Details of the Active Pharmaceutical Ingredient (API)

General Information of API (ID: D00335)
Name
Isotretinoin
Synonyms    Click to Show/Hide the Synonyms of This API
Isotretinoin; 13-cis-Retinoic acid; Accutane; 4759-48-2; Roaccutane; Neovitamin A acid; 13-cis-Vitamin A acid; 13-cis retinoic acid; Claravis; Amnesteem; Isotrex; Teriosal; Sotret; ISOTRETINON; isotretinoino; Isotretinoine; Isotretinoinum; Roaccutan; Absorica; Roacutan; Isotretinoine [INN-French]; Isotretinoinum [INN-Latin]; Isotretinoino [INN-Spanish]; CIP-Isotretinoin; Accutane (TN); Isotretinoin (USP); Ro-4-3780; UNII-EH28UP18IF; cis-RA; (7E,9E,11E,13Z)-retinoic acid; Ro 4-3780; (13cis)-retinoic acid; 13-cis RA; Ro-43780; CHEMBL547; EH28UP18IF; RETINOIC ACID, 13-cis-; CHEBI:6067; 13-cis-retinoic acid,Isotretinoin; Isotane; cis-Retinoic acid; Myorisan; Zenatane; Isosuprea Lidose; Sotret (TN); CCRIS 4286; HSDB 3929; 13 Cis-Retinoic Acid; SR-01000076103; EINECS 225-296-0; BRN 1885770; isotretinoina; cis-Retinoate; BML2-E07; Isotretinoin [USAN:BAN:INN]; MFCD00079542; cis retinoic acid; Trans-Retinoicacid; Absorica (TN); Prestwick_642; CAS-4759-48-2; Isotretinoin [USAN:USP:INN:BAN]; (13-cis)-Retinoate; CPD000471891; Prestwick2_000256; Prestwick3_000256; Spectrum5_001795; Spectrum5_001937; (13-cis)-Retinoic acid; DSSTox_CID_3177; R 3255; Retinoic acid 13-cis-form; Retinoic acid, (13cis)-; DSSTox_RID_76906; DSSTox_GSID_23177; Lopac0_001081; SCHEMBL38299; BSPBio_000072; BSPBio_001331; BSPBio_003345; 4-09-00-02388 (Beilstein Handbook Reference); MLS001074662; SPECTRUM1502013; BPBio1_000080; GTPL7600; DTXSID4023177; PAT-001; HMS1361C13; HMS1568D14; HMS1791C13; HMS1921D08; HMS1989C13; HMS2092N07; HMS2095D14; HMS2233A07; HMS3259J09; HMS3263I04; HMS3402C13; HMS3712D14; HMS3884A13; Pharmakon1600-01502013; BCP18950; ZINC3792789; Tox21_200093; Tox21_501081; BDBM50031459; LMPR01090021; NSC758156; AKOS015841158; CCG-205158; CS-1864; DB00982; DS-3367; LP01081; NC00635; NSC-758156; SDCCGSBI-0051051.P004; IDI1_033801; NCGC00094358-01; NCGC00094358-02; NCGC00094358-03; NCGC00094358-04; NCGC00094358-05; NCGC00094358-06; NCGC00094358-07; NCGC00094358-08; NCGC00094358-09; NCGC00094358-10; NCGC00094358-11; NCGC00094358-12; NCGC00094358-13; NCGC00094358-14; NCGC00094358-15; NCGC00094358-26; NCGC00257647-01; NCGC00261766-01; HY-15127; SMR000471891; 13-cis-Retinoic acid, >=98% (HPLC); 13-cis-Retinoic acid; Retinoid analogues; SBI-0051051.P003; EU-0101081; 5952-EP0930075A1; 5952-EP2295426A1; 5952-EP2311840A1; 59I482; C07058; D00348; 24210-EP2311808A1; 24210-EP2311829A1; 24210-EP2314590A1; Q287029; SR-01000076103-2; SR-01000076103-5; SR-01000076103-6; SR-01000076103-9; BRD-K76723084-001-05-9; SR-01000076103-10; Isotretinoin, European Pharmacopoeia (EP) Reference Standard; Isotretinoin, United States Pharmacopeia (USP) Reference Standard; Isotretinoin, Pharmaceutical Secondary Standard; Certified Reference Material
Clinical Status
Approved
Disease Indication Acne vulgaris ICD-11: ED80 [1]
PubChem CID
5282379
Formula
C20H28O2
Canonical SMILES
CC1=C(C(CCC1)(C)C)/C=C/C(=C/C=C/C(=C\\C(=O)O)/C)/C
InChI
1S/C20H28O2/c1-15(8-6-9-16(2)14-19(21)22)11-12-18-17(3)10-7-13-20(18,4)5/h6,8-9,11-12,14H,7,10,13H2,1-5H3,(H,21,22)/b9-6+,12-11+,15-8+,16-14-
InChIKey
SHGAZHPCJJPHSC-XFYACQKRSA-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=5282379"></iframe>
3D MOL 2D MOL
Physicochemical Properties Molecular Weight 300.4 Topological Polar Surface Area 37.3
XlogP 6.3 Complexity 567
Heavy Atom Count 22 Rotatable Bond Count 5
Hydrogen Bond Donor Count 1 Hydrogen Bond Acceptor Count 2
Full List of Drug Formulations (DFMs) Containing This API
          Isotretinoin 30 mg capsule 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
D&c yellow no. 10; Fd&c red no. 40; Alpha.-tocopherol; Fd&c blue no. 1; Fd&c blue no. 2; Indigotindisulfonate sodium; Butylated hydroxyanisole; Edetate disodium; Ferric oxide red; Ferric oxide yellow; Ferrosoferric oxide; Propylene glycol; Titanium dioxide; Polysorbate 80; Gelatin; Hydrogenated soybean oil; Shellac; Soybean oil; White wax
                   Dosage Form Oral Capsule
                   Company Teva Pharmaceuticals
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Allura red AC dye DIG Info Solute carrier SLCO2B1 (Ki = 4.7 uM) [2]
Alpha-tocopherol DIG Info Glutathione S-transferase P (IC50 = 500 nM) [3]
FD&C blue no. 1 DIG Info Solute carrier SLCO2B1 (Ki = 13 uM) [4]
FD&C blue no. 2 DIG Info Adenosine receptor A3 (IC50 = 1 uM) [2]
Quinoline yellow WS DIG Info Estrogen receptor alpha (IC50 = 18 uM) [2]
Allura red AC dye DIG Info Solute carrier SLCO2B1 (Ki = 2.59 uM) [4]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [5]
Butylhydroxyanisole DIG Info Prostaglandin G/H synthase 2 (IC50 = 2.6 uM) [2]
Polysorbate 80 DIG Info Prostaglandin G/H synthase 1 (IC50 = 1 uM) [2]
             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
D&c yellow no. 10; Fd&c red no. 40; Alpha.-tocopherol; Fd&c blue no. 1; Fd&c blue no. 2; Butylated hydroxyanisole; Edetate disodium; Ferric oxide red; Ferric oxide yellow; Ferrosoferric oxide; Propylene glycol; Titanium dioxide; Polysorbate 80; Aluminum oxide; Cottonseed oil; Gelatin; Shellac; Soybean oil; White wax
                   Dosage Form Oral Capsule
                   Company Physicians Total Care
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Allura red AC dye DIG Info Solute carrier SLCO2B1 (Ki = 4.7 uM) [2]
Alpha-tocopherol DIG Info Glutathione S-transferase P (IC50 = 500 nM) [3]
FD&C blue no. 1 DIG Info Solute carrier SLCO2B1 (Ki = 13 uM) [4]
FD&C blue no. 2 DIG Info Adenosine receptor A3 (IC50 = 1 uM) [2]
Quinoline yellow WS DIG Info Estrogen receptor alpha (IC50 = 18 uM) [2]
Allura red AC dye DIG Info Solute carrier SLCO2B1 (Ki = 2.59 uM) [4]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [5]
Butylhydroxyanisole DIG Info Prostaglandin G/H synthase 2 (IC50 = 2.6 uM) [2]
Polysorbate 80 DIG Info Prostaglandin G/H synthase 1 (IC50 = 1 uM) [2]
             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
Methylparaben; Butyl alcohol; Fd&c blue no. 2; Propylparaben; Butylated hydroxyanisole; Edetate disodium; Ferric oxide red; Ferric oxide yellow; Ferrosoferric oxide; Glycerin; Propylene glycol; Titanium dioxide; Medium-chain triglycerides; Gelatin; Hydrogenated soybean oil; Shellac; Soybean oil; White wax
                   Dosage Form Oral Capsule
                   Company Dr Reddy's Laboratories
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
methylparaben DIG Info Carbonic anhydrase VII (Ki = 780 nM) [6]
FD&C blue no. 2 DIG Info Adenosine receptor A3 (IC50 = 1 uM) [2]
Propyl 4-hydroxybenzoate DIG Info Estrogen receptor alpha (IC50 = 11 uM) [2]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [5]
Butylhydroxyanisole DIG Info Prostaglandin G/H synthase 2 (IC50 = 2.6 uM) [2]
Medium-chain triglyceride DIG Info Colon cancer Caco-2 cells (Inhibition ratio > 36 %) [7]
             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
Alpha.-tocopherol, dl-; Butyl alcohol; Isopropyl alcohol; Sorbitol; Ammonia; Butylated hydroxyanisole; Edetate disodium; Ferric oxide red; Ferrosoferric oxide; Glycerin; Propylene glycol; Titanium dioxide; Alcohol; Gelatin; Hydrogenated soybean oil; Shellac; Soybean oil; Yellow wax
                   Dosage Form Oral Capsule
                   Company VersaPharm
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
DL-alpha-tocopherol DIG Info Presenilin 1 (EC50 > 100000 nM) [10]
Isopropyl alcohol DIG Info Lymphoma P388/ADR cells (IC50 = 0.22 uM) [11]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [5]
Butylhydroxyanisole DIG Info Prostaglandin G/H synthase 2 (IC50 = 2.6 uM) [2]
             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
Sorbitan monooleate; Propyl gallate; Ferric oxide red; Ferric oxide yellow; Ferrosoferric oxide; Potassium hydroxide; Propylene glycol; Sodium hydroxide; Titanium dioxide; Gelatin; Peg-32 hydrogenated palm glycerides; Povidones; Shellac; Soybean oil
                   Dosage Form Oral Capsule
                   Company Ranbaxy Laboratories
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Propyl gallate DIG Info Arachidonate 5-lipoxygenase (Ki = 0.43 uM) [2]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [5]
             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
Sorbitan monooleate; Propyl gallate; Ferric oxide red; Ferric oxide yellow; Ferrosoferric oxide; Potassium hydroxide; Propylene glycol; Sodium hydroxide; Titanium dioxide; Gelatin, unspecified; Peg-32 hydrogenated palm glycerides; Shellac; Soybean oil
                   Dosage Form Oral Capsule
                   Company Sun Pharmaceutical Industries
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Propyl gallate DIG Info Arachidonate 5-lipoxygenase (Ki = 0.43 uM) [2]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [5]
             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
Fd&c yellow no. 6; Butylated hydroxyanisole; Edetate disodium; Glycerin; Titanium dioxide; Gelatin; Hydrogenated soybean oil; Soybean oil; White wax
                   Dosage Form Oral Capsule
                   Company Amneal Pharmaceuticals
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Sunset yellow FCF DIG Info Solute carrier SLCO2B1 (Ki = 68.4 uM) [4]
Butylhydroxyanisole DIG Info Prostaglandin G/H synthase 2 (IC50 = 2.6 uM) [2]
          Isotretinoin 10 mg capsule 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
Methylparaben; D&c yellow no. 10; Butyl alcohol; Fd&c blue no. 1; Fd&c blue no. 2; Propylparaben; Butylated hydroxyanisole; Edetate disodium; Ferrosoferric oxide; Glycerin; Propylene glycol; Titanium dioxide; Medium-chain triglycerides; Gelatin; Hydrogenated soybean oil; Shellac; Soybean oil; White wax
                   Dosage Form Oral Capsule
                   Company Dr Reddy's Laboratories
                   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) [4]
methylparaben DIG Info Carbonic anhydrase VII (Ki = 780 nM) [6]
FD&C blue no. 2 DIG Info Adenosine receptor A3 (IC50 = 1 uM) [2]
Quinoline yellow WS DIG Info Estrogen receptor alpha (IC50 = 18 uM) [2]
Propyl 4-hydroxybenzoate DIG Info Estrogen receptor alpha (IC50 = 11 uM) [2]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [5]
Butylhydroxyanisole DIG Info Prostaglandin G/H synthase 2 (IC50 = 2.6 uM) [2]
Medium-chain triglyceride DIG Info Colon cancer Caco-2 cells (Inhibition ratio > 36 %) [7]
             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
Alpha.-tocopherol; D&c red no. 7; Fd&c yellow no. 6; Butylated hydroxyanisole; Edetate disodium; Ferrosoferric oxide; Propylene glycol; Titanium dioxide; Polysorbate 80; Gelatin; Hydrogenated soybean oil; Shellac; Soybean oil; White wax
                   Dosage Form Oral Capsule
                   Company Teva Pharmaceuticals
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Alpha-tocopherol DIG Info Glutathione S-transferase P (IC50 = 500 nM) [3]
Sunset yellow FCF DIG Info Solute carrier SLCO2B1 (Ki = 68.4 uM) [4]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [5]
Butylhydroxyanisole DIG Info Prostaglandin G/H synthase 2 (IC50 = 2.6 uM) [2]
Polysorbate 80 DIG Info Prostaglandin G/H synthase 1 (IC50 = 1 uM) [2]
             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
Alpha.-tocopherol, dl-; Butyl alcohol; Isopropyl alcohol; Sorbitol; Ammonia; Butylated hydroxyanisole; Edetate disodium; Ferric oxide yellow; Ferrosoferric oxide; Glycerin; Propylene glycol; Titanium dioxide; Alcohol; Gelatin; Hydrogenated soybean oil; Shellac; Soybean oil; Yellow wax
                   Dosage Form Oral Capsule
                   Company VersaPharm
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
DL-alpha-tocopherol DIG Info Presenilin 1 (EC50 > 100000 nM) [10]
Isopropyl alcohol DIG Info Lymphoma P388/ADR cells (IC50 = 0.22 uM) [11]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [5]
Butylhydroxyanisole DIG Info Prostaglandin G/H synthase 2 (IC50 = 2.6 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
Sorbitan monooleate; Propyl gallate; Ferric oxide yellow; Potassium hydroxide; Propylene glycol; Titanium dioxide; Gelatin; Peg-32 hydrogenated palm glycerides; Shellac; Soybean oil
                   Dosage Form Oral Capsule
                   Company Ranbaxy Laboratories
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Propyl gallate DIG Info Arachidonate 5-lipoxygenase (Ki = 0.43 uM) [2]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [5]
             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
Sorbitan monooleate; Propyl gallate; Ferric oxide yellow; Potassium hydroxide; Propylene glycol; Titanium dioxide; Gelatin, unspecified; Peg-32 hydrogenated palm glycerides; Shellac; Soybean oil
                   Dosage Form Oral Capsule
                   Company Sun Pharmaceutical Industries
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Propyl gallate DIG Info Arachidonate 5-lipoxygenase (Ki = 0.43 uM) [2]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [5]
             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
Butylated hydroxyanisole; Edetate disodium; Ferric oxide yellow; Ferrosoferric oxide; Glycerin; Titanium dioxide; Gelatin; Hydrogenated soybean oil; Soybean oil; White wax
                   Dosage Form Oral Capsule
                   Company Amneal Pharmaceuticals
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Butylhydroxyanisole DIG Info Prostaglandin G/H synthase 2 (IC50 = 2.6 uM) [2]
             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
Butylated hydroxyanisole; Edetate disodium; Ferric oxide red; Glycerin; Soybean oil; Yellow wax
                   Dosage Form Oral Capsule
                   Company Mylan Pharamceuticals; Physicians Total Care
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Butylhydroxyanisole DIG Info Prostaglandin G/H synthase 2 (IC50 = 2.6 uM) [2]
          Isotretinoin 20 mg capsule Click to Show/Hide the Full List of Formulation(s):          9 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
Methylparaben; D&c red no. 30; Butyl alcohol; D&c red no. 27; Fd&c blue no. 2; Propylparaben; Butylated hydroxyanisole; Edetate disodium; Ferrosoferric oxide; Glycerin; Propylene glycol; Titanium dioxide; Medium-chain triglycerides; Gelatin; Hydrogenated soybean oil; Shellac; Soybean oil; White wax
                   Dosage Form Oral Capsule
                   Company Dr Reddy's Laboratories; Physicians Total Care
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
methylparaben DIG Info Carbonic anhydrase VII (Ki = 780 nM) [6]
D&C red no. 27 DIG Info Solute carrier SLCO2B1 (Ki = 1 uM) [4]
FD&C blue no. 2 DIG Info Adenosine receptor A3 (IC50 = 1 uM) [2]
D&C red no. 30 DIG Info Heat shock factor 1 (EC50 = 9054 nM) [8]
Propyl 4-hydroxybenzoate DIG Info Estrogen receptor alpha (IC50 = 11 uM) [2]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [5]
Butylhydroxyanisole DIG Info Prostaglandin G/H synthase 2 (IC50 = 2.6 uM) [2]
Medium-chain triglyceride DIG Info Colon cancer Caco-2 cells (Inhibition ratio > 36 %) [7]
             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
Alpha.-tocopherol, dl-; Butyl alcohol; Isopropyl alcohol; Sorbitol; Ammonia; Butylated hydroxyanisole; Edetate disodium; Ferrosoferric oxide; Glycerin; Propylene glycol; Titanium dioxide; Alcohol; Gelatin; Hydrogenated soybean oil; Shellac; Soybean oil; Yellow wax
                   Dosage Form Oral Capsule
                   Company VersaPharm
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
DL-alpha-tocopherol DIG Info Presenilin 1 (EC50 > 100000 nM) [10]
Isopropyl alcohol DIG Info Lymphoma P388/ADR cells (IC50 = 0.22 uM) [11]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [5]
Butylhydroxyanisole DIG Info Prostaglandin G/H synthase 2 (IC50 = 2.6 uM) [2]
             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
Alpha.-tocopherol; Butyl alcohol; Isopropyl alcohol; Sorbitol; Ammonia; Butylated hydroxyanisole; Edetate disodium; Ferrosoferric oxide; Glycerin; Propylene glycol; Titanium dioxide; Alcohol; Gelatin; Shellac; Soybean oil; Yellow wax
                   Dosage Form Oral Capsule
                   Company Physicians Total Care
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Alpha-tocopherol DIG Info Glutathione S-transferase P (IC50 = 500 nM) [3]
Isopropyl alcohol DIG Info Lymphoma P388/ADR cells (IC50 = 0.22 uM) [11]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [5]
Butylhydroxyanisole DIG Info Prostaglandin G/H synthase 2 (IC50 = 2.6 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
Alpha.-tocopherol; Ammonia; Butylated hydroxyanisole; Edetate disodium; Ferric oxide red; Ferric oxide yellow; Ferrosoferric oxide; Propylene glycol; Titanium dioxide; Polysorbate 80; Cottonseed oil; Dimethicone; Gelatin; Shellac; Soybean oil; White wax
                   Dosage Form Oral Capsule
                   Company Physicians Total Care
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Alpha-tocopherol DIG Info Glutathione S-transferase P (IC50 = 500 nM) [3]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [5]
Butylhydroxyanisole DIG Info Prostaglandin G/H synthase 2 (IC50 = 2.6 uM) [2]
Polysorbate 80 DIG Info Prostaglandin G/H synthase 1 (IC50 = 1 uM) [2]
             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
Alpha.-tocopherol; Ammonia; Butylated hydroxyanisole; Edetate disodium; Ferric oxide red; Ferric oxide yellow; Ferrosoferric oxide; Propylene glycol; Titanium dioxide; Polysorbate 80; Dimethicone 350; Gelatin; Hydrogenated soybean oil; Shellac; Silica, trimethylsilyl capped; Soybean oil; White wax
                   Dosage Form Oral Capsule
                   Company Teva Pharmaceuticals
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Alpha-tocopherol DIG Info Glutathione S-transferase P (IC50 = 500 nM) [3]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [5]
Butylhydroxyanisole DIG Info Prostaglandin G/H synthase 2 (IC50 = 2.6 uM) [2]
Polysorbate 80 DIG Info Prostaglandin G/H synthase 1 (IC50 = 1 uM) [2]
             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
Sorbitan monooleate; Propyl gallate; Ferric oxide red; Potassium hydroxide; Propylene glycol; Titanium dioxide; Gelatin; Peg-32 hydrogenated palm glycerides; Shellac; Soybean oil
                   Dosage Form Oral Capsule
                   Company Ranbaxy Laboratories
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Propyl gallate DIG Info Arachidonate 5-lipoxygenase (Ki = 0.43 uM) [2]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [5]
             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
Sorbitan monooleate; Propyl gallate; Ferric oxide red; Potassium hydroxide; Propylene glycol; Titanium dioxide; Gelatin, unspecified; Peg-32 hydrogenated palm glycerides; Shellac; Soybean oil
                   Dosage Form Oral Capsule
                   Company Sun Pharmaceutical Industries
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Propyl gallate DIG Info Arachidonate 5-lipoxygenase (Ki = 0.43 uM) [2]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [5]
             Drug Formulation 8 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
Butylated hydroxyanisole; Edetate disodium; Ferric oxide red; Ferric oxide yellow; Ferrosoferric oxide; Glycerin; Titanium dioxide; Gelatin; Hydrogenated soybean oil; Soybean oil; White wax
                   Dosage Form Oral Capsule
                   Company Amneal Pharmaceuticals
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Butylhydroxyanisole DIG Info Prostaglandin G/H synthase 2 (IC50 = 2.6 uM) [2]
             Drug Formulation 9 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
Butylated hydroxyanisole; Edetate disodium; Ferric oxide red; Ferric oxide yellow; Glycerin; Titanium dioxide; Soybean oil; Yellow wax
                   Dosage Form Oral Capsule
                   Company Mylan Pharamceuticals; Physicians Total Care
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Butylhydroxyanisole DIG Info Prostaglandin G/H synthase 2 (IC50 = 2.6 uM) [2]
          Isotretinoin 40 mg capsule Click to Show/Hide the Full List of Formulation(s):          9 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
Methylparaben; D&c yellow no. 10; Butyl alcohol; Fd&c blue no. 1; Fd&c blue no. 2; Propylparaben; Butylated hydroxyanisole; Edetate disodium; Ferrosoferric oxide; Glycerin; Propylene glycol; Titanium dioxide; Medium-chain triglycerides; Gelatin; Hydrogenated soybean oil; Shellac; Soybean oil; White wax
                   Dosage Form Oral Capsule
                   Company Dr Reddy's Laboratories; 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) [4]
methylparaben DIG Info Carbonic anhydrase VII (Ki = 780 nM) [6]
FD&C blue no. 2 DIG Info Adenosine receptor A3 (IC50 = 1 uM) [2]
Quinoline yellow WS DIG Info Estrogen receptor alpha (IC50 = 18 uM) [2]
Propyl 4-hydroxybenzoate DIG Info Estrogen receptor alpha (IC50 = 11 uM) [2]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [5]
Butylhydroxyanisole DIG Info Prostaglandin G/H synthase 2 (IC50 = 2.6 uM) [2]
Medium-chain triglyceride DIG Info Colon cancer Caco-2 cells (Inhibition ratio > 36 %) [7]
             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
Sodium lauryl sulfate; Alpha.-tocopherol; Fd&c blue no. 2; Fd&c yellow no. 6; Ammonia; Butylated hydroxyanisole; Edetate disodium; Ferrosoferric oxide; Propylene glycol; Titanium dioxide; Polysorbate 80; Silicon dioxide; Aluminum oxide; Cottonseed oil; Gelatin; Shellac; Soybean oil; White wax
                   Dosage Form Oral Capsule
                   Company Physicians Total Care
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Alpha-tocopherol DIG Info Glutathione S-transferase P (IC50 = 500 nM) [3]
Sunset yellow FCF DIG Info Solute carrier SLCO2B1 (Ki = 68.4 uM) [4]
Sodium lauryl sulfate DIG Info Solute carrier SLCO2B1 (Ki = 1.98 uM) [4]
FD&C blue no. 2 DIG Info Adenosine receptor A3 (IC50 = 1 uM) [2]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [5]
Butylhydroxyanisole DIG Info Prostaglandin G/H synthase 2 (IC50 = 2.6 uM) [2]
Polysorbate 80 DIG Info Prostaglandin G/H synthase 1 (IC50 = 1 uM) [2]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [9]
             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
Alpha.-tocopherol, dl-; Butyl alcohol; Fd&c yellow no. 6; Isopropyl alcohol; Sorbitol; Ammonia; Butylated hydroxyanisole; Edetate disodium; Ferrosoferric oxide; Glycerin; Propylene glycol; Titanium dioxide; Alcohol; Gelatin; Hydrogenated soybean oil; Shellac; Soybean oil; Yellow wax
                   Dosage Form Oral Capsule
                   Company VersaPharm
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Sunset yellow FCF DIG Info Solute carrier SLCO2B1 (Ki = 68.4 uM) [4]
DL-alpha-tocopherol DIG Info Presenilin 1 (EC50 > 100000 nM) [10]
Isopropyl alcohol DIG Info Lymphoma P388/ADR cells (IC50 = 0.22 uM) [11]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [5]
Butylhydroxyanisole DIG Info Prostaglandin G/H synthase 2 (IC50 = 2.6 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
Alpha.-tocopherol; Butyl alcohol; Fd&c yellow no. 6; Isopropyl alcohol; Sorbitol; Ammonia; Butylated hydroxyanisole; Edetate disodium; Ferrosoferric oxide; Glycerin; Propylene glycol; Titanium dioxide; Alcohol; Gelatin; Shellac; Soybean oil; Yellow wax
                   Dosage Form Oral Capsule
                   Company Physicians Total Care
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Alpha-tocopherol DIG Info Glutathione S-transferase P (IC50 = 500 nM) [3]
Sunset yellow FCF DIG Info Solute carrier SLCO2B1 (Ki = 68.4 uM) [4]
Isopropyl alcohol DIG Info Lymphoma P388/ADR cells (IC50 = 0.22 uM) [11]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [5]
Butylhydroxyanisole DIG Info Prostaglandin G/H synthase 2 (IC50 = 2.6 uM) [2]
             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
Alpha.-tocopherol; Fd&c yellow no. 6; Ammonia; Butylated hydroxyanisole; Edetate disodium; Ferrosoferric oxide; Propylene glycol; Titanium dioxide; Polysorbate 80; Gelatin; Hydrogenated soybean oil; Shellac; Soybean oil; White wax
                   Dosage Form Oral Capsule
                   Company Teva Pharmaceuticals
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Alpha-tocopherol DIG Info Glutathione S-transferase P (IC50 = 500 nM) [3]
Sunset yellow FCF DIG Info Solute carrier SLCO2B1 (Ki = 68.4 uM) [4]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [5]
Butylhydroxyanisole DIG Info Prostaglandin G/H synthase 2 (IC50 = 2.6 uM) [2]
Polysorbate 80 DIG Info Prostaglandin G/H synthase 1 (IC50 = 1 uM) [2]
             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
Sorbitan monooleate; Propyl gallate; Ferric oxide red; Ferric oxide yellow; Ferrosoferric oxide; Potassium hydroxide; Propylene glycol; Sodium hydroxide; Titanium dioxide; Gelatin; Peg-32 hydrogenated palm glycerides; Povidones; Shellac; Soybean oil
                   Dosage Form Oral Capsule
                   Company Ranbaxy Laboratories
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Propyl gallate DIG Info Arachidonate 5-lipoxygenase (Ki = 0.43 uM) [2]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [5]
             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
Sorbitan monooleate; Propyl gallate; Ferric oxide red; Ferric oxide yellow; Ferrosoferric oxide; Potassium hydroxide; Propylene glycol; Sodium hydroxide; Titanium dioxide; Gelatin, unspecified; Peg-32 hydrogenated palm glycerides; Shellac; Soybean oil
                   Dosage Form Oral Capsule
                   Company Sun Pharmaceutical Industries
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Propyl gallate DIG Info Arachidonate 5-lipoxygenase (Ki = 0.43 uM) [2]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [5]
             Drug Formulation 8 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
Fd&c yellow no. 6; Butylated hydroxyanisole; Edetate disodium; Glycerin; Titanium dioxide; Gelatin; Hydrogenated soybean oil; Soybean oil; White wax
                   Dosage Form Oral Capsule
                   Company Amneal Pharmaceuticals
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Sunset yellow FCF DIG Info Solute carrier SLCO2B1 (Ki = 68.4 uM) [4]
Butylhydroxyanisole DIG Info Prostaglandin G/H synthase 2 (IC50 = 2.6 uM) [2]
             Drug Formulation 9 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
Butylated hydroxyanisole; Edetate disodium; Ferric oxide red; Ferric oxide yellow; Glycerin; Titanium dioxide; Soybean oil; Yellow wax
                   Dosage Form Oral Capsule
                   Company Mylan Pharamceuticals; Physicians Total Care
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Butylhydroxyanisole DIG Info Prostaglandin G/H synthase 2 (IC50 = 2.6 uM) [2]
          Isotretinoin 25 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
Sorbitan monooleate; Fd&c blue no. 1; Fd&c yellow no. 5; Fd&c yellow no. 6; Propyl gallate; Propylene glycol; Sodium hydroxide; Titanium dioxide; Gelatin, unspecified; Peg-32 hydrogenated palm glycerides; Shellac; Soybean oil
                   Dosage Form Oral Capsule
                   Company Sun Pharmaceutical Industries
                   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) [4]
Sunset yellow FCF DIG Info Solute carrier SLCO2B1 (Ki = 68.4 uM) [4]
Hydrazine yellow DIG Info GABA(A) receptor alpha-1 (IC50 = 13 uM) [2]
Propyl gallate DIG Info Arachidonate 5-lipoxygenase (Ki = 0.43 uM) [2]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [5]
             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
Sorbitan monooleate; Fd&c blue no. 1; Fd&c yellow no. 5; Fd&c yellow no. 6; Propyl gallate; Propylene glycol; Sodium hydroxide; Titanium dioxide; Gelatin; Peg-32 hydrogenated palm glycerides; Povidones; Shellac; Soybean oil
                   Dosage Form Oral Capsule
                   Company Ranbaxy Laboratories
                   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) [4]
Sunset yellow FCF DIG Info Solute carrier SLCO2B1 (Ki = 68.4 uM) [4]
Hydrazine yellow DIG Info GABA(A) receptor alpha-1 (IC50 = 13 uM) [2]
Propyl gallate DIG Info Arachidonate 5-lipoxygenase (Ki = 0.43 uM) [2]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [5]
          Isotretinoin 35 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
Sorbitan monooleate; Fd&c blue no. 2; Propyl gallate; Ferric oxide red; Ferric oxide yellow; Ferrosoferric oxide; Propylene glycol; Sodium hydroxide; Titanium dioxide; Gelatin, unspecified; Peg-32 hydrogenated palm glycerides; Shellac; Soybean oil
                   Dosage Form Oral Capsule
                   Company Sun Pharmaceutical Industries
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
FD&C blue no. 2 DIG Info Adenosine receptor A3 (IC50 = 1 uM) [2]
Propyl gallate DIG Info Arachidonate 5-lipoxygenase (Ki = 0.43 uM) [2]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [5]
             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
Sorbitan monooleate; Fd&c blue no. 2; Propyl gallate; Ferric oxide red; Ferric oxide yellow; Ferrosoferric oxide; Propylene glycol; Sodium hydroxide; Titanium dioxide; Gelatin; Peg-32 hydrogenated palm glycerides; Povidones; Shellac; Soybean oil
                   Dosage Form Oral Capsule
                   Company Ranbaxy Laboratories
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
FD&C blue no. 2 DIG Info Adenosine receptor A3 (IC50 = 1 uM) [2]
Propyl gallate DIG Info Arachidonate 5-lipoxygenase (Ki = 0.43 uM) [2]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [5]
References
1 FDA label for approved isotretinoin 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 Reviewing Hit Discovery Literature for Difficult Targets: Glutathione Transferase Omega-1 as an Example. J Med Chem. 2018 Sep 13; 61(17):7448-7470.
4 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.
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 Mono-/dihydroxybenzoic acid esters and phenol pyridinium derivatives as inhibitors of the mammalian carbonic anhydrase isoforms I, II, VII, IX, XII and XIV. Bioorg Med Chem. 2013 Mar 15; 21(6):1564-9.
7 Interactions between human multidrug resistance related protein (MRP2; ABCC2) and excipients commonly used in self-emulsifying drug delivery systems (SEDDS). Int J Pharm. 2013 Apr 15;447(1-2):192-8.
8 PubChem BioAssay data set.
9 Effects of commonly used excipients on the expression of CYP3A4 in colon and liver cells. Pharm Res. 2010 Aug;27(8):1703-12.
10 Membrane anchoring -secretase modulators with terpene-derived moieties. Bioorg Med Chem Lett. 2013 Jul 1; 23(13):3852-6.
11 Synthesis and evaluation of dihydropyrroloquinolines that selectively antagonize P-glycoprotein. J Med Chem. 2004 Mar 11; 47(6):1413-22.

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