Rate of Dissolution of Digoxin Tablets as a Predictor of Absorption

Johnson, B. F.; Greer, H; McCrerie, J A; Bye, Carole; Fowle, A. S. E.

doi:10.1016/s0140-6736(73)91811-4

Cited by 71 publications

(14 citation statements)

References 8 publications

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“…These studies have shown that the bioavailability of digoxin is influenced by route of administration,l1, 35 dosage form,ll, 18,30,35 tablet dissolution rate,4, 8,18,20,25,30,32,35 and intestinal mucosal pathology. 12,15,21 Drugs have also been reported to interfere with the absorption of digoxin.…”

mentioning

confidence: 99%

Effect of sulfasalazine on digoxin bioavailability

Juhl

Summers

Guillory

et al. 1976

Clin Pharma and Therapeutics

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Low levels of digoxin were noted in a patient receiving digoxin and sulfasalazine (SSA). Discontinuation of SSA resulted in a significant increase in serum digoxin levels. To determine whether or not SSA consistently interfered with the therapeutic effect of digoxin, both drugs were administered to 10 normal subjects in a crossover study. Each received 2 doses of digoxin (0.5 mg, elixir): one dose given alone, and a second dose after 6 days of treatment with SSA. When digoxin was given with SSA, the average area under the serum digoxin curve fell from the control value of 8.79 ng-hr-ml(-1) to 6.66 ng-hr-ml(-1) (p less than 0.05), fell and total urinary excretion decreased from 278 mcg/10 days to 228 mcg/10 days (p less than 0.025). These changes suggest interference with the bioavailability of digoxin by SSA. Studies were conducted to determine whether SSA inhibited digoxin absorption by physically absorbing the glycoside from solution. In vitro tests failed to reveal any significant adsorptive properties for SSA.

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mentioning

confidence: 99%

Effect of sulfasalazine on digoxin bioavailability

Juhl

Summers

Guillory

et al. 1976

Clin Pharma and Therapeutics

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“…However, because of the critical importance of drug dissolution and release from a dosage form under physiological conditions, especially for drugs that are highly absorbed or for SR dosage forms, in vitro dissolution is more relevant than disintegration as a way to describe what will possibly happen in vivo. In the 1970s, a series of studies showed that the mean dissolution time resulting from IR tablets could be related to pharmacokinetic parameters such as the rate and extent of drug absorption, thus establishing a correlation between in vivo and in vitro performance (Johnson, Greer et al 1973;Lindenbaum, Butler Jr et al 1973;Shaw, Raymond et al 1973). These results supported the incorporation of dissolution tests and specifications into the United States Pharmacopeia (USP) General…”

Section: Importance Of In Vitro-in Vivo In the Development And Optimimentioning

confidence: 84%

High-amylose carboxymethyl starch matrices for oral sustained drug-release: In vitro and in vivo evaluation

Nabais

Brouillet

Kyriacos

et al. 2007

European Journal of Pharmaceutics and Biopharmaceutics

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“…(a) Sparingly soluble drugs such as digoxin, where there is a close relationship between dissolution rate and steady-rate plasma level, and where formulation with similar disintegration times may show marked differences in their dissolution rates (Johnson et al, 1973).…”

Section: Discussionmentioning

confidence: 99%