Qualität magistral hergestellter niedrig dosierter Phenobarbital-Kapseln
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3
摘要:
Many of the medicaments offered by the pharmaceutical industry are not produced in lower dosage required for special indications or paediatrics. Consequently, it is often necessary to produce solid-form individually dosedpreparations for oral administration. The purpose and objective of this present work is to draw attention to the quality-determining aspects involved in small-scale production in the pharmacy. Seven pharmacists produced phenobarbital 1 mg hard gelatine capsules (Size 4) in order to check the uniformity of weight and content uniformity of the active ingredient. The weight deviations and the content uniformity showed a relative standard deviation of 2.3 - 4.9 %. According to the European Pharmacopoeia, all capsules passed - some narrowly - the test of content uniformity. It is shown that every operation like mixing the powders and filling the capsules has to be done with accuracy. Furthermore, it is very important to prevent the loss of mixture material during these operations.
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年份:
2002
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