vitruvias therapeutics, inc. - Medication Listings

Icosapent ethyl, a lipid-regulating agent, is supplied as a 1 gram amber-colored, liquid-filled soft gelatin capsule for oral use. Each icosapent ethyl capsule contains 1 gram of icosapent ethyl (in a 1 gram capsule). Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The empirical formula of icosapent ethyl is C22H34O2 and the molecular weight is 330.51. The chemical name for icosapent ethyl is ethyl all-cis-5,8,11,14,17-icosapentaenoate with the following chemical structure: Icosapent ethyl capsules contain the following inactive ingredients: gelatin, glycerin, purified water, and white ink. The compositions of white ink are isopropyl alcohol, n-butyl alcohol, propylene glycol, shellac and titanium dioxide. chemical structure

Memantine hydrochloride extended-release capsules is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula: The molecular formula is C 12 H 21 N•HCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride extended-release capsules are supplied for oral administration as 7 mg, 14 mg, 21 mg and 28 mg capsules. Among them, 7 mg strength is supplied in opaque light green cap and opaque white body capsule, with "LPM" black imprint on the cap and "7 mg" black imprint on the body, 14 mg strength is supplied in opaque blue cap and opaque white body capsule, with "LPM" black imprint on the cap and "14 mg" black imprint on the body, 21 mg strength is supplied in opaque white cap and opaque white body capsule, with "LPM" black imprint on the cap and "21 mg" black imprint on the body, 28 mg strength is supplied in the opaque rich yellow cap and opaque white body capsule, with "LPM" black imprint on the cap and "28 mg" black imprint on the body. Each capsule contains extended-release white to off-white beads with the labeled amount of memantine hydrochloride and the following inactive ingredients: sugar spheres (sucrose, maize starch, and dextrin), polyvinylpyrrolidone, hypromellose, talc, polyethylene glycol, triethyl citrate, ethylcellulose, ammonium hydroxide, oleic acid, and medium chain triglycerides in hard gelatin capsules. In addition, the capsule shells contain gelatin and titanium dioxide and are imprinted with black ink. Colorants in capsule shells are brilliant blue (7 mg, 14 mg), erythrosine (14 mg only) and ferric oxide yellow (7 mg, 28 mg). The black ink mainly contains shellac, black iron oxide, dehydrated alcohol, purified water and propylene glycol, with trace amount of isopropyl alcohol, butyl alcohol, strong ammonia solution and potassium hydroxide. Structure

Memantine and donepezil hydrochlorides extended-release capsules contains memantine, an orally active NMDA receptor antagonist, as the hydrochloride salt and donepezil, a reversible inhibitor of the enzyme acetylcholinesterase, as the hydrochloride salt. Memantine Hydrochloride The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula: The molecular formula is C 12 H 21 N•HCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder. Memantine Hydrochloride Structural Formula Donepezil Hydrochloride The chemical name for donepezil hydrochloride is 2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. The molecular formula is C 24 H 29 NO 3 •HCl and the molecular weight is 415.96. Donepezil hydrochloride is a white crystalline powder. Memantine and donepezil hydrochlorides extended-release capsules contain 14 mg or 28 mg memantine hydrochloride, 10 mg donepezil hydrochloride, and the following inactive ingredients: colloidal silicon dioxide, corn starch, ethylcellulose, hypromellose, lactose monohydrate, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, triethyl citrate, ammonium hydroxide, oleic acid, polyethylene glycol, povidone, sugar spheres, and talc. The capsule shells contain gelatin and titanium dioxide and are imprinted with shellac and black iron oxide. Colorants are brilliant blue (14 mg/10 mg, 28 mg/10 mg), erythrosine (28 mg/10 mg) and ferric oxide yellow (14 mg/10 mg). Donepezil Hydrochloride Structural Formula

Pramipexole dihydrochloride extended-release tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is a non-ergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C 10 H 17 N 3 S•2HCl•H 2 O, and its molecular weight is 302.26. The structural formula is: Pramipexole dihydrochloride is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. Pramipexole dihydrochloride extended-release tablets 0.375 mg: Each extended-release tablet contains 0.375 mg pramipexole dihydrochloride monohydrate equivalent to 0.352 mg pramipexole dihydrochloride. Pramipexole dihydrochloride extended-release tablets 0.75 mg: Each extended-release tablet contains 0.75 mg pramipexole dihydrochloride monohydrate equivalent to 0.705 mg pramipexole dihydrochloride. Inactive ingredients for all strengths of pramipexole dihydrochloride extended-release tablets consist of corn starch, hypromellose, carbomer homopolymer, colloidal silicon dioxide, and magnesium stearate. Formula

Topiramate, USP, is a sulfamate-substituted monosaccharide. Topiramate extended-release capsules are available as 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg capsules for oral administration as whole capsules or opened and sprinkled onto a spoonful of soft food. Topiramate is a white to off-white powder. Topiramate is freely soluble in polar organic solvents such as acetonitrile and acetone; and very slightly soluble to practically insoluble in non-polar organic solvents such as hexanes. Topiramate has the molecular formula C 12 H 21 NO 8 S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula: Topiramate extended-release capsules contain beads of topiramate in a capsule. The inactive ingredients are microcrystalline cellulose, hypromellose 2910, ethylcellulose, triethyl citrate. In addition, the capsule shells for all strengths contain hypromellose 2910, carrageenan, potassium chloride, titanium dioxide, black pharmaceutical ink, carmine (25 mg only), lemon yellow (25 mg and 150 mg), brilliant blue (25 mg, 100 mg and 150 mg), erythrosine (100 mg only), sunset yellow (150 mg only) and may contain sodium dodecyl sulfate. Chemical Structure