WO2019226572A1 - Compositions and methods for diagnosis and treatment of conditions related to the quality of aging and longevity - Google Patents
Compositions and methods for diagnosis and treatment of conditions related to the quality of aging and longevity Download PDFInfo
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- WO2019226572A1 WO2019226572A1 PCT/US2019/033175 US2019033175W WO2019226572A1 WO 2019226572 A1 WO2019226572 A1 WO 2019226572A1 US 2019033175 W US2019033175 W US 2019033175W WO 2019226572 A1 WO2019226572 A1 WO 2019226572A1
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Classifications
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- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/17—Amino acids, peptides or proteins
- A23L33/175—Amino acids
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- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
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Definitions
- compositions including metabolites that are small molecules, and salts and derivatives thereof, and methods for treatment or prophylaxis of conditions related to the quality of aging are provided, including compositions and methods for treating conditions that negatively impact longevity and the quality of aging, including inflammation, anemia, hyperglycemia, dyslipidemia, hyperinsulinemia, liver disease, iron overload, impaired skin integrity, wound healing, scarring, pain, allergies, sleep disorders and problems, and gastrointestinal disorders and problems.
- compositions including metabolites that are small molecules, and salts and derivatives thereof, and methods for treatment or prophylaxis of conditions related to the quality of aging are provided, including compositions and methods for treating conditions that negatively impact longevity and the quality of aging, including inflammation, anemia, hyperglycemia, dyslipidemia, hyperinsulinemia, liver disease, iron overload, impaired skin integrity, wound healing, scarring, pain, allergies, sleep disorders and problems, and gastrointestinal disorders and problems.
- Aging increases the risk of health conditions that can decrease quality of life and longevity. As people age, they have a higher risk of developing a suite of conditions, including inflammation, anemia, hyperglycemia, dyslipidemia, hyperinsulinemia, liver disease, iron overload, impaired skin integrity, wound healing, scarring, pain, allergies, sleep disorders and problems, and gastrointestinal disorders and problems. These conditions are contributing factors to a reduced quality of life, and as such, treatments of these conditions have been proposed as a means to improve longevity and quality of life.
- compositions and methods for treatment or prophylaxis of conditions with aging that impact quality of life or longevity are provided. These compositions comprise one or more small molecule biochemicals, derivatives of these biochemicals, or salts thereof, which may be administered in combination with other medicaments or as part of various treatment regimens as described herein.
- the provided compositions are effective for modulating markers of aging- associated conditions that impact quality of life or longevity. Methods are provided for administering the compositions.
- compositions are suitable for the treatment, amelioration, or prevention of conditions including but not limited to Th1-type inflammation, Th2-type inflammation, T-cell dependent B cell proliferation, allergy, asthma, atherosclerosis, autoimmunity, chronic inflammation, chronic obstructive pulmonary disease (COPD), Crohn’s disease, cutaneous responses to tissue damage, fibrosis, hematological oncology, metabolic diseases, organ transplantation, psoriasis, pulmonary fibrosis, pulmonary responses to respiratory infections, restenosis, rheumatoid arthritis, sarcoidosis, stromal biology in tumors, systemic lupus erythematosus (SLE), ulcerative colitis, and vascular inflammation.
- conditions including but not limited to Th1-type inflammation, Th2-type inflammation, T-cell dependent B cell proliferation, allergy, asthma, atherosclerosis, autoimmunity, chronic inflammation, chronic obstructive pulmonary disease (COPD), Crohn’s disease, cutaneous responses to tissue damage, fibro
- alpha smooth muscle actin aSMA
- CD40 CD69
- collagen I collagen III
- decorin e-selectin
- eotaxin 3 CCL26
- fibroblast proliferation human leukocyte antigen-DR isotype (HLA-DR)
- immunoglobulin G human leukocyte antigen-DR isotype (HLA-DR)
- IP-10/CXCL10 interferon gamma-induced protein 10
- I- TAC/CXCL11 interleukin
- IL interleukin
- IL-1a interleukin-1a
- IL-2 interleukin-6
- IL-8 CXCL8
- IL-10 interleukin
- IL-17A IL-17F
- keratin 8/81 macrophage colony-stimulating factor
- M-CSF matrix metalloproteinase
- MMP-9 monocyte chemoattractant protein 1
- a pharmaceutical composition comprising: one or more small molecule metabolites, or pharmaceutically acceptable salts thereof, wherein the one or more small molecule metabolites are selected from the group consisting of one or more small molecule metabolites; and a pharmaceutically acceptable carrier.
- the one or more small molecules is a metabolite described herein.
- the composition is in a unit dosage form.
- the pharmaceutical composition is configured for administration of from 2.5 mg to 50 mg, per 1 kg of body weight, of the one or more small molecule metabolites or pharmaceutically acceptable salts thereof to a patient.
- the pharmaceutical composition is configured for administration once per day.
- the pharmaceutical composition comprises from 0.01 mg to 10000 mg of the one or more small molecule metabolites or pharmaceutically acceptable salts thereof.
- a pharmaceutical composition of the first aspect or any embodiment thereof in the manufacture of a medicament for treatment or prophylaxis of conditions related to quality of life or longevity, wherein the conditions related to quality of life or longevity are selected from the group consisting of inflammation, anemia, hyperglycemia, dyslipidemia, hyperinsulinemia, liver disease, iron overload, impaired skin integrity, wound healing, scarring, pain, allergies, sleep disorders and problems, and gastrointestinal disorders and problems.
- the use is in the manufacture of a medicament for treatment or prophylaxis of conditions related to quality of life or longevity.
- the pharmaceutical composition is configured to modulate a marker of aging-associated conditions related to quality of life or longevity or a symptom of conditions related to quality of life or longevity.
- the marker of conditions related to quality of life or longevity is selected from the group consisting of serum or plasma small molecule metabolite concentration, red blood cell indices (i.e. hemoglobin, red blood cells), serum or plasma cholesterol, triglycerides, insulin, glucose, gamma-glutamyl transpeptidase, ferritin, or iron.
- the pharmaceutical composition is configured to increase a serum, red blood cell, or tissue concentration of the one or more small molecule metabolites to between 0.2 ⁇ M and 20 ⁇ M.
- a method of treatment or prophylaxis of conditions associated with quality of life or longevity comprising: administering to a patient in need thereof, an effective amount of one or more small molecule metabolites, or pharmaceutically acceptable salts thereof, wherein the one or more small molecule metabolites are selected from the group described herein.
- the one or more small molecule metabolites or pharmaceutically acceptable salts thereof is provided as a pharmaceutical composition in a unit dosage form comprising the one or more small molecule metabolites or pharmaceutically acceptable salts thereof and a pharmaceutically acceptable carrier.
- the unit dosage form comprises from 0.01 mg to 10000 mg of the one or more small molecule metabolites or pharmaceutically acceptable salts thereof.
- the pharmaceutical composition comprises a plurality of different small molecule metabolites described herein.
- the one or more small molecule metabolites or pharmaceutically acceptable salts thereof is administered to the patient once per day.
- a serum, tissue, or a red blood cell membrane concentration of the one or more small molecule metabolites is increased 1.25 to 6 times above the patient’s baseline levels to achieve concentrations between 0.5 ⁇ M and 20 ⁇ M.
- a composition substantially as described herein is provided.
- a use substantially as described herein is provided.
- FIG.1. provides data on improving hematocrit among individual dolphins while on the modified fish diet.
- FIG.2 provides data regarding the impact of dolphin serum-based compounds on t-cell proliferation in a human cell system mimicking t-cell driven chronic inflammation and autoimmune diseases.
- FIG.3 provides data regarding the impact of dolphin serum-based compounds on CD40 in a human cell system mimicking t-cell driven chronic inflammation and autoimmune diseases.
- FIG.4 provides data regarding the impact of dolphin serum-based compounds on prostaglandin E2 secretion in a human cell system mimicking t-cell and monocyte driven chronic inflammation and cardiovascular diseases.
- FIG.5 provides data regarding the impact of dolphin serum-based compounds on IL-17A in a human cell system mimicking asthma, autoimmunity, and allergy.
- FIG.6 provides data regarding the impact of xanthurenate on IL-6 in a human cell system mimicking cardiovascular inflammation.
- FIG.7 provides data regarding the impact of dolphin serum-based compounds on decorin in a human cell system mimicking wound healing, remodeling, fibrosis, and chronic inflammation.
- FIG.8 provides data regarding the impact of dolphin serum-based compounds on IL-8 in a human cell system mimicking wound healing, remodeling, fibrosis, and chronic inflammation.
- FIG. 9 is a table providing information on dolphin-based compounds with demonstrated anti-inflammatory activity in human cell systems.
- compositions including one or more small molecule metabolites, and associated methods for treatment of conditions related to aging, including inflammation, anemia, hyperglycemia, dyslipidemia, hyperinsulinemia, liver disease, iron overload, impaired skin integrity, wound healing, scarring, pain, allergies, sleep disorders and problems, and gastrointestinal disorders and problems, and other related conditions, are provided.
- Aging is associated with chronic, low-grade inflammation characterized by increased circulating levels of proinflammatory cytokines, neutrophils, and progressively activated macrophages.
- This pro-inflammatory state is a significant risk factor for both morbidity and mortality in the elderly people (Franceschi C, Campisi J (2014) Chronic inflammation (inflammaging) and its potential contribution to age-associated diseases. J Gerontol Ser A 69:S4- S9). People who live at least 100 years are less likely to have developed a proinflammatory state with age, further supporting that chronic, low-grade inflammation impairs quality and duration of life (Vasto S, Candore G, Balistreri M, Colonna-Romano G, Grimaldi MP, Listi F et al.
- Elevated cholesterol with aging can negatively impact quality of life or longevity.
- Elevated cholesterol especially elevated low-density lipoprotein (LDL) cholesterol, have been identified as underlying causes of or contributors to cardiovascular disease, including atherosclerosis, which also increase in prevalence with age.
- LDL low-density lipoprotein
- Lower cholesterol levels, especially for people under 50 years old, have been associated with improved longevity (Anderson KM, Castelli WP, Levy D (1987) Cholesterol and mortality: 30 years of follow-up from the Framingham Study JAMA 257:2176-2180).
- triglyceride levels can be major predicting factors for human longevity, with lower triglyceride levels present in long-lived families compared to controls (Vaarhorst AAM, Beekman M, Suchiman EHD, van Heemst DV, Houwing- Duistermaat JJ, Westerndorp RG et al (2010) Lipid metabolism in long-lived families: the Leiden Longevity Study. AGE 33:219-227). Preventing and treating dyslipidemia have been highlighted as important to improve quality of life and expand longevity.
- Insulin resistance increases with advanced age, and people who live over one hundred years have lower insulin resistance compared to those who were younger (Paolisso G, Barbieri M, Rizzo MR, Carella C, Rotondi M, Bonafe M et al (2001) Low insulin resistance and preserved b-cell function contribute to human longevity but are not associated with TH-INS genes. Exp Gerontol 37:147-156). Treatments long used to treat type 2 diabetes, including metformin, have been demonstrated to expand longevity (Novelle MG, Ali A, Dieguez C, Bernier M, de Cabo R (2016) Metformin: A hopeful promise in aging research. CSH Perspectives 6:a025932), and there is an active effort to discover other compounds that may help treat hyperglycemia and insulin resistance and expand longevity.
- liver disease has been increasing at an alarming rate, especially in developed countries. This increase is due primarily to nonalcoholic fatty liver disease (NAFLD) associated with the global rise in obesity and metabolic syndrome (including elevated glucose, dyslipidemia, and insulin resistance).
- NAFLD nonalcoholic fatty liver disease
- Chronic liver disease contributes to morbidity and mortality, and by aiming to decrease liver failure, transplants, and cancer, therapeutics for liver disease can improve quality of life and expand longevity (Lim YS, Kim WR (2008) The global impact of hepatic fibrosis and end-stage liver disease. Clinics in Liver Dis 12:733-746).
- Iron overload and hyperferritinemia with aging can negatively impact quality of life or longevity. Iron accumulates with age in tissues, including the brain (Hirose W, Ikematsu K, and Tsuda R (2003) Age-associated increases in heme oxygenase-1 and ferritin immunoreactivity in the autopsied brain. Legal Med 5:S360-366). Because iron induces oxidative damage to tissues, resulting in age-related diseases, such as Alzheimer’s disease, compounds that reduce iron overload and hyperferritinemia have been proposed as therapeutic targets for aging- associated diseases (Bartzokis G, Tishler TA, Lu PH, Villablanca P, Altshuler LL, Carter M et al. (2007) Brain ferritin iron may influence age- and gender-related risks of neurodegeneration. Neurobiol Aging 28:414-423).
- Aging skin and poor wound healing can negatively impact quality of life.
- Aging skin has changes to structure and function that impairs its integrity and ability to heal (Farage MA, Miller KW, Elsner P, Maibach HI (2013) Characteristics of the aging skin. Adv Wound Care 2: doi: 10.1089).
- Compounds that prevent or correct intrinsic changes with age that influence skin integrity and repair can aid in improving the quality of life.
- IL-17a interleukin-17A
- IL-17a interleukin-17A
- a compound that lowers IL-17A may help to alleviate pain from rheumatoid arthritis (Iwakura Y et al. (2008) The roles of IL-17A inflammatory immune responses and host defense against pathogens. Immunol Rev 226:).
- compounds that reduce chronic systemic inflammation associated with aging and cardiometabolic diseases may attenuate these diseases and their associated pain.
- IL-17a Interleukin-17A
- IL-17a Interleukin-17A
- compounds that reduce allergy responses, including reduction of IL-17A can improve the quality of life for people, including the elderly.
- PGE2 inhibitors which can be used to reduce inflammation, pain and fevers, may also aid in stemming PGE2’s role in stimulating the wake centers near the posterior hypothalamus (Hayaishi O (1991) Molecular mechanisms of sleep-wake regulation: roles of prostaglandins D2 and E2. FASEB J 5:2575-2581).
- Interleukin-17A is a contributor to chronic intestinal inflammation,and lowering IL-17A secretion may aid in alleviating digestive disorders (Coccia M et al. (2012) IL- 1b mediates chronic intestinal inflammation by promoting the accumulation of IL-17A secreting innate lymphoid cells and CD4+ Th17 cells. J Exp Med 209:1595).
- This scarless repair may be due to lower levels of decorin and IL-8, an extracellular matrix proteoglycan and chemokine, respectively, observed in fetal tissue (Beanes SR et al. (2001) Down-regulation of decorin, a transforming growth factor-beta modulator, is associated with scarless fetal wound healing. J Pediatr Surg 36:1666-71; Liechty KW (1997) Diminished interleukin-8 (IL-8) production in the fetal wound healing response. J Surg Res 77:80-84). As such, lower levels of IL- 6, IL-8, and decorin may help stem inflammation associated with chronic, non-healing wounds and enable this healing to occur with minimal scarring.
- An object of certain of the embodiments is to provide a method for treating conditions including but not limited to aging-associated conditions that impact quality of life or longevity in mammal subjects, such as companion animals and humans.
- An object of certain of the embodiments is to provide a method for detecting conditions including but not limited to aging-associated conditions that impact quality of life or longevity in mammal subjects, such as companion animals and humans. It is an object of certain of the embodiments to provide a method for increasing the serum, plasma, or erythrocyte membrane level of one or more small molecule metabolites or small molecule metabolite derivatives, including but not limited to biochemicals listed in Table 1, for example, an amino acid, such as 2-methylserine, and/or certain lipids, such as 10-undecanoate, in mammal subjects, such as companion animals and humans.
- An object of certain of the embodiments is to provide a small molecule metabolite supplement or prescription therapeutic for treating or preventing conditions including but not limited to those associated with aging and conditions that impact quality of life or longevity.
- An object of certain of the embodiments is to provide a method for detecting and/or treating aging- associated conditions that impact quality of life or longevity in mammal subjects, such as companion animals and humans, that is easy to accomplish in a cost-effective manner.
- An object of certain of the embodiments is to employ the compositions of the embodiments in the prophylaxis, amelioration, and/or treatment of selected diseases and conditions.
- diseases and conditions include but are not limited to oral indications, e.g., cavities (tooth decay); gum disease (gingivitis); periodontitis; sensitive teeth; oral cancer; burning mouth syndrome; ulcers, sores, or tender areas in the mouth; bleeding or swollen gums after brushing or flossing; chronic bad breath; sensitivity to hot and cold temperatures or beverages; pain or toothache; loose teeth; receding gums; pain with chewing or biting; swelling of the face and cheek; clicking of the jaw; frequent dry mouth; and stomatitis.
- oral indications e.g., cavities (tooth decay); gum disease (gingivitis); periodontitis; sensitive teeth; oral cancer; burning mouth syndrome; ulcers, sores, or tender areas in the mouth; bleeding or swollen gums after brushing or flossing; chronic bad breath; sensitivity to
- These diseases and conditions include but are not limited to skin conditions, e.g., acne, cold sore, blister, hives, actinic keratosis, rosacea, carbuncle, exzcema, psoriasis, cellulitis, measles, basal cell carsinoma, squamous cell carcinoma, melanoma, lupus, contact dermatitis, vitiligo, wart, chickenpox, seborrheic eczema, keratosis pilaris, ringworm, melasma, impetigo, diaper rash, rashes from bacterial or fungal infections, rashes from allergic reactions, fifth disease, and vasculitis.
- skin conditions e.g., acne, cold sore, blister, hives, actinic keratosis, rosacea, carbuncle, exzcema, psoriasis, cellulitis, measles,
- These diseases and conditions include but are not limited to pain, e.g., chronic pain, nerve pain, psychogenic pain, musculoskeletal pain, chronic muscle pain, abdominal pain, joint pain, central pain syndrome, complex regional pain syndrome, diabetes related nerve pain (neuropathy), shingles pain (postherpetic neuralgia), and trigeminal neuralgia.
- pain e.g., chronic pain, nerve pain, psychogenic pain, musculoskeletal pain, chronic muscle pain, abdominal pain, joint pain, central pain syndrome, complex regional pain syndrome, diabetes related nerve pain (neuropathy), shingles pain (postherpetic neuralgia), and trigeminal neuralgia.
- These diseases and conditions include but are not limited to allergies, e.g., food allergies, seasonal allergies (e.g., hay fever, pollen), allergies to animal products (e.g., pet dander, dust mites, cockroaches), drugs such as penicillin and sulfa, foods (e.g., wheat, nuts, milk, shellfish, egg, legumes), insect stings (e.g., bees, wasps, mosquitoes), mold, plants (e.g., pollens from grass, weeds, trees; resins from plants such as poison ivy and poison oak), miscellaneous allergies (e.g., latex, nickel), contact dermatitis, rashes, eczema, sore throat, hives, swollen eyes, itching, burning, itchy eyes, watery eyes, runny nose, coughing, asthma, and airway inflammation.
- allergies e.g., food allergies, seasonal allergies (e.g., hay fever, pollen
- These diseases and conditions include but are not limited to sleep conditions, e.g., obstructive sleep apnea, central sleep apnea, insomnia, hypersomnia (daytime sleepiness), parasomnias, REM sleep behavior disorder, circadian rhythm sleep disorders, non-24-hour sleep-wake disorder, periodic limb movement disorder, shift work sleep disorder, and narcolepsy.
- sleep conditions e.g., obstructive sleep apnea, central sleep apnea, insomnia, hypersomnia (daytime sleepiness), parasomnias, REM sleep behavior disorder, circadian rhythm sleep disorders, non-24-hour sleep-wake disorder, periodic limb movement disorder, shift work sleep disorder, and narcolepsy.
- These diseases and conditions include but are not limited to digestive and/or gastroinestinal conditions or disorders, e.g., diarrhea, constipation, acid reflux, heartburn, vomiting, gastroesophageal reflux disease, gallstones, celiac disease, Crohn’s disease, ulcerative colitis, irritable bowel syndrome, hemorrhoids, diverticulitis, diverticulosis, anal fissure, peptic ulcers, gastroparesis, and nausea.
- digestive and/or gastroinestinal conditions or disorders e.g., diarrhea, constipation, acid reflux, heartburn, vomiting, gastroesophageal reflux disease, gallstones, celiac disease, Crohn’s disease, ulcerative colitis, irritable bowel syndrome, hemorrhoids, diverticulitis, diverticulosis, anal fissure, peptic ulcers, gastroparesis, and nausea.
- An object of certain of the embodiments is to provide a method for modulating markers of aging-associated conditions that impact quality of life or longevity in mammal subjects, such as companion animals and humans.
- An object of certain of the embodiments is to provide a method for detecting aging-associated conditions that impact quality of life or longevity in mammal subjects, such as companion animals and humans.
- An object of certain of the embodiments is to provide a method for treatment of aging-associated conditions that impact quality of life or longevity in mammal subjects, such as companion animals and humans.
- An object of certain of the embodiments is to provide a method for prophylaxis of aging-associated conditions that impact quality of life or longevity in mammal subjects, such as companion animals and humans.
- An object of certain of the embodiments is to provide a method for prophylaxis of a condition provided herein including aging-associated conditions that impact quality of life or longevity, including inflammation, anemia, hyperglycemia, dyslipidemia, hyperinsulinemia, liver disease, iron overload, impaired skin integrity, wound healing, scarring, pain, allergies, sleep disorders and problems, and gastrointestinal disorders and problems, and other related conditions, in mammal subjects, such as companion animals and humans.
- An object of certain of the embodiments is to provide a method for increasing a small molecule metabolite in the sera, plasma, or erythrocyte membranes of mammal subjects, such as companion animals and humans.
- An object of certain of the embodiments is to provide a method for detecting or treating aging-associated conditions that impact quality of life or longevity in mammal subjects, such as companion animals and humans.
- An object of certain of the embodiments is to provide a small molecule metabolite substantially free from other small molecule metabolites in mammal subjects, such as companion animals and humans.
- It is an object of certain of the embodiments is to provide a method for detecting and treating aging-associated conditions that impact quality of life or longevity in mammal subjects, such as companion animals and humans.
- An object of certain of the embodiments is to provide a small molecule metabolite, such as a biochemical listed in Table 1, for treating aging- associated conditions that impact quality of life or longevity in mammal subjects, such as companion animals and humans.
- An object of certain of the embodiments is to provide a method for prophylaxis of aging-associated conditions that impact quality of life or longevity in mammal subjects, such as companion animals and humans.
- An object of certain of the embodiments is to provide a method for detecting or treating aging-associated conditions that impact quality of life or longevity in mammal subjects, such as companion animals and humans.
- An object of certain of the embodiments is to provide a small molecule metabolite as described herein to supplement for treating conditions that impact quality of life or longevity in mammal subjects, such as companion animals and humans.
- An object of certain of the embodiments is to provide a bioavailable form of small molecule metabolites to mammal subjects, such as companion animals and humans.
- An object of certain of the embodiments is to provide one or more small molecule metabolites described herein with one or more other small molecule biochemicals described herein to mammal subjects, such as companion animals and humans.
- An object of certain embodiments is to provide a method for increasing small molecule biochemicals described herein in the sera of mammal subjects, such as companion animals and humans.
- An object of certain of the embodiments is to provide a method for altering concentrations of a variety of small molecule metabolites as described herein in the sera, plasma, or erythrocyte membranes of mammal subjects, such as companion animals and humans.
- compositions including one or more of certain small molecule metabolites from contained herein, and associated methods for treatment of inflammation are provided.
- Compositions including one or more bioavailable metabolites contained herein are provided.
- Compositions including one or more of certain small molecule metabolites from Table 1, and associated methods for treatment of anemia are provided.
- Compositions including one or more bioavailable metabolites contained herein are provided.
- compositions including one or more of certain small molecule metabolites from Table 1, and associated methods for treatment of hyperglycemia are provided.
- compositions including one or more of certain small molecule metabolites from Table 1, and associated methods for treatment of dyslipidemia are provided.
- Compositions including one or more bioavailable metabolites contained herein are provided.
- compositions including one or more of certain small molecule metabolites contained herein, and associated methods for treatment of hyperinsulinemia are provided.
- Compositions including one or more bioavailable metabolites contained herein are provided.
- compositions including one or more of certain small molecule metabolites contained herein, and associated methods for treatment of liver disease are provided.
- Compositions including one or more bioavailable metabolites contained herein are provided.
- compositions including one or more of certain small molecule metabolites contained herein, and associated methods for treatment of iron overload are provided.
- Compositions including one or more bioavailable metabolites contained herein are provided.
- compositions including one or more of certain small molecule metabolites contained herein, and associated methods for treatment of impaired skin integrity, wound healing, scarring, pain, allergies, sleep disorders and problems, and gastrointestinal disorders and problems are provided.
- Compositions including one or more bioavailable metabolites contained herein are provided.
- the term“alcohol” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to any compound as described herein incorporating one or more hydroxy groups, or being substituted by or functionalized to include one or more hydroxy groups.
- the term“short-chain fatty acid” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a fatty acid with 2-6 carbon atoms
- immediate-chain fatty acid as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a fatty acid with 7-12 carbon atoms.
- long-chain fatty acid as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a fatty acid with 13- 22 carbon atoms.
- very long chain fatty acid as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a fatty acid with 23 or more carbon atoms.
- derivative as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to any compound as described herein incorporating one or more derivative groups, or being substituted by or functionalized to include one or more derivative groups.
- Derivatives include but are not limited to esters, amides, anhydrides, acid halides, thioesters, phosphates, triphosphates, and b-sulfenyl derivatives.
- hydrocarbon as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to any moiety comprising only carbon and hydrogen atoms.
- a functionalized or substituted hydrocarbon moiety has one or more substituents as described elsewhere herein.
- lipid as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to saturated and unsaturated oils and waxes, derivatives, amides, glycerides, small molecule metabolites, fatty alcohols, sterol and sterol derivatives, phospholipids, ceramides, sphingolipids, tocopherols, and carotenoids, among others.
- pharmaceutically acceptable is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to those compounds, materials, compositions, and/or dosage forms which are, within the scope of sound medical judgment, suitable for contact with the tissues of and/or for consumption by human beings and animals without excessive toxicity, irritation, allergic response, or other problem complications commensurate with a reasonable risk/benefit ratio.
- pharmaceutically acceptable salts and “a pharmaceutically acceptable salt thereof” as used herein are broad terms, and are to be given their ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refer without limitation to salts prepared from pharmaceutically acceptable, non-toxic acids or bases.
- Suitable pharmaceutically acceptable salts include metallic salts, e.g., salts of aluminum, zinc, alkali metal salts such as lithium, sodium, and potassium salts, alkaline earth metal salts such as calcium and magnesium salts; organic salts, e.g., salts of lysine, N,N’-dibenzylethylenediamine, chloroprocaine, choline, diethanolamine, ethylenediamine, meglumine (N-methylglucamine), procaine, and tris; salts of free acids and bases; inorganic salts, e.g., sulfate, hydrochloride, and hydrobromide; and other salts which are currently in widespread pharmaceutical use and are listed in sources well known to those of skill in the art, such as, for example, The Merck Index.
- metallic salts e.g., salts of aluminum, zinc, alkali metal salts such as lithium, sodium, and potassium salts, alkaline earth metal salts such as calcium and magnesium salts
- Any suitable constituent can be selected to make a salt of the therapeutic agents discussed herein, provided that it is non-toxic and does not substantially interfere with the desired activity.
- pharmaceutically acceptable precursors and derivatives of the compounds can be employed.
- Pharmaceutically acceptable amides, lower alkyl derivatives, and protected derivatives can also be suitable for use in compositions and methods of preferred embodiments. While it may be possible to administer the compounds of the preferred embodiments in the form of pharmaceutically acceptable salts, it is generally preferred to administer the compounds in neutral form.
- composition as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a mixture of one or more compounds disclosed herein with other chemical components, such as diluents or carriers.
- the pharmaceutical composition facilitates administration of the compound to an organism.
- Pharmaceutical compositions can also be obtained by reacting compounds with inorganic or organic acids or bases. Pharmaceutical compositions will generally be tailored to the specific intended route of administration.
- carrier as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a compound that facilitates the incorporation of a compound into cells or tissues.
- DMSO dimethyl sulfoxide
- Water, saline solution, ethanol, and mineral oil are also carriers employed in certain pharmaceutical compositions.
- diluent as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to an ingredient in a pharmaceutical composition that lacks pharmacological activity but may be pharmaceutically necessary or desirable.
- a diluent may be used to increase the bulk of a potent drug whose mass is too small for manufacture and/or administration. It may also be a liquid for the dissolution of a drug to be administered by injection, ingestion or inhalation.
- a common form of diluent in the art is a buffered aqueous solution such as, without limitation, phosphate buffered saline that mimics the composition of human blood.
- excipient is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to a substance that is added to a pharmaceutical composition to provide, without limitation, bulk, consistency, stability, binding ability, lubrication, disintegrating ability etc., to the composition.
- A“diluent” is a type of excipient.
- subject as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to an animal that is the object of treatment, observation or experiment.
- Animal includes cold- and warm-blooded vertebrates and invertebrates such as fish, shellfish, reptiles and, in particular, mammals.
- “Mammal” includes, without limitation, dolphins, mice, rats, rabbits, guinea pigs, dogs, cats, sheep, goats, cows, horses, primates, such as monkeys, chimpanzees, and apes, and, in particular, humans.
- the subject is human.
- treatment is broad terms, and are to be given their ordinary and customary meaning (and are not to be limited to a special or customized meaning) and, without limitation, do not necessarily mean total cure or abolition of the disease or condition. Any alleviation of any undesired markers, signs or symptoms of a disease or condition, to any extent, can be considered treatment and/or therapy. Furthermore, treatment may include acts that may worsen the patient's overall feeling of well- being or appearance.
- a therapeutically effective amount of compound can be the amount needed to prevent, alleviate or ameliorate markers or symptoms of a condition or prolong the survival of the subject being treated. This response may occur in a tissue, system, animal or human and includes alleviation of the signs or symptoms of the disease being treated.
- a therapeutically effective amount is well within the capability of those skilled in the art, in view of the disclosure provided herein.
- the therapeutically effective amount of the compounds disclosed herein required as a dose will depend on the route of administration, the type of animal, including human, being treated, and the physical characteristics of the specific animal under consideration.
- the dose can be tailored to achieve a desired effect, but will depend on such factors as weight, diet, concurrent medication and other factors which those skilled in the medical arts will recognize.
- solvents as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and refers without limitation to compounds with some characteristics of solvency for other compounds or means, that can be polar or nonpolar, linear or branched, cyclic or aliphatic, aromatic, naphthenic and that includes but is not limited to: alcohols, derivatives, diesters, ketones, acetates, terpenes, sulfoxides, glycols, paraffins, hydrocarbons, anhydrides, heterocyclics, among others.
- Small molecule metabolites are low molecular weight (typically less than 900 daltons, but sometimes higher) and can include but are not limited to amino acids, peptides, carbohydrates, cofactors and vitamins, xenobiotics, or lipids (including monohydroxy fatty acids, medium chain fatty acids, long chain fatty acids, very long chain fatty acids, dicarboxylic fatty acids, phosphatidylcholines, phosphatidylethanolamines, lysophospholipids, plasmalogens, lysoplasmalogens, monoacylglycerols, diacylglycerols, sphingomyelins, or ceramides) that can be identified and measured in the body and as provided herein. Small molecule metabolites can originate from ingestion of food or other oral products or produced endogenously. Small molecule metabolites are referred to and described using conventional nomenclature as is employed by one of skill in the art.
- these compounds or classes of compounds may be produced by metabolic processes (e.g., by administration of a prodrug, or by endogenous production), or may be provided to a patient in a form of a pharmaceutical composition.
- metabolic processes e.g., by administration of a prodrug, or by endogenous production
- the term“metabolite” of necessity requires production of a compound by a metabolic process in a patient to be treated.
- the compound, identified as a“metabolite” may be administered directly to the patient in a pharmaceutical composition rather than in a prodrug form that yields the compound as a metabolite in vivo.
- the term“metabolite” is employed as a broad term that is not intended to limit compounds to be administered to a patient to compounds produced by a particular method of synthesis (in vivo from a prodrug versus ex vivo).
- a small molecule metabolite may be referred to by various names, for example, 2-methylserine may be referred to as 2-amino-3-hydroxy-2-methylpropanoic acid.
- the small molecule metabolite can be an amino acid, peptide, carbohydrate, cofactor and vitamin, xenobiotic, or lipid as provided herein.
- one or more small molecule metabolites can include at least one amino acid, peptide, carbohydrate, cofactor and vitamin, xenobiotic, or lipid as provided herein.
- Small molecule metabolites that are ideal candidates as both biomarkers and therapeutics are metabolites that are successfully detected in serum at high nanomolar or micromolar levels that have a low molecular weight ( ⁇ 900 daltons) and meet Lipinski’s rule of five. All metabolites provided herein meet these criteria.
- a small molecule metabolite can be an amino acid, including but not limited to 2-methylserine, 4-hydroxyglutamate, N-acetyl-aspartyl-glutamate, 2- pyrrolidinone, trans-urocanate, imidazole proprionate, 1-ribosyl-imidazoleacetate, 5- imidazoleacetate, N-acetylhistamine, hydantoin 5-prorionic acid, 5-hydroxylysine, 5- aminovalerate, 2-oxoadipate, xanthurenate, methionine sulfone, homocitrulline, trans-4- hydroxyproline, prolyl-hydroxyproline, or guanidinosuccinate.
- Derivatives can be synthesized by published methods.
- a small molecule metabolite can be a peptide, including but not limited to gamma-glutamylglutamine, or gamma-glutamylglycine; a carbohydrate, including but not limited to N6-carboxymethyllysine; a cofactor or vitamin, including N1-methyl- 2-pyridone-5-carboxamide, N1-methyl-4-pyridone-3-carboxamide; or a xenobiotic, including but not limited to 2,3-dihydroxyisovalerate.
- Derivatives can be synthesized by published methods.
- a small molecule metabolite can be a monohyroxy fatty acid, including but not limited to 2-hydroxyocatnoate, 2-hydroxydecanoate, 8-hydroxyoctanoate, 2-hydroxymyristate, or 16-hydroxypalmitate. Derivatives can be synthesized by published methods.
- a small molecule metabolite can be a medium chain fatty acid, e.g., a fatty acid including but not limited to one containing a group such as heptanoate (C7:0, e.g., heptanoic acid), caprylate (C8:0, e.g., caprylic acid), pelargonate (C9:0, e.g., pelargonic acid), undecanoate (C11:0, e.g., undecanoic acid), or 10-undecanoate (C11:1n1, e.g., 10-undecanoic acid); a long chain fatty acid, including but not limited to pentadecanoate (C15:0, e.g., pentadecanoic acid), margarate (C17:0, e.g., margaric acid), 10-heptadecanoate (C17:1n7, e.g., 10-
- a small molecule metabolite can be a part or product of fatty acid metabolism, including but not limited to propionylglycine, lignoceroylcarnitine (C24), cerotoylcarnitine (C26), N-palmitoylglycine, cis-4-decenoylcarnitine (C10:1), behenoylcarnitine (C22), pentadecanoylcarnitine (C15), or arachidonoylcholine. Derivatives can be synthesized by published methods.
- a small molecule metabolite can be a phosphatidylcholine, including but not limited to 1-stearoyl-2-arachidonoyl-GPC (18:0/20:4), 1- palmitoyl-2-arachidonoyl-GPC (16:0/20:4n6), PC (18:2/22:4), PC (20:0/14:1), PC (20:0/20:3), or PC (20:0/22:4); a phosphatidylethanolamine, including but not limited 1-palmitoyl-2- arachidonoyl-GPE (16:0/20:4), 1-stearoyl-2-arachidonoyl-GPE (18:0/20:4), or PE (16:0/16:0); a phosphatidylserine, including but not limited to 1-stearoyl-2-oleoyl-GPS (18:0/18:1); a lysophospholipid, including but not limited 1-arachidonoyl-GPC (20:
- a small molecule metabolite can be a plasmalogen, including but not limited to 1-(1-enyl-palmitoyl)-2-arachidonoyl-GPE (P-16:0/20:4), 1-(1-enyl- palmitoyl)-2-oleoyl-GPC (P-16:0/18:1), 1-(1-enyl-palmitoyl)-2-arachidonoyl-GPC (P-16:0/20:4), or 1-(1-enyl-stearoyl)-2-arachidonoyl-GPE (P-18:0/20:4); or a lysoplasmalogen, including but not limited to 1-(1-enyl-palmitoyl)-GPC (P-16:0).
- Derivatives can be synthesized by published methods.
- a small molecule metabolite can be a monoacylglycerol (MAG), including but not limited to MAG (12:0), MAG (17:0), MAG (20:0), MAG (20:2), 1- arachidonylglycerol (20:4) or 1-heptadecenoylglycerol (17:1); or a diacylglycerol (DAG), including but not limited to DAG (14:1/18:1), stearoyl-arachidonoyl-glycerol (18:0/20:4) [2], oleoyl-arachidonoyl-glycerol (18:1/20:4) [1], or oleoyl-arachidonoyl-glycerol (18:1/20:4) [2].
- Derivatives can be synthesized by published methods.
- a small molecule metabolite can be a sphingomyelin, including but not limited to stearoyl sphingomyelin (d18:1/18:0), behenoyl sphingomyelin (d18:1/22:0), tricosanoyl sphingomyelin (d18:1/23:0), lignoceroyl sphingomyelin (d18:1/24:0), sphingomyelin (d18:2/23:1), sphingomyelin (d18:2/24:2), sphingomyelin (d17:1/14:0, d16:1/15:0), sphingomyelin (d17:1/16:0, d18:1/15:0, d16:1/17:0), sphingomyelin (d17:2/16:0, d18:2/15:0), sphingomyelin (d17:2/16
- a small molecule metabolite can be a ceramide, including but not limited to CER (14:0), HCER (26:1), or LCER (26:0).
- Derivatives can be synthesized by published methods.
- a derivative of a small molecule metabolite can be a b– sulfenyl derivative. It is thought that b–sulfenyl derivatives, such as an acid or ester, can be resistant to b–oxidation in the body. Derivatives can be synthesized by published methods.
- a small molecule metabolite is provided in a bioavailable form.
- bioavailability refers to the fraction of an administered dose of unchanged drug that reaches the systemic circulation, one of the principal pharmacokinetic properties of drugs. By definition, when a medication is administered intravenously, its bioavailability is 100%.
- bioavailable refers to a form of the small molecule metabolite that is successfully absorbed by the body when using methods of administration other than intravenous, for example, an oral therapeutic).
- small molecule metabolite-based compositions may include adaptions that optimize absorption.
- a pure or purified small molecule metabolite may exist in various physical states.
- 4-hydroxyglutamate exists as a white powder that is stable at room temperature; this compound can be purchased in forms suitable for research purposes in small amounts from some commercial suppliers (for example, from Sigma-Aldrich Corp., of St. Louis, MO).
- Other small molecule metabolites, or stereoisomers, or solvates, or esters, or salts or other derivatives thereof, may exist as oils, solids, crystalline solids, or gases.
- a small molecule metabolite or the pharmaceutically acceptable salts or derivatives thereof may be provided in a purity (e.g., a percentage of the small molecule metabolite, or its pharmaceutically acceptable salts or derivatives, in a bulk form) of at least about 10%, at least about 20%, 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 95%, at least about 98%, at least about 99%, at least about 99.9%, at least about 99.99%, or substantially pure, wherein substantially pure may include, but not be limited to, a product with impurities at a level such that no physiological effect from the presence of the impurities is detectable.
- a mixture of small molecule metabolites such as, for example, an amino acid and/or lipid, or pharmaceutically acceptable salts or derivatives thereof, may be present in a purity of at least about 10%, at least about 20%, 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 95%, at least about 98%, at least about 99%, at least about 99.9%, at least about 99.99%, or substantially pure.
- the small molecule metabolite, or a mixture thereof, or a pharmaceutically acceptable salt or derivative thereof may be free from other small molecule metabolites.
- a small molecule metabolite as provided herein may be substantially free from other small molecule metabolites, singly or taken as a group; small molecule metabolites to exclude, for example, can include palmitic acid (C16:0) or stearic acid (C18:0). In some embodiments, a small molecule metabolite as provided herein may be substantially free from other species of lipids not included herein.
- a small molecule metabolite such as an amino acid, peptide, carbohydrate, cofactor, vitamins, xenobiotic, or lipid, or a pharmaceutically acceptable salt or derivative thereof, may be from any source.
- a small molecule metabolite, or its pharmaceutically acceptable salts or derivatives may be present in natural sources, may be isolated from natural sources, may be semi-synthetic, may be synthetic, or may be a mixture of one or more of these.
- the small molecule metabolite, or its pharmaceutically acceptable salts or derivatives may be produced in a laboratory, may be produced in nature, may be produced by enzymatic processes, may be produced by wild microbes, may be produced by genetically modified microbes, may be isolated from animal tissues, may be produced by chemical synthesis, or may be produced by a plurality of these processes.
- the small molecule metabolite may be derived from natural sources, e.g., fish oils, or can be synthesized by methods as are known in the art.
- the small molecule metabolite may be contaminated with undesired components present in unrefined or unpurified natural products. In such situations, it can be desirable to remove undesired components, or to increase the concentration of desired components using known separation or purification techniques.
- each double bond may independently be E or Z, or a mixture thereof.
- valencies are to be filled with hydrogens or isotopes thereof, e.g., hydrogen-1 (protium) and hydrogen-2 (deuterium).
- the small molecule metabolite such as an amino acid, peptide, carbohydrate, cofactors and vitamin, xenobiotics, or lipid, as described herein, includes crystalline forms (also known as polymorphs, which include the different crystal packing arrangements of the same elemental composition of a compound), amorphous phases, salts, solvates, and hydrates.
- the compounds described herein exist in solvated forms with pharmaceutically acceptable solvents such as water, ethanol, or the like. In other embodiments, the compounds described herein exist in unsolvated form.
- Solvates contain either stoichiometric or non- stoichiometric amounts of a solvent, and may be formed during the process of crystallization with pharmaceutically acceptable solvents such as water, ethanol, or the like. Hydrates are formed when the solvent is water, or alcoholates are formed when the solvent is alcohol.
- the compounds provided herein can exist in unsolvated as well as solvated forms. In general, the solvated forms are considered equivalent to the unsolvated forms for the purposes of the compounds and methods provided herein.
- the compounds described herein can be labeled isotopically.
- substitution with isotopes such as deuterium may afford certain therapeutic advantages resulting from greater metabolic stability, such as, for example, increased in vivo half- life or reduced dosage requirements.
- Isotopic substitution may be beneficial in monitoring subject response to administration of a compound, for example, by providing opportunity for monitoring of the fate of an atom in a compound.
- Each chemical element as represented in a compound structure may include any isotope of said element.
- a hydrogen atom may be explicitly disclosed or understood to be present in the compound.
- the hydrogen atom can be any isotope of hydrogen, including but not limited to hydrogen-1 (protium) and hydrogen-2 (deuterium).
- hydrogen-1 protium
- hydrogen-2 deuterium
- reference herein to a compound encompasses all potential isotopic forms unless the context clearly dictates otherwise.
- Formulations including a small molecule metabolite, such as an amino acid, peptide, carbohydrate, cofactor, vitamins, xenobiotic, or lipid, or a salt or derivative thereof, and at least one excipient are provided. It is generally preferred to administer the compounds of the embodiments in oral formulations; however, other routes of administration are also contemplated, such as topical.
- the formulations are suitable for use as consumer health and wellness products, including over the counter (OTC) products, as well as supplements and foodstuffs.
- compositions of the embodiments may be used in cosmetic, cosmeceutical and general skincare compositions or provided in pharmaceutical compositions, and can be employed in the promotion of healthy skin, skin regeneration and enhanced wound healing.
- Successful wound healing occurs when the tissue remodeling process alleviates the inflammatory response of the innate immune system and minimizes the scar forming process that occurs when fibrous tissue replaces normal skin after an injury.
- Less efficient or delayed wound healing often produces unsightly, irritating, and painful scars such as keloids or hypertrophic scars.
- compositions can help treat or prevent dermatologic conditions such as skin dryness, dullness, loss of elasticity, lack of radiance, exaggerated lines and wrinkles, stretch marks, spider vessels, red blotchiness, smile lines, deep nasolabial fold lines, crow's feet, fine lines/wrinkles, vertical lines between the eyebrows, horizontal forehead lines, sagging thin/frail skin, skin redness, dullness, the appearance of photodamaged skin, the appearance of fine lines and wrinkles, hyperpigmentation, age spots, aged skin, and generally increasing the quality of skin.
- dermatologic conditions such as skin dryness, dullness, loss of elasticity, lack of radiance, exaggerated lines and wrinkles, stretch marks, spider vessels, red blotchiness, smile lines, deep nasolabial fold lines, crow's feet, fine lines/wrinkles, vertical lines between the eyebrows, horizontal forehead lines, sagging thin/frail skin, skin redness, dullness, the appearance of photodamaged skin, the appearance of
- compositions of the embodiments can also be employed in the connection with mucous membranes, e.g., the lips and the vaginal mucosa.
- a vaginal applicator When applied to the vaginal mucosa, a vaginal applicator can be employed as are commercially available. Suitable applicators can be in a form of a pre-filled syringe, a tube attached to a prefilled squeezable reservoir, a prepackaged wand including a preselected amount of composition, or a universal vaginal applicator including perforations along its length for dispensing the composition through the perforations.
- compositions can contain further therapeutic agents.
- drugs such as antibacterial drugs, antiprotozoal drugs, antifungal drugs, antiviral drugs, spermicidal agents, prostaglandins, and steroids.
- Drugs suitable for delivery include bromocriptine, sildenafil, oxytocin, calcitonin, luteinizing hormone-releasing hormone and analogues, insulin, human growth hormone, oxybutynin, and steroids used in hormone replacement therapy or for contraception.
- Antifungal drugs include clotrimazole, econazole, miconazole, terbinafine, fluconazole, ketoconazole, and amphotericin.
- Antibiotics include amoxicillin, doxycycline, cephalexin, ciprofloxacin, clindamycin, metronidazole, azithromycin, sulfamethoxazole/trimethoprim, amoxicillin/clavulanate, and levofloxacin.
- Classes of antibiotics include penicillins, tetracyclines, cephalosporins, quinolones, lincomycins, macrolides, sulfonamides, glycopeptides, aminoglycosides, and carbapenems.
- hormones include 5- alpha-reductase inhibitors, adrenal cortical steroids, corticotropin, glucocorticoids, mineralocorticoids, adrenal corticosteroid inhibitors, antiandrogens, antidiuretic hormones, antigonadotropic agents, antithyroid agents, aromatase inhibitors,calcitonin, estrogen receptor antagonists, gonadotropin-releasing hormone antagonists, growth hormone receptor blockers, growth hormones, insulin-like growth factor, parathyroid hormone and analogs, progesterone receptor modulators, prolactin inhibitors, selective estrogen receptor modulators, sex hormones, androgens and anabolic steroids, contraceptives, estrogens, gonadotropin releasing hormones, gonadotropins, progestins, sex hormone combinations, somatostatin and somatostatin analogs, synthetic ovulation stimulants, and thyroid drugs.
- Antiviral agents include adamantane antivirals, antiviral boosters, antiviral combinations, antiviral interferons, chemokine receptor antagonist, integrase strand transfer inhibitor, miscellaneous antivirals, neuraminidase inhibitors, NNRTIs, NS5A inhibitors, nucleoside reverse transcriptase inhibitors (NRTIs), protease inhibitors, and purine nucleosides.
- Drugs for treating skin conditions include acne drugs (isotretinoin), atopic dermatitis drugs (topical steroids), herpes zoster drugs (antivirals such as valacyclovir), hives (antihistamines like loratadine or fexofenadine, omalizumab), sunburn (lidocaine), contact dermatitis (antihistamines, topical steroids), diaper rash (zinc oxide), rosacea (metronidazole, doxycycline, azelaic acid, isotretinoin, beta blockers, estrogen), athlete’s foot (antifungals), and basal cell carcinoma (imiquimod, fluorouracil, vismodegib).
- acne drugs isotretinoin
- atopic dermatitis drugs topical steroids
- herpes zoster drugs antivirals such as valacyclovir
- hives antihistamines like loratadine or fexofenadine
- compositions of the embodiments include topical formulations containing at least one excipient.
- Excipients can include a nonaqueous or aqueous carrier, and one or more agents selected from moisturizing agents, pH adjusting agents, deodorants, fragrances, chelating agents, preservatives, emulsifiers, thickeners, solubilizing agents, penetration enhancers, anti- irritants, colorants, surfactants, beneficial agents, pharmaceutical agents, and other components as known in the art for use in connection with topical formulations for treatment of the skin.
- the composition can be formulated such that preservatives need not be employed.
- the composition may be provided as an ointment, an oil, a lotion, a paste, a powder, a gel, or a cream.
- the composition may also include additional ingredients such as a protective agent, an emollient, an astringent, a humectant, a sun screening agent, a sun tanning agent, a UV absorbing agent, an antibiotic agent, an antifungal agent, an antiviral agent, an antiprotozoal agent, an anti-acne agent, an anesthetic agent, a steroidal anti- inflammatory agent, a non-steroidal anti-inflammatory agent, an antipruritic agent, an additional antioxidant agent, a chemotherapeutic agent, an anti-histamine agent, a vitamin or vitamin complex, a hormone, an anti-dandruff agent, an anti-wrinkle agent, an anti-skin atrophy agent, a skin whitening agent, a cleansing agent, and combinations thereof.
- the composition may avoid animal
- compositions can be employed to promote healthy skin, skin regeneration, enhanced wound healing, and to treat skin conditions such as inflammation, redness, soreness, skin sensitivity, dry skin, bruising, and similar conditions.
- suitable methods for objectively measuring improvement in skin redness and inflammation may include tristimulus colorimetry, narrow-band reflectance spectroscopy, diffuse reflectance spectroscopy, skin reflectance spectroscopy, and/or UV photography.
- Some embodiments include administering the small molecule metabolite, such as an amino acid, peptide, carbohydrate, cofactor, vitamins, xenobiotic, or lipid, or a salt or derivative thereof in topical formulations; however, other routes of administration are also contemplated (e.g., mucosal, subdermal, oral, or the like) in addition to oral administration.
- routes of administration include but are not limited to topical, mucosal, and subcutaneous. Suitable liquid forms include suspensions, emulsions, solutions, and the like.
- Unit dosage forms can also be provided, e.g., individual packets with a premeasured amount of the formulation, configured for administration to a body part on a predetermined schedule pre- procedure and post-procedure.
- Unit dosage forms configured for administration twice or three times a day are particularly preferred; however, in certain embodiments it can be desirable to configure the unit dosage form for administration once a day, four times a day, or more.
- the topical and other formulations typically comprise from about 0.001 wt. % or less to about 50 wt.
- active ingredient such as the small molecule metabolite, such as an amino acid, peptide, carbohydrate, cofactor, vitamins, xenobiotic, or lipid, or a salt or derivative thereof, preferably from about 0.005, 0.01, 0.02, 0.03, 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, or 1 wt. % to about 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, or 45 wt. %.
- active ingredient such as the small molecule metabolite, such as an amino acid, peptide, carbohydrate, cofactor, vitamins, xenobiotic, or lipid, or a salt or derivative thereof, preferably from about 0.005, 0.01, 0.02, 0.03, 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7,
- compositions and formulations for topical administration can include transdermal patches, ointments, lotions, creams, gels, drops, sprays, liquids, aerosols, and powders.
- Conventional pharmaceutical carriers, aqueous, powder or oily bases, thickeners and the like may be employed.
- an ointment, lotion, cream, gel or similar formulation can be provided that can be applied to the skin using the fingers.
- Such formulations are typically provided in a squeeze tube or bottle or a pot, or in a roll-on, wherein a ball is secured in the top of a container of the formulation, wherein the ball is permitted to roll. By rolling the ball over the skin surface, liquid in the container is transferred to the skin in a controlled manner.
- An alternative delivery mechanism includes a container with a perforated lid with a mechanism for advancing an extrudable formulation through the lid.
- a gel formulation with sufficient structural integrity to maintain its shape is provided, which is advanced up a tube and applied to the skin (e.g., in a stick form).
- An advantage of the stick form is that only the formulation contacts the skin in the application process, not the fingers or a portion of a container.
- a liquid or gel can also be placed using an applicator, e.g., a wand, a sponge, a syringe, or other suitable method.
- the small molecule metabolite such as an amino acid, peptide, carbohydrate, cofactor, vitamins, xenobiotic, or lipid, or a salt or derivative thereof
- a suitable carrier diluent, or excipient
- auxiliary substances such as wetting or emulsifying agents, pH buffering agents, gelling or viscosity enhancing additives, preservatives, scenting agents, colors, and the like, depending upon the route of administration and the preparation desired.
- Techniques for formulation and administration of the compounds described herein are known to those skilled in the art.
- Such preparations can include complexing agents, metal ions, polymeric compounds such as polyacetic acid, polyglycolic acid, hydrogels, dextran, and the like, liposomes, microemulsions, micelles, unilamellar or multilamellar vesicles, erythrocyte ghosts or spheroblasts.
- Suitable lipids for liposomal formulations include, without limitation, monoglycerides, diglycerides, sulfatides, lysolecithin, phospholipids, saponin, bile acids, and the like.
- monoglycerides diglycerides, sulfatides, lysolecithin, phospholipids, saponin, bile acids, and the like.
- additional components can influence the physical state, solubility, stability, rate of release, rate of clearance, and penetration of active ingredients.
- compositions for topical administration comprise the small molecule metabolite, such as an amino acid, peptide, carbohydrate, cofactor, vitamins, xenobiotic, or lipid, or a salt or derivative thereof and a dermatologically acceptable vehicle.
- the vehicle may be aqueous or nonaqueous.
- the dermatologically acceptable vehicle used in the topical composition may be in the form of a lotion, a gel, an ointment, a liquid, a cream, or an emulsion.
- the emulsion may have a continuous aqueous phase and a discontinuous nonaqueous or oil phase (oil-in-water emulsion), or a continuous nonaqueous or oil phase and a discontinuous aqueous phase (water-in-oil emulsion).
- a liquid carrier such as water, petroleum, oils of animal or plant origin such as peanut oil, mineral oil, soybean oil, or sesame oil, or synthetic oils can be added to the active ingredient(s).
- Physiological saline solution, dextrose, or other saccharide solution, or glycols such as ethylene glycol, propylene glycol, or polyethylene glycol are also suitable liquid carriers.
- the pharmaceutical compositions can also be in the form of oil-in-water emulsions.
- the oily phase can be a vegetable oil, such as olive or arachis oil, a mineral oil such as liquid paraffin, or a mixture thereof.
- Suitable emulsifying agents include naturally-occurring gums such as gum acacia and gum tragacanth, naturally occurring phosphatides, such as soybean lecithin, esters or partial esters derived from fatty acids and hexitol anhydrides, such as sorbitan mono-oleate, and condensation products of these partial esters with ethylene oxide, such as polyoxyethylene sorbitan mono-oleate.
- the emulsions can also contain coloring and scenting agents.
- a silicone elastomer e.g., dimethicone crosspolymer
- the small molecule metabolite such as an amino acid, peptide, carbohydrate, cofactor, vitamins, xenobiotic, or lipid, or a salt or derivative thereof
- the pharmaceutical excipients used in the topical preparations of the compositions may be selected from the group consisting of solvents, emollients and/or emulsifiers, oil bases, preservatives, antioxidants, tonicity adjusters, penetration enhancers and solubilizers, chelating agents, buffering agents, surfactants, one or more polymers, and combinations thereof.
- Suitable solvents for an aqueous or hydrophilic topical formulation include water; ethyl alcohol; isopropyl alcohol; mixtures of water and ethyl and/or isopropyl alcohols; glycerin; ethylene, propylene or butylene glycols; DMSO; and mixtures thereof.
- Suitable solvents for hydrophobic topical formulations include mineral oils, vegetable oils, and silicone oils. If desired, the compositions as described herein may be dissolved or dispersed in a hydrophobic oil phase, and the oil phase may then be emulsified in an aqueous phase comprising water, alone or in combination with lower alcohols, glycerin, and/or glycols.
- Anhydrous formulations may also be employed; however, in certain embodiments it may be acceptable to provide water based compositions, or to permit a limited amount of water to be present.
- Viscosity of the compositions can be maintained at the selected level using a pharmaceutically acceptable thickening agent.
- Suitable viscosity enhancers or thickeners which may be used to prepare a viscous gel or cream with an aqueous base include sodium polyacrylate, xanthan gum, polyvinyl pyrrolidone, acrylic acid polymer, carragenans, hydroxyethyl cellulose, hydroxypropyl cellulose, methyl cellulose, ethyl cellulose, propyl cellulose, hydroxypropyl methyl cellulose, polyethoxylated polyacrylamides, polyethoxylated acrylates, and polyethoxylated alkane thiols.
- Methylcellulose is preferred because it is readily and economically available and is easy to work with.
- suitable thickening agents include, for example, xanthan gum, carboxymethyl cellulose, hydroxypropyl cellulose, carbomer, and the like.
- concentration of the thickener will depend upon the thickening agent selected. An amount is preferably used that will achieve the selected viscosity. Viscous compositions are normally prepared from solutions by the addition of such thickening agents, or by employing a base that has an acceptable level of viscosity.
- Suitable emollients include hydrocarbon oils and waxes such as mineral oil, petrolatum, paraffin, ceresin, ozokerite, microcrystalline wax, polyethylene, squalene, perhydrosqualene, silicone oils, triglyceride esters, acetoglyceride esters, such as acetylated monoglycerides; ethoxylated glycerides, such as ethoxylated glyceryl monostearate; alkyl esters of fatty acids or dicarboxylic acids.
- hydrocarbon oils and waxes such as mineral oil, petrolatum, paraffin, ceresin, ozokerite, microcrystalline wax, polyethylene, squalene, perhydrosqualene, silicone oils, triglyceride esters, acetoglyceride esters, such as acetylated monoglycerides; ethoxylated glycerides, such as ethoxylated glyceryl mono
- Suitable silicone oils for use as emollients include dimethyl polysiloxanes, methyl(phenyl) polysiloxanes, and water-soluble and alcohol-soluble silicone glycol copolymers.
- Suitable triglyceride esters for use as emollients include vegetable and animal fats and oils including castor oil, safflower oil, cotton seed oil, corn oil, olive oil, cod liver oil, almond oil, avocado oil, palm oil, sesame oil, and soybean oil.
- Suitable esters of carboxylic acids or diacids for use as emollients include methyl, isopropyl, and butyl esters of fatty acids. Specific examples of alkyl esters including hexyl laurate, isohexyl laurate, iso-hexyl palmitate, isopropyl palmitate, decyl oleate, isodecyl oleate, hexadecyl stearate, decyl stearate, isopropyl isostearate, dilauryl lactate, myristyl lactate, and cetyl lactate; and alkenyl esters of fatty acids such as oleyl myristate, oleyl stearate, and oleyl oleate.
- alkyl esters of diacids include diisopropyl adipate, diisohexyl adipate, bis(hexyldecyl) adipate, and diisopropyl sebacate.
- emollients or emulsifiers which may be used in the topical formulations include fatty acids, fatty alcohols, fatty alcohol ethers, ethoxylated fatty alcohols, fatty acid esters of ethoxylated fatty alcohols, and waxes.
- fatty acids for use as emollients include pelargonic, lauric, myristic, palmitic, stearic, isostearic, hydroxystearic, oleic, linoleic, ricinoleic, arachidic, behenic, and erucic acids.
- fatty alcohols for use as emollients include lauryl, myristyl, cetyl, hexadecyl, stearyl, isostearyl, hydroxystearyl, oleyl, ricinoleyl, behenyl, and erucyl alcohols, as well as 2-octyl dodecanol.
- waxes suitable for use as emollients include lanolin and derivatives thereof including lanolin oil, lanolin wax, lanolin alcohols, lanolin fatty acids, isopropyl lanolate, ethoxylated lanolin, ethoxylated lanolin alcohols, ethoxolated cholesterol, propoxylated lanolin alcohols, acetylated lanolin, acetylated lanolin alcohols, lanolin alcohols linoleate, lanolin alcohols recinoleate, acetate of lanolin alcohols recinoleate, acetate of lanolin alcohols recinoleate, acetate of ethoxylated alcohols esters, hydrogenolysates of lanolin, hydrogenated lanolin, ethoxylated hydrogenated lanolin, ethoxylated sorbitol lanolin, and liquid and semisolid lanolin.
- lanolin and derivatives thereof including lanolin oil,
- waxes include hydrocarbon waxes, ester waxes, and amide waxes.
- useful waxes include wax esters such as beeswax, spermaceti, myristyl myristate and stearyl stearate; beeswax derivatives, e.g., polyoxyethylene sorbitol beeswax; and vegetable waxes including carnauba and candelilla waxes.
- Polyhydric alcohols and polyether derivatives may be used as solvents and/or surfactants in the topical formulations.
- Suitable polyhydric alcohols and polyethers include propylene glycol, dipropylene glycol, polypropylene glycols 2000 and 4000, poly(oxyethylene- co-oxypropylene) glycols, glycerol, sorbitol, ethoxylated sorbitol, hydroxypropylsorbitol, polyethylene glycols 200-6000, methoxy polyethylene glycols 350, 550, 750, 2000 and 5000, poly[ethylene oxide] homopolymers (100,000-5,000,000), polyalkylene glycols and derivatives, hexylene glycol, 2-methyl-2,4-pentanediol, 1,3-butylene glycol, 1,2,6-hexanetriol, 2-ethyl-1,3- hexanediol, vicinal glycols having 15 to 18 carbon atoms, and poly
- Polyhydric alcohol esters may be used as emulsifiers or emollients. Suitable polyhydric alcohol esters include ethylene glycol mono- and di-fatty acid esters, diethylene glycol mono- and di-fatty acid esters, polyethylene glycol (200-6000) mono- and di-fatty acid esters, propylene glycol mono- and di-fatty esters, polypropylene glycol 2000 monooleate, polypropylene glycol 2000 monostearate, ethoxylated propylene glycol monostearate, glyceryl mono- and di-fatty acid esters, polyglycerol poly-fatty acid esters, ethoxylated glyceryl monostearate, 1,3-butylene glycol monostearate, 1,3-butylene glycol distearate, polyoxyethylene polyol fatty acid ester, sorbitan fatty acid esters, and polyoxyethylene sorbitan fatty acid esters.
- Suitable emulsifiers for use in topical formulations include anionic, cationic, nonionic, and zwitterionic surfactants.
- Preferred ionic emulsifiers include phospholipids, such as lecithin and derivatives.
- the small molecule metabolite such as an amino acid, peptide, carbohydrate, cofactor, vitamins, xenobiotic, or lipid contained herein, or a salt or derivative thereof, can be formulated as a liposome.
- the small molecule metabolite can be a component of the lipid portion of the liposome or can be encapsulated in the aqueous portion of the liposome.
- the small molecule metabolite, such as an amino acid, peptide, carbohydrate, cofactor, vitamins, xenobiotic, or lipid contained herein, or a salt or derivative thereof, can also be coformulated with a cyclodextrin.
- the cyclodextrin can be, for example, hydroxypropyl-b-cyclodextrin or a sulfobutylether cyclodextrin.
- Lecithin and other phospholipids may be used to prepare liposomes containing active ingredients as described herein. Formation of lipid vesicles occurs when phospholipids such as lecithin are placed in water and consequently form one bilayer or a series of bilayers, each separated by water molecules, once enough energy is supplied. Liposomes can be created by sonicating phospholipids in water. Low shear rates create multilamellar liposomes. Continued high-shear sonication tends to form smaller unilamellar liposomes. Hydrophobic chemicals can be dissolved into the phospholipid bilayer membrane. The lipid bilayers of the liposomes deliver the compositions as described herein.
- the topical formulations may contain micelles, or an aggregate of surfactant molecules dispersed in an aqueous solution.
- Micelles may be prepared by dispersing an oil solvent in an aqueous solution comprising a surfactant, where the surfactant concentration exceeds the critical micelle concentration.
- the resulting formulation contains micelles, i.e., spherical oil droplets surrounded by a membrane of polar surfactant molecules, dispersed in the aqueous solvent.
- Sterols including, for example, cholesterol and cholesterol fatty acid esters; amides such as fatty acid amides, ethoxylated fatty acid amides, and fatty acid alkanolamides may also be used as emollients and/or penetration enhancers.
- a pharmaceutically acceptable preservative can be employed to increase the shelf life of the composition.
- suitable preservatives and/or antioxidants for use in topical formulations include benzalkonium chloride, benzyl alcohol, phenol, urea, parabens, butylated hydroxytoluene (BHT), butylated hydroxyanisole (BHA), tocopherol, thimerosal, chlorobutanol, or the like, and mixtures thereof, can be employed.
- BHT butylated hydroxytoluene
- BHA butylated hydroxyanisole
- tocopherol thimerosal, chlorobutanol, or the like, and mixtures thereof, can be employed.
- a preservative such as an antioxidant
- the concentration is typically from about 0.02% to about 2% based on the total weight of the composition, although larger or smaller amounts can be desirable depending upon the agent selected.
- Reducing agents, as described herein can be advantageously used to maintain good shelf life of
- Suitable chelating agents for use in topical formulations include ethylene diamine tetraacetic acid, alkali metal salts thereof alkaline earth metal salts thereof, ammonium salts thereof, and tetraalkyl ammonium salts thereof.
- the carrier preferably has a pH of between about 4.0 and 10.0, more preferably between about 6.8 and about 7.8.
- the pH may be controlled using buffer solutions or other pH modifying agents. Suitable pH modifying agents include phosphoric acid and/or phosphate salts, citric acid and/or citrate salts, hydroxide salts (i.e., calcium hydroxide, sodium hydroxide, potassium hydroxide) and amines, such as triethanolamine.
- Suitable buffer solutions include a buffer comprising a solution of monopotassium phosphate and dipotassium phosphate, maintaining a pH of between 5.8 and 8; and a buffer comprising a solution of monosodium phosphate and disodium phosphate, maintaining a pH of between 6 and 7.5.
- Other buffers include citric acid/sodium citrate, and dibasic sodium phosphate/citric acid.
- the compositions of the embodiments are preferably isotonic with the blood or other body fluid of the recipient. The isotonicity of the compositions can be attained using sodium tartrate, propylene glycol or other inorganic or organic solutes. Sodium chloride is particularly preferred.
- Buffering agents can be employed, such as acetic acid and salts, citric acid and salts, boric acid and salts, and phosphoric acid and salts. It can be desirable to include a reducing agent in the formulation, such as vitamin C, vitamin E, or other reducing agents as are known in the pharmaceutical arts.
- Surfactants can also be employed as excipients, for example, anionic detergents such as sodium lauryl sulfate, dioctyl sodium sulfosuccinate and dioctyl sodium sulfonate, cationic such as benzalkonium chloride or benzethonium chloride, or nonionic detergents such as polyoxyethylene hydrogenated castor oil, glycerol monostearate, polysorbates, sucrose fatty acid ester, methyl cellulose, or carboxymethyl cellulose.
- anionic detergents such as sodium lauryl sulfate, dioctyl sodium sulfosuccinate and dioctyl sodium sulfonate
- cationic such as benzalkonium chloride or benzethonium chloride
- nonionic detergents such as polyoxyethylene hydrogenated castor oil, glycerol monostearate, polysorbates, sucrose fatty acid ester, methyl cellulose, or carboxymethyl
- the formulations of the embodiments are administered by subcutaneous injection, it is preferably in the form of a pyrogen-free, parenterally acceptable aqueous solution or oleaginous suspension, emulsion or solution.
- Suspensions can be formulated according to methods well known in the art using suitable dispersing or wetting agents and suspending agents.
- suitable dispersing or wetting agents and suspending agents are within the skill in the art.
- an isotonic vehicle such as 1,3-butanediol, water, isotonic sodium chloride solution, Ringer’s solution, dextrose solution, dextrose and sodium chloride solution, lactated Ringer’s solution, or other vehicles as are known in the art can be employed, or a fixed oil can be employed conventionally as a solvent or suspending medium, e.g., synthetic mono or diglycerides, fatty acids, or the like.
- the formulations can also contain stabilizers, preservatives, buffers, antioxidants, or other additives known to those of skill in the art.
- Anti-infective agents include, but are not limited to, anthelmintic (mebendazole), antibiotics including aminoglycosides (gentamicin, neomycin, tobramycin), antifungal antibiotics (amphotericin b, fluconazole, griseofulvin, itraconazole, ketoconazole, nystatin, micatin, tolnaftate), cephalosporins (cefaclor, cefazolin, cefotaxime, ceftazidime, ceftriaxone, cefuroxime, cephalexin), beta-lactam antibiotics (cefotetan, meropenem), chloramphenicol, macrolides (azithromycin, clarithromycin, erythromycin), penicillins (penicillin G sodium salt, amoxicillin, ampicillin, dicloxacillin, nafc
- Anesthetics can include, but are not limited to, ethanol, bupivacaine, chloroprocaine, levobupivacaine, lidocaine, mepivacaine, procaine, ropivacaine, tetracaine, desflurane, isoflurane, ketamine, propofol, sevoflurane, codeine, fentanyl, hydromorphone, marcaine, meperidine, methadone, morphine, oxycodone, remifentanil, sufentanil, butorphanol, nalbuphine, tramadol, benzocaine, dibucaine, ethyl chloride, xylocaine, and phenazopyridine.
- Anti-inflammatory agents include but are not limited to, nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin, celecoxib, choline magnesium trisalicylate, diclofenac potassium, diclofenac sodium, diflunisal, etodolac, fenoprofen, flurbiprofen, ibuprofen, indomethacin, ketoprofen, ketorolac, melenamic acid, nabumetone, naproxen, naproxen sodium, oxaprozin, piroxicam, rofecoxib, salsalate, sulindac, and tolmetin; and corticosteroids such as cortisone, hydrocortisone, methylprednisolone, prednisone, prednisolone, betamethesone, beclomethasone dipropionate, budesonide, dexamethasone sodium phosphate, flunisolide, fluticasone propionate
- the addition of emollients, emulsion stabilizers, moisturizers, excipients, and other compounds may be modified to enhance the sensory properties of the topical compositions, including but not limited to: skin feel (silkiness, lightness, creaminess, etc.), absorbency (required time at which product loses wet feel and is no longer perceived on skin), consistency, firmness, spreadability (e.g. viscosity, flow onset, shear rates), stickiness, integrity of shape, glossiness, hydrophilicity or hydrophobicity, and others.
- systemic administration of the small molecule metabolite such as an amino acid, peptide, carbohydrate, cofactor, vitamins, xenobiotic, or lipid, or a salt or derivative thereof, can be desirable.
- the small molecule metabolite such as an amino acid, peptide, carbohydrate, cofactor, vitamins, xenobiotic, or lipid, or a salt or derivative thereof are formulated into a composition suitable for oral administration, but other routes of administration are also contemplated.
- compositions described herein can be administered by themselves to a subject, or in compositions where they are mixed with other active agents, as in combination therapy, or with carriers, diluents, excipients or combinations thereof. Formulation is dependent upon the route of administration chosen. Techniques for formulation and administration of the compounds described herein are known to those skilled in the art (see, e.g.,“Remington: The Science and Practice of Pharmacy”, Lippincott Williams & Wilkins; 20th edition (June 1, 2003) and“Remington’s Pharmaceutical Sciences,” Mack Pub. Co.; 18th and 19th editions (December 1985, and June 1990, respectively).
- compositions disclosed herein may be manufactured into administrable forms by a process that is itself known, e.g., by means of conventional mixing, dissolving, granulating, dragee-making, levigating, emulsifying, encapsulating, entrapping, tableting, or extracting processes.
- Many of the compounds used in the pharmaceutical combinations disclosed herein may be provided as salts with pharmaceutically acceptable counterions.
- a small molecule metabolite such as an amino acid, peptide, carbohydrate, cofactor, vitamins, xenobiotic, or lipid, or a salt or derivative thereof, exist in the art including, but not limited to, oral, rectal, topical, aerosol, injection and parenteral delivery, including intramuscular, subcutaneous, intravenous, intramedullary injections, intrathecal, direct intraventricular, intraperitoneal, intranasal and intraocular injections.
- the small molecule metabolite such as an amino acid, peptide, carbohydrate, cofactor, vitamins, xenobiotic, or lipid, or a salt or derivative thereof may be combined as the active ingredient in intimate admixture with a pharmaceutical carrier according to conventional pharmaceutical compounding techniques.
- the small molecule metabolite such as an amino acid, peptide, carbohydrate, cofactor, vitamins, xenobiotic, or lipid, or a salt or derivative thereof can be added directly to, e.g., a gelatin capsule or a softgel capsule for consumption by the patient.
- carriers can be employed.
- the carrier can take a wide variety of forms depending on the form of preparation desired for administration.
- compositions provided herein can be presented as discrete units suitable for oral administration such as capsules, cachets or tablets each containing a predetermined amount of the active ingredient.
- the compositions can be presented as an oil, a powder, as granules, as a solution, as a suspension in an aqueous liquid, as a non-aqueous liquid, as an oil-in-water emulsion, or as a water-in-oil liquid emulsion, similar to the topical formulations described elsewhere herein, but using components suitable for human consumption.
- the compositions provided herein can also be administered by controlled release and/or delivery devices.
- the compositions can be prepared by any of the methods of pharmacy.
- such methods include a step of bringing into association the active ingredient with the carrier that constitutes one or more necessary ingredients.
- the compositions are prepared by uniformly and intimately admixing the active ingredients with liquid carriers or finely divided solid carriers or both. The product can then be conveniently shaped into the desired presentation.
- a formulation may also be administered in a local rather than systemic manner, for example, via injection of the composition directly into a target area, e.g., in a depot or sustained release formulation.
- a targeted drug delivery system for the composition may be used, for example, in a liposome coated with a tissue specific antibody.
- compositions may contain the small molecule metabolite, such as an amino acid, peptide, carbohydrate, cofactor, vitamins, xenobiotic, or lipid, or a salt or derivative thereof in an amount effective for the desired therapeutic effect.
- the compositions are in a unit dosage form and comprise from about 0.1 mg or less to about 5000 mg or more of small molecule metabolite, such as an amino acid, peptide, carbohydrate, cofactor, vitamins, xenobiotic, or lipid, or a salt or derivative thereof per unit dosage form.
- compositions comprise from about 1 to about 500 mg per unit dosage form or from about 500 to 5000 mg per unit dosage form of small molecule metabolite, such as an amino acid, peptide, carbohydrate, cofactor, vitamins, xenobiotic, or lipid, or a salt or derivative thereof.
- dosage forms may be solid, semisolid, liquid, an emulsion, or adapted for delivery via aerosol or the like for inhalation administration.
- the carrier employed can be, for example, a solid, liquid, or gas.
- solid carriers include lactose, terra alba, sucrose, talc, gelatin, agar, pectin, acacia, magnesium stearate, and stearic acid.
- liquid carriers are sugar syrup, peanut oil, olive oil, lower alcohols, and water.
- gaseous carriers include carbon dioxide and nitrogen.
- compositions provided herein can be prepared as solutions or suspensions of the small molecule metabolite, such as an amino acid, peptide, carbohydrate, cofactor, vitamins, xenobiotic, or lipid, or a salt or derivative thereof in water or nonaqueous liquids.
- a suitable surfactant can be included such as, for example, hydroxypropylcellulose.
- Dispersions can also be prepared in glycerol, liquid polyethylene glycols, and mixtures thereof in oils. Further, a preservative can be included to, for example, prevent the detrimental growth of microorganisms.
- compositions provided herein suitable for injectable use include sterile aqueous solutions or dispersions.
- the compositions can be in the form of sterile powders for the extemporaneous preparation of such sterile injectable solutions or dispersions.
- the compositions must be stable under the conditions of manufacture and storage; thus, preferably should be preserved against the contaminating action of microorganisms such as bacteria and fungi.
- the carrier can be a solvent or dispersion medium containing, for example, water, ethanol, polyol (e.g., glycerol, propylene glycol and liquid polyethylene glycol), vegetable oils, and suitable mixtures thereof.
- the formulations described above can include, as appropriate, one or more additional carrier ingredients such as diluents, buffers, flavoring agents, binders, surface-active agents, thickeners, lubricants, preservatives (including anti-oxidants) and the like.
- additional carrier ingredients such as diluents, buffers, flavoring agents, binders, surface-active agents, thickeners, lubricants, preservatives (including anti-oxidants) and the like.
- additional carrier ingredients such as diluents, buffers, flavoring agents, binders, surface-active agents, thickeners, lubricants, preservatives (including anti-oxidants) and the like.
- additional carrier ingredients such as diluents, buffers, flavoring agents, binders, surface-active agents, thickeners, lubricants, preservatives (including anti-oxidants) and the like.
- other adjuvants can be included to render the formulation isotonic with the blood or other bodily fluid
- compositions including the small molecule metabolite, such as an amino acid, peptide, carbohydrate, cofactor, vitamins, xenobiotic, or lipid, or a salt or derivative thereof as described herein in combination with at least one additional active agent.
- the small molecule metabolite, such as an amino acid, peptide, carbohydrate, cofactor, vitamins, xenobiotic, or lipid, or a salt or derivative thereof and the at least one additional active agent(s) may be present in a single formulation or in multiple formulations provided together, or may be unformulated.
- the small molecule metabolite such as an amino acid, peptide, carbohydrate, cofactor, vitamins, xenobiotic, or lipid, or a salt or derivative thereof can be administered with one or more additional agents together in a single composition.
- the small molecule metabolite such as an amino acid, peptide, carbohydrate, cofactor, vitamins, xenobiotic, or lipid, or a salt or derivative thereof can be administered in one composition, and at least one of the additional agents can be administered in a second composition.
- the small molecule metabolite such as an amino acid, peptide, carbohydrate, cofactor, vitamins, xenobiotic, or lipid, or a salt or derivative thereof and the at least one additional active agent(s) are co-packaged in a kit.
- a drug manufacturer, a drug reseller, a physician, a compounding shop, or a pharmacist can provide a kit comprising the small molecule metabolite, such as an amino acid, peptide, carbohydrate, cofactor, vitamins, xenobiotic, or lipid, or a salt or derivative thereof in combination with another product or component for delivery to a patient.
- additional components can include anti-infective agents, anti-inflammatory agents, anesthetics, or the like.
- Some embodiments described herein relate to oral compositions of small molecule metabolite, such as an amino acid, peptide, carbohydrate, cofactor, vitamins, xenobiotic, or lipid, or a salt or derivative thereof, which can include a therapeutically effective amount of the small molecule metabolite, such as an amino acid, peptide, carbohydrate, cofactor, vitamins, xenobiotic, or lipid, or a salt or derivative thereof described herein and a pharmaceutically acceptable carrier, diluent, excipient or combination thereof.
- small molecule metabolite such as an amino acid, peptide, carbohydrate, cofactor, vitamins, xenobiotic, or lipid, or a salt or derivative thereof.
- compositions can include the small molecule metabolite, such as an amino acid, peptide, carbohydrate, cofactor, vitamins, xenobiotic, or lipid, or a salt or derivative thereof in an amount for example, > 1%, 3 2%, 3 3%, 3 4%, 3 5%, 3 6%, 3 7%, 3 8%, 3 9%, 3 10%, 3 20%, 3 30%, 3 40%, 3 50%, 3 60%, 3 70%, 3 80%, 3 90%, 3 95%, or 3 98% of the composition.
- small molecule metabolite such as an amino acid, peptide, carbohydrate, cofactor, vitamins, xenobiotic, or lipid, or a salt or derivative thereof in an amount for example, > 1%, 3 2%, 3 3%, 3 4%, 3 5%, 3 6%, 3 7%, 3 8%, 3 9%, 3 10%, 3 20%, 3 30%, 3 40%, 3 50%, 3 60%, 3 70%, 3 80%, 3 90%, 3 95%, or 3 98%
- the pharmaceutical composition can include a plurality of small molecule metabolites, such as one or more of an amino acid, peptide, carbohydrate, cofactor, vitamins, xenobiotic, and/or lipid described herein, or salts or derivatives thereof in, for example, > 1%, 3 2%, 3 3%, 3 4%, 3 5%, 3 6%, 3 7%, 3 8%, 3 9%, 3 10%, 3 20%, 3 30%, 3 40%, 3 50%, 3 60%, 3 70%, 3 80%, 3 90%, 3 95%, or 3 98% of the composition.
- small molecule metabolites such as one or more of an amino acid, peptide, carbohydrate, cofactor, vitamins, xenobiotic, and/or lipid described herein, or salts or derivatives thereof in, for example, > 1%, 3 2%, 3 3%, 3 4%, 3 5%, 3 6%, 3 7%, 3 8%, 3 9%, 3 10%, 3 20%, 3 30%, 3 40%, 3 50%, 3 60%
- Foodstuffs and other comestibles including a small molecule metabolite, such as an amino acid, peptide, carbohydrate, cofactor, vitamins, xenobiotic, or lipid described herein, or a salt or derivative thereof, are provided, wherein an amount of the small molecule metabolite in the foodstuff has been fortified (e.g., enriched or concentrated).
- a small molecule metabolite, such as an amino acid, peptide, carbohydrate, cofactor, vitamins, xenobiotic, or lipid, provided herein may be added to foodstuffs for consumption by a subject.
- the small molecule metabolite such as an amino acid, peptide, carbohydrate, cofactor, vitamins, xenobiotic, or lipid described herein, may be integrated into one or more ingredients of a foodstuff.
- the small molecule metabolite such as an amino acid, peptide, carbohydrate, cofactor, vitamins, xenobiotic, or lipid described herein, may be prepared as an ingredient, or may be unprepared.
- the compound, or preparation including the compound may be added prior to preparation, during preparation, or following preparation. Preparation may without limitation include cooking, mixing, flavoring, seasoning, blending, boiling, frying, baking, or other processes known in the art. Fortification is preferably at a level so as to provide a therapeutic daily dosage of the small molecule metabolite as described elsewhere herein; however, beneficial effects may also be obtained at amounts below such dosages.
- a small molecule metabolite such as an amino acid, peptide, carbohydrate, cofactor, vitamins, xenobiotic, or lipid, or salt or derivative thereof, as provided herein may be present as a constituency in foodstuffs by operation of processes known in nature, for example, by altering the metabolic processes of a plant, animal, bacteria, or fungus. Genetic alteration of a plant, animal, bacteria, or fungus to increase the concentration of a small molecule metabolite, such as an amino acid, peptide, carbohydrate, cofactor, vitamins, xenobiotic, or lipid as described herein, or a salt or derivative thereof, is contemplated.
- the small molecule metabolite can be present in the foodstuff in a concentration of at least about 1%, at least about 2%, at least about 3%, at least about 4%, at least about 5%, at least about 6%, at least about 7%, at least about 8%, at least about 9%, at least about 10%, at least about 20%, at least about 30%, at least about 40%, at least about 50%, or higher, for example, 1% to 2% or 3% or 4% or 5% or 6% or 7% or 8% or 9% or 10% or 20% or 30% or 40% or 50%.
- the small molecule metabolite if naturally present in a foodstuff, can be present in an enriched amount above that which is naturally occurring for the foodstuff, e.g., a concentration of 10% or more above the average or highest naturally occurring observed concentration, e.g., 20% or 30% or 40% or 50% or 100% or 200% or 300% or 400% or 1000% or 2000% or 5000% or more above the average or highest naturally occurring observed concentration.
- compositions and methods for treating conditions that negatively impact longevity and the quality of aging including but not limited to inflammation (including but not limited to inflammation of aging, obesity-associated inflammation, chronic low-lying inflammation, and autoimmune disorders (such as, for example Crohn disease, systemic lupus erythematosus, rheumatoid arthritis, psoriasis, type 1 diabetes, multiple sclerosis, and ulcerative colitis), hemolytic anemias (including but not limited to thalassemias, hereditary spherocytosis, hereditary elliptocytosis, glucose-6-phosphate dehydrogenase deficiency, pyruvate kinase deficiency, immune hemolytic anemia, alloimmune hemolytic anemia, drug-induced hemolytic anemia, mechanical hemolytic anemias, and paroxysmal nocturnal hemoglobinuria), anemia of chronic disease, anemia, aplastic anemias (including but not limited to con
- Aging refers to a series of morphological and functional changes in an organism which take place over time. The term also refers to the deterioration of the biological functions after an organism has attained its maximum reproductive potential. It is thought that inflammation may be related to aging through mutation to mitochondrial DNA and other processes.
- compositions and methods provided herein are indicated for treatment, prophylaxis, prevention or maintenance of aging-associated conditions, including hypercholesterolemia, obesity, thrombosis, fibrosis, impaired skin integrity, wound healing, scarring, hyperglobulinemia, hypersensitivity, cancer, pain, allergies, sleep disorders and problems, and gastrointestinal disorders and problems.
- the methods provided herein increase levels of serum, plasma, or erythrocyte membrane odd chain small molecule metabolites.
- levels of serum, plasma, or erythrocyte membrane very long even chain small molecule metabolites may increase following administration of one or more odd chain small molecule metabolites, or a salt or derivative thereof.
- the condition treated is anemia of chronic disease.
- the condition treated is autoimmune disease.
- the compositions and methods provided herein modulate a marker of aging-associated conditions that impair longevity or quality of life.
- the marker is serum, plasma, or red blood cell membrane small molecule metabolite percentage; serum, plasma, or red blood cell membrane concentration of a small molecule metabolite contained herein; serum plasma, or red blood cell membrane total small molecule metabolite; cholesterol.
- the small molecule metabolite is measured as a constituent of glycolipids.
- the small molecule metabolite is measured as a constituent of phospholipids.
- the marker is serum or red blood cell membrane very long even chain small molecule metabolite percentage, serum concentration of a very long even chain small molecule metabolite, serum total very long even chain small molecule metabolites.
- the methods provided herein include the step of measuring the concentration of a marker of inflammation.
- One of skill in the art will be able to perform suitable methods for such measurements, including but not limited to those described herein.
- a small molecule metabolite such as a small molecule metabolite or a very long even chain small molecule metabolite, at a predetermined interval, or at an interval left to the discretion of the subject.
- the compounds and methods provided herein may provide a threshold serum, plasma, or red blood cell membrane percentage of an small molecule metaboliterelative to all serum, plasma, or red blood cell membrane small molecule metabolites, respectively.
- the threshold value may be a value of about 0.05% or lower to 90% or higher, e.g., a value of at least about 0.05%, at least about 0.1%, at least about 0.2%, at least about 0.3%, at least about 0.4%, at least about 0.5%, at least about 0.6%, at least about 0.7%, at least about 0.8%, at least about 0.9%, at least about 1.0%, at least about 1.1%, at least about 1.2%, at least about 1.3%, at least about 1.4%, at least about 1.5%, at least about 1.6%, at least about 1.7%, at least about 1.8%, at least about 1.9%, at least about 2.1%, at least about 2.2%, at least about 2.3%, at least about 2.4%, at least about 2.5%, at least about 2.6%, at least
- the compounds and methods provided herein may provide an increase above a baseline value (e.g., pretreatment value in a patient being treated, or general value observed in a particular patient population) in a serum or plasma concentration of an odd chain small molecule metabolite, or red blood cell membrane concentration of an odd chain small molecule metabolite.
- a baseline value e.g., pretreatment value in a patient being treated, or general value observed in a particular patient population
- a serum or plasma small molecule metabolite or red blood cell membrane concentration of an small molecule metabolite may be increased by at least about 1 ⁇ g/ml, at least about 2 ⁇ g/ml, at least about 3 ⁇ g/ml, at least about 4 ⁇ g/ml, at least about 5 ⁇ g/ml, at least about 6 ⁇ g/ml, at least about 7 ⁇ g/ml, at least about 8 ⁇ g/ml, at least about 9 ⁇ g/ml, at least about 10 ⁇ g/ml, at least about 15 ⁇ g/ml, at least about 20 ⁇ g/ml, at least about 25 ⁇ g/ml, at least about 30 ⁇ g/ml, at least about 35 ⁇ g/ml, at least about 40 ⁇ g/ml, at least about 45 ⁇ g/ml, at least about 50 ⁇ g/ml, or more than 50 ⁇ g/ml.
- the serum concentration of an odd chain small molecule metabolite, or red blood cell membrane concentration of an small molecule metabolite may increase above a baseline value (e.g., pretreatment value in a patient being treated, or general value observed in a particular patient population) by at least about 0.01x10 -4 M, at least about 0.05x10 -4 M, at least about 0.1x10 -4 M, at least about 0.2x10 -4 M, at least about 0.3x10 -4 M, at least about 0.4x10 -4 M, at least about 0.5x10- 4 M, at least about 0.6x10 -4 M, at least about 0.7x10 -4 M, at least about 0.8x10 -4 M, at least about 0.9x10 -4 M, at least about 1x10 -4 M, at least about 2x10 -4 M, or at least about 3x10 -4 M.
- a baseline value e.g., pretreatment value in a patient being treated, or general value observed in a particular patient population
- the compounds and methods provided herein may provide an increase in serum or plasma total odd chain small molecule metabolites, or red blood cell membrane total small molecule metabolites.
- serum total odd chain small molecule metabolites, or red blood cell membrane total odd chain small molecule metabolites may be increased above a baseline value (e.g., pretreatment value in a patient being treated, or general value observed in a particular patient population) by at least about 5 ⁇ g/ml, at least about 6 ⁇ g/ml, at least about 7 ⁇ g/ml, at least about 8 ⁇ g/ml, at least about 9 ⁇ g/ml, at least about 10 ⁇ g/ml, at least about 15 ⁇ g/ml, at least about 20 ⁇ g/ml, at least about 25 ⁇ g/ml, at least about 30 ⁇ g/ml, at least about 35 ⁇ g/ml, at least about 40 ⁇ g/ml, at least about 45 ⁇ g/ml,
- the compounds and methods provided herein may provide an increase above a baseline value (e.g., pretreatment value in a patient being treated, or general value observed in a particular patient population) in a serum, plasma, or red blood cell membrane odd chain small molecule metabolites relative to all serum or red blood cell membrane small molecule metabolites, respectively.
- a baseline value e.g., pretreatment value in a patient being treated, or general value observed in a particular patient population
- a serum, plasma, or red blood cell membrane small molecule metabolite may be increased above a baseline value (e.g., pretreatment value in a patient being treated, or general value observed in a particular patient population) by at least about 0.01%, at least about 0.05%, at least about 0.1%, at least about 0.2%, at least about 0.3%, at least about 0.4%, at least about 0.5%, at least about 0.6%, at least about 0.7%, at least about 0.8%, at least about 0.9%, at least about 1%, at least about 1.1%, at least about 1.2%, at least about 1.3%, at least about 1.4%, at least about 1.5%, at least about 1.6%, at least about 1.7%, at least about 1.8%, at least about 1.9%, at least about 2%, at least about 2.1%, at least about 2.2%, at least about 2.3%, at least about 2.4%, at least about 2.5%, at least about 2.6%, at least about 2.7%, at least about 2.8%, at least about 2.9%, at least about 3%, at least about 3.
- the compounds and methods provided herein may provide a reduction in elevated erythrocyte sedimentation rate.
- the compounds and methods provided herein may provide a reduction in elevated alkaline phosphatase.
- the compounds and methods provided herein may provide a reduction in serum ferritin.
- serum ferritin may be reduced below a baseline value (e.g., pretreatment value in a patient being treated, or general value observed in a particular patient population) by at least about 10 ng/ml, at least about 100 ng/ml, at least about 200 ng/ml, at least about 300 ng/ml, at least about 400 ng/ml, at least about 500 ng/ml, at least about 600 ng/ml, at least about 700 ng/ml, at least about 800 ng/ml, at least about 900 ng/ml, at least about 1000 ng/ml, at least about 1100 ng/ml, at least about 1200 ng/ml, at least about 1300 ng/ml, at least about 1400 ng/ml, at least about 1500 ng/ml, at least about 2000 ng/ml, at least about 2500 ng/ml
- the compounds and methods provided herein may provide a reduction in serum ferritin below a specified level.
- serum ferritin may be reduced below about 20000 ng/ml, about 15000 ng/ml, about 12000 ng/ml, about 10000 ng/ml, about 8000 ng/ml, about 5000 ng/ml, about 2000 ng/ml, about 1000 ng/ml, or about 500 ng
- a small molecule metabolite is administered to maintain serum or plasma total percent of the odd chain small molecule metabolite, or all odd chain small molecule metabolites, above a predetermined threshold value.
- the small molecule metabolite is heptadecanoic acid.
- the small molecule metabolite is administered to maintain serum phospholipid percent of the odd chain small molecule metabolite, or all odd chain small molecule metabolites, above about 0.1%, about 0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.7%, about 0.8%, about 0.9%, about 1%, about 1.2%, about 1.4%, about 1.6%, about 1.8%, about 2%, about 2.2%, about 2.4%, or about 2.6%.
- the compounds and methods provided herein may provide a threshold serum, plasma, or red blood cell membrane percentage of a very long even chain small molecule metabolite relative to all serum or red blood cell membrane small molecule metabolites, respectively.
- the threshold value may be a value of about 0.05% or lower to 90% or higher, e.g., a value of at least about 0.05%, at least about 0.1%, at least about 0.2%, at least about 0.3%, at least about 0.4%, at least about 0.5%, at least about 0.6%, at least about 0.7%, at least about 0.8%, at least about 0.9%, at least about 1.0%, at least about 1.1%, at least about 1.2%, at least about 1.3%, at least about 1.4%, at least about 1.5%, at least about 1.6%, at least about 1.7%, at least about 1.8%, at least about 1.9%, at least about 2.1%, at least about 2.2%, at least about 2.3%, at least about 2.4%, at least about 2.5%, at least about 2.6%, at least least
- the compounds and methods provided herein may provide an increase above a baseline value (e.g., pretreatment value in a patient being treated, or general value observed in a particular patient population) in a serum or plasma concentration of a small molecule metabolite, or red blood cell membrane concentration of a small molecule metabolite.
- a baseline value e.g., pretreatment value in a patient being treated, or general value observed in a particular patient population
- a serum very long even chain small molecule metabolite or red blood cell membrane concentration of a very long even chain small molecule metabolite may be increased by at least about 0.01 ⁇ g/ml, at least about 0.05 ⁇ g/ml, at least about 0.1 ⁇ g/ml, at least about 0.4 ⁇ g/ml, 1 ⁇ g/ml, at least about 2 ⁇ g/ml, at least about 3 ⁇ g/ml, at least about 4 ⁇ g/ml, at least about 5 ⁇ g/ml, at least about 6 ⁇ g/ml, at least about 7 ⁇ g/ml, at least about 8 ⁇ g/ml, at least about 9 ⁇ g/ml, at least about 10 ⁇ g/ml, at least about 15 ⁇ g/ml, at least about 20 ⁇ g/ml, at least about 25 ⁇ g/ml, at least about 30 ⁇ g/ml, at least about 35 ⁇ g/ml, at least about 40
- the serum concentration of a very long even chain small molecule metabolite, or red blood cell membrane concentration of a very long even chain small molecule metabolite may increase above a baseline value (e.g., pretreatment value in a patient being treated, or general value observed in a particular patient population) by at least about 0.001x10 -4 M, at least about 0.005x10 -4 M, at least about 0.05x10 -4 M, at least about 0.01x10 -4 M, at least about 0.05x10 -4 M, at least about 0.1x10 -4 M, at least about 0.2x10 -4 M, at least about 0.3x10 -4 M, at least about 0.4x10 -4 M, at least about 0.5x10- 4 M, at least about 0.6x10 -4 M, at least about 0.7x10 -4 M, at least about 0.8x10 -4 M, at least about 0.9x10 -4 M, at least about 1x10 -4 M, at least about 2x10 -4 M, or
- the compounds and methods provided herein may provide an increase in serum or plasma total small molecule metabolites, or red blood cell membrane total small molecule metabolites.
- serum total very long even chain small molecule metabolites, or red blood cell membrane total chain small molecule metabolites may be increased above a baseline value (e.g., pretreatment value in a patient being treated, or general value observed in a particular patient population) by at least about 0.05 ⁇ g/ml, at least about 0.1 ⁇ g/ml, at least about 0.5 ⁇ g/ml, at least about 1 ⁇ g/ml, at least about 5 ⁇ g/ml, at least about 6 ⁇ g/ml, at least about 7 ⁇ g/ml, at least about 8 ⁇ g/ml, at least about 9 ⁇ g/ml, at least about 10 ⁇ g/ml, at least about 15 ⁇ g/ml, at least about 20 ⁇ g/ml, at least about 25 ⁇ g/m
- a composition or method provided herein may provide an increase in red blood cell count.
- a red blood cell count level may be increased above a baseline value (e.g., pretreatment value in a patient being treated, or general value observed in a particular patient population) by at least about 0.1 cells/ ⁇ L, at least about 0.2 cells/ ⁇ L, at least about 0.3 cells/ ⁇ L, at least about 0.4 cells/ ⁇ L, at least about 0.5 cells/ ⁇ L, at least about 0.6 cells/ ⁇ L, at least about 0.7 cells/ ⁇ L, at least about 0.8 cells/ ⁇ L, at least about 0.9 cells/ ⁇ L, at least about 1 cell/ ⁇ L, at least about 1.2 cells/ ⁇ L, at least about 1.4 cells/ ⁇ L, at least about 1.6 cells/ ⁇ L, or at least about 2 cells/ ⁇ L.
- a baseline value e.g., pretreatment value in a patient being treated, or general value observed in a particular patient population
- the compounds disclosed herein such as a small molecule metabolite, or a salt or derivative thereof, or a very long even chain small molecule metabolite, or a salt or derivative thereof, or a pharmaceutical composition that includes a compound described herein, or a salt or derivative thereof, may be used in combination with one or more additional active agents.
- additional active agents that can be used in combination with a compound of an small molecule metabolite, or a salt or derivative thereof, or a composition that includes a compound of an small molecule metabolite, or a salt or derivative thereof, include, but are not limited to, agents currently used for treating conditions provided herein, and as otherwise known to medical science.
- a compound of an odd chain small molecule metabolite, or a salt or derivative thereof, or a composition that includes a compound of a small molecule metabolite, or a salt or derivative thereof can be used with one, two, three or more additional active agents described herein.
- additional active agents include, but are not limited to, a second small molecule metabolite, such as a small molecule metabolite, or a salt or derivative thereof.
- a compound of an small molecule metabolite, or a salt or derivative thereof, or a composition that includes a compound of a small molecule metabolite described herein, or a salt or derivative thereof can be used (for example, administered or ingested) in combination with another agent or agents for treatment, prevention, maintenance, or prophylaxis of a condition provided herein including aging-associated conditions, including inflammation, anemia, hyperglycemia, dyslipidemia, hyperinsulinemia, liver disease, iron overload, impaired skin integrity, wound healing, scarring, pain, allergies, sleep disorders and problems, and gastrointestinal disorders and problems or for modulation of markers of the condition.
- the condition can be inflammation (including but not limited to inflammation of aging, obesity-associated inflammation, chronic low-lying inflammation, and autoimmune disorders (such as, for example Crohn disease, systemic lupus erythematosus, rheumatoid arthritis, psoriasis, type 1 diabetes, multiple sclerosis, and ulcerative colitis), hemolytic anemias (including but not limited to thalassemias, hereditary spherocytosis, hereditary elliptocytosis, glucose-6- phosphate dehydrogenase deficiency, pyruvate kinase deficiency, immune hemolytic anemia, alloimmune hemolytic anemia, drug-induced hemolytic anemia, mechanical hemolytic anemias, and paroxysmal nocturnal hemoglobinuria), anemia of chronic disease, anemia, aplastic anemias (including but not limited to congenital hypoplastic anemia, Diamond-Blackfan anemia and Fanconi anemia),
- a compound of a small molecule metabolite such as a small molecule metabolite disclosed herein can be used in combination with one or more agents selected from iron chelators, albiglutide, aleglitazar, balaglitazone, canagliflozin, CJ-30001 (CJ Cheiljedang Corporation), CJ-30002 (CJ Cheiljedang Corporation), Diamyd® (glutamic acid decarboxylase (rhGAD65)), dulaglutide, exendin 4, gemigliptin, lixisenatide, lobeglitazone, shengke I (Tibet Pharmaceuticals), SK-0403 (Sanwa Kagaku Kenkyusho), teneligliptin, teplizumab, tofogliflozin, acarbose, alogliptin benzoate, chlorpropamide, Diab II (Biotech Holdings), exenatide, glibenclamide, glicla
- gastrointestinal-neural pathway agents including those that increase cholecystokinin activity (CCK), PYY activity, NPY activity, and PP activity, increase glucagon-like peptide-1 activity (exendin 4, dipeptidyl peptidase IV inhibitors), and those that decrease ghrelin activity, as well as amylin analogues (pramlintide); agents that may increase resting metabolic rate (selective b-3 stimulators/agonist, uncoupling protein homologues, and thyroid receptor agonists); other more diverse agents, including melanin concentrating hormone antagonists, phytostanol analogues, functional oils, P57, amylase inhibitors, growth hormone fragments, synthetic analogues
- a small molecule metabolite or salt or derivative as provided herein can be used in combination with one or more agents selected from Altoprev (lovastatin), Crestor (rosuvastatin), Lescol (fluvastatin), Lipitor (atorvastatin), Livalo (pitavastatin), Pravachol (pravastatin), Zocor (simvastatin), an anti-platelet medication, a beta blocker, an ACE inhibitor, a calcium channel blocker, a diuretic, anticoagulants, aspirin, bile acid sequestrants, Ezetimibe, Fibrates, Glycoprotein IIb/IIIa Receptor Inhibitors, Niacin (Nicotinic Acid), Nitrates, Platelet Inhibitors, Thrombolytics, lisinopril oral, atenolol oral, Bystolic oral, Diovan oral, hydrochlorothiazide oral, metoprolol succinate oral, amlodipine oral,
- a compound of a small molecule metabolite disclosed herein can be used in combination with one or more agents selected from iron dextran, iron sumalate, polysaccharide iron, ferrus fumarate, carbonyl iron, ferrous asparto glycinate, heme iron polypeptide can be sometimes indicated, ferrus bisglycinate as can be the administration of other medicaments such as androgen hormones, such as erythropoietin, folic acid, vitamin B12, vitamin C, succinic acid, niacin, pyridoxine, riboflavin, biotin, thiamine, calcium formate, Aminoxin, Anadrol-50, Chromagen Forte, Epoetin alfa, Epogen, Fe C Tab Plus, FeRiva, FeRivaFA, Ferocon, Ferotrin, Ferralet 90, Ferrex 28, Ferrogels Forte, FoliTab 500, Fumatinic, Hematogen Forte, Hemetab
- the useful in vivo dosage to be administered and the particular mode of administration will vary depending upon the age, weight, the severity of the condition, and mammalian species treated, the particular forms of the compounds employed, and the specific use for which these compounds are employed.
- the determination of effective dosage levels that is the dosage levels necessary to achieve the desired result, can be accomplished by one skilled in the art using routine methods, for example, in vivo studies. Reference may be made to, for example,“Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers,” U.S. Food and Drug Administration, July 2005.
- a method provided herein may comprise administering a therapeutically effective amount of a composition provided herein.
- a therapeutically effective amount may be determined by reference to the modulation of a marker of a condition provided herein including inflammation, anemia, hyperglycemia, dyslipidemia, hyperinsulinemia, liver disease, iron overload, impaired skin integrity, wound healing, scarring, pain, allergies, sleep disorders and problems, and gastrointestinal disorders and problems.
- a therapeutically effective amount may be determined by reference to the modulation of a symptom of a condition provided herein.
- the dosage may vary broadly, depending upon the desired effects and the therapeutic indication, such as marker values. Alternatively, dosages may be based and calculated upon the surface area or weight of the patient, as understood by those of skill in the art. The exact dosage will be determined on a case-by-case basis, or, in some cases, will be left to the informed discretion of the subject.
- the daily dosage regimen for an adult human patient may be, for example, an oral dose of a small molecule metabolite, such as an small molecule metabolite or a very long even chain small molecule metabolite, or a salt or derivative thereof, or a mixture of a plurality of small molecule metabolites, or a salt or derivative thereof, from about 0.01 mg to about 10000 mg, from about 1 mg to about 5000 mg, from about 5 mg to about 2000 mg, from about 10 mg to about 1000 mg, or from about 50 mg to about 500 mg.
- a small molecule metabolite such as an small molecule metabolite or a very long even chain small molecule metabolite, or a salt or derivative thereof, or a mixture of a plurality of small molecule metabolites, or a salt or derivative thereof.
- a single dose may include a small molecule metabolite, or a salt or derivative thereof, in about 0.01 mg, about 0.1 mg, about 1 mg, about 5 mg, about 10 mg, about 20 mg, about 50 mg, about 100 mg, about 200 mg, about 300 mg, about 400 mg, about 500 mg, about 600 mg, about 800 mg, about 900 mg, about 1000 mg, about 2000 mg, about 5000 mg, or more.
- the dosage may be adjusted according to the body mass of the subject, for example, the dosage may be about 0.001 mg/kg, about 0.01 mg/kg, about 0.1 mg/kg, about 0.5 mg/kg, about 1 mg/kg, about 2 mg/kg, about 3 mg/kg, about 4 mg/kg, about 5 mg/kg, about 6 mg/kg, about 7 mg/kg, about 8 mg/kg, about 9 mg/kg, about 10 mg/kg, about 15 mg/kg, about 20 mg/kg, about 25 mg/kg, about 30 mg/kg, or higher.
- the dosage may be a single one or a series of two or more given in the course of one or more days, as is appropriate for the individual subject.
- the compounds will be administered for a period of continuous therapy, for example for about a week or more (e.g., one week, two weeks, three weeks, four weeks, five weeks, six weeks, seven weeks, eight weeks, or more), for several weeks, for about a month or more (e.g., one month, two months, three months, four months, five months, six months, seven months, eight months, nine months, ten months, eleven months, twelve months, or more), for about a year or more, or for a plurality of years.
- a week or more e.g., one week, two weeks, three weeks, four weeks, five weeks, six weeks, seven weeks, eight weeks, or more
- a month or more e.g., one month, two months, three months, four months, five months, six months, seven months, eight months, nine months, ten months, eleven months, twelve months, or more
- a small molecule metabolite such as an small molecule metabolite or a very long even chain small molecule metabolite, or a salt or derivative thereof, can be administered or ingested one time per day, two times per day, three times per day, or more.
- Unit dosage forms can also be provided, e.g., individual packages with a premeasured amount of the composition, configured for administration on a predetermined schedule.
- Unit dosage forms configured for administration one to three times a day are preferred; however, in certain embodiments it may be desirable to configure the unit dosage form for administration more than three times a day, or less than one time per day.
- Dosage amount and interval may be adjusted to the individual subject to provide plasma levels of the active moiety which are sufficient to maintain predetermined parameters, indicators, or marker values, or minimal effective concentration (MEC). Dosages necessary to achieve the desired result will depend on individual characteristics and route of administration. However, assays, for example, HPLC assays or bioassays, may be used to determine serum concentrations.
- the compounds and methods provided herein may be used in conjunction with devices and methods of using devices, for example, as provided in U.S. Pat. No. 7,651,845; U.S. Pat. No. 8,251,904; U.S. Pat. No. 8,251,904; U.S. Pat. No. 4,985,015; U.S. Pat. No. 8,827,957; U.S. Pat. No. 4,252,159; U.S. Pat. No. 5,318,521; U.S. Pat. No. 4,718,430; U.S. Pat. No. 9,713,600, U.S. Pat. No. 9,707,199, U.S. Pat. No. 9,687,461, U.S.
- Diagnosis and monitoring [0198] Provided herein are methods for the diagnosis and monitoring of conditions provided herein including inflammation.
- the method of diagnosis or monitoring may comprise the step of measuring a percentage of a small molecule metabolite, such as an amino acid, peptide, carbohydrate, cofactor and vitamin, xenobiotic, or lipid as described herein, in a bodily fluid.
- the method of diagnosis or monitoring may comprise the step of measuring a marker of a condition provided herein including inflammation in a subject.
- the method of diagnosis or monitoring may comprise the step of measuring a marker of anemia of chronic disease.
- a correlation between one marker and another may prove instructive.
- inflammation or a related condition may be diagnosed by reference to a threshold level of erythrocyte sedimentation rate, for example, or serum small molecule metabolite or serum very long even chain small molecule metabolite.
- a condition provided herein including inflammation may be diagnosed by reference to a threshold level of a marker of the condition, for example, serum small molecule metabolite percentage, serum concentration of a small molecule metabolite, serum total small molecule metabolite, serum small molecule metabolite, serum total very long even chain small molecule metabolites, or a ratio between two serum small molecule metabolites.
- the threshold may be determined by reference to a symptom or marker of a condition provided herein including inflammation.
- the condition can be metabolic syndrome.
- the percentage of a small molecule metabolite, such as an small molecule metabolite or a very long even chain small molecule metabolite, or a marker of a condition provided herein including inflammation, in a subject may be monitored by any means.
- Samples for analysis may be derived any fluid or tissue of the subject. For example, from serum, plasma, erythrocyte membranes, urine, and feces.
- Small molecule metabolites can serve as biomarkers, therapeutic targets, natural supplements, or therapeutics.
- the most promising metabolites are expected to 1) be detectable in blood, 2) have demonstrable differences between case and control populations, 3) have the ability to increase in concentration with interventions, and 4) have these increased levels correlated with clinical benefits. It was hypothesized that small molecule metabolite biomarkers, therapeutic targets, natural supplements, and therapeutics could be discovered by identifying metabolites that met at least three of four of the criteria above, using samples from bottlenose dolphin populations.
- Bottlenose dolphins are large-brained, long-lived mammals that develop aging-associated conditions similar to humans, including inflammation, anemia, hyperglycemia, dyslipidemia, hyperinsulinemia, liver disease, and iron overload (Venn- Watson S (2013) Blood-based indicators of insulin resistance and metabolic syndrome in bottlenose dolphins (Tursiops truncatus).
- Serum samples were analyzed for small molecules using global metabolomics and complex lipid profiling. Briefly, serum extracts were prepared and analyzed using three methods: ultrahigh performance liquid chromatography-tandem mass spectroscopy (UPLC- MS/MS) with positive ion mode electrospray ionization (ESI), UPLC-MS/MS with negative ion mode ESI, and hydrophilic interaction liquid chromatography (UPLC-MS/MS).
- UPLC- MS/MS ultrahigh performance liquid chromatography-tandem mass spectroscopy
- ESI positive ion mode electrospray ionization
- UPLC-MS/MS with negative ion mode ESI
- hydrophilic interaction liquid chromatography UPLC-MS/MS
- the informatics system consisted of four major components, the Laboratory Information Management System (LIMS), the data extraction and peak-identification software, data processing tools for QC and compound identification, and a collection of information interpretation and visualization tools for use by data analysts.
- the hardware and software foundations for these informatics components were the LAN backbone, and a database server running Oracle 10.2.0.1 Enterprise Edition.
- Raw data were extracted, peak-identified and QC processed using proprietary hardware and software. Compounds were identified by comparison to library entries of purified standards or recurrent unknown entities. Biochemical identifications were based on three criteria: retention index within a narrow RI window of the proposed identification, accurate mass match to the library +/- 10 ppm, and the MS/MS forward and reverse scores between the experimental data and authentic standards. Peaks were quantified using area-under-the-curve. A data normalization step was performed to correct variation resulting from instrument inter-day tuning differences.
- Serum samples were also analyzed for complex lipids. Briefly, lipids were extracted from samples in methanol:dichloromethane in the presence of internal standards. The extracts were concentrated under nitrogen and reconstituted in 0.25mL of 10mM ammonium acetate dichloromethane:methanol (50:50). The extracts were transferred to inserts and placed in vials for infusion-MS analysis, performed on a Shimazdu LC with nano PEEK tubing and the Sciex SelexIon-5500 QTRAP. The samples were analyzed via both positive and negative mode electrospray. The 5500 QTRAP scan was performed in MRM mode with the total of more than 1,100 MRMs.
- lipid species were quantified by taking the peak area ratios of target compounds and their assigned internal standards, then multiplying by the concentration of internal standard added to the sample. Lipid class concentrations were calculated from the sum of all molecular species within a class, and small molecule metabolite compositions were determined by calculating the proportion of each class comprised by individual small molecule metabolites.
- Bottlenose dolphins are large-brained, long-lived mammals that develop aging-associated conditions similar to humans, including inflammation, anemia, hyperglycemia, dyslipidemia, hyperinsulinemia, liver disease, and iron overload.
- the U.S. Navy has cared for a population of approximately 100 dolphins. While the average lifespan of dolphins in the wild is 20 years, Navy dolphins on average live 32 years, more than fifty percent longer than wild dolphins. Approximately one-third of Navy dolphins are between 30 to 50 years old.
- results from the dolphin study demonstrated that 1) serum-based metabolites can be altered by dietary interventions, 2) in most cases, metabolite concentrations in the serum increased between 1.1 to 3-fold higher than baseline, pre- intervention levels, 3) increased serum concentrations of specific small molecule metabolites correlated with demonstrated clinical benefits, including lower cholesterol, lower insulin, and/or alleviated anemia.
- Sample collection and transport
- Red blood cell indices including red blood cell count and hemoglobin, were performed by the Naval Medical Center San Diego. Betadine and alcohol swabs were used to clean the ventral aspect of the dolphin’s fluke using the appropriate aseptic technique. Blood was then drawn with a 21g x 3/4in. winged infusion set with a luer adapter and vacutainer hub. A BD vacutainer blood tube with 7.2mg EDTA was then applied to the luer adapter and blood was evacuated using the vacuum from the tubes. The blood was then shipped on ice packs to reference laboratories. A 4ml EDTA vacutainer was shipped on an ice pack and analyzed by the Naval Medical Center of San Diego.
- the automated HCT, hemoglobin and red blood cell count were analyzed using the Sysmex XE-5000 (Sysmex Canada Inc., Mississauga, Ontario) per the manufacturer's protocol.
- whole blood was taken from a 4 mL BD Vacutainer tube with 7.2mg EDTA and used to fill a heparinized mylar wrapped 75MM hematocrit tubes. Clay was packed into one end to prevent leakage during centrifugation. Once the hematocrit tube was sealed, it was placed into the Thermo IEC MICRO-MB centrifuge (Thermo Fisher Scientific, Waltham, Ma.02451). The blood sample was spun at 11,500 rpm for 5 minutes. The hematocrit tube was then removed and placed into the micro-capillary reader to determine results.
- Serum samples were analyzed for small molecules using global metabolomics and complex lipid profiling. Briefly, serum extracts were prepared and analyzed using three methods: ultrahigh performance liquid chromatography-tandem mass spectroscopy (UPLC- MS/MS) with positive ion mode electrospray ionization (ESI), UPLC-MS/MS with negative ion mode ESI, and hydrophilic interaction liquid chromatography (UPLC-MS/MS).
- UPLC- MS/MS ultrahigh performance liquid chromatography-tandem mass spectroscopy
- ESI positive ion mode electrospray ionization
- UPLC-MS/MS with negative ion mode ESI
- hydrophilic interaction liquid chromatography UPLC-MS/MS
- the informatics system consisted of four major components, the Laboratory Information Management System (LIMS), the data extraction and peak-identification software, data processing tools for QC and compound identification, and a collection of information interpretation and visualization tools for use by data analysts.
- the hardware and software foundations for these informatics components were the LAN backbone, and a database server running Oracle 10.2.0.1 Enterprise Edition.
- Raw data were extracted, peak-identified and QC processed using proprietary hardware and software. Compounds were identified by comparison to library entries of purified standards or recurrent unknown entities. Biochemical identifications were based on three criteria: retention index within a narrow RI window of the proposed identification, accurate mass match to the library +/- 10 ppm, and the MS/MS forward and reverse scores between the experimental data and authentic standards. Peaks were quantified using area-under-the-curve. A data normalization step was performed to correct variation resulting from instrument inter-day tuning differences.
- Serum samples were also analyzed for complex lipids. Briefly, lipids were extracted from samples in methanol:dichloromethane in the presence of internal standards. The extracts were concentrated under nitrogen and reconstituted in 0.25mL of 10mM ammonium acetate dichloromethane:methanol (50:50). The extracts were transferred to inserts and placed in vials for infusion-MS analysis, performed on a Shimazdu LC with nano PEEK tubing and the Sciex SelexIon-5500 QTRAP. The samples were analyzed via both positive and negative mode electrospray. The 5500 QTRAP scan was performed in MRM mode with the total of more than 1,100 MRMs.
- lipid species were quantified by taking the peak area ratios of target compounds and their assigned internal standards, then multiplying by the concentration of internal standard added to the sample. Lipid class concentrations were calculated from the sum of all molecular species within a class, and small molecule metabolite compositions were determined by calculating the proportion of each class comprised by individual small molecule metabolites.
- Small molecule (defined as less than 900 daltons in molecular weight) metabolites described herein can be present in serum due to either ingestion of food products or endogenous production. Thousands of small molecule metabolites can be detected and measured in serum of animals, including dolphins and humans. Metabolomics, the study of metabolites and their biologically relevant roles, is a relatively novel field of study. Due to the large number of metabolites present and high potential variation of metabolites driven by complex diets, environments, genetics, and long-term medications in human populations, identifying metabolites with the greatest biomarker and therapeutic potential has been complicated. Based upon the results using the methods of the embodiments, it can be proposed that small molecule metabolites described herein may be key players in detecting, preventing, and treating aging-associated conditions that impact quality of life and longevity.
- small molecule metabolites described herein can be used in a supplement, medical food, food additive, food fortifier, beverage additive, beverage fortifier, or pharmaceutical in any form, including as a tablet, encapsulated pill, gelcap pill, liquid suspension, spray, and powder.
- diagnostic tests and assays for small molecule metabolites described herein in human and animal samples can be used to detect low small molecule metabolites and to continually monitor small molecule metabolite levels in patients.
- small molecule metabolites can prevent, stem, and treat: aging and aging-associated conditions that impact quality of life and/or longevity, including inflammation, anemia, hyperglycemia, dyslipidemia, hyperinsulinemia, liver disease, iron overload, impaired skin integrity, wound healing, scarring, pain, allergies, sleep disorders and problems, and gastrointestinal disorders and problems, and other related conditions.
- the data demonstrate a direct effect for raised levels of small molecule metabolites described herein on lowering inflammation, cholesterol, triglycerides, glucose, insulin, liver enzymes, and iron, and treating or attenuating anemia.
- the data demonstrate beneficial activity of small molecule metabolites at dose-dependent (i.e. linear) concentrations ranging 1.1- to 6-fold increases above baseline serum levels, with most beneficial effects detected by at least 4-fold increases in serum levels. Dosing of small molecule metabolites to achieve these serum, plasma, cell, or tissue levels is expected to confer the observed beneficial effects.
- BioMAP panels consist of human primary cell-based systems designed to model different aspects of the human body in an in vitro format.
- the 12 systems in the Diversity PLUS panel allow test agent characterization in an unbiased way across a broad set of systems modeling various human disease states.
- BioMAP systems are constructed with one or more primary cell types from healthy human donors, with stimuli (such as cytokines or growth factors) added to capture relevant signaling networks that naturally occur in human tissue or pathological conditions.
- vascular biology is modeled in both a Th1 (3C system) and a Th2 (4H system) inflammatory environment, as well as in a Th1 inflammatory state specific to arterial smooth muscle cells (CASM3C system).
- LPS system monocyte-driven Th1 inflammation
- SAg system T cell stimulation
- lMphg system chronic Th1 inflammation driven by macrophage activation
- BT system T cell-dependent activation of B cells that occurs in germinal centers
- the BE3C system (Th1) and the BF4T system (Th2) represent airway inflammation of the lung, while the MyoF system models myofibroblast-lung tissue remodeling.
- skin biology is addressed in the KF3CT system modeling Th1 cutaneous inflammation and the HDF3CGF system modeling wound healing.
- Each test agent generates a signature BioMAP profile that is created from the changes in protein biomarker readouts within individual system environments.
- Biomarker readouts (7 - 17 per system) are selected for therapeutic and biological relevance, are predictive for disease outcomes or specific drug effects and are validated using agents with known mechanism of action (MoA). Each readout is measured quantitatively by immune-based methods that detect protein (e.g., ELISA) or functional assays that measure proliferation and viability.
- BioMAP readouts are diverse and include cell surface receptors, cytokines, chemokines, matrix molecules and enzymes. In total, the Diversity PLUS panel contains 148 biomarker readouts that capture biological changes that occur within the physiological context of the particular BioMAP system. Specific BioMAP activities have been correlated to in vivo biology, and multiparameter BioMAP profiles have been used to distinguish compounds based on MoA and target selectivity across diverse physiological systems.
- EXAMPLE 4 [0241] In order to demonstrate that our screened compounds have activity relevant to multiple aging-associated diseases, human cell-based studies were completed using a selected subset of synthesized compounds. As a proof of concept, 14 compounds were selected from our compound library based on predicted efficacy in lowering inflammation in dolphins. Pure synthetic forms of these compounds were screened for cell-based activities (relevant to multiple aging- associated diseases and diseases that may impact longevity) using twelve different human primary cell systems mimicking various disease states (TABLE 8 - description of primary human cell systems used to screen selected compounds in library).
- the Diversity PLUS panel allows test agent characterization in an unbiased way across a broad set of systems modeling various human disease states. These systems are designed to model complex human tissue and disease biology of the vasculature, skin, lung, and inflammatory tissues. Quantitative measurements of 148 biomarker activities across this broad panel, along with comparative analysis of biological activities from known bioactive agents, were used to predict and compare the efficacy and function of each selected compound at four concentrations (740 nm and 2.2, 6.7 and 20 ⁇ M).
- BioMAP systems are constructed with one or more primary cell types from healthy human donors, with stimuli (such as cytokines or growth factors) added to capture relevant signaling networks that naturally occur in human tissue or pathological conditions.
- Vascular biology is modeled in both a Th1 (3C system) and a Th2 (4H system) inflammatory environment, as well as in a Th1 inflammatory state specific to arterial smooth muscle cells (CASM3C system).
- Additional systems recapitulate aspects of the systemic immune response including monocyte- driven Th1 inflammation (LPS system) or T cell stimulation (SAg system), chronic Th1 inflammation driven by macrophage activation (lMphg system) and the T cell-dependent activation of B cells that occurs in germinal centers (BT system).
- LPS system monocyte- driven Th1 inflammation
- SAg system T cell stimulation
- lMphg system chronic Th1 inflammation driven by macrophage activation
- BT system germinal centers
- the BE3C system (Th1) and the BF4T system (Th2) represent airway inflammation of the lung, while the MyoF system models myofibroblast-lung tissue remodeling.
- the KF3CT system modeling Th1 cutaneous inflammation
- the HDF3CGF system modeling wound healing.
- Each test agent generates a signature BioMAP profile that is created from the changes in protein biomarker readouts within individual system environments.
- Biomarker readouts (7 - 17 per system) are selected for therapeutic and biological relevance, are predictive for disease outcomes or specific drug effects and are validated using agents with known mechanism of action (MoA). Each readout is measured quantitatively by immune-based methods that detect protein (e.g., ELISA) or functional assays that measure proliferation and viability.
- BioMAP readouts are diverse and include cell surface receptors, cytokines, chemokines, matrix molecules and enzymes. In total, the Diversity PLUS panel contains 148 biomarker readouts that capture biological changes that occur within the physiological context of the particular BioMAP system. Specific BioMAP activities have been correlated to in vivo biology, and multiparameter BioMAP profiles have been used to distinguish compounds based on MoA and target selectivity across diverse physiological systems.
- BioMAP assays do not currently have cell systems to model metabolic diseases, including hyperinsulinemia, hyperglycemia, and dyslipidemia; thus, these assays were limited to assessing compounds’ potential anti-inflammatory and antifibrotic properties.
- alpha smooth muscle actin aSMA
- CD40 CD69
- collagen I collagen III
- decorin e-selectin
- eotaxin 3 CCL26
- fibroblast proliferation human leukocyte antigen-DR isotype (HLA-DR)
- immunoglobulin G human leukocyte antigen-DR isotype (HLA-DR)
- IP-10/CXCL10 interferon gamma-induced protein 10
- I-TAC/CXCL11 interleukin
- IL interleukin
- IL-1a interleukin-1a
- IL-2 interleukin-6
- IL-8 CXCL8
- IL-10 interleukin-17A
- IL-17F keratin 8/81
- M-CSF matrix metalloproteinase
- MMP-9 monocyte chemoattractant
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JP2021525249A (en) | 2021-09-24 |
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