Stability of famotidine in polyvinyl chloride minibags and polypropylene syringes and compatibility of famotidine with selected drugs. 1993

X Keyi, and N Gagnon, and C Bisson, and M Desmarais, and M LeBel
Laboratoire de Pharmacocinétique Clinique, Université Laval, Québec, Canada.

OBJECTIVE (1) to determine the stability of famotidine 200 micrograms/mL in admixtures with dextrose 5% injection (D5W) and NaCl 0.9% injection (NS) in polyvinyl chloride (PVC) minibags and polypropylene syringes, at room temperature (22 degrees C), protected and unprotected from light for 15 days; and (2) to evaluate the visual compatibility of famotidine with 34 selected drugs for four hours at room temperature. METHODS Concentration of famotidine samples was determined on day 0 and again on days 3, 6, 9, 12, and 15 by a stability-indicating HPLC. Inspection for visual and pH changes was also performed at these time intervals. RESULTS More than 95 percent of the day 0 famotidine concentration remained in all samples over the 15-day study period. During this period, all samples remained clear and colorless and no change in absorbance at 450 and 540 nm was observed. The pH of the samples also remained unchanged. Famotidine 2000 micrograms/mL was found to be compatible with 33 selected drugs; only furosemide was found to be incompatible. A white precipitate was observed when an equal volume of famotidine 2000 micrograms/mL in NS was mixed with furosemide 3000 micrograms/mL in D5W. The concentration of famotidine in the supernatant gradually decreased during the 4-hour study period. At 0.5, 1.0, 2.0, and 4.0 hours after mixture of famotidine with furosemide, famotidine concentrations were 97.5, 23.6, 21.7, and 17.2 percent of the initial famotidine concentration, respectively. CONCLUSIONS Our results show that famotidine 200 micrograms/mL was stable in admixture with D5W and NS in PVC minibags and polypropylene syringes when these solutions were stored at room temperature, protected and unprotected from light for 15 days. Famotidine 2000 micrograms/mL in NS was compatible with 33 of the drugs, and was incompatible with furosemide.

UI MeSH Term Description Entries
D011126 Polypropylenes Propylene or propene polymers. Thermoplastics that can be extruded into fibers, films or solid forms. They are used as a copolymer in plastics, especially polyethylene. The fibers are used for fabrics, filters and surgical sutures. Propene Polymers,Propylene Polymers,Hostalen,Marlex,Marlex Polypropylene,Polypro,Polypropylene,Prolene,Polymers, Propene,Polymers, Propylene,Polypropylene, Marlex
D011143 Polyvinyl Chloride A polyvinyl resin used extensively in the manufacture of plastics, including medical devices, tubing, and other packaging. It is also used as a rubber substitute. Chloroethylene Polymer,Polychloroethylene,Vinyl Chloride Polymer,Chloroethylene Homopolymer,Geon,PVC,Ultron,Viaflex,Vinylite,Chloride, Polyvinyl,Homopolymer, Chloroethylene,Polymer, Chloroethylene,Polymer, Vinyl Chloride
D004344 Drug Incompatibility The quality of not being miscible with another given substance without a chemical change. One drug is not of suitable composition to be combined or mixed with another agent or substance. The incompatibility usually results in an undesirable reaction, including chemical alteration or destruction. (Dorland, 27th ed; Stedman, 25th ed) Drug Incompatibilities,Incompatibilities, Drug,Incompatibility, Drug
D004349 Drug Packaging Containers, packaging, and packaging materials for drugs and BIOLOGICAL PRODUCTS. These include those in ampule, capsule, tablet, solution or other forms. Packaging includes immediate-containers, secondary-containers, and cartons. In the United States, such packaging is controlled under the Federal Food, Drug, and Cosmetic Act which also stipulates requirements for tamper-resistance and child-resistance. Similar laws govern use elsewhere. (From Code of Federal Regulations, 21 CFR 1 Section 210, 1993) DRUG LABELING is also available. Drug Containers and Closures,Packaging, Drug,Drug Containers,Container, Drug,Containers, Drug,Drug Container,Drug Packagings,Packagings, Drug
D004355 Drug Stability The chemical and physical integrity of a pharmaceutical product. Drug Shelf Life,Drugs Shelf Lives,Shelf Life, Drugs,Drug Stabilities,Drugs Shelf Life,Drugs Shelf Live,Life, Drugs Shelf,Shelf Life, Drug,Shelf Live, Drugs,Shelf Lives, Drugs
D000704 Analysis of Variance A statistical technique that isolates and assesses the contributions of categorical independent variables to variation in the mean of a continuous dependent variable. ANOVA,Analysis, Variance,Variance Analysis,Analyses, Variance,Variance Analyses
D013594 Syringes Instruments used for injecting or withdrawing fluids. (Stedman, 25th ed) Hypodermic Syringes,Syringe, Karman,Hypodermic Syringe,Karman Syringe,Syringe,Syringe, Hypodermic,Syringes, Hypodermic
D015738 Famotidine A competitive histamine H2-receptor antagonist. Its main pharmacodynamic effect is the inhibition of gastric secretion. Famotidine Hydrochloride,MK-208,Pepcid,YM-11170,MK 208,MK208,YM 11170,YM11170

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