Details of the Active Pharmaceutical Ingredient (API)

General Information of API (ID: D00433)
Name
Miglitol
Synonyms    Click to Show/Hide the Synonyms of This API
MIGLITOL; 72432-03-2; Glyset; (2R,3R,4R,5S)-1-(2-hydroxyethyl)-2-(hydroxymethyl)piperidine-3,4,5-triol; Bay-m-1099; Bay m 1099; UNII-0V5436JAQW; Miglitol (Glyset); Seibule; C8H17NO5; CHEMBL1561; 0V5436JAQW; CHEBI:6935; Diastabol; 1,5-dideoxy-1,5-[(2-hydroxyethyl)imino]-D-glucitol; Plumarol; DSSTox_CID_3323; (2R,3R,4R,5S)-1-(2-Hydroxyethyl)-2-(hydroxymethyl)-3,4,5-piperidinetriol; DSSTox_RID_76977; DSSTox_GSID_23323; Miglitolum; N-(2-Hydroxyethyl)-1-deoxynojirimycin; SMR000466381; Miglitolum [Latin]; CAS-72432-03-2; Glyset (TN); 1,5-Dideoxy-1,5-((2-hydroxyethyl)imino)-D-glucitol; Miglitol [USAN:INN:BAN]; Bay 1099; HSDB 8022; NCGC00095127-01; EINECS 276-661-6; MFCD00867240; SK-983; PubChem6069; PubChem21444; baym1099; Bay m1009; SCHEMBL22593; MLS000759514; MLS001424128; MLS006011963; BIDD:GT0732; cid_441314; GTPL4842; Miglitol (JP17/USAN/INN); DTXSID0023323; AOB5559; SYN3027; HMS2051D05; HMS3713J07; N-hydroxylethyl-1-deoxynojirimycin; HY-B0481; ZINC4097426; Tox21_111436; BDBM50242271; AKOS015969689; N-(b-Hydroxyethyl)-1-deoxynojirimycin; Tox21_111436_1; ACN-040712; CCG-100920; DB00491; KS-1242; MCULE-2158237443; NC00170; NE45506; NCGC00270540-02; AB0014109; A11678; C07708; D00625; AB00639982-06; AB00639982_08; 432M032; A837526; Q772735; SR-01000759413; SR-01000759413-4; W-104490; BRD-K44779798-001-06-5; Z1541638520; (2R,3R,4R,5S)-1-ethoxy-2-(hydroxymethyl)piperidine-3,4,5-triol; (2R,3R,4R,5S)-1-(2-Hydroxyethyl)-2-(2-hydroxymethyl)-3,4,5-piperidinetriol; 3,4,5-Piperidinetriol, 1-(2-hydroxyethyl)-2-(hydroxymethyl)-, (2R,3R,4R,5S)-; 1204250-58-7; 3,4,5-Piperidinetriol, 1-(2-hydroxyethyl)-2-(hydroxymethyl)-, (2R-(2alpha,3beta,4alpha,5beta))-
Clinical Status
Approved
Disease Indication Diabetic complication ICD-11: 5A2Y [1]
PubChem CID
441314
Formula
C8H17NO5
Canonical SMILES
C1[C@@H]([C@H]([C@@H]([C@H](N1CCO)CO)O)O)O
InChI
1S/C8H17NO5/c10-2-1-9-3-6(12)8(14)7(13)5(9)4-11/h5-8,10-14H,1-4H2/t5-,6+,7-,8-/m1/s1
InChIKey
IBAQFPQHRJAVAV-ULAWRXDQSA-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=441314"></iframe>
3D MOL 2D MOL
Physicochemical Properties Molecular Weight 207.22 Topological Polar Surface Area 104
XlogP -2.6 Complexity 179
Heavy Atom Count 14 Rotatable Bond Count 3
Hydrogen Bond Donor Count 5 Hydrogen Bond Acceptor Count 6
Full List of Drug Formulations (DFMs) Containing This API
          Miglitol 100 mg tablet 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
Magnesium stearate; Titanium dioxide; Polyethylene glycol 400; Polysorbate 80; Cellulose, microcrystalline; Hypromelloses; Starch, corn
                   Dosage Form Oral Tablet
                   Company Orient Pharma; Sun Pharmaceutical Industries
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Polysorbate 80 DIG Info Prostaglandin G/H synthase 1 (IC50 = 1 uM) [2]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
Polyethylene glycol 400 DIG Info Albendazole monooxygenase (IC50 = 10.77 mg.mL-1) [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
Magnesium stearate; Titanium dioxide; Polysorbate 80; Hypromellose, unspecified; Microcrystalline cellulose; Polyethylene glycol, unspecified; Starch, corn
                   Dosage Form Oral Tablet
                   Company Pharmacia and Upjohn Company
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Polysorbate 80 DIG Info Prostaglandin G/H synthase 1 (IC50 = 1 uM) [2]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
          Miglitol 25 mg tablet 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
Magnesium stearate; Titanium dioxide; Polyethylene glycol 400; Polysorbate 80; Cellulose, microcrystalline; Hypromelloses; Starch, corn
                   Dosage Form Oral Tablet
                   Company Orient Pharma; Sun Pharmaceutical Industries
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Polysorbate 80 DIG Info Prostaglandin G/H synthase 1 (IC50 = 1 uM) [2]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
Polyethylene glycol 400 DIG Info Albendazole monooxygenase (IC50 = 10.77 mg.mL-1) [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
Magnesium stearate; Titanium dioxide; Polysorbate 80; Hypromellose, unspecified; Microcrystalline cellulose; Polyethylene glycol, unspecified; Starch, corn
                   Dosage Form Oral Tablet
                   Company Pharmacia and Upjohn Company
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Polysorbate 80 DIG Info Prostaglandin G/H synthase 1 (IC50 = 1 uM) [2]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
          Miglitol 50 mg tablet 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
Magnesium stearate; Titanium dioxide; Polyethylene glycol 400; Polysorbate 80; Cellulose, microcrystalline; Hypromelloses; Starch, corn
                   Dosage Form Oral Tablet
                   Company Orient Pharma; Sun Pharmaceutical Industries
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Polysorbate 80 DIG Info Prostaglandin G/H synthase 1 (IC50 = 1 uM) [2]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
Polyethylene glycol 400 DIG Info Albendazole monooxygenase (IC50 = 10.77 mg.mL-1) [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
Magnesium stearate; Titanium dioxide; Polysorbate 80; Hypromellose, unspecified; Microcrystalline cellulose; Polyethylene glycol, unspecified; Starch, corn
                   Dosage Form Oral Tablet
                   Company Pharmacia and Upjohn Company
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Polysorbate 80 DIG Info Prostaglandin G/H synthase 1 (IC50 = 1 uM) [2]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
References
1 FDA label for approved miglitol 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 Effects of commonly used excipients on the expression of CYP3A4 in colon and liver cells. Pharm Res. 2010 Aug;27(8):1703-12.
4 Pharmaceutical excipients inhibit cytochrome P450 activity in cell free systems and after systemic administration. Eur J Pharm Biopharm. 2008 Sep;70(1):279-88.

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