EXCIPIENTS PROFILE

Stearic acid Synonyms Description Empirical Formula Solubility Acidum stearicum; cetylacetic acid; Crodacid; Cristal G; Cristal S; Dervacid Stearic acid is a hard, white or faintly yellow-colored, somewhat glossy, crystalline solid or a white or yellowish white powder.
C18H36O2

Freely soluble in benzene, carbon tetrachloride, chloroform, and ether; soluble in ethanol (95%), hexane, and propylene glycol; practically insoluble in water. Emulsifying agent; solubilizing agent; tablet and capsule lubricant. 0.537 g/cm3 6970 C Stearic acid is widely used in oral and topical pharmaceutical formulations. It is mainly used in oral formulations as a tablet and capsule lubricant; although it may also be used as a binder or in combination with shellac as a tablet coating. It has also been suggested that stearic acid may be used in enteric tablet coatings and as a sustained-release drug carrier. Stearic acid is incompatible with most metal hydroxides and may be incompatible with bases, reducing agents, and oxidizing agents.

Functional categories Density (bulk) Melting point

Applications

Incompatibilities

Stability and storage Stearic acid is a stable material; an antioxidant may also be added to it; The bulk material should be stored in a well closed container conditions in a cool, dry place.

sucrose Synonyms Beet sugar; cane sugar; a-D-glucopyranosyl-b-D-fructofuranoside; refined sugar; saccharose; saccharum; sugar

Description Empirical Formula Solubility

white crystalline powder; it is odorless and has a sweet taste.

C12H22O11
Practically insoluble in water, soluble in ethanol (96%) and in light petroleum (50-70C). Confectionery base; coating agent; granulation aid; suspending agent; sweetening agent; tablet binder; tablet and capsule diluent; tablet filler; therapeutic agent; viscosity-increasing agent
0.93 g/cm3 (crystalline sucrose); 0.60 g/cm3 (powdered sucrose)
160186 C

Functional categories Density (bulk) Melting point

Sucrose is widely used in oral pharmaceutical formulations. Sucrose syrup, containing 5067% w/w sucrose, is used in Applications tableting as a binding agent for wet granulation. In the powdered form, sucrose serves as a dry binder (220% w/w) or as a bulking agent and sweetener in chewable tablets and lozenges. Powdered sucrose may be contaminated with traces of heavy Incompatibilities metals, which can lead to incompatibility with active ingredients, e.g. ascorbic acid. Sucrose has good stability at room temperature and at moderate Stability and storage relative humidity. It absorbs up to 1% moisture, which is released conditions upon heating at 90 C. The bulk material should be stored in a wellclosed container in a cool, dry place. Xanthan Gum Synonym Description Molecular Formula Solubility Corn sugar gum; polysaccharide B-1459; Rhodigel; Vanzan NF; Xantural. Xanthan gum occurs as a cream- or white-colored, odorless, free-flowing, fine powder. (C35H49O29)n Practically insoluble in ethanol and ether; soluble in cold or warm water

Viscosity Functional category Grade Stability and storage condition

12001600 mPa s (12001600 cP) for a 1% w/v aqueous solution at 258C. Gelling agent; stabilizing agent; suspending agent; sustained-release agent; viscosity-increasing agent. Keltrol CG, Grindsted Xanthan 80, Vanzan NF Aqueous solutions are stable over a wide pH range (pH 312), although they demonstrate maximum stability at pH 410 and temperatures of 10608C. Xanthan gum is an anionic material and is not usually compatible with cationic surfactants, polymers, or preservatives, as precipitation occurs. Xanthan gum is used to prepare sustained-release matrix. Xanthan gum has also been used to produce

Incompatibilities

Application

directly compressed matrices that display a high degree of swelling due to water uptake, and a small amount of erosion due to polymer relaxation. The estimated acceptable daily intake for Xanthan

Safety

gum has been set by the WHO at up to 10 mg/kg body-weight.

Povidone Kollidon; Plasdone; poly [1-(2-oxo-1-pyrrolidinyl) ethylene]; Synonym polyvidone; polyvinylpyrrolidone; PVP; 1-vinyl-2pyrrolidinone polymer. Povidone occurs as a fine, white to creamy-white colored, odorless or almost odorless, hygroscopic powder. (C6H9NO)n Disintegrant; dissolution aid; suspending agent; tablet binder. Freely soluble in acids, chloroform, ethanol (95%), ketones, methanol, and water; practically insoluble in ether, hydrocarbons, and mineral oil. Softens at 150 0C.

Description Molecular Formula Functional Category Solubility Melting point

Density (bulk) Density (tapped) Stability and storage conditions

0.290.39 g/cm3 0.390.54 g/cm3 Povidone may be stored under ordinary conditions without undergoing decomposition or degradation. However, since the powder is hygroscopic, it should be stored in an airtight container in a cool, dry place. It forms molecular adducts in solution with sulfathiazole,

Incompatibilities

sodium salicylate, salicylic acid, phenobarbital, tannin, and other compounds; When consumed orally, povidone may be regarded as essentially nontoxic since it is not absorbed from the

Safety

gastrointestinal tract or mucous membranes. Povidone additionally has no irritant effect on the skin and causes no sensitization. In tableting, povidone solutions are used as binders in wet granulation processes.

Application

neotame 3-(3,3-Dimethylbutylamino)-N-(a-carboxyphenethyl)succinamic Synonyms acid methyl ester; N-[N-(3,3-dimethylbutyl)-L-a-aspartyl]-Lphenylalanine 1-methyl ester; L-phenylalanine, N-[N-(3,3dimethylbutyl)- L-a-aspartyl]-1-methyl ester. Neotame occurs as an odorless, white to off-white powder. It has Description Empirical Formula Functional categories an intense sweet taste 700013 000 times sweeter than sucrose depending on the matrix. C20H30N2O5

Flavor enhancer; sweetening agent

pH

5.07.0

Density (bulk) Melting point 8083 C Neotame is a water-soluble, nonnutritive, intense sweetening agent Applications used in beverages and foods. Neotame may be used in subsweetening quantities as a flavor enhancer, e.g. with mint or

strawberry flavor. Stability and storage Neotame stability is affected by moisture, pH, and temperature. The bulk material should be stored in a well-closed container, in conditions a cool, dry place; it is stable for up to 5 years at room temperature

Acesulfame Potassium Synonyms Acesulfame K; ace K; acesulfamum kalicum; E950; 6-methyl-3,4dihydro-1,2,3-oxathiazin-4(3H)-one-2,2-dioxide potassium salt; potassium 6-methyl-2,2-dioxo-oxathiazin-4-olate; Sunett; Sweet One. Acesulfame potassium occurs as a colorless to white-colored, odorless, crystalline powder with an intensely sweet taste.
C4H4KNO4S

Description Empirical Formula Solubility Functional categories Density (bulk) Melting point

Soluble in water, very slightly soluble in acetone and in ethanol (96%). Sweetening agent.
1.04 g/cm3

250 C Acesulfame potassium is used as an intense sweetening agent in cosmetics, foods, beverage products, table-top sweeteners, vitamin

Applications

and pharmaceutical preparations, including powder mixes, tablets, and liquid products.It enhances flavor systems and can be used to

mask some unpleasant taste characteristics. Stability and storage In the bulk form it shows no sign of decomposition at ambient temperature over many years. In aqueous solutions (pH 3.03.5 at conditions 208C) no reduction in sweetness was observed over a period of approximately 2 years. Stability at elevated temperatures is good,

although some decomposition was noted following storage at 408C for several months. The bulk material should be stored in a wellclosed container in a cool, dry place and protected from light.

STEARIC ACID Synonyms Nonproprietary Names Acidum stearicum; cetylacetic acid; Crodacid; Cristal G; Cristal S; BP: Stearic Acid JP: Stearic Acid

PhEur: Stearic Acid

USP-NF: Stearic Acid

Stearic acid is a hard, white or faintly yellow-colored, Description somewhat glossy, crystalline solid or a white or yellowish white powder. It has a slight odor (with an odor threshold of 20 ppm) and taste Suggesting tallow. Empirical Formula & Molecular Weight Solubility C18H36O2 284.47 Freely soluble in benzene, carbon tetrachloride, chloroform, and ether; soluble in ethanol (95%), hexane, and propylene glycol; practically insoluble in water. Emulsifying agent; solubilizing agent; tablet and capsule lubricant 69708C 0.537gm/cm3 0.571gm/cm3 The bulk material should be stored in a well closed container in a cool, dry place. Stearic acid is widely used in oral and topical pharmaceutical Formulations. Applications It has also been suggested that stearic acid may be used in enteric tablet Coating and as a sustained-release drug carrier. Stearic acid is also

Functional categories Melting point Density (bulk) Density (tapped) Stability and storage conditions