Abstract
The composition and antacid properties of 10 samples of crystalline antacids containing both aluminum and magnesium were determined. The composition was found to vary significantly, even within the same type of antacid. For example, three of four hydrotalcite samples exhibit evidence of the presence of a minor phase of amorphous aluminum hydroxide. Almagate and almagcit, which are claimed to be unique compounds, were found to be composed of hydrotalcite, magnesium hydroxycarbonate, and/or magnesium carbonate and amorphous aluminum hydroxide. All three magaldrate samples examined contained a minor phase of amorphous aluminum hydroxide. All 10 samples passed the preliminary antacid test and had high acid neutralizing capacities. However, the rate of acid neutralization varied between samples. In some cases the rate of acid neutralization at a dose of 400 mg was too slow to raise the pH to 3.0 as required by the Rossett–Rice test.
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REFERENCES
J. E. F. Reynolds (ed.). In Martindale The Extra Pharmacopoeia, 29th ed., Pharmaceutical Press, London, 1989, p. 1091.
C. J. Serna, J. L. White, and S. L. Hem. A structural survey of carbonate-containing antacids. J. Pharm. Sci. 67:324–327 (1978).
J. E. F. Reynolds (ed.). In Martindale The Extra Pharmacopoeia, 29th ed., Pharmaceutical Press, London, 1989, p. 1074.
J. Moragues, J. E. Beneyto, J. L. Fabregas, and R. G. W. Spickett. Characterization of a new crystalline synthetic gastric antacid, almagate. Arzneim.-Forsch. 34:1346–1349 (1984).
J. E. Beneyto, J. L. Fabregas, J. Moragues, and R. G. W. Spickett. Evaluation of a new antacid, almagate. Arzneim.-Forsch. 34:1350–1354 (1984).
J. L. Fabregas and J. E. Beneyto. Stability of almagate and pharmaceutical formulations prepared from it. Arzneim.-Forsch. 34:1354–1357 (1984).
J. L. Fabregas and J. Cucala. Influence of microphysical structure on in vitro activity of new synthetic antacids. Int. J. Pharm. 52:173–178 (1989).
The United States Pharmacopeia, 22nd rev., United States Pharmacopoeia Convention, Rockville, MD, 1990, pp. 785–789.
W. Horwitz (ed.). Official Methods of Analysis of the Association of Official Analytical Chemists, 12th ed., Association of Official Analytical Chemists, Washington, DC, 1975, p. 147.
Standard Methods for the Examination of Water and Wastewater, 15th ed., American Public Health Association, Washington, DC, 1981, pp. 436–438.
The United States Pharmacopeia, 22nd rev., United States Pharmacopeial Convention, Rockville, MD, 1990, pp. 1624–1625.
N. E. Rossett and M. L. Rice. An in-vitro evaluation of the efficacy of the more frequently used antacids with particular attention to tablets. Gastroenterology 36:490–495 (1954).
N. J. Kerkhof, R. K. Vanderlaan, J. L. White, and S. L. Hem. pH-stat titration of aluminum hydroxide gel. J. Pharm. Sci. 66:1528–1533 (1977).
G. W. Brindley and S. Kikkawa. Thermal behavior of hydrotalcite and of anion-exchanged forms of hydrotalcite. Clays Clay Miner. 28:87–91 (1980).
S. Miyata. Anion-exchange properties of hydrotalcite-like compounds. Clays Clay Miner. 31:305–311 (1983).
V. A. Drits, T. N. Sokolova, G. V. Sokolova, and V. I. Cherkashin. New members of the hydrotalcite-manasseite group. Clays Clay Miner. 35:401–417 (1987).
R. K. Vanderlaan, J. L. White, and S. L. Hem. Formation of hydrotalcite in mixtures of aluminum hydroxycarbonate gel and magnesium hydroxide gel. J. Pharm. Sci. 71:780–786 (1982).
J. L. White and S. L. Hem. Role of carbonate in aluminum hydroxide gel established by Raman and IR analysis. J. Pharm. Sci. 64:468–469 (1975).
J.-C. Liu, J. R. Feldkamp, J. L. White, S. L. Hem, N. Otsuka, D. F. Conroy, C. Pendharkar, K. M. Feld, R. J. Harwood, and W. M. Grim. Particle morphology of amorphous aluminum hydroxycarbonate and its effect on tablet production. Drug Dev. Ind. Pharm. 13:2087–2110 (1987).
S. Shirodkar, R. L. Hutchinson, D. L. Perry, J. L. White, and S. L. Hem. Aluminum compounds used as adjuvants in vaccines. Pharm. Res. 7:1282–1288 (1990).
S. L. Hem and J. L. White. Pharmaceutical uses of aluminum. In H. J. Gitelman (ed.) Aluminum and Health: A Critical Review, Dekker, New York, 1988.
J. S. Fordtran, S. G. Morawski, and C. T. Richardson. In vivo and in vitro evaluation of liquid antacids. N. Engl. J. Med. 288:923–928 (1973).
R. K. Vanderlaan, J. L. White, and S. L. Hem. Effect of the interaction of aluminum hydroxycarbonate gel and magnesium hydroxide gel on acid neutralization. J. Pharm. Sci. 68:1498–1501 (1978).
L. G. Berry. Selected Powder Diffraction Data for Minerals, Joint Committee on Powder Diffraction Standard, Swarthmore, PA, 1989, Monographs 25-513, 29-857, 20-669, 35-680.
J. H. Canterford and G. Tsambourakis. Some observations on the properties of dypingite and related minerals. Min. Mag. 48:437–442 (1984).
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Peterson, C.L., Perry, D.L., Masood, H. et al. Characterization of Antacid Compounds Containing Both Aluminum and Magnesium. I. Crystalline Powders. Pharm Res 10, 998–1004 (1993). https://doi.org/10.1023/A:1018958621782
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DOI: https://doi.org/10.1023/A:1018958621782