Details of the Active Pharmaceutical Ingredient (API)

General Information of API (ID: D00553)
Name
Pregabalin
Synonyms    Click to Show/Hide the Synonyms of This API
Pregabalin; 148553-50-8; Lyrica; (S)-3-(Aminomethyl)-5-methylhexanoic acid; (3S)-3-(aminomethyl)-5-methylhexanoic acid; 3-isobutyl GABA; CI-1008; (S)-Pregabalin; Hexanoic acid, 3-(aminomethyl)-5-methyl-, (3S)-; CI 1008; PD 144723; UNII-55JG375S6M; PD-144723; (S)-3-Isobutyl GABA; CHEMBL1059; CHEBI:64356; (3S)-3-(aminomethyl)-5-methyl-hexanoic acid; 55JG375S6M; MFCD00917044; Hexanoic acid, 3-(aminomethyl)-5-ethyl-, (3S)-; (R-)-3-isobutyl GABA; Hexanoic acid, 3-(aminomethyl)-5-methyl-, (S)-; Nervalin; Pregablin; HSDB 7530; Pregabalin [USAN:INN:BAN:JAN]; NCGC00095186-01; Lyrica (TN); (S)-3-(Aminomethyl)-5-methylhexanoicacid; SCHEMBL8227; DSSTox_CID_25950; DSSTox_RID_81246; DSSTox_GSID_45950; Pregabalin (JAN/USAN/INN); (S)-(+)-4-amino-3-(2-methylpropyl)butanoic acid; GTPL5484; ZINC5152; DEA No. 2782; Pregabalin, >=97% (NMR); DTXSID1045950; HMS3715J16; Pregabalin 1.0 mg/ml in Methanol; YNP-1807; Tox21_111475; BDBM50164279; CP0100; AKOS001476611; AKOS005145504; Lyrica;CI-1008;PD-144723; AC-1158; ACN-038395; CCG-221247; CM14412; CS-1247; DB00230; KS-5378; (S)-3-aminomethyl-5-methylhexanoic acid; NCGC00346738-01; 121GE001; HY-17414; (S)-3-Aminomethyl-5-methyl-hexanoic acid; AB0074009; AM20080369; CAS-148553-50-8; EN300-92104; (3S)-3-(aminomethyl)-5-methyl hexanoic acid; (S)-(+)-3-Aminomethyl-5-Methylhexanoic Acid; D02716; W-5218; AB01563007_01; 553P508; A808784; Q412174; SR-01000942257; SR-01000942257-2; Pregabalin, EuropePharmacopoeia (EP) Reference Standard; Z2757554242; 1414928-41-8
Clinical Status
Approved
Disease Indication Neuropathic pain ICD-11: 8E43 [1]
PubChem CID
5486971
Formula
C8H17NO2
Canonical SMILES
CC(C)C[C@@H](CC(=O)O)CN
InChI
1S/C8H17NO2/c1-6(2)3-7(5-9)4-8(10)11/h6-7H,3-5,9H2,1-2H3,(H,10,11)/t7-/m0/s1
InChIKey
AYXYPKUFHZROOJ-ZETCQYMHSA-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=5486971"></iframe>
3D MOL 2D MOL
Physicochemical Properties Molecular Weight 159.23 Topological Polar Surface Area 63.3
XlogP -1.6 Complexity 123
Heavy Atom Count 11 Rotatable Bond Count 5
Hydrogen Bond Donor Count 2 Hydrogen Bond Acceptor Count 3
Full List of Drug Formulations (DFMs) Containing This API
          Pregabalin 225 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; Sodium lauryl sulfate; Ferric oxide red; Ferrosoferric oxide; Potassium hydroxide; Propylene glycol; Talc; Titanium dioxide; Silicon dioxide; Gelatin; Shellac; Starch, corn
                   Dosage Form Oral Capsule
                   Company Aphena Pharma Solutions-Tennessee; Rebel Distributors
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Sodium lauryl sulfate DIG Info Solute carrier SLCO2B1 (Ki = 1.98 uM) [2]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [3]
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; Sodium lauryl sulfate; Ferric oxide red; Ferrosoferric oxide; Potassium hydroxide; Propylene glycol; Talc; Titanium dioxide; Silicon dioxide; Gelatin, unspecified; Shellac; Starch, corn
                   Dosage Form Oral Capsule
                   Company Lake Eire Medical & Surgical Supply DBA Quality Care Products; Parke-Davis Div of Pfizer Inc
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Sodium lauryl sulfate DIG Info Solute carrier SLCO2B1 (Ki = 1.98 uM) [2]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [3]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
          Pregabalin 300 mg capsule 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
Lactose monohydrate; Sodium lauryl sulfate; Ferric oxide red; Ferrosoferric oxide; Potassium hydroxide; Propylene glycol; Talc; Titanium dioxide; Silicon dioxide; Gelatin; Shellac; Starch, corn
                   Dosage Form Oral Capsule
                   Company Aphena Pharma Solutions-Tennessee; Bryant Ranch Prepack; Rebel Distributors
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Sodium lauryl sulfate DIG Info Solute carrier SLCO2B1 (Ki = 1.98 uM) [2]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [3]
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; Sodium lauryl sulfate; Ferric oxide red; Ferrosoferric oxide; Potassium hydroxide; Propylene glycol; Talc; Titanium dioxide; Silicon dioxide; Gelatin, unspecified; Shellac; Starch, corn
                   Dosage Form Oral Capsule
                   Company PD-Rx Pharmaceuticals; Parke-Davis Div of Pfizer Inc; Unit Dose Services
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Sodium lauryl sulfate DIG Info Solute carrier SLCO2B1 (Ki = 1.98 uM) [2]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [3]
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; Talc; Starch, corn
                   Dosage Form Oral Capsule
                   Company Lake Eire Medical & Surgical Supply DBA Quality Care Products
          Pregabalin 75 mg capsule 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
Lactose monohydrate; Sodium lauryl sulfate; Ferric oxide red; Ferrosoferric oxide; Potassium hydroxide; Propylene glycol; Talc; Titanium dioxide; Silicon dioxide; Gelatin; Shellac; Starch, corn
                   Dosage Form Oral Capsule
                   Company A-S Medication Solutions; Aphena Pharma Solutions-Tennessee; DirectRX; Dispensing Solution; H. J. Harkins Company; Physicians Total Care; Rebel Distributors; RemedyRepack; Stat Rx USA
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Sodium lauryl sulfate DIG Info Solute carrier SLCO2B1 (Ki = 1.98 uM) [2]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [3]
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; Sodium lauryl sulfate; Ferric oxide red; Ferrosoferric oxide; Potassium hydroxide; Propylene glycol; Talc; Titanium dioxide; Silicon dioxide; Gelatin, unspecified; Shellac; Starch, corn
                   Dosage Form Oral Capsule
                   Company Bryant Ranch Prepack; PD-Rx Pharmaceuticals; Parke-Davis Div of Pfizer Inc; RemedyRepack; Unit Dose Services
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Sodium lauryl sulfate DIG Info Solute carrier SLCO2B1 (Ki = 1.98 uM) [2]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [3]
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; Sodium lauryl sulfate; Ferrosoferric oxide; Potassium hydroxide; Propylene glycol; Talc; Titanium dioxide; Silicon dioxide; Gelatin; Shellac; Starch, corn
                   Dosage Form Oral Capsule
                   Company Lake Eire Medical & Surgical Supply DBA Quality Care Products; U.S. Pharmaceuticals
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Sodium lauryl sulfate DIG Info Solute carrier SLCO2B1 (Ki = 1.98 uM) [2]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [3]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
          Pregabalin 150 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; Sodium lauryl sulfate; Ferrosoferric oxide; Potassium hydroxide; Propylene glycol; Talc; Titanium dioxide; Silicon dioxide; Gelatin, unspecified; Shellac; Starch, corn
                   Dosage Form Oral Capsule
                   Company Bryant Ranch Prepack; PD-Rx Pharmaceuticals; Parke-Davis Div of Pfizer Inc; RemedyRepack; Unit Dose Services
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Sodium lauryl sulfate DIG Info Solute carrier SLCO2B1 (Ki = 1.98 uM) [2]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [3]
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; Sodium lauryl sulfate; Ferrosoferric oxide; Potassium hydroxide; Propylene glycol; Talc; Titanium dioxide; Silicon dioxide; Gelatin; Shellac; Starch, corn
                   Dosage Form Oral Capsule
                   Company A-S Medication Solutions; Aphena Pharma Solutions-Tennessee; DirectRX; Dispensing Solution; H. J. Harkins Company; Lake Eire Medical & Surgical Supply DBA Quality Care Products; Physicians Total Care; Rebel Distributors; St Marys Medical Park Pharmacy
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Sodium lauryl sulfate DIG Info Solute carrier SLCO2B1 (Ki = 1.98 uM) [2]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [3]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
          Pregabalin 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
Lactose monohydrate; Sodium lauryl sulfate; Ferrosoferric oxide; Potassium hydroxide; Propylene glycol; Talc; Titanium dioxide; Silicon dioxide; Gelatin, unspecified; Shellac; Starch, corn
                   Dosage Form Oral Capsule
                   Company Parke-Davis Div of Pfizer Inc; Unit Dose Services
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Sodium lauryl sulfate DIG Info Solute carrier SLCO2B1 (Ki = 1.98 uM) [2]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [3]
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; Sodium lauryl sulfate; Ferrosoferric oxide; Potassium hydroxide; Propylene glycol; Talc; Titanium dioxide; Silicon dioxide; Gelatin; Shellac; Starch, corn
                   Dosage Form Oral Capsule
                   Company Bryant Ranch Prepack; Lake Eire Medical & Surgical Supply DBA Quality Care Products; Physicians Total Care; Rebel Distributors
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Sodium lauryl sulfate DIG Info Solute carrier SLCO2B1 (Ki = 1.98 uM) [2]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [3]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
          Pregabalin 50 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; Sodium lauryl sulfate; Ferrosoferric oxide; Potassium hydroxide; Propylene glycol; Talc; Titanium dioxide; Silicon dioxide; Gelatin, unspecified; Shellac; Starch, corn
                   Dosage Form Oral Capsule
                   Company Bryant Ranch Prepack; PD-Rx Pharmaceuticals; Parke-Davis Div of Pfizer Inc; RemedyRepack; Unit Dose Services
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Sodium lauryl sulfate DIG Info Solute carrier SLCO2B1 (Ki = 1.98 uM) [2]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [3]
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; Sodium lauryl sulfate; Ferrosoferric oxide; Potassium hydroxide; Propylene glycol; Talc; Titanium dioxide; Silicon dioxide; Gelatin; Shellac; Starch, corn
                   Dosage Form Oral Capsule
                   Company A-S Medication Solutions; Aphena Pharma Solutions-Tennessee; DirectRX; H. J. Harkins Company; Lake Eire Medical & Surgical Supply DBA Quality Care Products; Physicians Total Care; Rebel Distributors; Stat Rx USA
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Sodium lauryl sulfate DIG Info Solute carrier SLCO2B1 (Ki = 1.98 uM) [2]
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [3]
Silicon dioxide DIG Info Albendazole monooxygenase (Protein expression downregulation) [4]
          Pregabalin 100 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; Ferric oxide red; Ferrosoferric oxide; Potassium hydroxide; Propylene glycol; Talc; Titanium dioxide; Gelatin; Shellac; Starch, corn
                   Dosage Form Oral Capsule
                   Company A-S Medication Solutions; Aphena Pharma Solutions-Tennessee; Bryant Ranch Prepack; DirectRX; H. J. Harkins Company; Lake Eire Medical & Surgical Supply DBA Quality Care Products; Physicians Total Care; Rebel Distributors; St Marys Medical Park Pharmacy
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [3]
             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; Ferric oxide red; Ferrosoferric oxide; Potassium hydroxide; Propylene glycol; Talc; Titanium dioxide; Gelatin, unspecified; Shellac; Starch, corn
                   Dosage Form Oral Capsule
                   Company PD-Rx Pharmaceuticals; Parke-Davis Div of Pfizer Inc; RemedyRepack; Unit Dose Services
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [3]
          Pregabalin 200 mg capsule 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
Lactose monohydrate; Ferric oxide red; Ferrosoferric oxide; Potassium hydroxide; Propylene glycol; Talc; Titanium dioxide; Gelatin; Shellac; Starch, corn
                   Dosage Form Oral Capsule
                   Company Aphena Pharma Solutions-Tennessee; Bryant Ranch Prepack; Physicians Total Care; Rebel Distributors; RemedyRepack; St Marys Medical Park Pharmacy
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [3]
             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; Ferric oxide red; Ferrosoferric oxide; Potassium hydroxide; Propylene glycol; Talc; Titanium dioxide; Gelatin, unspecified; Shellac; Starch, corn
                   Dosage Form Oral Capsule
                   Company Parke-Davis Div of Pfizer Inc; Unit Dose Services
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Propylene glycol DIG Info Albendazole monooxygenase (Inhibition ratio < 20 %) [3]
             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; Talc; Starch, corn
                   Dosage Form Oral Capsule
                   Company Lake Eire Medical & Surgical Supply DBA Quality Care Products
References
1 FDA label for approved pregabalin from the official website of the U.S. Food and Drug Administration.
2 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.
3 Pharmaceutical excipients inhibit cytochrome P450 activity in cell free systems and after systemic administration. Eur J Pharm Biopharm. 2008 Sep;70(1):279-88.
4 Effects of commonly used excipients on the expression of CYP3A4 in colon and liver cells. Pharm Res. 2010 Aug;27(8):1703-12.

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