Kinase Inhibitor

Mitogen-Activated Protein Kinase Kinase 1 Inhibitors

Mitogen-Activated Protein Kinase Kinase 2 Inhibitors

Neurofibromatosis 1

<section class="Section" data-sectioncode="34089-3"><a name="ID_f210f16e-0521-478e-a1c0-1af4469e3b2e"></a><a name="section-10"></a><p></p><h1>11 DESCRIPTION </h1><p class="First">Selumetinib is a kinase inhibitor. The chemical name is 5-[(4-bromo-2-chlorophenyl)amino]-4-fluoro-6-[(2-hydroxyethoxy)carbamoyl]-1-methyl-1<span class="Italics">H</span>-benzimidazol-3-ium hydrogen sulfate. The molecular formula for selumetinib sulfate is C<span class="Sub">17</span>H<span class="Sub">17</span>BrClFN<span class="Sub">4</span>O<span class="Sub">7</span>S and the relative molecular mass is 555.76 g/mol. Selumetinib sulfate has the following structural formula:</p><div class="Figure"><a name="id1688010714"></a><img alt="structure" src="chemicalstructure_selumetinib.jpg"/></div><p>Selumetinib sulfate is a white to yellow monomorphic crystalline powder that exhibits a pH dependent solubility. Selumetinib sulfate is freely soluble at pH &lt; 1.5, sparingly soluble in the pH range at 1.5 to 3 and slightly soluble at pH &gt; 3. Selumetinib sulfate has two ionizable functions with pKa values of 2.8 and 8.4.</p><p>KOSELUGO (selumetinib) 10 mg capsules for oral use, contain 10 mg selumetinib (equivalent to 12.1 mg selumetinib sulfate) and the excipient, vitamin E polyethylene glycol succinate. The capsule shell contains hypromellose, carrageenan, potassium chloride, titanium dioxide, carnauba wax, and purified water. The capsule is imprinted with black ink that contains shellac, iron oxide black, propylene glycol and ammonium hydroxide.</p><p>KOSELUGO (selumetinib) 25 mg capsules for oral use, contain 25 mg selumetinib (equivalent to 30.25 mg selumetinib sulfate) and the excipient, vitamin E polyethylene glycol succinate. The capsule shell contains hypromellose, carrageenan, potassium chloride, titanium dioxide, FD&amp;C blue 2, ferric oxide yellow, purified water, carnauba wax, and/or corn starch. The capsule is imprinted with black ink that contains ferric oxide red, ferric oxide yellow, FD&amp;C Blue 2 aluminum lake, carnauba wax, shellac, and glyceryl monooleate.</p></section>

KOSELUGO

selumetinib

selumetinib 10 MG Oral Capsule

Koselugo

selumetinib 10 MG Oral Capsule [Koselugo]

selumetinib 25 MG Oral Capsule

selumetinib 25 MG Oral Capsule [Koselugo]

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