Effect of absorbents on water vapor transmission of free and applied polymer films.

The influence of different types of absorbents on moisture transmission through free (cast films) and applied (coated tablets) polymer films was investigated. In free film studies, lubricated granulations were considered to be the absorbent. The compressed tablet was considered to be the absorbent in applied film studies. The results suggested that, using the same film formulation and film thickness in all cases, the polymer film reduced moisture absorption to the same degree, independent of the absorbent used, suggesting a constant moisture permeation. The results of the free film studies also simulated those of the applied films, allowing the correlation of the data.

Rapid and accurate stability-indicating assay for nitroglycerin.

A rapid high-pressure liquid chromatographic method for determining the nitroglycerin concentration in liquid dosage forms and intravenous admixture solutions is presented. A coefficient of variation of less than 1.8% was achieved over the concentration range most commonly encountered (50-500 microgram/ml). A variable wavelength detector (lambda = 218 nm) and a micro-alkyl phenyl column were employed. The mobile phase was acetonitrile-tetrahydrofuran-water (26:10:64). Total analysis time was 12 min.

Loss of nitroglycerin from solutions to intravenous plastic containers: a theoretical treatment.

The physical instability of nitroglycerin solutions in plastic containers has been reported extensively. A systematic study of potency loss in plastic infusion bags were reported recently. This paper presents a theoretical treatment of the data and a proposed model consisting of adsorption onto the surface followed by partitioning into the plastic.

Evaluation of sustained-action chlorpheniramine-pseudoephedrine dosage form in humans.

This investigation compared the bioavailability of chlorpheniramine and pseudoephedrine from a sustained-action capsule and a combination of two reference standard tablets in 24 normal human subjects. The capsule contained 8 mg of chlorpheniramine maleate and 120 mg of pseudoephedrine hydrochloride, and the tablets each contained half of the amount of the chlorpheniramine or pseudoephedrine in the capsule. Because the capsule was a combination product, a new study design had to be developed to accommodate steady-state conditions for both drugs. Each subject received the capsule (every 12 hr) and the combination of the reference tablets (every 6 hr) for 8 days according to a two-way crossover design. Serial blood and urine samples were taken during the entire study. Plasma and urine samples were assayed for chlorpheniramine and pseudoephedrine by sensitive and specific high-pressure liquid chromatographic or GLC methods. There were no significant differences in the plasma concentration profiles of chlorpheniramine and pseudoephedrine at all times, except when the capsule developed peaks or the tablets developed nadirs. The highest mean peak plasma concentrations for the capsule and the tablets were 38.7 and 32.9 ng of chlorpheniramine/,ml and 525 and 515 ng of pseudoephedrine/ml, respectively. The mean biological half-lives of chlorpheniramine and pseudoephedrine were 21.6 and 8.0 hr, respectively. The AUC and unchanged drug excreted in urine, after a single dose and at steady state, showed that the sustained-action capsule (given every 12 hr) and the reference standard tablets (given every 6 hr) were bioequivalent.

Pharmaceutical considerations of nitroglycerin.

During the past few years, there have been rapid changes in the pharmaceutical uses of nitroglycerin. New dosage forms and new delivery systems have become available, which have resulted in potential confusion to all concerned with the proper use of these systems. The goal of this review is to prevent confusion and to bring all the relevant information together. The various analytical techniques available for quality control of the dosage forms and for the study of the pharmacokinetics are reviewed, with the intent of enabling the reader to identify pertinent references rapidly. The interaction of nitroglycerin with packaging and plastic delivery devices is also reviewed so that the reader can make informed choices. Finally, the clinical pharmacy and pharmacokinetics are reviewed so as to bring the reader up to date in that area. After reading this article, the areas of nitroglycerin research that still need to be explored should be apparent.

Nitroglycerin compatibility with intravenous fluid filters, containers, and administration sets.

The effect of intravenous filters, containers and administration sets on nitroglycerin potency was studied. Solutions of nitroglycerin (50 and 100 microgram/ml) in water for injection, in 5% dextrose injection and in 0.9% sodium chloride injection were prepared. The concentration of these solutions was measured after (1) filtration through a 0.2-micron filter, (2) storage in glass and plastic containers and (3) administration through eight i.v. administration sets. Filters decreased nitroglycerin concentration by 2--55%. Nitroglycerin concentration was not changed after storage for 48 hours in glass bottles. In plastic i.v. bags, concentration decreases were substantial and related to surface contact area and storage temperature. The i.v. administration sets caused immediate, substantial decreases in nitroglycerin concentration that were a function of drip rate, surface area, length of exposure to tubing, and tubing materials. The study suggests that concentrations of nitroglycerin solutions could be reduced by as much as 80% when filtered, placed in a plastic i.v. bag and given through an i.v. administration set.

Bretylium tosylate intravenous admixture compatibility. I: Stability in common large-volume parenteral solutions.

The stability of bretylium tosylate in 11 common large-volume parenteral solutions was studied. Two containers of each solution, one glass and one plastic (except for mannitol and sodium bicarbonate solutions, which were available in glass only), were stored at each of the following conditions: intense light (1400-2000 foot candles), ambient room temperature with normal light, 40 degrees C, and 4 degrees C. All samples were tested at 0 and 24 hours; some samples were also tested at 48 hours and 7 days. Testing included measurement for optical density at 4000 and 600 nm, pH level, and bretylium content as determined by HPLC. The admixtures remained clear and colorless, except that mannitol precipitated out of mannitol solutions stored at 4 degrees C. No appreciable changes in pH were observed. HPLC assays showed no significant changes in bretylium tosylate concentrations. Bretylium tosylate is compatible with each of the 11 common intravenous solutions chosen for investigation under the storage conditions studied. Admixtures with mannitol should not be refrigerated, because mannitol crystallizes from solution at refrigerator temperatures.