Digitoxin Tablets Research Articles

Determination of Cardiac Glycosides in Digitoxin Tablets and Deslanoside Injections by Micro-HPLC

A micro high-performance liquid chromatographic (micro-HPLC) procedure for the assay of digitoxin tablets and deslanoside injections has been developed. Micro-HPLC is performed on an ODS micro column, with acetonitrile-methanol-water (10:20:17) for digitoxin tablets and acetonitrile-water (21:70) for deslanoside injections. The effluent is monitored by UV absorption at 220 nm. Quantitation of cardiac glycosides in tablets and injections is carried out by the internal standard method. The composite assay results for digitoxin tablets and deslanoside injections provide average values of 101.2 and 99.9% with standard deviations of 1.2 and 0.93%, respectively. This micro-HPLC method is sensitive, quantitative, and reproducible. It is suitable for use in examining the content uniformity of pharmaceutical preparations.

A case of divergent digitoxin values under treatment of a patient with acute digitoxin overdose with digitalis antibody fragments

A 36 year old male was admitted to the intensive care unit with acute digitalis intoxication after ingestion of 350 digitoxin tablets (= 35 mg digitoxin). He was treated with Fab fragments of a digitalis antiserum raised in sheep, the concentrations of digitoxin in serum, urine and dialysates being measured with two automated digitoxin immunoassays based on fluorescence labelling techniques. Whereas one assay reflected the total digitoxin concentrations, including that bound to the antidote, the other measured only the bioactive "free" form of the drug. This article examines the use and limitations of both assay systems in assessing and monitoring cases of digitalis poisoning.

A new approach of ordered mixing applied to digitoxin tablets

In ordered mixing it is assumed that mixing very different amounts of two materials is improved by adsorption of small particles onto large carrier particles. This hypothesis could be confirmed with tablets of 120 mg containing 0.1 mg digitoxin, prepared by dry coating of particles.

A new approach of ordered mixing applied to digitoxin tablets.

In ordered mixing it is assumed that mixing very different amounts of two materials is improved by adsorption of small particles onto large carrier particles. This hypothesis could be confirmed with tablets of 120 mg containing 0.1 mg digitoxin, prepared by dry coating of particles.

Stability of Digitoxin Tablets Submitted by U.S. Hospitals

The stability of digitoxin tablets that had been stored in hospital pharmacies across the United States was studied. Through a voluntary FDA drug stability program, all hospital pharmacies in the United States were asked in October 1981 to complete a response card indicating information about the digitoxin products they had in stock. Based on the responses, FDA selected 25 samples (representing seven manufacturers) from pharmacies that represented an adequate cross section of the country. These samples were analyzed for content uniformity, strength, dissolution, identification, and other digitoxosides. Of the 25 samples, 19 lots were represented, including 11, 6, 1, and 1 lots of 0.1-mg, 0.2-mg, 0.15-mg and 0.05-mg tablets, respectively. Samples from two lots failed to meet USP requirements for strength, content uniformity, and dissolution; samples from four lots failed to meet the requirements for dissolution only. All six defective lots did not show an expiration date, indicating that they were manufactured before 1975. Digitoxin tablet products still within the expiration date showed no evidence of degradation after storage under actual marketplace conditions.

Advice Regarding Digoxin and Digitoxin Tablets

Advice Regarding Digoxin and Digitoxin Tablets

Bioavailability of Digoxin

A variable or poor response to a therapeutic agent may not have its origin in the patient; it may be due to a formulation defect in the drug product administered. The most commonly recognized formulation defect in a dosage form such as a tablet is a deficiency or excess of the active ingredient. The fact that difficulties of this type were occurring with certain lots of digoxin and digitoxin tablets on the market was discovered by the Food and Drug Administration through a systematic testing program inaugurated in April, 1970, by the Bureau of Drugs with the testing done at . . .

Accidental Poisoning From Pet Medicines in Children

To the Editor.— Recommendations and warnings by the American Academy of Pediatrics regarding accidental drug ingestion by children point out the dangers and complications that may result from carelessness.1In fact, warnings pertaining to medications left where children can reach them, or to the improper closing of containers are constantly being published.2-4 Diseases transmitted from pets to humans are also well documented and include salmonella from turtles,5,6psittacosis from parakeets,7worms from dogs,8and allergic reactions.9 Recently we admitted to our service a 20-month-old child who combined the problem of accidental drug ingestion with a disease re-resulting from one's pet by ingesting approximately ten digitoxin tablets (0.25 mg) that had been prescribed by a veterinarian for the family's dog. The current large number of house pets and the good medical care they get will often result in medications that are potentially toxic being around

Dosage Forms of Digitoxin

Letters and Comments1 July 1970Dosage Forms of DigitoxinG. C. CHIU, M.D.G. C. CHIU, M.D.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-73-1-144_1 SectionsAboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail ExcerptTo the editor: In their article entitled "An Improved Method of Digitoxin Therapy" (Ann Intern Med72: 453-464, 1970), Jelliffe and co-workers stated under Dosage Forms of Digitoxin (p. 461): "Current tablets of digitoxin are restricted to 0.1, 0.15, and 0.2 mg." Actually, digitoxin tablets, U.S.P., have also been available since 1948 in the strength of 0.05 mg. (Tablets Crystodigin®, No. 1736). Furthermore, these tablets are scored so that they can be readily broken into halves.... This content is PDF only. To continue reading please click on the PDF icon. Author, Article, and Disclosure InformationAffiliations: Medical Research Division The Lilly Research Laboratories Indianapolis, Ind. 46206 PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetails Metrics 1 July 1970Volume 73, Issue 1Page: 144-144 Issue Published: 1 July 1970 PDF downloadLoading ...

Automated Fluorometric Procedure for Unit Dose Analysis of Digitoxin and Digoxin in Tablet Formulations

A sensitive and specific automated procedure is described for the unit dose analysis of digitoxin and digoxin in tablet formulations. The technique is based on the fluorometric measurement of the dehydration products of the cardiotonic steroids, resulting from their reaction with hydrogen peroxide in concentrated hydrochloric acid. The automated system is capable of analyzing 12 tablets per hour with a relative standard deviation of ±1.4% at the 0.05-mg. digitoxin level. Accuracy of the procedure was determined by collecting comparative data on digitoxin tablets by both the automated method and the manual USP procedure. Specificity of the method, with respect to the analysis of intact digitoxin in the presence of the products of photochemical, alkaline hydrolytic, and thermal degradation, was demonstrated by comparison to quantitative TLC values. This method has also been shown to be applicable to the unit dose analysis of digoxin in the 0.02 to 1.0 mg./tablet range.

A Comparison of Methods of Assay of Digitoxin Tablets*

A comparative study was made of the assay of digitoxin tablets by the official Canadian method (essentially the same as the U. S. P. XIV pigeon method) and by a preliminary draft of the U. S. P. XV method. A slight modification of the latter procedure was found to give more accurate results for digitoxin content and was incorporated in the U. S. P. XV method of assay. Sixty per cent of the representative samples taken of preparations on sale in Canada failed to meet the requirements of U. S. P. XV because of low digitoxin content. Only 11 per cent of the samples failed to comply with present Canadian requirements. It is apparent that a greater purity of product will be required of some manufacturers to comply with the U. S. P. XV monograph on digitoxin and digitoxin preparations.

The Analysis of Digitoxin Tablets

A method is proposed for the isolation of pure digitoxin from digitoxin tablets by partition chromatography, and the determination of the glycoside by colorimetric procedures. The method permits the recovery and estimation of gitoxin and digitoxigenin in digitoxin tablets.