1954 Nutritional Agents and Vitamins
Ferrum Hausmann; Unifer†; Malaysia: Venofer; Mex.: Venoferrum; 3. Heyman MB. Committee on Nutrition. Lactose intolerance in in-
Neth.: Venofer; Norw.: Venofer; NZ: Venofer; Port.: Venofer; S.Afr.: fants, children, and adolescents. Pediatrics 2006; 118: 1279–86.
Venofer; Singapore: Venofer; Spain: Feriv; Venofer; Swed.: Venofer; 4. Suarez FL, et al. A comparison of symptoms after the consump-
Switz.: Venofer; Thai.: Venofer; Turk.: Venofer; UK: Venofer; USA: Ven- HO tion of milk or lactose-hydrolysed milk by people with self-re-
ofer; Venez.: Venofer. ported severe lactose intolerance. N Engl J Med 1995; 333: 1–4.
Multi-ingredient: Ger.: Hicoton†; Junisana†; Selectafer N†. 5. Fiocchi A, et al. Clinical tolerance to lactose in children with
O cows’ milk allergy. Pediatrics 2003; 112: 359–62.
HO O OH
Pharmacokinetics
Isoleucine (USAN, rINN) Lactose is hydrolysed by lactase in the small intestine
HO OH O OH to glucose and galactose, which are then absorbed.
I; Ile; Isoleucin; Isoleucina; L-Isoleucine; Isoleucinum; Isoleusiini;
Izoleucin; Izoleucinas. L-2-Amino-3-methylvaleric acid.
OH Uses and Administration
Изолейцин
Lactose, the carbohydrate component of milk, is less
C 6 H 13 NO 2 = 131.2. OH
sweet than sucrose.
C AS — 73-32-5.
(anhydrous lactose) Lactose is widely used as an excipient in pharmaceuti-
cal manufacturing. In the production of capsules or tab-
OH Description. Lactose is a disaccharide obtained from the whey lets it may be used as a diluent, bulking agent, or filler,
of milk. It may exist in a number of distinct forms depending and in powders as a bulking agent. Lactose is also used
O upon the crystallisation and drying processes employed. The as a carrier for drugs in dry powder inhalers. Character-
NH2 forms can vary in the contents of crystalline and amorphous lac- istics such as particle size or flow characteristics make
tose, the amounts of α-lactose (O-β-D-galactopyranosyl-(1→4)-
H3C α-D-glucopyranose) and β-lactose (O-β-D-galactopyranosyl- different grades of lactose suitable for different appli-
CH3 (1→4)-β-D-glucopyranose), and in their hydration states. The α- cations.
form of lactose exists in either the anhydrous
(C12H22O11 = 342.3) or monohydrate (C12H22O11,H2O = 360.3) Preparations
Pharmacopoeias. In Chin., Eur. (see p.vii), Jpn, and US. state whereas the β-form exists only in the anhydrous state. Com- Proprietary Preparations (details are given in Part 3)
Ph. Eur. 6.2 (Isoleucine). A white or almost white, crystalline mercial lactose is mainly the α-monohydrate. Multi-ingredient: Austria: Ichth-Oestren; Fr.: Tavag.
powder or flakes. Sparingly soluble in water; slightly soluble in Pharmacopoeias. In Chin., Eur. (see p.vii), Int., Jpn, and Viet.
alcohol. It dissolves in dilute mineral acids and in dilute solutions Also in USNF. Some pharmacopoeias include separate mono-
of alkali hydroxides. Protect from light. graphs for anhydrous lactose and lactose monohydrate.
USP 31 (Isoleucine). White, practically odourless crystals. Sol- Ph. Eur. 6.2 (Lactose, Anhydrous). It is β-lactose or a mixture of
Leucine (USAN, rINN)
uble in water; slightly soluble in hot alcohol; insoluble in ether. α-lactose and β-lactose. A white or almost white, crystalline α-Aminoisocaproic Acid; L; Leu; Leucin; Leucina; Leucinas; L-Leu-
pH of a 1% solution in water is between 5.5 and 7.0. powder. Freely but slowly soluble in water; practically insoluble cine; Leucinum; Leucyna; Leusiini. L-2-Amino-4-methylvaleric ac-
Profile in alcohol. id.
Isoleucine is a branched-chain aliphatic amino acid that is an es- Ph. Eur. 6.2 (Lactose Monohydrate; Lactose BP 2008). It is the Лейцин
sential constituent of the diet. It is used as a dietary supplement. monohydrate of α-lactose. It may be modified as to its physical C 6 H 13 NO 2 = 131.2.
It is also an ingredient of several preparations that have been pro- characteristics and may contain varying proportions of amor- C AS — 61-90-5.
moted for disorders of the liver. phous lactose. A white or almost white, crystalline powder. Free-
ly but slowly soluble in water; practically insoluble in alcohol.
Preparations Store in airtight containers. O
Proprietary Preparations (details are given in Part 3) USNF 26 (Anhydrous Lactose). It is β-lactose or a mixture of α-
and β-lactose. It is a white or almost white powder. Freely soluble CH3
Multi-ingredient: Ger.: Bramin-hepa†; Falkamin; Ital.: Falkamin†; Iso- in water; practically insoluble in alcohol. Store in airtight con- HO
branch; Isoram.
tainers.
USNF 26 (Lactose Monohydrate). It is a natural disaccharide, NH2 CH3
obtained from milk, which consists of one glucose and one ga-
lactose moiety. It may be modified as to its physical characteris- Pharmacopoeias. In Chin., Eur. (see p.vii), Jpn, and US.
Isomalt (BAN) tics, and may contain varying proportions of amorphous lactose. Ph. Eur. 6.2 (Leucine). A white or almost white, crystalline
Bay-i-3930; E953; Isomalta; Isomalti; Isomaltitol; Isomaltum; It is a white, free-flowing powder. Freely, but slowly soluble in powder or shiny flakes. Sparingly soluble in water; practically
Izomalt; Izomaltas; Palatinit. water; practically insoluble in alcohol. Store in airtight contain- insoluble in alcohol. It dissolves in dilute mineral acids and in di-
ers. lute solutions of alkali hydroxides. Protect from light.
C AS — 64519-82-0. USP 31 (Leucine). White, practically odourless crystals. Spar-
Pharmacopoeias. In Eur. (see p.vii). Also in USNF. Adverse Effects and Precautions ingly soluble in water; insoluble in ether. pH of a 1% solution in
Ph. Eur. 6.2 (Isomalt). A mixture of 6-O-α-D-glucopyranosyl-D- water is between 5.5 and 7.0.
glucitol (C12H24O11 = 344.3) and 1-O-α-D-glucopyranosyl-D-
Lactose intolerance occurs due to a deficiency of the
intestinal enzyme lactase. Ingestion of lactose by pa- Profile
mannitol dihydrate (C12H24O11,2H2O = 380.3) and neither of the Leucine is a branched-chain aliphatic amino acid that is an essen-
two components is less than 3%, calculated with reference to the tients with lactase deficiency leads to a clinical syn- tial constituent of the diet. It is used as a dietary supplement. It is
anhydrous substance. A white or almost white powder or gran- drome of abdominal pain, diarrhoea, distension, and also an ingredient of several preparations that have been promot-
ules. Freely soluble in water; practically insoluble in dehydrated flatulence; symptoms may also occur in persons with- ed for disorders of the liver.
alcohol.
USNF 26 (Isomalt). 6-O-α-D-Glucopyranosyl-D-glucitol (1,6-
out such a deficiency who have ingested excessive Preparations
GPS) and 1-O-α-D-glucopyranosyl-D-mannitol (1,1-GPM), and amounts of lactose. Proprietary Preparations (details are given in Part 3)
neither of the two components is less than 3.0% of the mixture, Lactose is contra-indicated in patients with galactosae- Multi-ingredient: Fr.: Revitalose; Ger.: Bramin-hepa†; Falkamin; Ital.:
calculated on the anhydrous basis. mia, the glucose-galactose malabsorption syndrome, Falkamin†; Isobranch; Isoram.
Profile or lactase deficiency.
Isomalt is a sugar alcohol (polyol) used as a bulk sweetener in
Lactose intolerance. Reviews of lactose intolerance.1-3 The Lutein
foods. The ingestion of large quantities may produce flatulence
capacity of the infant intestine to produce lactase, the enzyme
and have a laxative effect.
responsible for digesting lactose, is retained into adulthood only E161(b); Xanthophyll. (3R,3′R,6′R)-β,ε-Carotene-3,3′-diol.
Metabolism. Isomalt is partly metabolised in the small intes- by a minority of the world’s population, mostly in those of north Лютеин
tine to glucose, mannitol, and sorbitol and the remaining isomalt European descent; in Africa and Asia more than 90% of the pop- C 40 H 56O 2 = 568.9.
is completely metabolised by the flora of the large intestine.1 The ulation are lactase deficient. Because of the ubiquity of lactose in C AS — 127-40-2.
Australian manufacturers have commented that the hydrolysis the diet and the consequent frequency of abdominal symptoms,
and absorption is minimal and does not significantly affect attempts have been made to treat lactose intolerance by dietary
blood-sugar or insulin concentrations; they consider isomalt to exclusion (which need not be complete since lactase deficiency
be suitable for use by diabetic patients.2 is rarely absolute). An alternative is enzyme replacement therapy
with β-galactosidase from micro-organisms (see Tilactase,
1. FAO/WHO. Evaluation of certain food additives and contami-
nants: twenty-ninth report of the joint FAO/WHO expert com- p.2402), but the role of such therapy has yet to be fully deter-
mittee on food additives. WHO Tech Rep Ser 733 1986. mined. The findings of one study4 suggested that, in adults with
2. Barnes JA. Martindale and isomalt. Aust J Pharm 1994; 75: 183. lactose intolerance, the use of lactose-digestive aids is unneces-
sary if lactose intake is limited to the equivalent of 240 mL of
milk or less daily.
There has been concern that lactose might be contaminated with
protein from milk, and it has been recommended that children
Lactose with cow’s milk allergy avoid lactose-containing foods. Howev-
er, a small study5 found that children allergic to cow’s milk could
Lactosa; Lactosum; Laktoosi; Laktos; Laktosa; Laktóz; Laktoza;
still tolerate lactose. Pharmacopoeias. In US.
Laktozė; Lattosio; Milk Sugar; Saccharum Lactis; Saccharum Lac-
For the use of soya in infants intolerant to cow’s milk, see Food US. also includes Lutein Preparation.
tis.
Intolerance, p.1967. USP 31 (Lutein). A red crystalline powder. Soluble in dehydrat-
C AS — 63-42-3 (anhydrous lactose); 5989-81-1 (lactose 1. Anonymous. Lactose intolerance. Lancet 1991; 338: 663–4. ed alcohol, in dichloromethane, and in ethyl acetate; partially sol-
monohydrate); 10039-26-6 (lactose monohydrate, cyclic); 2. Vesa TH, et al. Lactose intolerance. J Am Coll Nutr 2000; 19 uble in hexane. Store at 8° to 15° in tightly-sealed, airtight con-
64044-51-5 (lactose monohydrate, open form). (suppl): 165S–175S. tainers. Protect from light and oxygen.
