cycle pharmaceuticals ltd. - Medication Listings

Penicillamine is a chelating agent used in the treatment of Wilson's disease. It is also used to reduce cystine excretion in cystinuria and to treat patients with severe, active rheumatoid arthritis unresponsive to conventional therapy (see INDICATIONS ). It is 3-mercapto-D-valine. It is a white or practically white, crystalline powder, freely soluble in water, slightly soluble in alcohol, and insoluble in ether, acetone, benzene, and carbon tetrachloride. Although its configuration is D, it is levorotatory as usually measured: calculated on a dried basis. The empirical formula is C 5 H 11 NO 2 S, giving it a molecular weight of 149.21. The structural formula is: It reacts readily with formaldehyde or acetone to form a thiazolidine-carboxylic acid. AAGYLUR (penicillamine) capsules, USP, for oral administration contain 250 mg of penicillamine. Each capsule contains the following inactive ingredients: mannitol and magnesium stearate. The capsule shell contains: gelatin, D & C Yellow 10 and titanium dioxide. Imprinting ink contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water. Formula Structure

HARLIKU (nitisinone) is a hydroxyphenyl-pyruvate dioxygenase inhibitor. Nitisinone occurs as a white to yellowish-white, crystalline powder. It is practically insoluble in water, soluble in 2M sodium hydroxide and in methanol, and sparingly soluble in alcohol. The chemical name of nitisinone is 2-(2-nitro-4-trifluoromethylbenzoyl) cyclohexane-1,3-dione. The molecular formula is C 14 H 10 F 3 NO 5 and the molecular weight is 329.23. The structural formula is: Each HARLIKU (nitisinone) tablet contains 2 mg of nitisinone to be administered orally. The inactive ingredients are glyceryl dibehenate and lactose monohydrate. Figure 1 Structural Formula

NITYR (nitisinone) is a hydroxyphenyl-pyruvate dioxygenase inhibitor. Nitisinone occurs as a white to yellowish-white, crystalline powder. It is practically insoluble in water, soluble in 2M sodium hydroxide and in methanol, and sparingly soluble in alcohol. The chemical name of nitisinone is 2-(2-nitro-4-trifluoromethylbenzoyl) cyclohexane-1,3-dione. The empirical formula is C 14 H 10 F 3 NO 5 and the molecular weight is 329.23. The structural formula is: Each NITYR (nitisinone) tablet contains 2, 5 or 10 mg of nitisinone. Inactive ingredients are: glyceryl dibehenate, and lactose monohydrate. NITYR tablets are intended for oral administration. Figure 1 Structural Formula

ORMALVI tablets, USP contain dichlorphenamide, an oral carbonic anhydrase inhibitor. Dichlorphenamide, USP a dichlorinated benzenedisulfonamide, is known chemically as 4, 5–dichloro-1,3-benzenedisulfonamide. Its empirical formula is C 6 H 6 Cl 2 N 2 O 4 S 2 and its structural formula is: Dichlorphenamide USP is a white or practically white, crystalline powder with a molecular weight of 305.16. It is very slightly soluble in water but soluble in dilute solutions of alkali carbonate and hydroxide. ORMALVI (dichlorphenamide) tablets, USP are supplied as tablets, for oral administration, each containing 50 mg dichlorphenamide. Inactive ingredients are lactose monohydrate, partially pregelatinized starch and magnesium stearate. FDA approved dissolution test specifications differ from USP. image description

PHYRAGO (dasatinib) is a kinase inhibitor. The chemical name for dasatinib (anhydrous) is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide. The molecular formula is C 22 H 26 ClN 7 O 2 S, which corresponds to a formula weight of 488.01. Dasatinib (anhydrous) has the following chemical structure: Dasatinib (anhydrous) is a white to light yellow powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. PHYRAGO is supplied as white to light yellow, biconvex, immediate release tablets for oral use containing dasatinib (anhydrous), with the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, methacrylic acid-ethyl acrylate copolymer, microcrystalline cellulose, propyl gallate, and silica dimethyl silylate. structure

Fingolimod is a sphingosine 1-phosphate receptor modulator. Chemically, fingolimod lauryl sulfate is 2-amino-2-[2-(4-octylphenyl)ethyl]propan-1,3-diol lauryl sulfate. Its structure is shown below: Fingolimod lauryl sulfate is a white to practically white powder that is practically insoluble in water. It has a molecular weight of 573.87 g/mol. TASCENSO ODT is provided as 0.25 mg and 0.5 mg orally disintegrating tablets for oral use. Each orally disintegrating tablet contains 0.25 mg or 0.5 mg of fingolimod (equivalent to 0.47 mg or 0.93 mg of fingolimod lauryl sulfate) and the following inactive ingredients: gelatin, mannitol, medium-chain triglycerides, sodium chloride, and sodium lauryl sulfate. Chemical Structure

VENXXIVA (tiopronin) delayed-release tablets are a reducing and cystine-binding thiol drug (CBTD) for oral use. Tiopronin is N‑(2‑Mercaptopropionyl) glycine and has the following structure: Tiopronin has the empirical formula C 5 H 9 NO 3 S and a molecular weight of 163.19. In this drug product tiopronin exists as a dl racemic mixture. Tiopronin is a white to off-white color crystalline powder, which is freely soluble in water. Each VENXXIVA tablet contains 100 or 300 mg of tiopronin. The inactive ingredients in VENXXIVA tablets include lactose monohydrate, low substitute hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate, hypromellose 2910, methacrylic acid: ethyl acrylate copolymer (Eudragit L 100-55), talc, triethyl citrate. The imprinting ink contains shellac, ferrosoferric oxide and propylene glycol. image description