ABSTRACT
The purpose of this project was to evaluate the short-term shelf-life stability of an extemporaneously compounded mechlorethamine hydrochloride 0.01% topical ointment stored at room temperature. Mechlorethamine hydrochloreide injection 10-mg vials were reconstituted with 1 mL of dehydrated alcohol injection, USP, yielding a 10-mg/mL solution. One milliliter of the reconstituted liquid was incorporated by spatulation into 100 g of Aquaphor ointment base, yielding an ointment containing mechlorethamine hydrochloride 0.01%. The ointment was packaged in screw-cap ointment jars and stored at 23 deg C. Chemical stability was evaluated over a 90 day-period using derivatization and a stability-indicating high-performance liquid chromatographic analytical method. Decomposition of the intact drug occurred at a mcuh slower rate than that observed in aqueous solutions. The loss appeared to be biphasic, occurring more rapidly during the first week and proceeding much more slowly thereafter. Mechlorethamine hydrochloride solubilized with dehydrated alcohol injection and incorporated into Aquaphor ointment base at a concentration of 0.01% lost 10% potency in seven days when stored at 23 deg C.
ABSTRACT
Norwegian hearing-impaired persons, since 1 May 1986, have been entitled to free hearing instruments (HI), and also to free repair of defective HIs. In order to reduce the community's expense, national regulation recommends that HIs not in use should be returned to a hearing centre for re-use. To achieve a further reduction of expense, the National Health Insurance (NHI) decided that from 1 January 1989, only persons under 18 years of age could have their HIs repaired free of charge. The NHI supposed that some users of HIs would be unwilling to pay for repair of defective instruments, and realized that this would lead to an increased number of defective HIs remaining among the users. A pilot study performed in 1990 supported this assumption. A further consequence of this change of regulation was that clients, entitled to free HIs, could not be given used instruments with or without reduced guarantee--when they had to pay for repair of the instruments themselves. Therefore, the NHI saved expense through user-paid repair of HIs, yet on the other hand had increased costs by buying new HIs instead of giving some of the clients used instruments. The aim of this investigation was to evaluate whether the NHI could pay for the repair of HIs and have these costs covered by savings from the re-use of HIs. During 1992, 1993 and 1994, the cost for repair of the 5150 HIs was 176,560 pounds. During the same period, 2105 HIs were re-used, representing a saving of 445,712 pounds. This repair/re-use system unburdens the users of HIs of expense, and in turn saves money for the community. For approximately 10% of all HIs sent for repair, the main problem was not that the instruments were defective.
