Glyxambi Description

GLYXAMBI 10 mg/5 mg film-coated tablets are pale yellow, arc triangular, flat-faced, bevel-edged. One side is debossed with the Boehringer Ingelheim company symbol, the other side is debossed with "10/5".
GLYXAMBI 25 mg/5 mg film-coated tablets are pale pink, arc triangular, flat-faced, bevel-edged. One side is debossed with the Boehringer Ingelheim company symbol, the other side is debossed with "25/5".
GLYXAMBI are film-coated tablets for oral administration.
GLYXAMBI 10 mg/5 mg contains 10 mg empagliflozin and 5 mg linagliptin.
GLYXAMBI 25 mg/5 mg contains 25 mg empagliflozin and 5 mg linagliptin.
Physicochemical properties: Empagliflozin is a white to yellowish powder. It is very slightly soluble in water, slightly soluble in acetonitrile and ethanol, sparingly soluble in methanol and practically insoluble in toluene. Empagliflozin is not hygroscopic and no polymorphism has been observed. It is neither a hydrate nor a solvate. Partition coefficient: log P = log D (pH 7.4): 1.7.
Linagliptin is a white to yellowish, not or only slightly hygroscopic solid substance. It is very slightly soluble in water. Linagliptin is soluble in methanol, sparingly soluble in ethanol, very slightly soluble in isopropanol and very slightly soluble in acetone. Dissociation Constants: pKa₁ = 8.6; pKa₂ = 1.9. Partition Co-efficient: Log P = 1.7 (free base); Log D (pH 7.4) = 0.4.
Chemical structure: GLYXAMBI contains two oral antihyperglycaemic drugs used in the management of type 2 diabetes mellitus: empagliflozin (a SGLT2 inhibitor) and linagliptin (a dipeptidyl peptidase-4 (DPP-4) inhibitor).
Empagliflozin: Chemical name: (1S)-1,5-anhydro-1-(4-chloro-3-{4-[(3S)-tetrahydrofuran-3-yloxy]benzyl}phenyl)-D-glucitol.
Molecular formula: C₂₃H₂₇ClO₇.
Molecular weight: 450.91.
Linagliptin: Chemical name: 1H-Purine-2,6-dione,8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl].
Molecular formula: C₂₅H₂₈N₈O₂.
Molecular weight: 472.54.
CAS number: Empagliflozin: 864070-44-0.
Linagliptin: 668270-12-0.
Excipients/Inactive Ingredients: Each film-coated tablet of GLYXAMBI 10 mg/5 mg contains the following inactive ingredients: mannitol, pregelatinized starch, maize starch, copovidone, crospovidone, talc, magnesium stearate, hypromellose 2910, titanium dioxide (E171), macrogol 6000, iron oxide yellow (E172).
Each film-coated tablet of GLYXAMBI 25 mg/5 mg contains the following inactive ingredients: mannitol, pregelatinized starch, maize starch, copovidone, crospovidone, talc, magnesium stearate, hypromellose 2910, titanium dioxide (E171), macrogol 6000, iron oxide red (E172).