibiotics can be administered to eliminate the cancer-associated bacteria from the subject.
  • Antibiotics broadly refers to compounds capable of inhibiting or preventing a bacterial infection.
  • Ansamycins include, but are not limited to, Geldanamycin, Herbimycin, Rifamycin, and Streptovaricin.
  • Geldanamycin and Herbimycin are believed to inhibit or alter the function of Heat Shock Protein 90.
  • the additional therapeutic agent is an RNA molecule, such as a double stranded RNA.
  • the additional therapeutic agent is an anti-sense oligonucleotide.
  • provided herein is a method of delivering a solid dosage form described herein to a subject.
  • the solid dosage form that comprises bacteria and/or mEVs is administered in conjunction with the administration of an additional therapeutic agent.
  • the solid dosage form comprises a pharmaceutical agent co-formulated with the additional therapeutic agent.
  • the solid dosage form is co-administered with the additional therapeutic agent.
  • the additional therapeutic agent is administered to the subject before administration of the solid dosage form (e.g., about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45, 50 or 55 minutes before, about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
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  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
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  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Gynecology & Obstetrics (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Microbiology (AREA)
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  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

L'invention concerne des procédés et des compositions associés à des formes posologiques solides améliorées qui facilitent l'administration orale de bactéries ou d'agents d'origine bactérienne.
PCT/US2022/018842 2021-03-05 2022-03-04 Formes posologiques solides WO2022187578A1 (fr)

Applications Claiming Priority (4)

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US202163157138P 2021-03-05 2021-03-05
US63/157,138 2021-03-05
US202163234490P 2021-08-18 2021-08-18
US63/234,490 2021-08-18

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115778913A (zh) * 2022-10-28 2023-03-14 广西壮族自治区水牛研究所 一种泡腾片、制备方法及其应用
WO2023239728A1 (fr) 2022-06-07 2023-12-14 Evelo Biosciences, Inc. Compositions et méthodes de traitement d'une inflammation à l'aide de vésicules extracellulaires de prevotella histicola

Citations (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4775536A (en) 1986-02-24 1988-10-04 Bristol-Myers Company Enteric coated tablet and process for making
US5047258A (en) 1989-07-14 1991-09-10 Sterling Drug Inc. Aqueous spray-coating process
US5292522A (en) 1989-06-20 1994-03-08 Rohm Gmbh Aqueous film coating agent for solid medicaments
US6312728B1 (en) 1998-07-07 2001-11-06 Cascade Development, Inc. Sustained release pharmaceutical preparation
US6555124B1 (en) 1996-08-01 2003-04-29 Basf Aktiengesellschaft Use of (meth)acrylic acid copolymers to increase the permeability of mucous membranes
US6623759B2 (en) 1996-06-28 2003-09-23 Astrazeneca Ab Stable drug form for oral administration with benzimidazole derivatives as active ingredient and process for the preparation thereof
US6638534B1 (en) 1998-07-28 2003-10-28 Tanabe Seiyaku Co., Ltd. Preparation capable of releasing drug at target site in intestine
US20040028737A1 (en) 2002-08-12 2004-02-12 Kopran Research Laboratories Limited Enteric coated stable oral pharmaceutical composition of acid unstable drug and process for preparing the same
WO2005044240A2 (fr) 2003-10-31 2005-05-19 Dexcel, Ltd. Formulation stable contenant du lansoprazole
US20050271778A1 (en) 2002-12-20 2005-12-08 Roehm Gmbh & Co., Kg Method for producing coated pharmaceuticals and food supplements with concentration gradients in the coating thereof
US20060210631A1 (en) 2005-03-21 2006-09-21 Patel Ashish A Multi-particulate, modified-release composition
US20080200482A1 (en) 2005-07-12 2008-08-21 Evonik Roehm Gmbh Use of a Partially Neutralized, Anionic (Meth)Acrylate Copolymer as a Coating for the Production of a Medicament Releasing Active Substance at Reduced Ph Values
US20150087616A1 (en) * 2011-11-30 2015-03-26 Ritter Pharmaceuticals, Inc. Prebiotic formulations and methods of use
US9233074B2 (en) 2013-03-01 2016-01-12 Bpsi Holdings, Llc Delayed release film coatings containing calcium silicate and substrates coated therewith
WO2018229216A1 (fr) 2017-06-14 2018-12-20 4D Pharma Research Limited Compositions comprenant une souche bactérienne du genre megasphera et leurs utilisations
WO2020120714A1 (fr) 2018-12-12 2020-06-18 4D Pharma Research Limited Compositions comprenant des souches bactériennes
WO2020172492A2 (fr) * 2019-02-22 2020-08-27 Evelo Biosciences, Inc. Préparations de membrane bactérienne
WO2021146523A1 (fr) * 2020-01-17 2021-07-22 Evelo Biosciences, Inc. Formes posologiques solides à profils de désintégration améliorés

Patent Citations (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4775536A (en) 1986-02-24 1988-10-04 Bristol-Myers Company Enteric coated tablet and process for making
US5292522A (en) 1989-06-20 1994-03-08 Rohm Gmbh Aqueous film coating agent for solid medicaments
US5047258A (en) 1989-07-14 1991-09-10 Sterling Drug Inc. Aqueous spray-coating process
US6623759B2 (en) 1996-06-28 2003-09-23 Astrazeneca Ab Stable drug form for oral administration with benzimidazole derivatives as active ingredient and process for the preparation thereof
US6555124B1 (en) 1996-08-01 2003-04-29 Basf Aktiengesellschaft Use of (meth)acrylic acid copolymers to increase the permeability of mucous membranes
US6312728B1 (en) 1998-07-07 2001-11-06 Cascade Development, Inc. Sustained release pharmaceutical preparation
US6638534B1 (en) 1998-07-28 2003-10-28 Tanabe Seiyaku Co., Ltd. Preparation capable of releasing drug at target site in intestine
US20040028737A1 (en) 2002-08-12 2004-02-12 Kopran Research Laboratories Limited Enteric coated stable oral pharmaceutical composition of acid unstable drug and process for preparing the same
US20050271778A1 (en) 2002-12-20 2005-12-08 Roehm Gmbh & Co., Kg Method for producing coated pharmaceuticals and food supplements with concentration gradients in the coating thereof
WO2005044240A2 (fr) 2003-10-31 2005-05-19 Dexcel, Ltd. Formulation stable contenant du lansoprazole
US20060210631A1 (en) 2005-03-21 2006-09-21 Patel Ashish A Multi-particulate, modified-release composition
US20080200482A1 (en) 2005-07-12 2008-08-21 Evonik Roehm Gmbh Use of a Partially Neutralized, Anionic (Meth)Acrylate Copolymer as a Coating for the Production of a Medicament Releasing Active Substance at Reduced Ph Values
US20150087616A1 (en) * 2011-11-30 2015-03-26 Ritter Pharmaceuticals, Inc. Prebiotic formulations and methods of use
US9233074B2 (en) 2013-03-01 2016-01-12 Bpsi Holdings, Llc Delayed release film coatings containing calcium silicate and substrates coated therewith
WO2018229216A1 (fr) 2017-06-14 2018-12-20 4D Pharma Research Limited Compositions comprenant une souche bactérienne du genre megasphera et leurs utilisations
WO2020120714A1 (fr) 2018-12-12 2020-06-18 4D Pharma Research Limited Compositions comprenant des souches bactériennes
WO2020172492A2 (fr) * 2019-02-22 2020-08-27 Evelo Biosciences, Inc. Préparations de membrane bactérienne
WO2021146523A1 (fr) * 2020-01-17 2021-07-22 Evelo Biosciences, Inc. Formes posologiques solides à profils de désintégration améliorés

Non-Patent Citations (27)

* Cited by examiner, † Cited by third party
Title
"Guide to Huge Computers", 1994, ACADEMIC PRESS
"Handbook of Pharmaceutical Excipients", 2009, PHARMACEUTICAL PRESS AND AMERICAN PHARMACISTS ASSOCIATION
ACHTMAN MWAGNER M: "Microbial diversity and the genetic nature of microbial species", NAT. REV. MICROBIOL., vol. 6, 2008, pages 431 - 440, XP037115178, DOI: 10.1038/nrmicro1872
ATSCHUL, S. F. ET AL., J MOLEC BIOL, vol. 215, 1990, pages 403
CARDING ET AL.: "Dysbiosis of the gut microbiota in disease", MICROB. ECOL. HEALTH DIS., vol. 26, 2015, pages 10
CARILLO ET AL., SIAM J APPLIED MATH, vol. 48, 1988, pages 1073
CITI, S.: "Intestinal Barriers protect against disease", SCIENCE, vol. 359, 2018, pages 1098 - 99
CLAESSON MJWANG QO'SULLIVAN OGREENE-DINIZ RCOLE JRROSS RPO'TOOLE PW: "Comparison of two next-generation sequencing technologies for resolving highly complex microbiota composition using tandem variable 16S rRNA gene regions", NUCLEIC ACIDS RES, vol. 38, 2010, pages e200, XP055250083, DOI: 10.1093/nar/gkq873
DEVEREUX, J. ET AL., NUCLEIC ACIDS RESEARCH, vol. 12, 1984, pages 387
ENGISCH WILLIAM E ET AL: "Loss-in-Weight Feeding Trials Case Study: Pharmaceutical Formulation", JOURNAL OF PHARMACEUTICAL INNOVATION, SPRINGER US, BOSTON, vol. 10, no. 1, 6 December 2014 (2014-12-06), pages 56 - 75, XP035447522, ISSN: 1872-5120, [retrieved on 20141206], DOI: 10.1007/S12247-014-9206-1 *
G. NORHEIM ET AL., PLOS ONE, vol. 10, no. 9, 2015, pages e0134353
HOOKSO'MALLEY: "mBio", vol. 8, October 2017, AMERICAN SOCIETY FOR MICROBIOLOGY, article "Dysbiosis and its discontents", pages: 8
JEPPESEN ET AL., CELL, vol. 177, 2019, pages 428
KONSTANTINIDIS KTRAMETTE ATIEDJE JM: "The bacterial species definition in the genomic era", PHILOS TRANS R SOC LOND B BIOL SCI, vol. 361, 2006, pages 1929 - 1940
LEEKHA ET AL.: "General Principles of Antimicrobial Therapy", MAYO CLIN PROC., vol. 86, no. 2, 2011, pages 156 - 167, XP055372896, DOI: 10.4065/mcp.2010.0639
LEVY ET AL.: "Dysbiosis and the Immune System", NATURE REVIEWS IMMUNOLOGY, vol. 17, April 2017 (2017-04-01), pages 219
LYNCH ET AL.: "The Human Microbiome in Health and Disease", N. ENGL. J. MED, vol. 375, 2016, pages 2369 - 79
PEARSON ET AL., PROC. NATL. ACAD. SCI. USA, vol. 85, 1988, pages 2444
S. BIN PARK ET AL., PLOS ONE, vol. 6, no. 3, 2011, pages el7629
SANDRINI ET AL., BIO-PROTOCOL, vol. 4, no. 21, 2014, pages el287
SCHOCH ET AL.: "Nuclear ribosomal internal transcribed spacer (ITS) region as a universal DNA barcode marker for Fungi", PNAS, vol. 109, 2012, pages 6241 - 6246, XP055194048, DOI: 10.1073/pnas.1117018109
SHANMUGAM, BIOIMPACTS, vol. 5, 2015, pages 55 - 63
SRINIVASAN ET AL.: "TEER measurement techniques for in vitro barrier model systems", J. LAB. AUTOM., vol. 20, 2015, pages 107 - 126, XP055560328, DOI: 10.1177/2211068214561025
SUNIT SAHA ET AL: "Multifunctional coprocessed excipients for improved tabletting performance", EXPERT OPINION ON DRUG DELIVERY, INFORMA HEALTHCARE, GB, vol. 6, no. 2, 1 February 2009 (2009-02-01), pages 197 - 208, XP009113706, ISSN: 1742-5247, DOI: 10.1517/17425240802708978 *
THEIN ET AL., J. PROTEOME RES., vol. 9, no. 12, 2010, pages 6135 - 6147
WALKER, W.A.DYSBIOSIS, THE MICROBIOTA IN GASTROINTESTINAL PATHOPHYSIOLOGY, 2017
WEISSTHIERRY: "Mechanisms and consequences of intestinal dysbiosis", CELLULAR AND MOLECULAR LIFE SCIENCES, vol. 74, no. 16, 2017, pages 2959 - 2977, XP036272294, DOI: 10.1007/s00018-017-2509-x

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023239728A1 (fr) 2022-06-07 2023-12-14 Evelo Biosciences, Inc. Compositions et méthodes de traitement d'une inflammation à l'aide de vésicules extracellulaires de prevotella histicola
CN115778913A (zh) * 2022-10-28 2023-03-14 广西壮族自治区水牛研究所 一种泡腾片、制备方法及其应用

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