General Information of DFM (ID: F24312)
Name	Safinamide Mesylate 100 mg tablet
Company	Mdd Us Operations
Active Pharmaceutical Ingredient (API)	Safinamide		API Info click to show the detail info of this API
	Parkinsonism		ICD-11: 8A00	Approved
Drug Inactive Ingredient (DIGs)
	DIG ID	DIG Info	DIG Name	DIG Functional Class
	E0V2QO	DIG Info	Cellulose microcrystalline	Adsorbent ...
	E0PE9M	DIG Info	Crospovidone	Disintegrant
	E0L1TV	DIG Info	Haematite red	Colorant
	E0P9YZ	DIG Info	Hydrophobic colloidal silica	Anticaking agent ...
	E0T4YW	DIG Info	Hypromellose	Coating agent
	E01UTP	DIG Info	Magnesium stearate	lubricant
	E09BYS	DIG Info	Polyethylene glycol 6000	Coating agent ...
	E0D9CM	DIG Info	Potassium aluminum disilicate	Other agent
	E05BSD	DIG Info	Titanium dioxide	Coating agent ...

Full List of Biological Targets of DIG (DBTs) Regulated by DIG(s) in This DFM
Oxidoreductase (ORase)
DBT Name: Albendazole monooxygenase (CYP3A4)				Click to Show/Hide
Detailed Information	DBT Info click to show the detail info of this DBT
Experiment (1) for Assessing the Biological Activity of the Studied DIG on This DBT
Interacting DIG	Magnesium stearate
Biological Activity	Protein expression downregulation (tested by experiment)					[1]
Tested Species	Homo sapiens (Human)
UniProt ID	CP3A4_HUMAN
Experiment (2) for Assessing the Biological Activity of the Studied DIG on This DBT
Interacting DIG	Crospovidone
Biological Activity	Protein expression downregulation (tested by experiment)					[1]
Tested Species	Homo sapiens (Human)
UniProt ID	CP3A4_HUMAN
Experiment (3) for Assessing the Biological Activity of the Studied DIG on This DBT
Interacting DIG	Hypromellose
Biological Activity	Protein expression upregulation (tested by experiment)					[1]
Tested Species	Homo sapiens (Human)
UniProt ID	CP3A4_HUMAN
Experiment (4) for Assessing the Biological Activity of the Studied DIG on This DBT
Interacting DIG	Hypromellose
Biological Activity	Protein expression downregulation (tested by experiment)					[1]
Tested Species	Homo sapiens (Human)
UniProt ID	CP3A4_HUMAN
Experiment (5) for Assessing the Biological Activity of the Studied DIG on This DBT
Interacting DIG	Polyethylene glycol 6000
Biological Activity	Inhibition ratio < 70 % (tested by experiment)					[2]
Tested Species	Homo sapiens (Human)
UniProt ID	CP3A4_HUMAN
DBT Name: Cytochrome P450 2E1 (CYP2E1)				Click to Show/Hide
Detailed Information	DBT Info click to show the detail info of this DBT
Experiment for Assessing the Biological Activity of the Studied DIG on This DBT
Interacting DIG	Hypromellose
Biological Activity	IC50 = 253.5 uM (tested by experiment)					[3]
Tested Species	Homo sapiens (Human)
UniProt ID	CP2E1_HUMAN
DBT Name: Mephenytoin 4-hydroxylase (CYP2C19)				Click to Show/Hide
Detailed Information	DBT Info click to show the detail info of this DBT
Experiment for Assessing the Biological Activity of the Studied DIG on This DBT
Interacting DIG	Hypromellose
Biological Activity	EC50 = 211.8 uM (tested by experiment)					[3]
Tested Species	Homo sapiens (Human)
UniProt ID	CP2CJ_HUMAN
DBT Name: Debrisoquine 4-hydroxylase (CYP2D6)				Click to Show/Hide
Detailed Information	DBT Info click to show the detail info of this DBT
Experiment for Assessing the Biological Activity of the Studied DIG on This DBT
Interacting DIG	Hypromellose
Biological Activity	EC50 = 159.3 uM (tested by experiment)					[3]
Tested Species	Homo sapiens (Human)
UniProt ID	CP2D6_HUMAN
DBT Name: Cytochrome P450 3A5 (CYP3A5)				Click to Show/Hide
Detailed Information	DBT Info click to show the detail info of this DBT
Experiment for Assessing the Biological Activity of the Studied DIG on This DBT
Interacting DIG	Hypromellose
Biological Activity	IC50 = 19.4 uM (tested by experiment)					[3]
Tested Species	Homo sapiens (Human)
UniProt ID	CP3A5_HUMAN
Lyase/isomerase/ligase (L/I/G)
DBT Name: Cholesterol 25-hydroxylase (CYP1A2)				Click to Show/Hide
Detailed Information	DBT Info click to show the detail info of this DBT
Experiment for Assessing the Biological Activity of the Studied DIG on This DBT
Interacting DIG	Hypromellose
Biological Activity	EC50 = 106.7 uM (tested by experiment)					[3]
Tested Species	Homo sapiens (Human)
UniProt ID	CP1A2_HUMAN
Cell line (CELL)
DBT Name: Colon cancer Caco-2 cells (Caco-2)				Click to Show/Hide
Detailed Information	DBT Info click to show the detail info of this DBT
Experiment (1) for Assessing the Biological Activity of the Studied DIG on This DBT
Interacting DIG	Hypromellose
Biological Activity	Promotion ratio > 18 % (tested by experiment)					[4]
Tested Species	Homo sapiens (Human)
Experiment (2) for Assessing the Biological Activity of the Studied DIG on This DBT
Interacting DIG	Hypromellose
Biological Activity	Promotion ratio > 27 % (tested by experiment)					[4]
Tested Species	Homo sapiens (Human)

References
1	Effects of commonly used excipients on the expression of CYP3A4 in colon and liver cells. Pharm Res. 2010 Aug;27(8):1703-12.
2	Pharmaceutical excipients inhibit cytochrome P450 activity in cell free systems and after systemic administration. Eur J Pharm Biopharm. 2008 Sep;70(1):279-88.
3	Mediation of in vitro cytochrome p450 activity by common pharmaceutical excipients. Mol Pharm. 2013 Jul 1;10(7):2739-48.
4	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.

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