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The Manufacture of Digitalis

The Manufacture of Digitalis Abstract To the Editor. —The editorial by Dr Selzer entitled "Digitalis in Cardiac Failure: Do Benefits Justify Risks?" in the Archives (1981;141-18-20) certainly raises some interesting concepts. However, the section on "Digitalis Dosage" needs clarification insofar as it applies to the use of the Lanoxin brand of digoxin in the United States.No manufacturing variation occurred in Lanoxin tablets manufactured and used in the United States. The Burroughs Wellcome Co in this country has maintained highly consistent manufacturing and formulation techniques on the 200 to 300 lots they produce yearly. Each lot undergoes rigid quality-control procedures, including one-hour dissolution rates that have correlated strongly with in vivo bioavailability determinations.1 Through this approach, Burroughs Wellcome Co produces a digoxin tablet with specifications that are even more rigid than the Food and Drug Administration's requirements. Such Lanoxin brand of digoxin tablets has been the in vivo standard for bioavailability studies in this References 1. Johnson BF, Greer H, McCrerie J, et al: Rate of dissolution of digoxin tablets as a predictor of absorption. Lancet 1973;1:1473-1475.Crossref 2. Jelliffe RW, Brooker G: A nomogram for digoxin therapy. Am J Med 1974;57:63-68.Crossref 3. Gault MH, Jeffrey JR, Chirito E, et al: Studies of digoxin dosage, kinetics and serum concentrations in renal failure and review of the literature. Nephron 1976;17:161-187.Crossref 4. Johnson BF, Fowle ASE, Lader S, et al: Biologic availability of digoxin from Lanoxin produced in the United Kingdom. Br Med J 1973; 4:323.Crossref 5. Shaw TRD, Raymond K, Howard MR, et al: Therapeutic non-equivalence of digoxin tablets in the United Kingdom: Correlation with tablet dissolution rate. Br Med J 1973;4:763.Crossref 6. Lindenbaum J, Mellow BW, Blackstone MO, et al: Variation in biologic availability of digoxin from four preparations. N Engl J Med 1971;285:1344-1347.Crossref 7. Arnold SB, Byrd RC, Meister W, et al: Long-term digitalis therapy improves left ventricular function in heart failure. N Engl J Med 1980;303:1443-1448.Crossref http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Archives of Internal Medicine American Medical Association

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Publisher
American Medical Association
Copyright
Copyright © 1982 American Medical Association. All Rights Reserved.
ISSN
0003-9926
eISSN
1538-3679
DOI
10.1001/archinte.1982.00340140202040
Publisher site
See Article on Publisher Site

Abstract

Abstract To the Editor. —The editorial by Dr Selzer entitled "Digitalis in Cardiac Failure: Do Benefits Justify Risks?" in the Archives (1981;141-18-20) certainly raises some interesting concepts. However, the section on "Digitalis Dosage" needs clarification insofar as it applies to the use of the Lanoxin brand of digoxin in the United States.No manufacturing variation occurred in Lanoxin tablets manufactured and used in the United States. The Burroughs Wellcome Co in this country has maintained highly consistent manufacturing and formulation techniques on the 200 to 300 lots they produce yearly. Each lot undergoes rigid quality-control procedures, including one-hour dissolution rates that have correlated strongly with in vivo bioavailability determinations.1 Through this approach, Burroughs Wellcome Co produces a digoxin tablet with specifications that are even more rigid than the Food and Drug Administration's requirements. Such Lanoxin brand of digoxin tablets has been the in vivo standard for bioavailability studies in this References 1. Johnson BF, Greer H, McCrerie J, et al: Rate of dissolution of digoxin tablets as a predictor of absorption. Lancet 1973;1:1473-1475.Crossref 2. Jelliffe RW, Brooker G: A nomogram for digoxin therapy. Am J Med 1974;57:63-68.Crossref 3. Gault MH, Jeffrey JR, Chirito E, et al: Studies of digoxin dosage, kinetics and serum concentrations in renal failure and review of the literature. Nephron 1976;17:161-187.Crossref 4. Johnson BF, Fowle ASE, Lader S, et al: Biologic availability of digoxin from Lanoxin produced in the United Kingdom. Br Med J 1973; 4:323.Crossref 5. Shaw TRD, Raymond K, Howard MR, et al: Therapeutic non-equivalence of digoxin tablets in the United Kingdom: Correlation with tablet dissolution rate. Br Med J 1973;4:763.Crossref 6. Lindenbaum J, Mellow BW, Blackstone MO, et al: Variation in biologic availability of digoxin from four preparations. N Engl J Med 1971;285:1344-1347.Crossref 7. Arnold SB, Byrd RC, Meister W, et al: Long-term digitalis therapy improves left ventricular function in heart failure. N Engl J Med 1980;303:1443-1448.Crossref

Journal

Archives of Internal MedicineAmerican Medical Association

Published: Jan 1, 1982

References