Stability of an extemporaneously compounded terbutaline sulfate oral liquid. 1991

R K Horner, and C E Johnson
University Medical Center, Jacksonville, FL.

The stability of terbutaline sulfate in an extemporaneous oral liquid formulation refrigerated for 55 days was studied. A suspension was prepared by grinding commercially available 5-mg terbutaline sulfate tablets, adding Purified Water, USP, to form a paste, and then adding Simple Syrup, NF. A control solution was prepared from analytical grade terbutaline sulfate powder in Simple Syrup, NF. The final concentration of terbutaline sulfate in both preparations was 1 mg/mL. Three samples of each formulation were stored in 4-ounce amber glass prescription bottles in the dark at 4 degrees C. Immediately after preparation and at 10, 19, 35, and 55 days, samples were visually inspected, tested for pH, and assayed in duplicate by high-performance liquid chromatography. On days 0 and 35, 100-microL samples of each suspension and solution were placed on agar plates for microbiological testing. On day 55, the mean percentages of the initial terbutaline sulfate concentrations remaining were 103.8% in the suspension and 91.7% in the solution. Color, odor, and pH of the samples did not change appreciably, and colony counts of bacteria were within acceptable limits. An extemporaneously prepared liquid preparation of terbutaline sulfate in Simple Syrup, NF, is stable under the conditions studied for up to 55 days; however, since microbiological testing was not performed on day 55, it is recommended that the preparation be stored for no longer than 30 days.

UI MeSH Term Description Entries
D012034 Refrigeration The mechanical process of cooling. Cold Chain,Chain, Cold,Chains, Cold,Cold Chains
D004339 Drug Compounding The preparation, mixing, and assembly of a drug. (From Remington, The Science and Practice of Pharmacy, 19th ed, p1814). Drug Formulation,Drug Preparation,Drug Microencapsulation,Pharmaceutical Formulation,Compounding, Drug,Formulation, Drug,Formulation, Pharmaceutical,Microencapsulation, Drug,Preparation, 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
D004356 Drug Storage The process of keeping pharmaceutical products in an appropriate location. Drug Storages,Storage, Drug,Storages, Drug
D013726 Terbutaline A selective beta-2 adrenergic agonist used as a bronchodilator and tocolytic. Arubendol,Asthmoprotect,Brethaire,Brethine,Bricanyl,Bricanyl SA,Butaliret,Butalitab,Contimit,KWD-2019,Monovent,Taziken,Tedipulmo,Terbasmin,Terbul,Terbutalin AL,Terbutalin Stada,Terbutalin-ratiopharm,Terbutaline Sulfate,Terbuturmant,terbutalin von ct,KWD 2019,KWD2019,Terbutalin ratiopharm
D013997 Time Factors Elements of limited time intervals, contributing to particular results or situations. Time Series,Factor, Time,Time Factor

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