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At least 595 records · Page 33Linked to original sources
PubMed1976

[On the development of oral preparations of the combination sulfamoxole/trimethoprim (CN 3123) (author's transl)].

Within the broad range of activities in pharmaceutical research, the technological development and analytical evaluation of a new drug formulation represent only one step. The pharmaceutical development of three oral formulations of a combination product containing N1-(4,5-dimethyl-2-oxazolyl)-sulfanilamide (sulfamoxole) and 2,4-diamino-5-(3,4,5-trimethoxy-benzyl)-pyrimidine (trimethoprim) in a 5:1 ratio (investigational drug CN 3123; Nevin; Supristol), which was based on the physico-chemical characteristics of the 2 active substances, is presented. The various chemical and physical tests conducted with the drug formulations are described. The pharmaceutical or in-vitro availabilities (dissolution rate) of the active ingredients were determined by way of release-rate profiles, both of the active ingredients alone and in their final formulations. Also presented are the results of plasma level determinations following oral administration of film-coated tablets and a suspension. Finally, preliminary results of extensive stability tests with the three drug formulations are discussed.

Administration, Oral↗
PubMed1976

Complications of "slow-K" therapy.

(1) The failure of ;Slow-K' tablets to disintegrate prevents rapid release but allows them to be trapped by their bulk in the intestine.(2) Two cases are reported. In the first the tablet was trapped in a caecal diverticulum and the patient developed an abcess. In the second, abdominal pain developed which subsided when ;Slow-K' was stopped. Later ;Slow-K' was again started and the patient developed dysphagia.(3) The possibility of abdominal complications with this treatment should be remembered.(4) Effervescent KC1 preparations may replace ;Slow-K' but KC1 supplementation may be necessary only in cardiac disease.

Abscess↗
PubMed1979

An enteric-coated pancreatic enzyme preparation that works.

A new enteric-coated pancreatic enzyme preparation (microspheres) was compared with traditional enzyme tablets in six subjects with severe exocrine pancreatic insufficiency. The microspheres were found to be as effective as traditional enzyme supplements. In most patients in balance studies, the lowest fecal fat values were obtained with microsphere therapy in spite of a smaller amount of lipase administered (6015 vs 10,800-43,200 lipase units per meal). In contrast to enteric-coated tablets, microspheres can be recommended in the treatment of pancreatic steatorrhea.

Adult↗
PubMed1987

Concentration of clofibric acid in blood after the administration of delayed-release form of etofibrate.

The clofibric acid levels in blood are studied after the oral administration of 500 mg of etofibrate given as a unique dose in three different delayed-release tablets. These are enteric-coated, obtained by granule compression. An inert matrix containing the drug is the basis of these granules, differentiated by their granulometry and the chemical treatment applied. One of the three tablets presents a very interesting KE, which permits the substitution of three intakes throughout the day by only one dose daily.

Adult↗
PubMed1992

Enteric-coated charcoal as a means of blinding studies comparing bismuth and H2-receptor antagonists.

Clinical trials comparing H2-receptor antagonists and bismuth-containing regimens in ulcer healing, ulcer relapse, or dyspepsia have not been double-blind, because bismuth darkens stools. This study was designed to determine whether enteric-coated charcoal could darken stools of subjects taking an H2-receptor antagonist without interfering with absorption of the drug. Twelve healthy volunteers participated in a randomized, double-blind, crossover trial of oral ranitidine (300 mg at bedtime) alone, ranitidine plus bismuth (30 ml Pepto-Bismol four times daily), and ranitidine plus enteric-coated charcoal (four tablets daily). Mean stool colors both with ranitidine plus charcoal and with ranitidine plus bismuth were significantly darker than with ranitidine alone, but were not significantly different from each other. Blood levels of ranitidine during the 10 h after its administration did not differ significantly among the three regimens. We conclude that enteric-coated charcoal can be used to blind clinical trials comparing an H2-receptor antagonist (e.g., ranitidine) and a bismuth regimen.

Administration, Oral↗
PubMed1987

Drug release from tablets containing cellulose acetate phthalate as an additive or enteric-coating material.

A formulation containing cellulose acetate phthalate for preparing enteric-coated granules was developed with the use of granulation and microencapsulation techniques. Drug release from tablets or tableted microcapsules was measured in a disintegration apparatus and an in vitro variable-pH release simulator of the flow type. The release mechanism for the tablets or tableted microcapsules was determined with the Higuchi matrix model, a first-order kinetic model, and the Weibull distribution function. Adding acetone directly to the mixture of sulfamethoxazole and cellulose acetate phthalate resulted in enteric-coated granules with more prolonged release than other granulation methods. Microencapsulation of the granules significantly delayed the drug release and enhanced the effectiveness of the enteric coating. Microencapsulated granules show release patterns that are sustained and can be simulated with three different release models, i.e., with square-root time plotting, diffusional first-order plotting, and Weibull distribution plotting. The enteric-coating behavior of the tablets was more clearly demonstrated with the variable-pH release stimulator than with a fixed-pH dissolution method.

Capsules↗
PubMed1985

Ulceration of the small intestine due to slow-release potassium chloride tablets.

A retrospective study at surgical clinics in Stockholm County disclosed 22 cases of small-bowel ulceration in which a connection with use of slow-release potassium chloride tablets was probable. Most ulcers had caused stenosis of 1-2 cm of gut, and in four of these cases there was also perforation of the bowel wall. Five patients had perforation without signs of stenosis. The pathology of the ulcers was similar to that described after use of enteric-coated potassium chloride tablets. Since 1970 the frequency of potassium-induced ulceration has been low--3 cases per 100 000 patient-years of slow-release tablet use. On the other hand, this complication of drug therapy can be serious--the mortality in the present series was 27%. Other types of potassium chloride preparations should therefore be tested. Microencapsulated potassium chloride tablets have been reported to be less irritating to the gastrointestinal tract.

Aged↗
PubMed1978

The effect of oral magnesium chloride therapy on the QTc and QUc intervals of the electrocardiogram.

The effect of magnesium, given orally as enteric-coated magnesium chloride tablets, on the ECG of 25 randomly selected patients was investigated. Each patient, who served as his own control, was given 4--6 tablets, each containing 0,5 g MgCl26H2O, at night for periods varying from 6 weeks to 2 years. Findings included (i) a statistically significant decrease in OTc and QUc intervals; (ii) a progressive shortening of QTc and QUc intervals with continuing therapy; (iii) reversion to normal of ECG abnormalities, especially of ST segments and T waves.

Administration, Oral↗