Details of the Active Pharmaceutical Ingredient (API)

General Information of API (ID: D00401)
Name
Mesalamine
Synonyms    Click to Show/Hide the Synonyms of This API
5-Aminosalicylic acid; mesalamine; Mesalazine; 5-Amino-2-hydroxybenzoic acid; 89-57-6; Asacol; Pentasa; Claversal; Canasa; Salofalk; Rowasa; m-Aminosalicylic acid; Mesasal; Lialda; Benzoic acid, 5-amino-2-hydroxy-; Fisalamine; Lixacol; Apriso; p-Aminosalicylsaeure; Asacolitin; Mesalazina; Mesalazinum; sfRowasa; 5-amino-2-hydroxy-benzoic acid; Asacol HD; 5-Amino Salicylic Acid; SALICYLIC ACID, 5-AMINO-; MFCD00007877; 2-Hydroxy-5-aminobenzoic acid; 3-carboxy-4-hydroxyaniline; UNII-4Q81I59GXC; NSC 38877; MAX-002; MLS001424012; 4Q81I59GXC; CHEBI:6775; NSC-38877; CAS-89-57-6; NCGC00016344-03; Mesalazinum [Latin]; SMR000145728; DSSTox_CID_4506; DSSTox_RID_77435; DSSTox_GSID_24506; 5-Aminosalicylic acid, 99%; Mesalazina [Spanish]; p-Aminosalicylsaeure [German]; Mesavancol; Delzicol; Mesavance; Mezavant; Iialda; Mesalazine MMX; Mezavant XL; Mesalamine (USP); Pentasa (TN); Salofalk Granu-Stix; Apriso (TN); Asacol (TN); Canasa (TN); Lialda (TN); Rowasa (TN); CCRIS 7334; SR-01000763486; Mesalamine [USAN:USP]; EINECS 201-919-1; BRN 2090421; AI3-15564; HSDB 7512; AJG-501; SPD 476; SPD-476; SPD-480; Mesalamine (TN); Delzicol (TN); Sfrowasa (TN); Mesalazine [INN]; mesalamine (USAN); Mesalamine (Lialda); 5-aminosalicylic_acid; MD-0901; 5-Aminosalicyclic acid; 5-amino-salicylic acid; PubChem17623; Mesalamine; Mesalazine; ACMC-1BKFR; Prestwick0_001069; Prestwick1_001069; Prestwick2_001069; Prestwick3_001069; WLN: ZR DQ CVQ; CHEMBL704; Mesalazine (JP17/INN); EC 201-919-1; cid_4075; Oprea1_847633; SCHEMBL31297; 3amino-6-hydroxybenzoic acid; BSPBio_001058; KBioGR_002425; KBioSS_002431; 4-14-00-02058 (Beilstein Handbook Reference); MLS000758287; 5-Aminosalicylic acid, 95%; 5-Aminosalicylic acid, tablet; ARONIS23914; BIDD:GT0811; 3-amino-6-hydroxybenzoic acid; SPBio_002969; BPBio1_001164; GTPL2700; ZINC1688; 5-Amino 2-hydroxy benzoic acid; DTXSID5024506; SCHEMBL18038934; 5-Aminosalicylic acid, >=99%; BDBM60918; KBio2_002425; KBio2_004993; KBio2_007561; KBio3_002904; cMAP_000045; HMS1571E20; HMS2051M21; HMS2090I09; HMS2098E20; HMS3393M21; HMS3649K15; HMS3651M15; HMS3715E20; Pharmakon1600-01505993; BCP05326; NSC38877; Tox21_110384; Tox21_201610; Tox21_303125; 5-?Aminosalicylic Acid (Mesalazine); ANW-39326; BBL013046; NSC759301; SBB052617; STK301678; AKOS000118959; Tox21_110384_1; AC-2764; BCP9000175; CCG-100829; DB00244; HS-0100; LS11426; MCULE-5752745805; NC00079; NSC-759301; NCGC00016344-01; NCGC00016344-02; NCGC00016344-04; NCGC00016344-05; NCGC00016344-07; NCGC00090934-01; NCGC00090934-02; NCGC00257142-01; NCGC00259159-01; 5-amino-2-hydroxobenzoic acid monohydrate; AK-72925; BP-13074; BR-72925; HY-15027; SY002854; 5-Aminosalicylic acid, analytical standard; ST4109571; AB00374979; AM20060091; FT-0619950; SW197303-4; 1764-EP2272825A2; 1764-EP2275420A1; C07138; D00377; M-7246; 24215-EP2289518A1; 24215-EP2295053A1; 24215-EP2295409A1; 24215-EP2314574A1; 24215-EP2314590A1; 90701-EP2371811A2; AB00374979-09; AB00374979-10; AB00374979_11; AB00374979_12; Q412479; 5-amino-2-hydroxybenzoic acid,5-Aminosalicylic acid; Q-201355; SR-01000763486-3; SR-01000763486-4; SR-01000763486-9; Z57127471; F1918-0003; Mesalazine, European Pharmacopoeia (EP) Reference Standard; Mesalamine, United States Pharmacopeia (USP) Reference Standard; Mesalamine, Pharmaceutical Secondary Standard; Certified Reference Material; 51481-17-5
Clinical Status
Approved
Disease Indication Inflammatory bowel disease ICD-11: DD72 [1]
PubChem CID
4075
Formula
C7H7NO3
Canonical SMILES
C1=CC(=C(C=C1N)C(=O)O)O
InChI
1S/C7H7NO3/c8-4-1-2-6(9)5(3-4)7(10)11/h1-3,9H,8H2,(H,10,11)
InChIKey
KBOPZPXVLCULAV-UHFFFAOYSA-N
   Click to Show/Hide the Molecular Data (Structure/Property) of This API
Structure
<iframe style="width: 300px; height: 300px;" frameborder="0" src="https://embed.molview.org/v1/?mode=balls&cid=4075"></iframe>
3D MOL 2D MOL
Physicochemical Properties Molecular Weight 153.14 Topological Polar Surface Area 83.6
XlogP 1.3 Complexity 160
Heavy Atom Count 11 Rotatable Bond Count 1
Hydrogen Bond Donor Count 3 Hydrogen Bond Acceptor Count 4
Full List of Drug Formulations (DFMs) Containing This API
          Mesalamine 1200 mg tablet Click to Show/Hide the Full List of Formulation(s):          3 Formulation(s)
             Drug Formulation 1 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Stearic acid; Magnesium stearate; Ferric oxide red; Talc; Titanium dioxide; Triethyl citrate; Carboxymethylcellulose sodium; Polyethylene glycol 6000; Silicon dioxide; Carnauba wax; Methacrylic acid - methyl methacrylate copolymer (1:1); Methacrylic acid - methyl methacrylate copolymer (1:2); Sodium starch glycolate type a potato
                   Dosage Form Delayed Release Oral Tablet
                   Company Kaiser Foundation Hospitals
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Stearic acid DIG Info Phosphodiesterase 3A (IC50 = 3.1 uM) [2]
Carboxymethylcellulose sodium DIG Info Albendazole monooxygenase (EC50 = 12.6 uM) [3]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
Polyethylene glycol 6000 DIG Info Albendazole monooxygenase (Inhibition ratio < 70 %) [5]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
             Drug Formulation 2 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Stearic acid; Magnesium stearate; Ferric oxide red; Talc; Titanium dioxide; Triethyl citrate; Polyethylene glycol 6000; Silicon dioxide; Carboxymethylcellulose sodium, unspecified form; Carnauba wax; Methacrylic acid - methyl methacrylate copolymer (1:1); Methacrylic acid - methyl methacrylate copolymer (1:2); Sodium starch glycolate type a potato
                   Dosage Form Delayed Release Oral Tablet
                   Company Avera McKennan Hospital; Shire
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Stearic acid DIG Info Phosphodiesterase 3A (IC50 = 3.1 uM) [2]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
Polyethylene glycol 6000 DIG Info Albendazole monooxygenase (Inhibition ratio < 70 %) [5]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
             Drug Formulation 3 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Talc; Titanium dioxide; Triethyl citrate; Carboxymethylcellulose sodium; Silicon dioxide; Cellulose, microcrystalline; Hypromelloses; Methacrylic acid; Polyethylene glycol, unspecified; Sodium starch glycolate type a potato
                   Dosage Form Delayed Release Oral Tablet
                   Company Cadila Healthcare; Zydus Pharmaceuticals
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Carboxymethylcellulose sodium DIG Info Albendazole monooxygenase (EC50 = 12.6 uM) [3]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
          Mesalamine 375 mg capsule Click to Show/Hide the Full List of Formulation(s):          2 Formulation(s)
             Drug Formulation 1 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Anhydrous citric acid; Aspartame; Magnesium stearate; Talc; Titanium dioxide; Triethyl citrate; Povidone; Silicon dioxide; Cellulose, microcrystalline; Hypromelloses; Methacrylic acid - methyl methacrylate copolymer (1:1)
                   Dosage Form 24 HR Extended Release Oral Capsule
                   Company Physicians Total Care
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Kyselina citronova DIG Info Perilipin-1 (IC50 = 3708 nM) [6]
Aspartame DIG Info Pregnane X receptor (Ki = 13 uM) [2]
Povidone DIG Info Cholesterol 25-hydroxylase (IC50 = 78.3 uM) [3]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
             Drug Formulation 2 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Anhydrous citric acid; Aspartame; Magnesium stearate; Talc; Titanium dioxide; Triethyl citrate; Silicon dioxide; Crospovidone, unspecified; Hypromellose, unspecified; Methacrylic acid - methyl methacrylate copolymer (1:1); Microcrystalline cellulose
                   Dosage Form 24 HR Extended Release Oral Capsule
                   Company Aphena Pharma Solutions-Tennessee; Salix Pharmaceuticals
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Kyselina citronova DIG Info Perilipin-1 (IC50 = 3708 nM) [6]
Aspartame DIG Info Pregnane X receptor (Ki = 13 uM) [2]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
          Mesalamine 400 mg tablet Click to Show/Hide the Full List of Formulation(s):          7 Formulation(s)
             Drug Formulation 1 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Lactose monohydrate; Dibutyl phthalate; Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Talc; Povidone; Silicon dioxide; Methacrylic acid - methyl methacrylate copolymer (1:2); Polyethylene glycols; Sodium starch glycolate type a potato
                   Dosage Form Delayed Release Oral Tablet
                   Company RemedyRepack
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Dibutyl phthalate DIG Info Cathepsin B (IC50 = 230000 nM) [7]
Povidone DIG Info Cholesterol 25-hydroxylase (IC50 = 78.3 uM) [3]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
             Drug Formulation 2 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Lactose monohydrate; Dibutyl phthalate; Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Talc; Povidone; Silicon dioxide; Methacrylic acid - methyl methacrylate copolymer (1:2); Polyethylene glycol; Sodium starch glycolate type a potato
                   Dosage Form Delayed Release Oral Tablet
                   Company Kaiser Foundation Hospitals; Lake Eire Medical & Surgical Supply DBA Quality Care Products; RemedyRepack
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Dibutyl phthalate DIG Info Cathepsin B (IC50 = 230000 nM) [7]
Povidone DIG Info Cholesterol 25-hydroxylase (IC50 = 78.3 uM) [3]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
             Drug Formulation 3 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Lactose monohydrate; Dibutyl phthalate; Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Talc; Povidone; Silicon dioxide; Methacrylic acid - methyl methacrylate copolymer (1:2); Polyethylene glycols; Sodium starch glycolate type a potato
                   Dosage Form Delayed Release Oral Tablet
                   Company State of Florida DOH Central Pharmacy
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Dibutyl phthalate DIG Info Cathepsin B (IC50 = 230000 nM) [7]
Povidone DIG Info Cholesterol 25-hydroxylase (IC50 = 78.3 uM) [3]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
             Drug Formulation 4 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Lactose monohydrate; Dibutyl phthalate; Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Talc; Povidone; Silicon dioxide; Methacrylic acid; Poly(methyl methacrylate 450000 mw); Polyethylene glycols; Sodium starch glycolate type a potato
                   Dosage Form Delayed Release Oral Tablet
                   Company Allergan
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Dibutyl phthalate DIG Info Cathepsin B (IC50 = 230000 nM) [7]
Povidone DIG Info Cholesterol 25-hydroxylase (IC50 = 78.3 uM) [3]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
             Drug Formulation 5 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Lactose monohydrate; Dibutyl phthalate; Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Talc; Silicon dioxide; Methacrylic acid - methyl methacrylate copolymer (1:2); Polyethylene glycols; Povidones; Sodium starch glycolate type a potato
                   Dosage Form Delayed Release Oral Tablet
                   Company Cardinal Health
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Dibutyl phthalate DIG Info Cathepsin B (IC50 = 230000 nM) [7]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
             Drug Formulation 6 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Lactose monohydrate; Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Talc; Povidone; Methacrylic acid - methyl methacrylate copolymer (1:2); Polyethylene glycol; Sodium starch glycolate type a potato
                   Dosage Form Delayed Release Oral Tablet
                   Company State of Florida DOH Central Pharmacy
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Povidone DIG Info Cholesterol 25-hydroxylase (IC50 = 78.3 uM) [3]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
             Drug Formulation 7 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Lactose monohydrate; Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Talc; Methacrylic acid - methyl methacrylate copolymer (1:2); Polyethylene glycol, unspecified; Povidone, unspecified; Sodium starch glycolate type a potato
                   Dosage Form Delayed Release Oral Tablet
                   Company Cardinal Health
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
          Mesalamine 800 mg tablet Click to Show/Hide the Full List of Formulation(s):          5 Formulation(s)
             Drug Formulation 1 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Lactose monohydrate; Dibutyl phthalate; Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Talc; Povidone; Silicon dioxide; Methacrylic acid - ethyl acrylate copolymer (1:1) type a; Methacrylic acid - methyl methacrylate copolymer (1:2); Polyethylene glycols; Sodium starch glycolate type a potato
                   Dosage Form Delayed Release Oral Tablet
                   Company Zydus Pharmaceuticals
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Dibutyl phthalate DIG Info Cathepsin B (IC50 = 230000 nM) [7]
Povidone DIG Info Cholesterol 25-hydroxylase (IC50 = 78.3 uM) [3]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
             Drug Formulation 2 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Lactose monohydrate; Dibutyl phthalate; Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Talc; Silicon dioxide; Methacrylic acid - ethyl acrylate copolymer (1:1) type a; Methacrylic acid - methyl methacrylate copolymer (1:2); Polyethylene glycols; Povidones; Sodium starch glycolate type a potato
                   Dosage Form Delayed Release Oral Tablet
                   Company American Health Packaging
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Dibutyl phthalate DIG Info Cathepsin B (IC50 = 230000 nM) [7]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
             Drug Formulation 3 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Lactose monohydrate; Dibutyl sebacate; Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Talc; Povidone; Silicon dioxide; Methacrylic acid - methyl methacrylate copolymer (1:1); Methacrylic acid - methyl methacrylate copolymer (1:2); Polyethylene glycols; Sodium starch glycolate type a potato
                   Dosage Form Delayed Release Oral Tablet
                   Company Zydus Pharmaceuticals
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Povidone DIG Info Cholesterol 25-hydroxylase (IC50 = 78.3 uM) [3]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
             Drug Formulation 4 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Lactose monohydrate; Dibutyl sebacate; Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Talc; Povidone; Silicon dioxide; Methacrylic acid - ethyl acrylate copolymer (1:1) type a; Methacrylic acid - methyl methacrylate copolymer (1:2); Polyethylene glycols; Sodium starch glycolate type a potato
                   Dosage Form Delayed Release Oral Tablet
                   Company Allergan
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Povidone DIG Info Cholesterol 25-hydroxylase (IC50 = 78.3 uM) [3]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
             Drug Formulation 5 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Lactose monohydrate; Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Talc; Povidone; Methacrylic acid - ethyl acrylate copolymer (1:1) type a; Methacrylic acid - methyl methacrylate copolymer (1:2); Polyethylene glycols; Sodium starch glycolate type a potato
                   Dosage Form Delayed Release Oral Tablet
                   Company Allergan
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Povidone DIG Info Cholesterol 25-hydroxylase (IC50 = 78.3 uM) [3]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
          Mesalamine 250 mg capsule Click to Show/Hide the Full List of Formulation(s):          2 Formulation(s)
             Drug Formulation 1 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Stearic acid; D&c yellow no. 10; Fd&c blue no. 1; Talc; Titanium dioxide; Silicon dioxide; Castor oil; Fd&c green no. 3; Gelatin
                   Dosage Form Extended Release Oral Capsule
                   Company Avera McKennan Hospital; Cardinal Health; Carilion Materials Management; Prasco
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
FD&C blue no. 1 DIG Info Solute carrier SLCO2B1 (Ki = 13 uM) [8]
Stearic acid DIG Info Phosphodiesterase 3A (IC50 = 3.1 uM) [2]
Quinoline yellow WS DIG Info Estrogen receptor alpha (IC50 = 18 uM) [2]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
             Drug Formulation 2 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Stearic acid; D&c yellow no. 10; Fd&c blue no. 1; Talc; Titanium dioxide; Silicon dioxide; Castor oil; Fd&c green no. 3; Gelatin, unspecified
                   Dosage Form Extended Release Oral Capsule
                   Company Shire
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
FD&C blue no. 1 DIG Info Solute carrier SLCO2B1 (Ki = 13 uM) [8]
Stearic acid DIG Info Phosphodiesterase 3A (IC50 = 3.1 uM) [2]
Quinoline yellow WS DIG Info Estrogen receptor alpha (IC50 = 18 uM) [2]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
          Mesalamine 500 mg capsule Click to Show/Hide the Full List of Formulation(s):          4 Formulation(s)
             Drug Formulation 1 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Stearic acid; Fd&c blue no. 1; Talc; Titanium dioxide; Silicon dioxide; Castor oil; Gelatin
                   Dosage Form Extended Release Oral Capsule
                   Company Prasco; RemedyRepack
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
FD&C blue no. 1 DIG Info Solute carrier SLCO2B1 (Ki = 13 uM) [8]
Stearic acid DIG Info Phosphodiesterase 3A (IC50 = 3.1 uM) [2]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
             Drug Formulation 2 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Stearic acid; Fd&c blue no. 1; Talc; Titanium dioxide; Silicon dioxide; Castor oil; Gelatin, unspecified
                   Dosage Form Extended Release Oral Capsule
                   Company Shire
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
FD&C blue no. 1 DIG Info Solute carrier SLCO2B1 (Ki = 13 uM) [8]
Stearic acid DIG Info Phosphodiesterase 3A (IC50 = 3.1 uM) [2]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
             Drug Formulation 3 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Stearic acid; Fd&c blue no. 1; Talc; Titanium dioxide; Castor oil; Colloidal silicon dioxide; Gelatin
                   Dosage Form Extended Release Oral Capsule
                   Company RemedyRepack
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
FD&C blue no. 1 DIG Info Solute carrier SLCO2B1 (Ki = 13 uM) [8]
Stearic acid DIG Info Phosphodiesterase 3A (IC50 = 3.1 uM) [2]
             Drug Formulation 4 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Stearic acid; Fd&c blue no. 1; Talc; Titanium dioxide; Castor oil; Colloidal silicon dioxide; Gelatin
                   Dosage Form Extended Release Capsule
                   Company Physicians Total Care
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
FD&C blue no. 1 DIG Info Solute carrier SLCO2B1 (Ki = 13 uM) [8]
Stearic acid DIG Info Phosphodiesterase 3A (IC50 = 3.1 uM) [2]
          Mesalamine 400 mg capsule Click to Show/Hide the Full List of Formulation(s):          2 Formulation(s)
             Drug Formulation 1 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Lactose monohydrate; Dibutyl sebacate; Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Talc; Povidone; Silicon dioxide; Hypromelloses; Methacrylic acid - methyl methacrylate copolymer (1:2); Polyethylene glycols; Sodium starch glycolate type a potato
                   Dosage Form Delayed Release Oral Capsule
                   Company Allergan
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Povidone DIG Info Cholesterol 25-hydroxylase (IC50 = 78.3 uM) [3]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
             Drug Formulation 2 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Lactose monohydrate; Dibutyl sebacate; Magnesium stearate; Ferric oxide red; Ferric oxide yellow; Talc; Silicon dioxide; Hypromelloses; Methacrylic acid - methyl methacrylate copolymer (1:2); Polyethylene glycols; Povidones; Sodium starch glycolate type a potato
                   Dosage Form Delayed Release Oral Capsule
                   Company Carilion Materials Management
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
References
1 FDA label for approved mesalamine from the official website of the U.S. Food and Drug Administration.
2 The activities of drug inactive ingredients on biological targets. Science. 2020 Jul 24;369(6502):403-413.
3 Mediation of in vitro cytochrome p450 activity by common pharmaceutical excipients. Mol Pharm. 2013 Jul 1;10(7):2739-48.
4 Effects of commonly used excipients on the expression of CYP3A4 in colon and liver cells. Pharm Res. 2010 Aug;27(8):1703-12.
5 Pharmaceutical excipients inhibit cytochrome P450 activity in cell free systems and after systemic administration. Eur J Pharm Biopharm. 2008 Sep;70(1):279-88.
6 PubChem BioAssay data set.
7 Cathepsin B inhibitory activities of phthalates isolated from a marine Pseudomonas strain. Bioorg Med Chem Lett. 2008 Mar 15; 18(6):2083-8.
8 Bacterial metabolism rescues the inhibition of intestinal drug absorption by food and drug additives. Proc Natl Acad Sci U S A. 2020 Jul 7;117(27):16009-16018.

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