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Handling Precautions

Observe normal precautions appropriate to the circumstances and quantity of material handled. Stearic acid dust may be irritant to the skin, eyes, and mucous membranes. Eye protection, gloves, and a dust respirator are recommended. Stearic acid is combustible.


Stearic Acid 739

Table III: Specifications of different stearic acid grades.











Regulatory Status

GRAS listed. Accepted as a food additive in Europe (fatty acids). Included in the FDA Inactive Ingredients Guide (sublingual tablets; oral capsules, solutions, suspensions, and tablets; topical and vaginal preparations). Included in nonpar- enteral medicines licensed in the UK. Included in the Canadian List of Acceptable Non-medicinal Ingredients.


Related Substances

Calcium stearate; magnesium stearate; polyoxyethylene stea- rates; purified stearic acid; zinc stearate.

Purified stearic acid

Empirical formula: C18H36O2

Molecular weight: 284.47

CAS number: [57-11-4] Synonyms: octadecanoic acid. Acid value: 195–200

Boiling point: 3618C Density: 0.847 g/cm3 at 708C Flash point: 1968C

Iodine number: 41.5

Melting point: 66–698C

Refractive index: n80 = 1.4299

Solubility: soluble 1 in 5 parts benzene, 1 in 6 parts carbon

tetrachloride, 1 in 2 parts chloroform, 1 in 15 parts ethanol, 1 in 3 parts ether; practically insoluble in water.

Vapor density (relative): 9.80 (air = 1)

Comments: The USPNF 23 describes purified stearic acid as a mixture of stearic acid (C18H36O2) and palmitic acid (C16H32O2), which together constitute not less than 96.0% of the total content. The content of C18H36O2 is no less than 90.0% of the total.


Comments

A wide range of different grades of stearic acid are commer- cially available that have varying chemical compositions and hence different physical and chemical properties; see Table III.(12) A specification for stearic acid is contained in the Food Chemicals Codex (FCC).

The EINECS number for stearic acid is 200-313-4.









Specific References

Iranloye TA, Parrott EL. Effects of compression force, particle size, and lubricants on dissolution rate. J Pharm Sci 1978; 67: 535–539.

Jarosz PJ, Parrott EL. Effect of tablet lubricants on axial and radial work of failure. Drug Dev Ind Pharm 1982; 8: 445–453.

Mitrevej KT, Augsburger LL. Adhesion of tablets in a rotary tablet press II: effects of blending time, running time, and lubricant concentration. Drug Dev Ind Pharm 1982; 8: 237–282.

Musikabhumma P, Rubinstein MH, Khan KA. Evaluation of stearic acid and polyethylene glycol as binders for tabletting potassium phenethicillin. Drug Dev Ind Pharm 1982; 8: 169–188.

Zhang Q, Yie G, Li Y, et al. Studies on the cyclosporin A loaded stearic acid nanoparticles. Int J Pharm 2000; 200: 153–159.

Suzuki K. Rheological study of vanishing cream. Cosmet Toilet

1976; 91(6): 23–31.

Mores LR. Application of stearates in cosmetic creams and lotions.

Cosmet Toilet 1980; 95(3): 79, 81–84.

Yalkowsky SH, He Y, eds. Handbook of Solubility Data. Boca Raton, FL: CRC Press; 2003: 1119–1120.

Botha SA, Lo¨ tter AP. Compatibility study between naproxen and tablet excipients using differential scanning calorimetry. Drug Dev Ind Pharm 1990; 16: 673–683.

Rowe RC, Forse SF. Pitting: a defect on film-coated tablets. Int J Pharm 1983; 17: 347–349.

Lewis RJ, ed. Sax’s Dangerous Properties of Industrial Materials, 11th edn. New York: Wiley, 2004: 3229–3300.

Phadke DS, Keeney MP, Norris DA. Evaluation of batch-to-batch and manufacturer-to-manufacturer variability in the physical properties of talc and stearic acid. Drug Dev Ind Pharm 1994; 20: 859–871.



General References

Allen LV. Featured excipient: capsule and tablet lubricants. Int J Pharm Compound 2000; 4(5): 390–392, 404–405.

Pilpel N. Metal stearates in pharmaceuticals and cosmetics. Manuf Chem Aerosol News 1971; 42(10): 37–40.



Authors

LV Allen.


Date of Revision

9 August 2005.


Stearyl Alcohol





Nonproprietary Names

BP: Stearyl alcohol JP: Stearyl alcohol

PhEur: Alcohol stearylicus USPNF: Stearyl alcohol


Synonyms

Cachalot; Crodacol S95; Hyfatol 18-95; Hyfatol 18-98; Lanette 18; Lipocol S; Lipocol S-DEO; n-octadecanol; octadecyl alcohol; Rita SA; Stearol; Stenol; Tego Alkanol 18.


Chemical Name and CAS Registry Number

Octadecanol [112-92-5]


Empirical Formula and Molecular Weight

C18H38O   270.48 (for pure material)

The PhEur 2005 describes stearyl alcohol as a mixture of solid alcohols containing not less than 95% of 1-octadecanol, C18H38O. The USPNF 23 states that stearyl alcohol contains not less than 90% of 1-octadecanol, the remainder consisting

Table I: Pharmacopeial specifications for stearyl alcohol.


 

Test JP 2001 PhEur 2005 USPNF 23    

Identification + +    

Characters +    

Appearance of solution + +    

Melting range 56–628C 57–608C 55–608C    

Acid value 41.0 41.0 42.0    

Iodine value 42.0 42.0 42.0    

Hydroxyl value 200–220 197–217 195–220    

Saponification value 42.0    

Ester value 43.0    

Residue on ignition 40.05%    

Assay (of C18H38O) 595% 590.0%  



10 Typical Properties

Autoignition temperature: 4508C

Boiling point: 210.58C at 2 kPa (15 mmHg)

Density (true): 0.884–0.906 g/cm3(10) Flash point: 1918C (open cup) Freezing point: 55–578C

Melting point: 59.4–59.88C for the pure material.

Refractive index: n60 = 1.4388 at 608C


chiefly of related alcohols.

Solubility:

D

soluble in chloroform, ethanol (95%), ether, hexane,



Structural Formula


 


Functional Category

Stiffening agent.


Applications in Pharmaceutical Formulation or Technology

Stearyl alcohol is used in cosmetics(1,2) and topical pharma- ceutical creams and ointments as a stiffening agent. By increasing the viscosity of an emulsion, stearyl alcohol increases its stability. Stearyl alcohol also has some emollient and weak emulsifying properties and is used to increase the water-holding capacity of ointments, e.g. petrolatum. In addition, stearyl alcohol has been used in controlled-release tablets,(3,4) suppo- sitories,(5,6) and microspheres.(7,8) It has also been investigated for use as a transdermal penetration enhancer.(9)


Description

Stearyl alcohol occurs as hard, white, waxy pieces, flakes, or granules with a slight characteristic odor and bland taste.


Pharmacopeial Specifications

See Table I.

propylene glycol, and vegetable oils; practically insoluble in water.

Vapor pressure: 133.3 Pa (1 mmHg) at 150.38C

Viscosity (dynamic): 9.82 mPa s at 648C(10)


Stability and Storage Conditions

Stearyl alcohol is stable to acids and alkalis and does not usually become rancid. It should be stored in a well-closed container in a cool, dry place.


Incompatibilities

Incompatible with strong oxidizing agents and strong acids.


Method of Manufacture

Historically, stearyl alcohol was prepared from sperm whale oil but is now largely prepared synthetically by reduction of ethyl stearate with lithium aluminum hydride.


Safety

Stearyl alcohol is generally considered to be an innocuous, nontoxic material. However, adverse reactions to stearyl alcohol present in topical preparations have been reported. These include contact urticaria and hypersensitivity reactions, which are possibly due to impurities contained in stearyl alcohol rather than stearyl alcohol itself.(11–15)

The probable lethal oral human dose is greater than 15 g/kg.

LD50 (rat, oral): 20 g/kg(16)


Stearyl Alcohol 741



Handling Precautions

Observe normal precautions appropriate to the circumstances and quantity of material handled. Eye protection and gloves are recommended. Stearyl alcohol is not a fire hazard, although it will burn and may give off noxious fumes containing carbon monoxide.


Regulatory Status

Included in the FDA Inactive Ingredients Guide (oral tablets, rectal topical, and vaginal preparations). Included in nonpar- enteral medicines licensed in the UK. Included in the Canadian List of Acceptable Non-medicinal Ingredients.


Related Substances

Cetostearyl alcohol; cetyl alcohol.


Comments

The EINECS number for stearyl alcohol is 204-017-6.


Specific References

Egan RR, Portwood O. Higher alcohols in skin lotions. Cosmet Perfum 1974; 89(3): 39–42.

Alexander P. Organic rheological additives. Manuf Chem 1986;

57(9): 49, 52.

Prasad CM, Srivastava GP. Study of some sustained release granulations of aspirin. Indian J Hosp Pharm 1971; 8: 21–28.

Kumar K, Chakrabarti T, Srivastava GP. Studies on the sustained release tablet formulation of diethylcarbamazine citrate (Hetra- zan). Indian J Pharm 1975; 37: 57–59.

Kaiho F, Aoki T, Nakagane F, Nagano K, Kato Y. Application of fatty alcohols to pharmaceutical dosage forms. Yakuzaigaku 1984; 44: 99–102.

Tanabe K, Yoshida S, Yamamoto K, et al. Effect of additives on release of ibuprofen from suppositories. Yakuzaigaku 1988; 48: 262–269.

Giannola LI, De Caro V. Entrapment of phenytoin into micro- spheres of oleaginous materials: process development and in vitro evaluation of drug release. Drug Dev Ind Pharm 1997; 23(12): 1145–1152.

Liggins RT, Burt HM. Paclitaxel loaded poly(L-lactic acid) micro- spheres: properties of microspheres made with low molecular weight polymers. Int J Pharm 2001; 222(1): 19–33.


Chiang CH, Lai JS, Yang KH. The effects of pH and chemical enhancers on the percutaneous absorption of indomethacin. Drug Dev Ind Pharm 1991; 17: 91–111.

Weller PJ. Stearyl alcohol. In: Kibbe AH, ed. Handbook of Pharmaceutical Excipients, 3rd edn. London and Washington, DC: Pharmaceutical Press and American Pharmaceutical Associa- tion, 2000: 537–538.

Gaul LE. Dermatitis from cetyl and stearyl alcohols. Arch Dermatol 1969; 99: 593.

Fisher AA. Contact dermatitis from stearyl alcohol and propylene glycol. Arch Dermatol 1974; 110: 636.

Black H. Contact dermatitis from stearyl alcohol in Metosyn (flucinonide) cream. Contact Dermatitis 1975; 1: 125.

Cronin E. Contact Dermatitis. Edinburgh: Churchill Livingstone, 1980: 808.

Yesudian PD, King CM. Allergic contact dermatitis from stearyl alcohol in Efudix cream. Contact Dermatitis 2001; 45: 313–314.

Lewis RJ, ed. Sax’s Dangerous Properties of Industrial Materials, 11th edn. New York: Wiley, 2004: 2758.



General References

Barry BW. Continuous shear, viscoelastic and spreading properties of a new topical vehicle, FAPG base. J Pharm Pharmacol 1973; 25: 131–

137.

Japan Pharmaceutical Excipients Council. Japanese Pharmaceutical Excipients Directory 1996. Tokyo: Yakuji Nippo, 1996: 527.

Madan PL, Luzzi LA, Price JC. Microencapsulation of a waxy solid: wall thickness and surface appearance studies. J Pharm Sci 1974; 63: 280–284.

Rowe RC. A quantitative assessment of the reactivity of the fatty alcohols with cetrimide using immersion calorimetry. J Pharm Pharmacol 1987; 39: 50–52.

Schott H, Han SK. Effect of inorganic additives on solutions of nonionic surfactants II. J Pharm Sci 1975; 64: 658–664.

Wan LSC, Poon PKC. The interfacial activity of sodium lauryl sulfate in the presence of alcohols. Can J Pharm Sci 1970; 5: 104–107.



Authors

RT Guest.



Date of Revision

23 August 2005.


Sucralose





Nonproprietary Names

USPNF: Sucralose


Synonyms

Splenda;  TGS;  1',4',6'-trichlorogalactosucrose;  4,1',6'-tri-

chloro-4,1',6'-trideoxy-galacto-sucrose.


Chemical Name and CAS Registry Number

1,6-Dichloro-1,6-dideoxy-b-D-fructofuranosyl-4-chloro-4- deoxy-a-D-galactopyranoside [56038-13-2]


Empirical Formula and Molecular Weight

C12H19Cl3O8 397.64


Structural Formula

 


Functional Category

Sweetening agent.


Applications in Pharmaceutical Formulation or Technology

Sucralose is used as a sweetening agent in beverages, foods, and pharmaceutical applications. It has a sweetening power approximately 300–1000 times that of sucrose and has no aftertaste. It has no nutritional value, is noncariogenic, and produces no glycemic response. See also Table I.


Table I: Uses of sucralose.


Use Concentration (%)


Food products 0.03–0.24




Description

Sucralose is a white to off-white colored, free-flowing, crystal- line powder.


Pharmacopeial Specifications

See Table II.

Table II: Pharmacopeial specifications for sucralose.


Test USPNF 23


Identification +

Specific rotation +84.08 to +87.58

Water 42.0%

Residue on ignition 40.7%

Heavy metals 40.001%

Limit of hydrolysis products 40.1%

Limit of methanol 40.1%

Related compounds 40.5%

Assay (dried basis) 98.0–102.0%




Typical Properties

Acidity/alkalinity: pH = 5–6 (10% w/v aqueous solution at 208C)

Density (bulk): 0.35 g/cm3 Density (tapped): 0.62 g/cm3 Density (true): 1.63 g/cm3

Melting point: 1308C (for anhydrous crystalline form); 36.58C (for pentahydrate).

Particle size distribution: 90% < 12 mm in size.

Partition coefficient: log10 P = —0.51 (octanol:water)

Refractive index: 1.33 to 1.37

Solubility: freely soluble in ethanol (95%), methanol, and water; slightly soluble in ethyl acetate.

Specific rotation [a]20: +84.08 to +87.58 (1% w/v aqueous solution); +68.28 (1.1% w/v solution in ethanol).

Viscosity: 0.6–3.8 mPa s


Stability and Storage Conditions

Sucralose is a relatively stable material. In aqueous solution, at highly acidic conditions (pH < 3), and at high temperatures (4358C), it is hydrolyzed to a limited extent, producing 4- chloro-4-deoxygalactose and 1,6-dichloro-1,6-dideoxyfruc- tose. In food products, sucralose remains stable throughout

extended storage periods, even at low pH. However, it is most stable at pH 5–6.

Sucralose should be stored in a well-closed container in a cool, dry place, at a temperature not exceeding 218C. Sucralose, when heated at elevated temperatures, may break down with the release of carbon dioxide, carbon monoxide, and minor amounts of hydrogen chloride.


Incompatibilities


Method of Manufacture

Sucralose may be prepared by a variety of methods that involve the selective substitution of three sucrose hydroxyl groups by chlorine. Sucralose can also be synthesized by the reaction of sucrose (or an acetate) with thionyl chloride.


Sucralose 743



Safety

Sucralose is generally regarded as a nontoxic and nonirritant material and is approved, in a number of countries, for use in food products. Following oral consumption, sucralose is mainly unabsorbed and is excreted in the feces.(1–3)

The WHO has set an acceptable daily intake for sucralose of up to 15 mg/kg body-weight.(4)

LD50 (mouse, oral): > 16 g/kg LD50 (rat, oral): > 10 g/kg



Handling Precautions

Observe normal precautions appropriate to the circumstances and quantity of material handled.



Regulatory Status

The FDA, in April 1998, approved sucralose for use as a tabletop sweetener and as an additive in a variety of food products. In the UK, sucralose was authorized for use in food products on a 2-year temporary basis in March 2002.(5) It is also accepted for use in many other countries worldwide. Included in the Canadian List of Acceptable Non-medicinal Ingredients.



Related Substances

Sucrose.



Comments

The sweetening effect of sucralose is not reduced by heating and food products containing sucralose may be subjected to high- temperature processes such as pasteurization, sterilization, UHT processing and baking. Sucralose is often blended with maltodextrin or dextrose as bulking agents in its granular form. A specification for sucralose is contained in the Food

Chemicals Codex (FCC).

Specific References

Grice HC, Goldsmith LA. Sucralose – an overview of the toxicity data. Food Chem Toxicol 2000; 38 (Suppl. 2): S1–S6.

Roberts A, Renwick AG, Sims J, Snodin DJ. Sucralose metabolism and pharmacokinetics in man. Food Chem Toxicol 2000; 38 (Suppl. 2): S31–S41.

Mclean Baird I, Shephard NW, Merritt RJ, Hildick-Smith G. Repeated dose study of sucralose tolerance in human subjects. Food Chem Toxicol 2000; 38(Suppl 2): S123–S129.

FAO/WHO. Evaluation of certain food additives and contami- nants. Thirty-seventh report of the joint FAO/WHO expert committee on food additives. World Health Organ Tech Rep Ser 1991; No. 806: 21–23.

Statutory Instrument (SI) 2002: No. 379. The Sweeteners in Food (Amendment) (England) Regulations 2002. London: Stationery Office, 2002.


General References

American Dietic Association. Position of the American Dietic Associa- tion: use of nutritive and nonnutritive sweetners. J Am Diet Assoc 2004; 104: 255–275.

Anonymous. Artificial sweeteners. Can Pharm J 1996; 129(Apr): 22. Anonymous. Sucralose – a new artificial sweetener. Med Lett Drugs

Ther 1998; 40: 67–68.

Jenner MR, Smithson A. Physicochemical properties of the sweetner sucralose. J Food Sci 1989; 54(6): 1646–1649.

Kloesel L. Sugar substitutes. Int J Pharm Compound 2000; 4(2): 86–87. Knight I. The development and applications of sucralose, a new high- intensity sweetener. Can J Physiol Pharmacol 1994; 72(4): 435–

439.

Kroschwiz JI, Howe-Grant M, eds. In: Kirk-Othmer Encyclopedia of Chemical Technology, 4th edn. New York: John Wiley & Sons, 1994; 11: 295.

McNeil Nutritionals. Splenda: the online guide to cooking, eating and living well. http://www.splenda.com (accessed 31 February 2004).

Tate and Lyle. Technical literature: Sucralose. 2001.


Authors

BA Langdon, MP Mullarney.


Date of Revision

26 August 2005.


Sucrose





Nonproprietary Names

BP: Sucrose JP: Sucrose

PhEur: Saccharum USPNF: Sucrose


Synonyms

Beet sugar; cane sugar; a-D-glucopyranosyl-b-D-fructofurano- side; refined sugar; saccharose; sugar.


Chemical Name and CAS Registry Number

b-D-fructofuranosyl-a-D-glucopyranoside [57-50-1]


Empirical Formula and Molecular Weight

C12H22O11 342.30


Structural Formula

 


Functional Category

Base for medicated confectionery; coating agent; granulating agent; sugar coating adjunct; suspending agent; sweetening agent; tablet binder; tablet and capsule diluent; tablet filler; viscosity-increasing agent.


Applications in Pharmaceutical Formulation or Technology

Sucrose is widely used in oral pharmaceutical formulations.

Sucrose syrup, containing 50–67% w/w sucrose, is used in tableting as a binding agent for wet granulation. In the powdered form, sucrose serves as a dry binder (2–20% w/w) or as a bulking agent and sweetener in chewable tablets and lozenges.(1,2) Tablets that contain large amounts of sucrose may harden to give poor disintegration.

Sucrose syrups are used as tablet-coating agents at concentrations between 50% and 67% w/w. With higher concentrations, partial inversion of sucrose occurs, which makes sugar coating difficult.

Sucrose syrups are also widely used as vehicles in oral liquid- dosage forms to enhance palatability or to increase viscos- ity.(3,4)

Sucrose has been used as a diluent in freeze-dried protein products.(5,6)

Sucrose is also widely used in foods and confectionery, and therapeutically in sugar pastes that are used to promote wound healing.(7,8) See Table I.


Table I: Uses of sucrose.


Use Concentration (% w/w)

Syrup for oral liquid formulations 67

Sweetening agent 67

Tablet binder (dry granulation) 2–20

Tablet binder (wet granulation) 50–67

Tablet coating (syrup) 50–67




Description

Sucrose is a sugar obtained from sugar cane (Saccharum officinarum Linne´ (Fam. Gramineae)), sugar beet (Beta vulgaris Linne´ (Fam. Chenopodiaceae)), and other sources. It contains no added substances. Sucrose occurs as colorless crystals, as crystalline masses or blocks, or as a white crystalline powder; it is odorless and has a sweet taste.


Pharmacopeial Specifications

See Table II.


Typical Properties

Density (bulk):

0.93 g/cm3 (crystalline sucrose);

0.60 g/cm3 (powdered sucrose).

Density (tapped):

g/cm3 (crystalline sucrose);

0.82 g/cm3 (powdered sucrose). Density (true): 1.6 g/cm3 Dissociation constant: pKa = 12.62

Flowability: crystalline sucrose is free flowing, whereas powdered sucrose is a cohesive solid.

Melting point: 160–1868C (with decomposition)

Moisture content: finely divided sucrose is hygroscopic and absorbs up to 1% water.(9) See Figure 1.

Osmolarity: a 9.25% w/v aqueous solution is isoosmotic with serum.

Particle size distribution: powdered sucrose is a white, irregular-sized granular powder. The crystalline material consists of colorless crystalline, roughly cubic granules. See Figures 2 and 3.


Sucrose 745




Table II: Pharmacopeial specifications for sucrose.


 

Test JP 2001 PhEur 2005 USPNF 23    

Identification + + +    

Characters +    

Appearance of + +    

solution    

Acidity or alkalinity + +    

Specific optical +66.38 to +66.38 to 5+65.98    

rotation +67.08 +67.08    

Color value 445    

Conductivity + +    

Loss on drying 40.1% 40.1%    

Bacterial endotoxins(a) 40.25 IU/mg 40.25 IU/mg    

Dextrins(a) + +    

Reducing sugars +    

Invert sugar + +    

Chloride 40.0035%    

Sulfate 40.006%    

Sulfites 415 ppm 410 ppm    

Calcium 45 ppm    

Heavy metals 45 ppm    

Lead 40.5 ppm 40.5 ppm    

Residue on ignition 40.05%    

Organic volatile +  

impurities


(a) If sucrose is to be used in large volume infusions.





Refractive index: n25 = 1.34783 (10% w/v aqueous solution)

SEM: 1

Excipient: Sucrose

Manufacturer: Great Western Sugar Co.

Lot No.: 1-2-80

Magnification: 60×

Voltage: 10 kV


 


SEM: 2

Excipient: Sucrose

Manufacturer: Great Western Sugar Co.


Solubility:

D

see Table III.

Lot No.: 1-2-80


Specific gravity: see Table IV.




Table III: Solubility of sucrose.


Solvent Solubility at 208C unless otherwise stated


Chloroform Practically insoluble

Ethanol 1 in 400

Ethanol (95%) 1 in 170

Propan-2-ol 1 in 400

Water 1 in 0.5

1 in 0.2 at 1008C





Table IV: Specific gravity of aqueous sucrose solutions.


 

Concentration of aqueous sucrose solution (% w/w) Specific gravity at 208C    

2 1.0060    

6 1.0219    

10 1.0381    

20 1.0810    

30 1.1270    

40 1.1764    

50 1.2296    

60 1.2865    

70 1.3471    

76 1.3854  

Magnification: 600×

Voltage: 10 kV

 


Stability and Storage Conditions

Sucrose has good stability at room temperature and at moderate relative humidity. It absorbs up to 1% moisture, which is released upon heating at 908C. Sucrose caramelizes when heated to temperatures above 1608C. Dilute sucrose solutions are liable to fermentation by microorganisms but resist decomposition at higher concentrations, e.g., above 60%


746    Sucrose


w/w concentration. Aqueous solutions may be sterilized by autoclaving or filtration.

When sucrose is used as a base for medicated confectionery, the cooking process, at temperatures rising from 110 to 1458C, causes some inversion to form dextrose and fructose (invert sugar). The fructose imparts stickiness to confectionery but prevents cloudiness due to graining. Inversion is accelerated particularly at temperatures above 1308C and by the presence of acids.

The bulk material should be stored in a well-closed container in a cool, dry place.

 


Figure 1: Moisture sorption–desorption isotherm of powdered sucrose.

Samples dried initially at 608C over silica gel for 24 hours. Note: at 90% relative humidity, sufficient water was absorbed to cause dissolution of the solid.


Incompatibilities

Powdered sucrose may be contaminated with traces of heavy metals, which can lead to incompatibility with active ingre- dients, e.g. ascorbic acid. Sucrose may also be contaminated with sulfite from the refining process. With high sulfite content, color changes can occur in sugar-coated tablets; for certain colors used in sugar-coating the maximum limit for sulfite content, calculated as sulfur, is 1 ppm. In the presence of dilute or concentrated acids, sucrose is hydrolyzed or inverted to dextrose and fructose (invert sugar). Sucrose may attack aluminum closures.(10)


Method of Manufacture

Sucrose is obtained from the sugar cane plant, which contains 15–20% sucrose, and sugar beet, which contains 10–17% sucrose. Juice from these sources is heated to coagulate water- soluble proteins, which are removed by skimming. The resultant solution is then decolorized with an ion-exchange resin or charcoal and concentrated. Upon cooling, sucrose crystallizes out. The remaining solution is concentrated again and yields more sucrose, brown sugar, and molasses.

 


Figure 2: Particle size distribution of crystalline sucrose.

 


Figure 3: Particle size distribution of powdered sucrose.



Safety

Sucrose is hydrolyzed in the small intestine by the enzyme sucrase to yield dextrose and fructose, which are then absorbed. When administered intravenously, sucrose is excreted unchanged in the urine.

Although sucrose is very widely used in foods and pharmaceutical formulations, sucrose consumption is a cause of concern and should be monitored in patients with diabetes mellitus or other metabolic sugar intolerance.(11)

Sucrose is also considered to be more cariogenic than other carbohydrates since it is more easily converted to dental plaque.


Sucrose 747



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