Softgel shell formulations, manufacturing

Over the 1990 and 2000 periods, 95%i of patents granted for pharmaceutical Softgel products relate to drugs or fill formulations and not to specific claims or improvements regarding shell formulations or manufacturing processes. On the surface, this would appear to indicate a mature technology, but as patents are public domain, and process patents are difficult to enforce, it is more likely that industry leaders are reluctant to pursue patents, except in unusual circumstances. In this process critical industry, it is more reasonable to expect that companies prefer to maintain technological advances as internal in-house matters for competitive reasons. 

Softgel capsules come in a variety of shapes, sizes, and colors that may be speciLcto the mani facturer. In Figure 21.1, some representative shapes and sizes are presented. This chapter providi an overview of the manufacturing methods, formulation of the content medicament, composition of the shell, quality control procedures, stability, and shelf-life testing. V fe also discuss in some detail examples of the products formulated in softgel dosage form. 

This section will describe the typical stepwise process by which Softgels may be developed. The steps generally include fill formulation development, shell compatibility, prototype development (lab scale encapsulation), experimental batch manufacture (process development), clinical supply and conclude with a product performance review of the manufacturing process and specialized formulation approaches to enhance pharmacokinetic performance. 

It is very important to note that, when formulating the fill material for Softgel encapsulation, appropriate consideration is given to the shell development at the same time. It is commonly and erroneously assumed by those not skilled in the art of Softgel manufacture, that the shell is inert and imdergoes no changes itself nor imparts any changes on the encapsulated material. 

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