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Biomedical subjects

E DeRitter

Publications and source records attributed to E DeRitter.

4 recordsLinked to original sources

Stability of phenylpropanolamine hydrochloride in liquid formulations containing sugars.

Stability studies with a decongestant syrup formulation containing phenylpropanolamine hydrochloride in a sugar vehicle indicated a loss of phenylpropanolamine hydrochloride. To ascertain the biological significance of this indicated chemical loss, the degraded formulation was administered to human volunteers and the urinary excretion of phenylpropanolamine hydrochloride was determined. The excretion and chemical assay patterns were in good agreement, indicating that the sugar vehicle was both chemically and biologically incompatible with phenlypropanolamine hydrochloride. A control formulation made with phenylpropanolamine hydrochloride in a sorbitol vehicle showed good chemical stability and urinary excretion patterns. Further studies showed chemical losses with phenylpropanolamine hydrochloride in the presence of fructose, dextrose, and 5-(hydroxymethyl)-2-furaldehyde but not with levulinic acid. Possible mechanisms for the sugar-phenylpropanolamine hydrochloride interaction are discussed.

Carbohydrates↗

Thiamine destruction by sodium bisulfite in infusion solutions.

The degree of degradation of thiamine hydrochloride in sodium bisulfite-containing infusion solutions was investigated. Two amino acid and one electrolyte infusion solution containing sodium bisulfite and four infusion solutions (5 and 10% dextrose, Lactated Ringer's, and 0.9% sodium chloride injections) without sodium bisulfite were obtained in 500-ml glass or plastic containers. Three thiamine sources, two commercial multivitamin preparations, and one investigational multivitamin product were added to the infusion solutions. The percentage of added thiamine remaining after storage was determined in four experiments: (1) The investigational product was added to the infusion solutions with bisulfite, and the determinations were made after 24 hours of storage at room temperature (RT) under both light and dark conditions; (2) the two commercial multivitamin preparations were mixed with an amino acid solution containing bisulfite and the determination was made after 24 hours of storage at RT under dark conditions; (3) the investigational product was added to the infusion solutions with bisulfite, and the determinations were made after 2, 4, 6, 8, and 24 hours storage at 7 degrees C and following four hours at RT under dark conditions; and (4) the investigational product was added to the four infusion solutions without bisulfite, and the determinations were made after 24 hours of storage at RT under both light and dark conditions. In the infusion solutions containing bisulfite, the stability of thiamine was inversely related to the pH. In an amino acid solution at a pH of 6.5, only 3-8% of the added thiamine was found after 24 hours storage at RT, and only 37% was found after 24 hours at 7 degrees C. In the electrolyte solution with bisulfite (pH = 5), the percentages of thiamine remaining after 24 hours RT and 7 degrees C storage were 50 and 69%, respectively. Light exposure was not found to affect the stability of thiamine in the solutions containing bisulfite. In the infusion solutions without bisulfite, a minimal loss of thiamine occurred even though the pH range was 4.7-5.6. The degradation effect of light exposure was greater for the solutions stored in plastic than in glass. Infusion solutions containing bisulfite were found to be unsuitable vehicles for the administration of vitamin formulations containing thiamine. If a patient must receive multivitamins in infusion solutions with bisulfite, the solutions should be used immediately after their preparation, and the patient should be monitored for signs of thiamine deficiency.

Drug Incompatibility↗

Stability of vitamin C (ascorbic acid) in tablets.

Stability of ascorbic acid (vitamin C) in various tablet formulations and the nature and extent of formation of decomposition products (dehydroascorbic acid, diketogulonic acid, and oxalic acid) were determined under normal conditions of storage and in simulated use tests. IR spectrophotometric, colorimetric, fluorometric, titrimetric, polarographic, and chromatographic methods were applied. Recent implications concerning the instability of ascorbic acid in tablets and the potentially harmful nature of the breakdown products are shown to be unfounded. Under normal storage conditions, commerical-type ascorbic acid tablets are stable for over 5 years (greater than 95% potency retention). The amounts of all three breakdown products formed under the various storage conditions constitute a small percentage of the ascorbic acid content and pose no dietary hazard. IR spectroscopy was inadequate as a quantitative method for evaluating ascorbic acid potency in tablet formulations. The official titration methods and TLC, colorimetric, and polarographic determinations correlate well and define accurately the stability of ascorbic acid in these dosage forms.

Ascorbic Acid↗