Stability of an extemporaneously compounded levothyroxine sodium oral liquid. 1996

D W Boulton, and J P Fawcett, and D J Woods
School of Pharmacy, University of Otago, Dunedin, New Zealand.

The stability of levothyroxine sodium in oral liquid dosage forms compounded from commercially available tablets was studied. Levothyroxine sodium oral liquids (25 micrograms/mL) were prepared from tablets and from powder with and without methylparaben preservative and transferred to amber, high-density polyethylene bottles. Five bottles of each tablet-based formulation were stored at 2-8 degrees C, 23-27 degrees C, and 38-42 degrees C, and five bottles of each powder-based formulation were stored at 38-42 degrees C. On days 3, 8, 14, 22, 31, 61, and 90, samples were taken from each bottle and analyzed for drug concentration by stability-indicating high-performance liquid chromatography. There was significant degradation of levothyroxine sodium in all the formulations. However, the tablet-based formulation without preservative stored at 4 degrees C retained at least 90% of its initial concentration for eight days after compounding. Degradation occurred faster in the tablet-based formulation with preservative. None of the formulations retained > or = 90% initial potency by day 14. An extemporaneous oral liquid formulation of levothyroxine sodium 25 micrograms/mL compounded from crushed tablets was stable for eight days when stored in amber bottles at 4 degrees C.

UI MeSH Term Description Entries
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
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
D013974 Thyroxine The major hormone derived from the thyroid gland. Thyroxine is synthesized via the iodination of tyrosines (MONOIODOTYROSINE) and the coupling of iodotyrosines (DIIODOTYROSINE) in the THYROGLOBULIN. Thyroxine is released from thyroglobulin by proteolysis and secreted into the blood. Thyroxine is peripherally deiodinated to form TRIIODOTHYRONINE which exerts a broad spectrum of stimulatory effects on cell metabolism. L-Thyroxine,Levothyroxine,T4 Thyroid Hormone,3,5,3',5'-Tetraiodothyronine,Berlthyrox,Dexnon,Eferox,Eltroxin,Eltroxine,Euthyrox,Eutirox,L-3,5,3',5'-Tetraiodothyronine,L-Thyrox,L-Thyroxin Henning,L-Thyroxin beta,L-Thyroxine Roche,Levo-T,Levothroid,Levothyroid,Levothyroxin Deladande,Levothyroxin Delalande,Levothyroxine Sodium,Levoxine,Levoxyl,Lévothyrox,Novothyral,Novothyrox,O-(4-Hydroxy-3,5-diiodophenyl) 3,5-diiodo-L-tyrosine,O-(4-Hydroxy-3,5-diiodophenyl)-3,5-diiodotyrosine,Oroxine,Sodium Levothyroxine,Synthroid,Synthrox,Thevier,Thyrax,Thyroxin,Tiroidine,Tiroxina Leo,Unithroid,L Thyrox,L Thyroxin Henning,L Thyroxin beta,L Thyroxine,L Thyroxine Roche,Levo T,Thyroid Hormone, T4

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