Details of the Active Pharmaceutical Ingredient (API)

General Information of API (ID: D00663)
Name
Terbinafine
Synonyms    Click to Show/Hide the Synonyms of This API
terbinafine; 91161-71-6; Lamisil; Lamasil; Lamisil AT; SF-86-327; (E)-N,6,6-trimethyl-N-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine; SF 86-327; terbinafin; UNII-G7RIW8S0XP; (E)-N-(6,6-Dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthalenemethylamine; Terbinafina; (E)-N-(6,6-Dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthalene methanamine; Terbinafine free base; G7RIW8S0XP; CHEMBL822; CHEBI:9448; Lamisil Tablet; 91161-71-6 (free base); Terbinafinum; NCGC00159346-02; (2E)-N,6,6-trimethyl-N-(1-naphthylmethyl)hept-2-en-4-yn-1-amine; (2E)-N,6,6-trimethyl-N-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine; DSSTox_CID_3640; N-[(2E)-6,6-dimethyl-2-hepten-4-yn-1-yl]-N-methyl-1-naphthalenemethanamine; 1-NAPHTHALENEMETHANAMINE, N-(6,6-DIMETHYL-2-HEPTEN-4-YNYL)-N-METHYL-, (E)-; DSSTox_RID_77123; DSSTox_GSID_23640; Terbinex; Lamasil (TN); CAS-91161-71-6; Terbinafine (USAN/INN); BRN 4256376; Corbinal; Terbinafine [USAN:INN:BAN]; TDT-067; N,6,6-trimethyl-N-(1-naphthylmethyl)hept-2-en-4-yn-1-amine hydrochloride; erbinafine hydrochloride; Terbinafine, SF-86-327, Lamisil, TBNF; EC 618-706-8; SCHEMBL36794; SCHEMBL37843; MLS006011885; BIDD:GT0825; DTXSID2023640; Terbinafine (Lamisil, Terbinex); CHEBI:94705; HMS2089B20; HMS3715L08; ALBB-027269; BCP22896; ZINC1530981; Tox21_111591; (E)-N,6,6-trimethyl-N-(1-naphthylmethyl)hept-2-en-4-yn-1-amine; BBL010959; BDBM50018518; HY-17395A; MFCD00242672; STK802069; AKOS001451917; Tox21_111591_1; AB05470; AC-8561; AT-6016; CCG-221253; CS-1944; DB00857; GS-3099; (E)-N,6,6-trimethyl-N-(naphthalen-1; NCGC00159346-03; NCGC00159346-04; NCGC00188975-01; SMR004703509; SBI-0206829.P001; AB0007727; SW197656-3; C08079; D02375; AB00698510-07; AB00698510-09; AB00698510-10; AB00698510-11; AB00698510_12; AB00698510_13; AB00698510_14; 161T716; A843743; Q415259; BRD-K68132782-003-05-4; (6,6-Dimethyl-hept-2-en-4-ynyl)-methyl-naphthalen-1-ylmethyl-amine; N,6,6-Trimethyl-N-(1-naphthylmethyl)-2-heptene-4-yne-1-amine; SF 86-327; SF-86-327; SF86-327; Lamasil; Lamisil AT; ((E)-6,6-Dimethyl-hept-2-en-4-ynyl)-methyl-naphthalen-1-ylmethyl-amine; (E)-N,6,6-trimethyl-N-(1-naphthalenylmethyl)-1-hept-2-en-4-ynamine; 1N,6,6-trimethyl-1N-(1-naphthylmethyl)-(E)-2-hepten-4-yn-1-amine; trans-n-(6,6-dimethyl-2-hepten-4-ynyl)-n-methyl-1-naphthylmethylamine; (6,6-Dimethyl-hept-2-en-4-ynyl)-methyl-naphthalen-1-ylmethyl-amine(Terbinafine); (6,6-dimethylhept-2-en-4-yn-1-yl)methyl(1-naphthylmethyl)amine hydrochloride; [(2E)-6,6-dimethylhept-2-en-4-yn-1-yl](methyl)[(naphthalen-1-yl)methyl]amine; [(E)-6,6-dimethyl-hept-2-en-4-ynyl]-methyl-(naphthalen-1-yl-methyl)-amine
Clinical Status
Approved
Disease Indication Onychomycosis ICD-11: EE12 [1]
PubChem CID
1549008
Formula
C21H25N
Canonical SMILES
CC(C)(C)C#C/C=C/CN(C)CC1=CC=CC2=CC=CC=C21
InChI
1S/C21H25N/c1-21(2,3)15-8-5-9-16-22(4)17-19-13-10-12-18-11-6-7-14-20(18)19/h5-7,9-14H,16-17H2,1-4H3/b9-5+
InChIKey
DOMXUEMWDBAQBQ-WEVVVXLNSA-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=1549008"></iframe>
3D MOL 2D MOL
Physicochemical Properties Molecular Weight 291.4 Topological Polar Surface Area 3.2
XlogP 5.6 Complexity 428
Heavy Atom Count 22 Rotatable Bond Count 5
Hydrogen Bond Donor Count 0 Hydrogen Bond Acceptor Count 1
Full List of Drug Formulations (DFMs) Containing This API
          Terbinafine 250 mg tablet Click to Show/Hide the Full List of Formulation(s):        16 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
Magnesium stearate; Croscarmellose sodium; Silicon dioxide; Cellulose, microcrystalline; Hypromelloses
                   Dosage Form Oral Tablet
                   Company Dr Reddy's Laboratories
                   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) [2]
Carmellose sodium DIG Info Albendazole monooxygenase (Protein expression upregulation) [2]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [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
Magnesium stearate; Croscarmellose sodium; Silicon dioxide; Methylcellulose (100 cps)
                   Dosage Form Oral Tablet
                   Company Physicians Total Care
                   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) [2]
Carmellose sodium DIG Info Albendazole monooxygenase (Protein expression upregulation) [2]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [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
Magnesium stearate; Crospovidone; Silicon dioxide; Cellulose, microcrystalline; Hypromelloses
                   Dosage Form Oral Tablet
                   Company Glenmark Generics
                   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) [2]
Crospovidone DIG Info Albendazole monooxygenase (Protein expression downregulation) [2]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [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
Magnesium stearate; Hypromellose; Silicon dioxide; Cellulose, microcrystalline; Sodium starch glycolate type a potato
                   Dosage Form Oral Tablet
                   Company Lake Eire Medical & Surgical Supply DBA Quality Care Products
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Hypromellose DIG Info Cytochrome P450 3A5 (IC50 = 19.4 uM) [3]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [2]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [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
Magnesium stearate; Ferric oxide red; Silicon dioxide; Cellulose, microcrystalline; Hypromellose 2910 (5 mpa.s); Sodium starch glycolate type a potato
                   Dosage Form Oral Tablet
                   Company NorthStar Rx
                   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) [2]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [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
Magnesium stearate; Silicon dioxide; Cellulose, microcrystalline; Hypromellose 2910 (6 mpa.s); Sodium starch glycolate type a potato
                   Dosage Form Oral Tablet
                   Company Wockhardt
                   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) [2]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [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
Magnesium stearate; Silicon dioxide; Cellulose, microcrystalline; Hypromellose 2910 (6 mpa.s); Sodium starch glycolate type a potato
                   Dosage Form Oral Tablet
                   Company Wockhardt
                   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) [2]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [2]
             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
Magnesium stearate; Silicon dioxide; Cellulose, microcrystalline; Hypromellose 2910 (5 mpa.s); Sodium starch glycolate type a potato
                   Dosage Form Oral Tablet
                   Company Lake Eire Medical & Surgical Supply DBA Quality Care Products
                   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) [2]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [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
Magnesium stearate; Silicon dioxide; Cellulose, microcrystalline; Hypromelloses; Sodium starch glycolate type a potato
                   Dosage Form Oral Tablet
                   Company Rebel Distributors
                   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) [2]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [2]
             Drug Formulation 10 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; Silicon dioxide; Cellulose, microcrystalline; Hypromellose 2910 (5 mpa.s); Sodium starch glycolate type a potato
                   Dosage Form Oral Tablet
                   Company Teva Pharmaceuticals
                   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) [2]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [2]
             Drug Formulation 11 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; Silicon dioxide; Hypromellose 2910 (5 mpa.s); Microcrystalline cellulose; Sodium starch glycolate type a potato
                   Dosage Form Oral Tablet
                   Company Aurobindo Pharma
                   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) [2]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [2]
             Drug Formulation 12 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; Silicon dioxide; Cellulose, microcrystalline; Hypromellose 2910 (15 mpa.s); Hypromellose 2910 (3 mpa.s); Sodium starch glycolate type a potato
                   Dosage Form Oral Tablet
                   Company DirectRX; PD-Rx Pharmaceuticals
                   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) [2]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [2]
             Drug Formulation 13 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; Silicon dioxide; Hypromellose 2910 (15 mpa.s); Hypromellose 2910 (3 mpa.s); Microcrystalline cellulose; Sodium starch glycolate type a potato
                   Dosage Form Oral Tablet
                   Company Harris Pharmaceutical; NuCare Pharmaceuticals; Proficient Rx
                   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) [2]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [2]
             Drug Formulation 14 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; Silicon dioxide; Cellulose, microcrystalline; Hypromelloses; Sodium glycolate
                   Dosage Form Oral Tablet
                   Company Innocutis
                   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) [2]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [2]
             Drug Formulation 15 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; Silicon dioxide; Hypromellose, unspecified; Microcrystalline cellulose; Sodium starch glycolate type a potato
                   Dosage Form Oral Tablet
                   Company Bryant Ranch Prepack
                   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) [2]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [2]
             Drug Formulation 16 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; Silicon dioxide; Cellulose, microcrystalline; Hypromelloses; Sodium starch glycolate type a potato
                   Dosage Form Oral Tablet
                   Company American Health Packaging; AvKARE; Bryant Ranch Prepack; Camber Pharmaceuticals; Carilion Materials Management; Cipla; Exelan Pharmaceuticals; Harris Pharmaceutical; Novartis Pharmaceuticals Corporation; PD-Rx Pharmaceuticals; Preferred Pharamaceuticals; Proficient Rx; RemedyRepack
                   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) [2]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [2]
          Terbinafine Hydrochloride eq 250mg base tablet Click to Show/Hide the Full List of Formulation(s):          1 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
Colloidal Silicon Dioxide; Hypromellose; Magnesium Stearate; Microcrystalline Cellulose; Sodium Starch Glycolate
                   Dosage Form Tablet
                   Company Cipla Usa ; Directrx; Preferred Pharmaceuticals
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Hypromellose DIG Info Cytochrome P450 3A5 (IC50 = 19.4 uM) [3]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [2]
References
1 FDA label for approved terbinafine from the official website of the U.S. Food and Drug Administration.
2 Effects of commonly used excipients on the expression of CYP3A4 in colon and liver cells. Pharm Res. 2010 Aug;27(8):1703-12.
3 Mediation of in vitro cytochrome p450 activity by common pharmaceutical excipients. Mol Pharm. 2013 Jul 1;10(7):2739-48.

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