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All dosage forms prepared in hospital pharmacies should be labelled with an appropriate shelf-life. This shelf-life should be validated taking chemical, physical and microbiological data into consideration. This guidance focuses on parenteral aseptically prepared products, as they are high-risk preparations. The risk is exacerbated by a requirement for longer shelf lives for reasons of economy and efficiency. The scope of this guidance includes individual patient preparations, preparations prepared in series (same type of preparation being repeatedly prepared) and batch preparations prepared from the same initial bulk admixture.

The effect of treatment on maintenance of remission was examined in 90 patients with healed duodenal ulcer shown by endoscopy. They were randomized to take treatment for 6 months with a prostaglandin synthetase promoter (263E) 500 mg three times daily or cimetidine 400 mg at night or an identical placebo. Sixty-five patients completed the trial or had a relapse of symptoms. The percentage of patients who had recurrent ulcers or duodenitis alone on endoscopy was 297, on 263E, 36," with cimetidine, and 50°J0 on placebo. These figures did not differ significantly. Trials of this design are now difficult to conduct because patients take an H, receptor antagonist soon after recurrence of symptoms, before their next clinic appointment. Maintenance treatment of recurrent peptic ulcer by Cirnetidine. Winship, D.H. (1978) Cimetidine in the treatment of duodenal ulcer. Review and commentary. management of severe duodenal ulcer dyspesia. Ganrroenrerology, 74,397-340. Lancer, i, 403407. Gasr roenrerology , 7 4,402-406.

SUMMARY Isosorbide dinitrate is shown to be absorbed onto PVC bags and administration sets, resulting in a fall in potency to about 70–80% of its initial value in the first 15–30 min of an i.v. infusion. The drug was not absorbed by glass or polypropylene.

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