Abstract
In 1998, two clinical trials were started in the Netherlands to evaluate the effect of coprescription of heroin and methadone on the mental and physical health and social functioning of chronic, treatment‐resistant, heroin dependent patients. Since 75–85% of the heroin addicts in the Netherlands use their heroin by “chasing the dragon,” one of the two study arms concerned the coprescription of inhalable heroin. A pharmaceutical dosage form for inhalable heroin was developed for this trial, consisting of a 3:1 powder mixture of diacetylmorphine base and caffeine anhydrate. We describe the manufacturing process that was developed for filling sachets with this mixture in four dosages using a microdose auger filler. In order to control product quality, in‐process controls were developed to monitor the filling process and quality control tests were performed on the finished product. In‐process control results have shown the filling process to be accurate and precise. The diacetylmorphine/caffeine sachets were shown to comply with the specifications for content and uniformity of mass. The finished product was found to be stable for two years when stored at 25°C, 60% relative humidity and for 6 months when stored at 40°C, 75% relative humidity.
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