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EAHP Statement 3: Production and Compounding.
Introduction
Pharmaceutical compounding and extemporaneous preparations are effective ways to produce personalised medicine. In particular, suitable dosage forms or doses are not available from the pharmaceutical industry.1 2 In many cases, liquid formulations are used for individual drug therapy.3 However, there are several problems with liquids, involving storage stability, bacterial contamination, and medication errors by the patient when quantifying syrup. In a few cases, tablets and capsules are reformulated into powder formulations to regulate the dose of the medicines.4 However, weight loss of the powders during dispensing and administration due to their bulky and adhesive properties creates challenges. Therefore, we considered that, for children or elderly patients, the granule form would be more preferable.
However, it has been difficult to produce granules in the dispensing process because manufacturing technologies used in industries cannot be applied in a pharmacy setting. Recently, a concise granulation method for reformulating tablets or capsules into granules in pharmacies has been reported.5 The technique employs a desktop compounding mixer based on a planetary centrifugal mixer, commonly used for blending ointments. It enables small-scale and rapid production—for example, 10 g in a 58 mL vessel in less than 1 min.6
In this study, we used rifampicin capsules as a model medicine. Rifampicin is a bactericidal antibiotic drug of the rifamycin group7 and is an essential drug for the treatment of tuberculosis. However, side effects, such as fever, rash, and liver failure, are frequently caused by allergic reactions.8 Although patients may be allergic to the medicine, rifampicin remains the recommended treatment after drug desensitisation therapy. The typical schedule for desensitisation is a 25 mg dose for 3 days, followed by 50 mg for 3 days, 75 mg for 3 days, and 100 mg for 3 days, before receiving one capsule (150 mg) for 3 days.9 Therefore, powders or liquids must be reconstituted from the capsules to obtain the required doses of 25–100 mg.
The purpose of this study was to prepare and evaluate rifampicin granules reformulated from capsules. The granulation was performed at a production scale of 0.4–1.6 g in 12 mL vessels using a compounding mixer. To assess the quality of the granules, we conducted X-ray diffraction measurements...