Filling capsules is a very common activity in pre-clinical and first-in-man (early clinical phase) studies for pharmaceutical drug development. Capsules tend to be filled manually at these stages, either because the sample series are too small for most automated capsule filling machines or because different amounts of active ingredient are required per capsule, which is not easy to automate.
The Food and Drug Administration (FDA), or equivalent authority outside the US, demand that pre-clinical trials be carried out for every new drug to determine its toxicity and pharmacological effects. One of the goals of pre-clinical testing is to estimate the safe starting dose for the human clinical trials that follow. Early clinical trials – phase 0 and phase 1 – are designed to evaluate a drug’s delivery method and dosage regimen. These trials may last up to a year, and can be managed internally by the pharmaceutical company’s toxicology department or be outsourced to specialist contract research organizations (CROs).
New pharmaceuticals are often administered via gelatine capsules. The fill weight of each capsule must be accurately calculated and prepared according to the test subject’s weight. This involves manually weighing highly potent, potentially hazardous substances precisely with a spatula.
Automated capsule filling processes offer increased productivity, more efficient use of materials, improved product quality and greater safety for the operator.