Title: Alternative Sweeteners

Isomalt 279
isomalt is significantly reduced. A lower moisture pickup leads to an improved
shelf-life.
H. Pharmaceutical Applications
Isomalt is of particular interest for pharmaceutical applications because of its:
• Chemical stability
• Slow dissolution kinetics
• Low hygroscopicity
• Heat stability
Isomalt can be used as a neutral vehicle in a wide range of pharmaceutical
applications, for example, high-boilings, tablets, and instant drink powders. The
low solubility of isomalt is an advantage in high-boilings and tablets with active
ingredients (34). A high-boiling made with isomalt dissolves approximately onethird
slower than a sugar high-boiling, and an isomalt tablet dissolves almost
twice as slow as its sugar counterpart. Active ingredients are therefore released
more slowly and remain in the oral cavity for a longer time. The low hygroscopicity
of isomalt ensures that pharmaceutical products remain stable for several
years. This is especially important when hydrolysis-prone ingredients are involved.
VII. REGULATORY STATUS
Isomalt is regulated in countries worldwide, including NAFTA, EU, Japan, Australia,
New Zealand, East European countries, and a number of Asian and South-
American countries. In most European countries, isomalt is approved as a food
additive. A Generally Recognized As Safe affirmation petition was accepted for
filing by the U.S. Food and Drug Administration in 1990. Since then, isomalt
has been marketed in the United States as a GRAS substance. In Japan isomalt
is accepted as a food.
REFERENCES
1. PJ Sträter. Palatinit (isomalt), an energy-reduced bulk sweetener derived from saccharose.
In: GG Birch, MG Lindley, eds. Low-Calorie Products. London: Elsevier
Applied Science, 1988, p 36.
2. PJ Sträter. Palatinit-technological and processing characteristics. In: LO Nabors, RC
Gelardi, eds. Alternative Sweeteners. New York: 1986, p 217.