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Pharmaceutical Manufacturing and Packing Sourcer

The Small Scale Production of Hard Gelatine Capsules

Since its first production in Paris in 1834, the two-piece hard gelatine capsule has proved to be a versatile dosage form able to accommodate both liquid and powder fills. It is now proving especially useful for the preparation of test materials for the early stages of clinical trials programmes.

The last couple of decades has seen the emergence of biotechnology and virtual companies, with new active pharmaceutical ingredients (APIs), wishing to move from the stage of chemical synthesis into the clinic. Many of these emergent companies do not have the infrastructure to develop suitable dosage forms for the clinic, and so it has become one of the roles of the pharmaceutical services industry to work with them to produce these crucial test materials. The hard gelatine capsule has become the dosage form of choice for producing clinical trials medicines.

Phase I Studies

So what are the advantages of this particular dosage form? In Phase I studies the test drug is usually given to a small number of healthy volunteers. The objective of such a trial is to determine the plasma concentration and profile of the drug, and at this stage of development the quantity of API available is invariably very limited, often a matter of a few grams.


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By Fred Higton, Head of Formulation Development at Penn Pharmaceutical Services Limited

Fred Higton is Head of Formulation Development at Penn Pharmaceutical Services Limited. Fred studied for both his BSc and PhD in Chemistry at the University of London from where he joined the Boots Company. Within that organisation he held a number of development-related posts including Head of Analgesics Development, Head of Formulation and Director of Consumer Products Development within Boots Healthcare International.

In these various roles he was responsible for the development of a large number of both licensed and unlicensed products. Leaving the Boots Company after over 25 years' service, Fred joined Penn Pharmaceutical in 2002.

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