zydus pharmaceuticals usa inc. - Medication Listings

Methotrexate (formerly Amethopterin) is an antimetabolite used in the treatment of certain neoplastic diseases, severe psoriasis, and adult rheumatoid arthritis. Chemically methotrexate is N-[4-[[(2,4diamino-6-pteridinyl) methyl]methylamino]benzoyl]-L glutamic acid. The structural formula is: Molecular Formula : C 20 H 20 N 8 O 5 Na 2 Molecular Weight : 498.40 Methotrexate sodium is orange, brownish, or yellow crystalline hygroscopic powder. It is freely soluble in water. Methotrexate Tablets, USP contain an amount of methotrexate sodium equivalent to 2.5 mg of methotrexate and the following inactive ingredients: anhydrous lactose, lactose monohydrate, microcrystalline cellulose, magnesium stearate and pregelatinized starch. Image

Methylene blue, USP is an oxidation-reduction agent. Its chemical name is 3,7-bis(dimethylamino)phenothiazin-5-ium, chloride hydrate. The molecular formula of methylene blue is C 16 H 18 ClN 3 S xH 2 O and its molecular weight of 319.86 g/mol for the anhydrous form. The structural formula of methylene blue, USP is: Methylene blue injection, USP is a sterile solution intended for intravenous administration. Each mL of solution contains 5 mg methylene blue USP and water for injection USP. Additionally, it contains the excipients sodium citrate dihydrate USP and citric acid anhydrous USP in single dose glass vial. Methylene blue injection, USP is a clear dark blue solution with a pH value between 3.0 and 4.5. The osmolality is between 10 and 15 mOsm/kg. Methylene blue injection, USP strength is expressed in terms of trihydrate. Image

Methylprednisolone tablets contain methylprednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone, USP occurs as a white to practically white, odorless, crystalline powder. It melts at about 240°C, with some decomposition. It is practically insoluble in water, sparingly soluble in ethanol (96 %), in dioxane, in methanol and slightly soluble in acetone, in methylene chloride and in chloroform, very slightly soluble in ether. The chemical name for methylprednisolone is pregna-1,4-diene-3,20-dione, 11, 17, 21-trihydroxy-6-methyl-,(6α,11β)- and the molecular weight is 374.48. The structural formula is represented below: C 22 H 30 O 5 Each methylprednisolone tablet USP, contains 4 mg, 8 mg, 16 mg or 32 mg of methylprednisolone. In addition each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. ACTIONS Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli. methylpredisolone

Micafungin for injection, USP is a sterile, lyophilized product for intravenous (IV) infusion that contains micafungin sodium, USP. Micafungin sodium, USP is a semisynthetic lipopeptide (echinocandin) synthesized by a chemical modification of a fermentation product of Coleophoma empetri F-11899. Micafungin inhibits the synthesis of 1,3-beta-D-glucan, an integral component of the fungal cell wall. Each single-dose vial contains 50 mg micafungin (equivalent to 50.86 mg micafungin sodium, USP) or 100 mg micafungin (equivalent to 101.73 mg micafungin sodium, USP), 200 mg lactose monohydrate, with citric acid anhydrous and/or sodium hydroxide (used for pH adjustment). Micafungin for injection, USP must be diluted with 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP [see Dosage and Administration ( 2 )] . Following reconstitution with 0.9% Sodium Chloride Injection, USP, the resulting pH of the solution is between 5 to 7. Micafungin sodium, USP is chemically designated as: Pneumocandin A0,1-[(4R,5R)-4,5-dihydroxy-N 2 -[4-[5-[4-(pentyloxy) phenyl]-3-isoxazolyl]benzoyl]-L-ornithine]-4-[(4 S )-4-hydroxy-4-[4-hydroxy-3-(sulfooxy)phenyl]-L-threonine]-, monosodium salt. The chemical structure of micafungin sodium, USP is: The molecular formula is C 56 H 70 N 9 NaO 23 S and the molecular weight is 1292.3. Micafungin sodium, USP is a light-sensitive, hygroscopic white powder that is freely soluble in dimethyl sulfoxide, soluble in dimethyl formamide and water, sparingly soluble in methanol and slightly soluble to practically insoluble in acetone, methylethylketone, methylisobutylketone, ethanol, isopropanol, ethyl acetate, isopropyl acetate, acetonitrile, toluene, heptane and tetrahydrofuran. Image

Name: Midodrine hydrochloride tablets, USP Dosage Form: 2.5 mg, 5 mg and 10 mg tablets for oral administration Active Ingredient: Midodrine hydrochloride USP, 2.5 mg, 5 mg and 10 mg Inactive Ingredients: Colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and pregelatinized starch. Pharmacological Classification: Vasopressor/Antihypotensive Chemical Names (USAN: Midodrine Hydrochloride): (1) Acetamide, 2-amino-N-[2-(2,5-dimethoxyphenyl)-2-hydroxyethyl]-monohydrochloride, (±)-; (2) (±)-2-amino-N-(ß-hydroxy-2,5-dimethoxyphenethyl)acetamide monohydrochloride BAN, INN, JAN: Midodrine Structural formula: Molecular formula: C 12 H 18 N 2 O 4 HCl; Molecular Weight: 290.7 Organoleptic Properties: Odorless, white, crystalline powder Solubility: Water: Soluble Methanol: Sparingly soluble pKa: 7.8 pH: 4 to 5 (5% aqueous solution) Melting Range: About 200°C Image

Miglustat capsules, 100 mg are glucosylceramide synthase inhibitor, which is a glucosyl transferase enzyme responsible for the first step in the synthesis of most glycosphingolipids. Miglustat is an N-alkylated imino sugar, a synthetic analog of D-glucose. The chemical name for miglustat is 1,5-(butylimino)-1,5-dideoxy-D-glucitol with the chemical formula C 10 H 21 NO 4 and a molecular weight of 219.28. Miglustat is a white to off-white crystalline powder and has a bitter taste. It is highly soluble in water (>1000 mg/mL as a free base). Miglustat capsules are supplied in hard gelatin capsules each containing 100 mg miglustat for oral administration. Each miglustat 100 mg capsule also contains magnesium stearate, povidone (K30), and sodium starch glycolate. Ingredients in the capsule shell include gelatin and titanium dioxide, and the shells are printed with black ink consisting of black iron oxide, potassium hydroxides and shellac. Image

Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [ 4S -(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10, 12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide mono hydrochloride. The structural formula is represented below: C 23 H 27 N 3 O 7 •HCl M. W. 493.95 Each minocycline hydrochloride extended-release tablet, USP intended for oral administration contains minocycline hydrochloride equivalent to 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg or 135 mg of minocycline. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol (55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg and 135 mg only), titanium dioxide and triacetin. Additionally, the 45 mg tablets contain ferric oxide black and ferric oxide yellow; the 55 mg tablets contain ferric oxide red and ferric oxide yellow; the 65 mg tablets contain FD & C blue #2 aluminum lake; the 80 mg tablets contain FD & C blue #2 aluminum lake and FD & C red #40 aluminum lake; the 90 mg tablets contain D & C yellow #10 aluminum lake, ferric oxide red and ferric oxide yellow; the 105 mg tablets contain FD & C blue #2 aluminum lake and FD & C red #40 aluminum lake; the 115 mg tablets contain FD & C blue #2 aluminum lake and ferric oxide yellow; the 135 mg tablets contain D & C red #27 aluminum lake, D & C yellow #10 aluminum lake and FD & C blue #2 aluminum lake. USP dissolution test-8 used. USP organic impurities procedure pending. figure

Minocycline hydrochloride, USP, is a semisynthetic derivative of tetracycline, 4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is: C 23 H 27 N 3 O 7 •HCl M.W. 493.94 Minocycline hydrochloride capsules USP for oral administration contain minocycline hydrochloride, USP equivalent to 50 mg, 75 mg, or 100 mg of minocycline. Inactive Ingredients Drug Product: corn starch and magnesium stearate. Capsule Shell: Gelatin and titanium dioxide. In addition, the 100 mg capsule shells contain D&C Red #28, FD&C Blue #1, FD&C Red #40, and red iron oxide; the 75 mg capsule shells contain black iron oxide; and the 50 mg capsule shells contain D&C Red #33, FD&C Red #3, and FD&C Yellow #6. Printing Ink: black iron oxide, propylene glycol, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake and shellac. In addition, the 50 mg and 100 mg ink contains strong ammonia solution. Image

Mirabegron extended-release tablets for oral use is a beta-3 adrenergic agonist. The chemical name is 2-(2-Amonothiazol-4-yl)-N-(4-(2-(2R)-hydroxy-2-phenylethylamino)ethyl)phenyl)acetamide having an empirical formula of C 21 H 24 N 4 O 2 S and a molecular weight of 396.51. The structural formula of mirabegron is: Mirabegron is a white powder. It is practically insoluble in water. It is soluble in methanol and dimethyl sulfoxide. Each mirabegron extended-release tablet for oral use contains either 25 mg or 50 mg of mirabegron and the following inactive ingredients: polyethylene oxide, polyethylene glycol, magnesium stearate, hypromellose, ferrosoferric oxide, yellow iron oxide, and red iron oxide (25 mg tablet only). structure

Nadolol is a synthetic nonselective beta-adrenergic receptor blocking agent designated chemically as 1-( tert -butylamino)-3-[(5,6,7,8-tetrahydro- cis -6,7-dihydroxy-1- naphthyl)oxy]-2-propanol. Structural formula: Nadolol, USP is a white to off-white, practically odorless crystalline powder. It is freely soluble in alcohol and in methanol, soluble in water at pH 2, slightly soluble in chloroform,,methylenechloride, isopropylalcohol and in water(between pH 7 and pH 10); insoluble in acetone, benzene, ether, hexane and trichloroethane. Nadolol tablets, USP are available for oral administration as 20 mg, 40 mg and 80 mg tablets. Inactive ingredients: anhydrous citric acid, colloidal silicon dioxide, corn starch, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. Additionally each 40 mg tablet contains ferric oxide yellow and each 80 mg tablet contains FD&C blue 2. Nadolol tablets

Nateglinide is an oral blood glucose-lowering drug of the glinide class. Nateglinide, (-)-N-[(trans-4- isopropylcyclohexane)carbonyl]-D-phenylalanine, is structurally unrelated to the oral sulfonylurea insulin secretagogues. The structural formula is as shown: Nateglinide, USP is a white powder with a molecular weight of 317.43 g/mol. It is freely soluble in methanol and alcohol, soluble in ether, sparingly soluble in acetonitrile and octanol, practically insoluble in water. Each nateglinide tablet, USP intended for oral administration contains nateglinide, USP 60 mg and 120 mg. In addition, each tablet contains the following inactive ingredients: citric acid anhydrous, colloidal silicon dioxide, corn starch, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, polysorbate 80, polyethylene glycol, povidone, talc and titanium dioxide. Additionally, each 120 mg tablet contains iron oxide red and iron oxide yellow. Image

Nelarabine is a prodrug of the cytotoxic deoxyguanosine analogue, 9-β- D arabinofuranosylguanine (ara-G). The chemical name for nelarabine is 2-amino-9-β- D -arabinofuranosyl-6-methoxy-9 H -purine. It has the molecular formula C 11 H 15 N 5 O 5 and a molecular weight of 297.27. Nelarabine has the following structural formula: Nelarabine is slightly soluble to soluble in water and melts with decomposition between 209℃ and 217℃. Nelarabine Injection is supplied as a clear, colorless, sterile solution in glass single-dose vials. Each vial contains 250 mg of nelarabine (5 mg nelarabine per mL) and the inactive ingredient sodium chloride, USP (4.5 mg per mL) in 50 mL water for injection, USP. Hydrochloric acid and sodium hydroxide may have been used to adjust the pH. The solution pH ranges from 5.0 to 7.0. Nelarabine Injection is intended for intravenous infusion. Image

Nelarabine is a prodrug of the cytotoxic deoxyguanosine analogue, 9-β- D arabinofuranosylguanine (ara-G). The chemical name for nelarabine is 2-amino-9-β- D -arabinofuranosyl-6-methoxy-9 H -purine. It has the molecular formula C 11 H 15 N 5 O 5 and a molecular weight of 297.27. Nelarabine has the following structural formula: Nelarabine is slightly soluble to soluble in water and melts with decomposition between 209℃ and 217℃. Nelarabine Injection is supplied as a clear, colorless, sterile solution in glass single-dose vials. Each vial contains 250 mg of nelarabine (5 mg nelarabine per mL) and the inactive ingredient sodium chloride, USP (4.5 mg per mL) in 50 mL water for injection, USP. Hydrochloric acid and sodium hydroxide may have been used to adjust the pH. The solution pH ranges from 5.0 to 7.0. Nelarabine Injection is intended for intravenous infusion. Image

Nicardipine hydrochloride capsules for oral administration each contain 20 mg or 30 mg of nicardipine hydrochloride, USP. Nicardipine hydrochloride capsules are a calcium ion influx inhibitor (slow channel blocker or calcium channel blocker). Nicardipine hydrochloride, USP is a dihydropyridine structure with the IUPAC (International Union of Pure and Applied Chemistry) chemical name 2-(benzyl-methyl amino)ethyl methyl 1,4-dihydro-2,6-dimethyl-4-(m-nitrophenyl)-3,5-pyridinedicarboxylate monohydrochloride, and it has the following structure: Nicardipine Hydrochloride, USP Molecular Formula C 26 H 29 N 3 O 6 . HCl Nicardipine hydrochloride, USP is a pale greenish-yellow, odorless, crystalline powder that melts at about 167°C to 171°C. It is freely soluble in methanol and acetic acid, sparingly soluble in ethanol, slightly soluble in water. It has a molecular weight of 515.99. Nicardipine hydrochloride capsules are available in hard gelatin capsules containing 20-mg or 30-mg nicardipine hydrochloride, USP with magnesium stearate and pregelatinized starch as the inactive ingredients. The 20-mg strength is provided in opaque light blue cap and opaque white body, while the 30-mg capsules are provided in opaque blue cap and opaque light blue body. The capsule shells contains gelatin, titanium dioxide, and FD&C Blue No. 1. The black imprinting ink contains black iron oxide, potassium hydroxide and shellac. Image

Nifedipine is a drug belonging to a class of pharmacological agents known as the calcium channel blockers. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4(2-nitrophenyl)-, dimethyl ester, C 17 H 18 N 2 O 6 , and has the structural formula: Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine extended release tablet is formulated as a once-a-day controlled-release tablet for oral administration to provide 30, 60, or 90 mg of nifedipine. Each tablet contains 33 mg nifedipine to provide a 30 mg dose. Each tablet contains 66 mg nifedipine to provide a 60 mg dose. Each tablet contains 99 mg nifedipine to provide a 90 mg dose. Inert ingredients in the formulations are: cellulose acetate; ferrosoferric oxide; hypromellose; magnesium stearate; polyethylene glycol; polyethylene oxide; red iron oxide; shellac; sodium chloride; titanium dioxide; yellow iron oxide and FD&C yellow #6 (90 mg tablet only). System Components and Performance Nifedipine extended-release tablets are similar in appearance to a conventional tablet. It consists, however, of a semipermeable membrane surrounding an osmotically active drug core. The core itself is divided into two layers: an "active" layer containing the drug, and a "push" layer containing pharmacologically inert (but osmotically active) components. As water from the gastrointestinal tract enters the tablet, pressure increases in the osmotic layer and "pushes" against the drug layer, releasing drug through the precision laser-drilled tablet orifice in the active layer. Nifedipine extended-release tablets are designed to provide nifedipine at an approximately constant rate over 24 hours. This controlled rate of drug delivery into the gastrointestinal lumen is independent of pH or gastrointestinal motility. Nifedipine extended-release tablets depends for its action on the existence of an osmotic gradient between the contents of the bi-layer core and fluid in the gastrointestinal tract. Drug delivery is essentially constant as long as the osmotic gradient remains constant, and then gradually falls to zero. Upon swallowing, the biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the feces as an insoluble shell. USP Dissolution test is pending. Structure

Nifedipine extended-release tablet, USP is an extended release tablet dosage form of the calcium channel blocker nifedipine. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-dimethyl ester, C 17 H 18 N 2 O 6 , and has the structural formula: Nifedipine USP is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine extended-release tablets consist of an external coat and an internal core. Both contain nifedipine, the coat as a slow release formulation and the core as a fast release formulation. Nifedipine extended-release tablets contain either: 30, 60, or 90 mg of nifedipine for once-a-day oral administration. Inert ingredients in the formulation are hydroxypropylcellulose, lactose monohydrate, pregelatinized Starch, crospovidone, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate. The inert ingredients in the film coating for nifedipine extended-release tablets 30 mg and 60 mg are: hypromellose, titanium dioxide, polyethylene glycol, iron oxide yellow and iron oxide red. The inert ingredients in the film coating for nifedipine extended-release tablets 90 mg are hypromellose, titanium dioxide, polyethylene glycol, iron oxide yellow, iron oxide red and ferrosoferic oxide. USP Dissolution Test pending. structure

Nitrofurantoin capsules, USP (macrocrystals) is a synthetic chemical of controlled crystal size. It is a stable, lemon-yellow, crystalline compound. Nitrofurantoin capsules, USP (macrocrystals) is an antibacterial agent for specific urinary tract infections. It is available in 50 mg and 100 mg capsules for oral administration. 1-[[(5-nitro-2-furanyl)methylene] amino]-2,4-imidazolidinedione Nitrofurantoin macrocrystals is a lemon-yellow crystalline compound. It is soluble in dimethylformamide, very slightly soluble in water and in alcohol. Each nitrofurantoin capsules, USP (macrocrystals) intended for oral administration contains 50 mg and 100 mg of nitrofurantoin macrocrystals. In addition, each capsule contains the following inactive ingredients: gelatin, lactose monohydrate, magnesium stearate, pregelatinized starch, talc and titanium dioxide. Additionally each 50 mg and 100 mg capsule shell contains FD & C Blue # 1, FD & C Red # 3 and sodium lauryl sulphate. The capsule is printed with black pharmaceutical ink which contains black iron oxide, potassium hydroxide, propylene glycol and shellac. figure

Norelgestromin and ethinyl estradiol transdermal system is a transdermal system with a contact surface area of 15.75 cm 2 . It contains 4.678 mg norelgestromin, USP (NGMN) and 0.53 mg ethinyl estradiol, USP (EE), and its delivery rate is approximately 150 mcg of NGMN and 35 mcg of EE per day. Systemic exposures (as measured by area under the curve [AUC] and steady state concentration [C ss ]) of NGMN and EE during use of norelgestromin and ethinyl estradiol transdermal system are higher and the C max is lower than those produced by an oral contraceptive containing NGM 250 mcg / EE 35 mcg. [See Boxed Warning and Clinical Pharmacology ( 12.3 ).] Norelgestromin and ethinyl estradiol transdermal system is a thin, matrix-type transdermal system consisting of three layers. The backing layer is composed of a peach flexible film consisting of a pigmented polyethylene outer layer and a polyester inner layer. It provides structural support and protects the middle adhesive layer from the environment. The middle layer contains crospovidone, lauryl lactate, polyisobutylene/polybutene adhesive and non-woven polyester fabric as inactive components. The active components in this layer are the hormones, NGMN and EE. The third layer is the release liner , which protects the adhesive layer during storage and is removed just prior to application. It is a transparent polyethylene terephthalate (PET) film with a polydimethylsiloxane coating on the side that is in contact with the middle adhesive layer. The outside of the backing layer is printed with "Norelgestromin and ethinyl estradiol 150/35 mcg per day" in red ink. Norelgestromin and ethinyl estradiol transdermal system is packaged with additional piece of protective film above the system within each pouch. This piece of protective film is removed and discarded at the time of use. The structural formulas of the components are: Molecular weight, NGMN: 327.47 Molecular weight, EE: 296.41 Chemical name for NGMN: 18, 19-dinorpregn-4-en-20-yn-3-one, 13-ethyl-, 17-hydroxy, 3-oxime, (17α)- Chemical name for EE: 19-Norpregna-1,3,5(10)-trien-20-yne-3, 17β-diol, (17α)- structure

Nortriptyline hydrochloride, USP is 1-propanamine, 3-(10,11-dihydro-5 H dibenzo[ a,d ]cyclohepten-5-ylidene)- N -methyl-, hydrochloride. The structural formula is as follows: 10 mg, 25 mg, 50 mg, and 75 mg Capsules Active Ingredient: nortriptyline hydrochloride, USP. Inactive Ingredients: Colloidal silicon dioxide, magnesium stearate and pregelatinized starch. In addition, each capsule contains gelatin, sodium lauryl sulphate and titanium dioxide. The 10 mg, 25 mg and 75 mg capsules also contains FD & C Red 40, D & C Yellow 10. The capsule is printed with black pharmaceutical ink which contains black iron oxide, potassium hydroxide and shellac. FDA approved dissolution method and acceptance criterion differ from the USP dissolution specification. Image

Nystatin is a polyene antifungal antibiotic obtained from Streptomyces noursei. Structural formula: Nystatin topical powder is for dermatologic use. Nystatin topical powder contains 100,000 USP nystatin units per gram dispersed in talc. Structure

Oseltamivir Phosphate Capsules, USP, an influenza neuraminidase inhibitor (NAI), are available as capsules containing 30 mg, 45 mg, or 75 mg of oseltamivir for oral use, in the form of oseltamivir phosphate. In addition to the active ingredient, each capsule contains pregelatinized starch, talc, povidone, croscarmellose sodium, and sodium stearyl fumarate. The 30 mg capsule shell contains gelatin, titanium dioxide, and sodium lauryl sulfate. The 45 mg and 75 mg capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate, FD&C Blue 1, D&C Red 28, and FD&C Red 40. Each capsule is printed with black ink, which includes black iron oxide. Oseltamivir phosphate is a white crystalline solid with the chemical name (3R,4R,5S)-4-acetylamino-5- amino-3(1-ethylpropoxy)-1-cyclohexene-1-carboxylic acid, ethyl ester, phosphate (1:1). The chemical formula is C16H28N2O4 (free base). The molecular weight is 312.4 for oseltamivir free base and 410.4 for oseltamivir phosphate salt. The structural formula is as follows: Structure Structure

Oseltamivir Phosphate for Oral Suspension, an influenza neuraminidase inhibitor (NAI), is available as a powder for oral suspension, which when constituted with water as directed contains 6 mg per mL oseltamivir base. In addition to the active ingredient, the powder for oral suspension contains sorbitol, titanium dioxide, xanthan gum, sodium benzoate, monosodium citrate, tutti-frutti flavoring, and saccharin sodium. Oseltamivir phosphate is a white crystalline solid with the chemical name (3R,4R,5S)-4-acetylamino-5- amino-3(1-ethylpropoxy)-1-cyclohexene-1-carboxylic acid, ethyl ester, phosphate (1:1). The chemical formula is C 16 H 28 N 2 O 4 (free base). The molecular weight is 312.4 for oseltamivir free base and 410.4 for oseltamivir phosphate salt. The structural formula is as follows: Structure

Oxcarbazepine Tablet USP is an AED available as 150 mg, 300 mg and 600 mg film-coated tablets for oral administration. Oxcarbazepine USP is 10,11-Dihydro-10-oxo-5 H- dibenz[b, f ]azepine-5-carboxamide, and its structural formula is: Oxcarbazepine USP is a light orange to creamish white or off-white powder. It is sparingly soluble in chloroform. Its molecular weight is 252.27 g/mol. Oxcarbazepine Tablets, USP contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, polyethylene glycol, hypromellose, iron oxide yellow, iron oxide red, microcrystalline cellulose, magnesium stearate, titanium dioxide and talc. FDA approved organic impurities acceptance criteria differs from USP test. structure

Pemetrexed for injection, USP is a folate analog metabolic inhibitor. The drug substance, pemetrexed disodium 2.5 hydrate, has the chemical name N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl-L-glutamic acid, disodium salt, dihydrate and hemihydrate with a molecular formula of C 20 H 19 N 5 Na 2 O 6 •2.5H 2 O and a molecular weight of 516.41. The structural formula is as follows: Pemetrexed for injection, USP is a sterile white to either light yellow or green-yellow lyophilized powder or cake in single-dose vials to be reconstituted for intravenous infusion. Each 100-mg vial of pemetrexed for injection, USP contains 100 mg pemetrexed (equivalent to 110.28 mg pemetrexed disodium) and 106 mg mannitol USP. Each 500-mg vial of pemetrexed for injection, USP contains 500 mg pemetrexed (equivalent to 551.4 mg pemetrexed disodium) and 500 mg mannitol USP. Each 1000-mg vial of pemetrexed for injection, USP contains 1000 mg pemetrexed (equivalent to 1102.8 mg pemetrexed disodium) and 1000 mg mannitol USP. Hydrochloric acid NF and/or sodium hydroxide NF may have been added to adjust pH. Image

Perphenazine (4-[3-(2-chlorophenothiazin-10-yl)propyl]-1-piperazineethanol), a piperazinyl phenothiazine, having the molecular formula, C 21 H 26 CIN 3 OS. It is available as oral tablets containing 2 mg, 4 mg, 8 mg, and 16 mg of perphenazine. Its structural formula is: Perphenazine is a white or yellowish-white crystalline powder. It is practically insoluble in water; freely soluble in alcohol and in chloroform; soluble in acetone. Each film-coated perphenazine tablet intended for oral administration contains 2 mg, 4 mg, 8 mg and 16 mg of perphenazine. In addition, each tablet contains the following inactive ingredients: corn starch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. Additionally, each film-coated perphenazine tablet contains opadry II white 03B28796 which contains hypromellose, polyethylene glycol and titanium dioxide. figure

Phytonadione, USP is a vitamin K replacement, which is a clear, yellow to amber, viscous, and nearly odorless liquid. It is soluble in dehydrated alcohol, in benzene, in chloroform, in ether and slightly soluble in alcohol. It has a molecular weight of 450.7. Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its molecular formula is C 31 H 46 O 2 and its structural formula is: Each uncoated phytonadione tablet, USP for oral administration contains 5 mg of phytonadione, USP and contains following inactive ingredients: croscarmellose sodium, colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. Image

Pitavastatin tablets for oral use is an HMG-CoA reductase inhibitor. The chemical name for pitavastatin is (+)monocalcium bis {(3R, 5S, 6 E )-7-[2-cyclopropyl-4-(4-fluorophenyl)-3-quinolyl]-3,5 -dihydroxy-6-heptenoate}. The structural formula is: The molecular formula for pitavastatin is C 50 H 46 CaF 2 N 2 O 8 and the molecular weight is 880.98. Pitavastatin is a white to off-white powder. It is freely soluble in tetrahydrofuran, soluble in dimethylsulphoxide, slightly soluble in methanol, very slightly soluble in ethanol. Pitavastatin is hygroscopic and slightly unstable in light. Each film-coated tablet of pitavastatin contains 1.045 mg, 2.09 mg, or 4.18 mg of pitavastatin calcium, which is equivalent to 1 mg, 2 mg, or 4 mg, respectively of free base and the following inactive ingredients: calcium carbonate, crospovidone, hypromellose, lactose monohydrate, magnesium stearate and sodium carbonate anhydrous and film-coating containing the following inactive ingredients: hypromellose, polyethylene glycol, talc and titanium dioxide. Image

Plerixafor Injection is a sterile, preservative-free, clear, colorless to pale-yellow, isotonic solution for subcutaneous injection. Each mL of the sterile solution contains 20 mg of plerixafor. Each single-dose vial is filled to deliver 1.2 mL of the sterile solution that contains 24 mg of plerixafor and 5.9 mg of sodium chloride in Water for Injection adjusted to a pH of 6.0 to 7.5 with hydrochloric acid and with sodium hydroxide, if required. Plerixafor is a hematopoietic stem cell mobilizer with a chemical name 1,4-Bis ((1,4,8,11-tetraazacyclotetradecan-1-yl) methyl) benzene. It has the molecular formula C 28 H 54 N 8 . The molecular weight of plerixafor is 502.79 g/mol. The structural formula is provided in Figure 1. Plerixafor is a white to off-white crystalline solid. It is hygroscopic. Plerixafor has a typical melting point of 131.5°C. The partition coefficient of plerixafor between 1-octanol and pH 7 aqueous buffer is < 0.1. Structure

Potassium chloride extended-release capsules, USP are an oral dosage form of microencapsulated potassium chloride containing 600 mg and 750 mg of potassium chloride, USP, equivalent to 8 mEq and 10 mEq of potassium, respectively. The chemical name of the active ingredient is potassium chloride and the structural formula is KCl. It has a molecular mass of 74.55. Potassium chloride, USP, occurs as a white crystalline powder or as colorless crystals. It is odorless and has a salty taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Inactive ingredients: colloidal silicon dioxide, ethyl cellulose, D&C yellow 10, FD&C red 40, gelatin, hypromellose, polyethylene glycol, sodium lauryl sulfate, talc and titanium dioxide. Each capsule is printed with opacode black ink which contains propylene glycol, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, ferrosoferric oxide and shellac. Meets USP Dissolution Test 4.

The Potassium Chloride Extended-release Tablets, USP 20 mEq product is an immediately dispersing extended release oral dosage form of potassium chloride containing 1500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet. The Potassium Chloride Extended-release Tablets, USP 10 mEq product is an immediately dispersing extended release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced. Potassium chloride is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl. Potassium chloride, USP occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Potassium chloride is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, potassium chloride extended-release tablets begin disintegrating into microencapsulated crystals within seconds and completely disintegrate within one minute. The microencapsulated crystals are formulated to provide an extended release of potassium chloride. Inactive Ingredients: Colloidal silicon dioxide, croscarmellose sodium, ethylcellulose, hyrpromellose, microcrystalline cellulose, polyethylene glycol and povidone. USP Assay preparation is pending.

Potassium citrate is a citrate salt of potassium. Its molecular formula is K 3 C 6 H 5 O 7 • H 2 O, and it has the following chemical structure: Potassium citrate, USP is a transparent crystals or white, granular powder. It is freely soluble in water and slightly soluble in alcohol. Potassium citrate extended-release tablets, USP intended for oral administration, each contains 5 mEq (540 mg), 10 mEq (1,080 mg) or 15 mEq (1,620 mg) of potassium citrate, USP as monohydrate. In addition, each tablet contains the following inactive ingredients: carnauba wax and magnesium stearate. Meets USP Dissolution Test 2 figure

Prochlorperazine, USP is a phenothiazine derivative, present in prochlorperazine tablets as the maleate. Prochlorperazine maleate, USP is designated chemically as 2-chloro-10-[3-(4- methyl-1 -piperazinyl)propyl] phenothiazine maleate [molecular weight 606.09] and has the following structure Prochlorperazine Maleate, USP is classified as an anti-emetic and antipsychotic agent. Prochlorperazine maleate, USP is white or pale yellow, crystalline powder. It is practically insoluble in water and in alcohol; slightly soluble in warm chloroform. Each tablet, for oral administration contains prochlorperazine maleate, USP equivalent to 5 mg or 10 mg of prochlorperazine. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, hypromellose, colloidal silicon dioxide, magnesium stearate, polyethylene glycol 400, polyethylene glycol 6000, talc, titanium dioxide, D&C yellow no.10 aluminum lake, yellow iron oxide. Meets USP Dissolution Test 2 Image

Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C 17 H 20 N 2 S HCl and its molecular weight is 320.88. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H -Phenothiazine-10-ethanamine, N , N ,α-trimethyl-, monohydrochloride, (±)- with the following structural formula. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate. Structured product formula for Promethazine

Propafenone hydrochloride, USP is an antiarrhythmic drug supplied in extended-release capsules of 225 mg, 325 mg, and 425 mg for oral administration. Chemically, propafenone hydrochloride, USP is 2'-[2-hydroxy-3-(propylamino)-propoxy]-3- phenylpropiophenone hydrochloride, with a molecular weight of 377.9. The molecular formula is C 21 H 27 NO 3 •HCl. Propafenone hydrochloride, USP has some structural similarities to beta-blocking agents. The structural formula of propafenone hydrochloride, USP is given below: Propafenone hydrochloride, USP occurs as white powder. It is soluble in hot water and methanol and slightly soluble in chloroform. Propafenone hydrochloride extended-release capsules, USP are filled with white to off-white minitablets containing propafenone hydrochloride, USP and the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate and silicon dioxide. In addition, each capsule contains gelatin, sodium lauryl sulphate and titanium dioxide. The 325 mg capsules also contain FD&C Blue 1 and FD & C Red 40. The 425 mg capsules also contain FD & C Red 3, FD & C Red 40 and FD & C Yellow 6. The capsule is printed with black pharmaceutical ink which contains black iron oxide, potassium hydroxide and shellac. FDA approved dissolution method and acceptance criterion differ from the USP dissolution specification. Image

Pyridostigmine bromide tablets, USP are an orally active cholinesterase inhibitor. Chemically, pyridostigmine bromide is 3-hydroxy-1-methylpyridinium bromide dimethylcarbamate. Its structural formula is: Pyridostigmine bromide, USP is a white or almost white crystalline, deliquescent powder. It is very soluble in water and in alcohol, slightly soluble in hexane, practically insoluble in ether. Each pyridostigmine bromide tablet, USP intended for oral administration contains 60 mg of pyridostigmine bromide, USP. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, low substituted hydroxypropyl cellulose, silicon dioxide and stearic acid. figure

Ramelteon is an orally active hypnotic chemically designated as ( S )- N -[2-(1, 6, 7, 8 tetrahydro-2 H -indeno-[5, 4- b ]furan-8-yl)ethyl]propionamide and containing one chiral center. The compound is produced as the ( S )-enantiomer, with an molecular formula of C 16 H 21 NO 2 , molecular weight of 259.34, and the following chemical structure: Ramelteon is a white to cream color powder and it is freely soluble in methanol and practically insoluble in water. Each film-coated tablet contains 8 mg ramelteon and contains following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, ferrosoferric oxide, hypromellose, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch (botanical source: maize), sodium stearyl fumarate, titanium dioxide. Image

Ramipril is a 2-aza-bicyclo [3.3.0]-octane-3-carboxylic acid derivative. Ramipril, USP is a white to almost white crystalline powder. It is freely soluble in methanol and sparingly soluble in water. Ramipril melts between 105°C and 112° C. Ramipril’s chemical name is (2S, 3aS, 6aS)-1[(S)-N-[(S)-1-Carboxy-3-phenylpropyl]alanyl] octahydrocyclopenta [b]pyrrole-2-carboxylic acid, 1 -ethyl ester; its structural formula is: Its molecular formula is C 23 H 32 N 2 O 5 , and its molecular weight is 416.5. Ramiprilat, the diacid metabolite of ramipril, is a non-sulfhydryl angiotensin converting enzyme inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group. Each ramipril capsule, USP intended for oral administration contains 1.25 mg or 2.5 mg or 5 mg or 10 mg of ramipril, USP. In addition, each capsule contains the following inactive ingredients: gelatin, pregelatinized starch and titanium dioxide. Additionally each 1.25 mg capsule shell contains: FD&C red # 40, FD&C yellow # 5 and FD&C yellow # 6, 2.5 mg capsule shell contains: D&C yellow # 10 and FD&C red # 40, 5 mg capsule shell contains: FD&C blue # 1, FD&C red # 40 and FD&C yellow # 6 and 10 mg capsule shell contains:, D&C red # 28, D&C yellow # 10 and FD&C blue # 1. The capsule is printed with black pharmaceutical ink which contains black iron oxide as a coloring agent. Structured product formula for Ramipril

Ribavirin is a synthetic nucleoside with antiviral activity. Ribavirin for inhalation solution, USP is a sterile, lyophilized powder to be reconstituted for aerosol administration. Each 100 mL glass vial contains 6 grams of ribavirin, and when reconstituted to the recommended volume of 300 mL with sterile water for injection or sterile water for inhalation (no preservatives added), will contain 20 mg of ribavirin per mL, pH approximately 5.5. Aerosolization is to be carried out in a Small Particle Aerosol Generator (SPAG-2) nebulizer only. Ribavirin is 1-beta-D-ribofuranosyl-1H-1,2,4-triazole-3-carboxamide, with the following structural formula: Ribavirin is a stable, white crystalline compound with a maximum solubility in water of 142 mg/mL at 25°C and with only a slight solubility in ethanol. The empirical formula is C 8 H 12 N 4 O 5 and the molecular weight is 244.21. Image

Risperidone Tablets contains risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C 23 H 27 FN 4 O 2 and its molecular weight is 410.49. The structural formula is: Risperidone, USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. Each risperidone tablet intended for oral administration contains 0.25 mg or 0.5 mg or 1 mg or 2 mg or 3 mg or 4 mg of risperidone. Additionally each tablet also contains the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium lauryl sulfate, and titanium dioxide. Additionally each 0.25 mg tablet contains iron oxide red and iron oxide yellow, 0.5 mg tablet contains iron oxide red, 2 mg tablet contains FD&C yellow # 6/sunset yellow FCF aluminum lake, 3 mg tablet contains D&C yellow # 10 aluminum lake and 4 mg tablet contains D&C yellow # 10 aluminum lake and FD&C blue # 2/ indigo carmine aluminum lake. Image

Rivastigmine transdermal system contains rivastigmine USP, a reversible cholinesterase inhibitor known chemically as (S)-3-[1-(dimethylamino)ethyl]phenyl ethylmethylcarbamate. It has an empirical formula of C 14 H 22 N 2 O 2 as the base and a molecular weight of 250.34 g/mol (as the base). Rivastigmine is a viscous, clear, and colorless to yellow to very slightly brown liquid that is sparingly soluble in water and very soluble in ethanol, acetonitrile, n-octanol and ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 4.27. Rivastigmine transdermal system is for transdermal administration. The transdermal system is a four-layer laminate containing (1) a foam backing with adhesive layer, (2) a polyester film, (3) an adhesive matrix containing rivastigmine, and (4) a fluoropolymer coated polyester release liner (see Figure 1). The release liner is removed and discarded prior to use. Figure 1: Cross Section of the Rivastigmine Transdermal System Layer 1: Copolymer foam backing with adhesive layer Layer 2: Polyester Film Layer 3: Adhesive Matrix Layer 4: Fluoropolymer coated Release Liner (removed at time of use) The active component of the system is rivastigmine. The remaining components of the system (colloidal silicon dioxide, light mineral oil, polyisobutylene adhesive, copolymer foam and polyester film) are pharmacologically inactive. Additionally, rivastigmine transdermal system is printed with pharmaceutical grade brown ink which contains acrylic polymers, carbon black, ethoxylated 2,4,7,9-tetramethyl 5 decyn-4,7-diol, iron oxide, octylphenoxypolyethoxyethanol, polyethylene glycol, polyethylene wax and polytetrafluoroethylene. Rivastigmine transdermal system Rivastigmine transdermal system

The active ingredient in roflumilast tablet is roflumilast. Roflumilast and its active metabolite (roflumilast N-oxide) are selective phosphodiesterase 4 (PDE4) inhibitors. The chemical name of roflumilast is N-(3,5- dichloropyridin-4-yl)-3-cyclopropylmethoxy-4-difluoromethoxy-benzamide. Its molecular formula is C 17 H 14 Cl 2 F 2 N 2 O 3 and the molecular weight is 403.22. The Chemical Structure is: Roflumilast is white to off-white solid. It is practically insoluble in water and in hexane, sparingly soluble in ethanol and tetrahydrofuran and freely soluble in acetone. Roflumilast tablets are white to off-white, round tablets, debossed with "T6" for 250 mcg and "T5" for 500 mcg on one side and plain on other side. Each tablet of roflumilast for oral administration contains the following inactive ingredients: corn starch, colloidal silicon dioxide, low substituted hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer 407 and pregelatinized starch (corn). Roflumilast tablets

Sacubitril and valsartan tablets are a combination of sacubitril, a neprilysin inhibitor, and valsartan, an angiotensin II receptor blocker. Sacubitril and valsartan tablets contain a complex comprised of anionic forms of sacubitril and valsartan, sodium cations, and water molecules in the molar ratio of 1:1:3:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Trisodium [3-((1S,3R)-1-biphenyl-4-yl methyl-3-ethoxycarbonyl-1-butylcarbamoyl)propionate-(S)-3-methyl-2-(pentanoyl{2-(tetrazol-5-ylate)biphenyl-4-ylmethyl} amino)butyrate] trihydrate. Its molecular formula (trihydrate) is C 48 H 55 N 6 O 8 Na 3 3H 2 O. Its molecular mass is 967 and its schematic structural formula is: Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. Each film-coated tablet contains following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, low substituted hyproxypropylcellulose, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate and titanium dioxide. Additionally, each 49 mg/51 mg tablet contains ferrosoferric oxide, iron oxide red and iron oxide yellow and each 97 mg/103 mg tablet contains FD&C blue #2 Aluminum Lake, FD&C red #40 Aluminum Lake and FD&C yellow #5 (tartrazine) Aluminum Lake. Image

Scopolamine transdermal system is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.237 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.0 2,4 ]nonan-7-yl) 3-hydroxy-2-phenylpropanoate. The molecular formula is C 17 H 21 NO 4 and its structural formula is: Scopolamine has a molecular weight of 303.4 and a pKa of 7.55-7.81. The scopolamine transdermal system is a circular, 0.2 mm thick, 1.57 cm 2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing layer of tan-colored polyethylene/polyester film; (2) a drug layer of scopolamine, povidone and silicone adhesive; (3) a microporous polypropylene membrane that controls the rate of delivery of scopolamine from the system to the skin surface; and (4) a contact layer formulation of scopolamine, povidone and silicone adhesive. A protective, oversized release liner of fluorosilicone-coated polyester, which covers the adhesive formulation layer, is removed before the system is used. Scopolamine transdermal systems are packaged with an additional piece of protective film covering the system within each pouch. This piece of protective film is removed and discarded at the time of use. Cross section of the system: Image Image

Selexipag tablets contains selexipag, a prostacyclin receptor agonist. The chemical name of selexipag is 2-{4-[(5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy}- N (methylsulfonyl) acetamide. It has a molecular formula of C 26 H 32 N 4 O 4 S and a molecular weight of 496.62. Selexipag has the following structural formula: Selexipag is an off white to pale yellow crystalline powder that is practically insoluble in water. In the solid state selexipag is very stable, is not hygroscopic, and is not light sensitive. Depending on the dose strength, each round film-coated tablet for oral administration contains 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,000 mcg, 1,200 mcg, 1,400 mcg, or 1,600 mcg of selexipag. The tablets include the following inactive ingredients: corn starch, colloidal silicon dioxide, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, microcrystalline cellulose and magnesium stearate. The tablets are film coated with a coating material containing hypromellose, propylene glycol, carnauba wax, titanium dioxide, along with mixtures of ferrosoferric oxide, iron oxide red or iron oxide yellow. Image

Sevelamer carbonate is a polymeric amine that binds phosphate and is meant for oral administration. It was developed as a pharmaceutical alternative to sevelamer hydrochloride. Sevelamer carbonate is an anion exchange resin, with the same polymeric structure as sevelamer hydrochloride, in which carbonate replaces chloride as the counterion. While the counterions differ for the two salts, the polymer itself, the active moiety involved in phosphate-binding, is the same. Sevelamer carbonate is known chemically as poly(allylamine- co -N,N'-diallyl-1,3-diamino-2-hydroxypropane) carbonate salt. Sevelamer carbonate is hygroscopic, but insoluble in water. The structure is represented in Figure 1. Figure 1 Chemical Structure of Sevelamer Carbonate a, b = number of primary amine groups a + b = 9 c = number of cross-linking groups c = 1 m = large number to indicate extended polymer network Each film-coated tablet of sevelamer carbonate contains 800 mg of sevelamer carbonate on an anhydrous basis. The inactive ingredients are castor oil, colloidal silicon dioxide, crospovidone, dibutyl sebacate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, polyvinyl alcohol, purified water and triacetin. The tablet is printed with black pharmaceutical ink which contains ferrosoferric oxide, propylene glycol and shellac. Image

The active ingredient in sevelamer hydrochloride tablets is sevelamer hydrochloride, a polymeric amine that binds phosphate and is meant for oral administration. Sevelamer hydrochloride is poly(allylamine hydrochloride) crosslinked with epichlorohydrin in which 40% of the amines are protonated. It is known chemically as poly(allylamine- co -N,N′-diallyl-1,3-diamino-2-hydroxypropane) hydrochloride. Sevelamer hydrochloride is hydrophilic, but insoluble in water. The structure is represented in Figure 1. Figure 1: Chemical Structure of Sevelamer Hydrochloride The primary amine groups shown in the structure are derived directly from poly(allylamine hydrochloride). The crosslinking groups consist of two secondary amine groups derived from poly(allylamine hydrochloride) and one molecule of epichlorohydrin. Sevelamer Hydrochloride Tablets: Each film-coated tablet of sevelamer hydrochloride contains 800 mg of sevelamer hydrochloride on an anhydrous basis. The inactive ingredients are microcrystalline cellulose, silicon dioxide, sodium stearyl fumarate and purified water. The film coating contains di-acetylated monoglycerides, hypromellose, and titanium dioxide. Figure 1: Chemical Structure of Sevelamer Hydrochloride

Sildenafil for oral suspension, phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil is also marketed as VIAGRA ® for erectile dysfunction. Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo [4,3-d] pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula: Sildenafil citrate, USP is a white or almost white crystalline powder with a solubility of 10mg/100ml in water and a molecular weight of 666.7. Sildenafil for oral suspension is supplied as white to off-white granular powders containing 1.57 g of sildenafil citrate (equivalent to 1.12 g sildenafil) in an amber glass bottle and in HDPE bottle intended for reconstitution. Following reconstitution with 90 mL water, the volume of the oral suspension is 112 mL and the oral suspension contains 10 mg/mL sildenafil. The inactive ingredients include sorbitol, citric acid anhydrous, sucralose, tri-sodium citrate dihydrate, xanthan gum, titanium dioxide, sodium benzoate, colloidal silicon dioxide, carbomer homopolymer and grape flavor. In addition to the bottle, a press-in bottle adapter and an oral dosing syringe (with 0.5 mL and 2 mL dose markings) are provided. Image

Sirolimus is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus . The chemical name of sirolimus (also known as rapamycin) is (3 S ,6 R ,7 E ,9 R ,10 R ,12 R ,14 S ,15 E ,17 E ,19 E ,21 S ,23 S ,26 R ,27 R ,34a S )-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-hexadecahydro-9,27-dihydroxy-3-[(1 R )-2-[(1 S ,3 R ,4 R )-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3 H -pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4 H ,6 H ,31 H )-pentone. Its molecular formula is C 51 H 79 NO 13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Each sirolimus tablet intended for oral administration contains 0.5 mg or 1 mg or 2 mg of sirolimus. In addition, each tablet contains the following inactive ingredients: citric acid monohydrate, crospovidone, glyceryl monooleate, hypromellose, lactose monohydrate, microcrystalline cellulose, poloxamer, polyethylene glycol, povidone, sucrose, talc, titanium dioxide and vitamin E acetate. Additionally, each 0.5 mg tablet contains FD&C yellow #5 Aluminum Lake and iron oxide yellow and 2 mg tablet contains iron oxide black, iron oxide red and iron oxide yellow. Image

Sitagliptin Tablets contain sitagliptin free base, an orally active inhibitor of the DPP-4 enzyme. Sitagliptin free base is described chemically as 7-[(3 R )-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3- a ]pyrazine. The empirical formula is C 16 H 15 F 6 N 5 O and the molecular weight is 407.31. The structural formula is: Sitagliptin free base is a white to off-white, non-hygroscopic powder. Sitagliptin free base is soluble in methanol and slightly soluble in water. Each film coated tablet of sitagliptin contains sitagliptin free base 25 mg, 50 mg, or 100 mg as active ingredient and the following inactive ingredients: anhydrous dibasic calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, malic acid, magnesium stearate, microcrystalline cellulose, and povidone. In addition, the film coating contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. The 50 mg tablet's film coating also contains ferrosoferric oxide and iron oxide yellow. The 100 mg tablet's film coating also contains FD&C Yellow #6 Aluminum Lake and iron oxide yellow. Image

Sitagliptin and metformin hydrochloride extended-release tablets for oral use contain two antihyperglycemic medications: sitagliptin and metformin hydrochloride. Sitagliptin Sitagliptin is an orally-active inhibitor of the DPP-4 enzyme. Sitagliptin free base drug substance is used to manufacture sitagliptin and metformin hydrochloride extended-release tablets. Sitagliptin free base is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-α]pyrazine with an empirical formula of C 16 H 15 F 6 N 5 O and a molecular weight of 407.31. The structural formula is: Sitagliptin free base is a white to off-white, non-hygroscopic powder. It is soluble in methanol and slightly soluble in water. Metformin hydrochloride Metformin hydrochloride ( N , N -dimethylimidodicarbonimidic diamide hydrochloride) is a white crystalline powder with a molecular formula of C 4 H 11 N 5 •HCl and a molecular weight of 165.62. Metformin hydrochloride is freely soluble in water, slightly soluble in ethanol (95%), practically insoluble in acetone and in methylene chloride. The pK a of metformin hydrochloride is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is as shown: Sitagliptin and metformin hydrochloride extended-release tablets Sitagliptin and metformin hydrochloride extended-release tablets are available as film-coated tablets containing: 50 mg sitagliptin and 389.93 mg of metformin equivalent to 500 mg metformin hydrochloride (sitagliptin and metformin hydrochloride extended-release tablets 50/500). 50 mg sitagliptin and 779.86 mg of metformin equivalent to 1,000 mg metformin hydrochloride (sitagliptin and metformin hydrochloride extended-release tablets 50/1,000). 100 mg sitagliptin and 779.86 mg of metformin equivalent to 1,000 mg metformin hydrochloride (sitagliptin and metformin hydrochloride extended-release tablets 100/1,000). All doses of sitagliptin and metformin hydrochloride extended-release tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate anhydrous, ferric oxide yellow, hypromellose, magnesium stearate, malic acid, microcrystalline cellulose, povidone, pregelatinized starch (maize) and sodium stearyl fumarate. In addition, the film-coating for all doses contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol-partially hydrolyzed, iron oxide yellow, talc and titanium dioxide. Additionally, sitagliptin and metformin hydrochloride extended-release tablets 50 mg/500 mg and 100 mg/1,000 mg tablets film-coating contain the inactive ingredient red iron oxide and 50 mg/1,000 mg and 100 mg/1,000 mg tablets film-coating contain the FD&C yellow#6 Aluminum Lake. Image Image