compounding HOTLINE

Mr. Erickson is director of professional affairs at Gallipot Inc.

I have a request to compound a combination of liothyronine (T3) and levothyroxine (T4) as a "sustained- release" (SR) or "slow-release" capsule. The commercially manufactured preparations are not "SR." What is the logic?

Presuming that the request is based upon the special needs of a particular patient and does not duplicate therapy that could be administered using commercially manufactured drug products, compounding a capsule of this type is appropriate. T3 and T4 are administered in very small doses, which means that the pharmacist must employ aliquot dilution technique to obtain accurate dosing where a balance with readability to 1 mg is employed. (Accuracy is 20 mg.) A bolus-forming cellulose material such as Methocel E4M Premium often is included as 1/3 of the capsule formulation to permit a "medicated" bolus to form in the stomach after administration. The bolus apparently erodes as it passes through the intestine at a rate dependent upon motility, gut contents, etc, to release the drug(s). Clinical observation reportedly suggests that patients experience reduced incidence of side effects with the slower release or delayed-release form; T4 has a longer half-life than T3, but is often included in the formulation to improve patient compliance. Nomenclature is important? any terminology requiring support from time/absorption studies ("continuous release," "slow release," "extended release") should be avoided because extemporaneous compounding does not employ such studies.

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