Softgel manufacture

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. 

Several tests are conducted on a regular basis throughout the encapsulation portion of the Softgel manufacturing... 

Because of the highly cost-intensive operation of softgel capsule production, it is not possible for formulation scientists to conduct research on all phases of the formulation and process development of soft gelatin capsules. However, based on the unique advantages and special properties of this type of dosage form, the formulators should familiarize themselves with the overall technology and processes involved both in the development and manufacturing aspects. 

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. 

Patel M. S., F. S. Morton, and H. Seager. 1989a. Advances in softgel formulation technology. Part 1. Manufacturing Chemist, 60 26-28. 

Healthcare, a division of Johnson Johnson, manufactured and marketed Take Control " and Benecol " spreads, respectively. Current Benecol products include Benecol Buttery Taste Spread, Benecol Light Spread, Benecol Olive Spread, Benecol Light Cream Cheese Style Spreads, Benecol Low Fat Bio Yogurts, Benecol Snack Bars, and, as a supplement, Softgels (a nonfood supplement). 

Softgels are formed, filled, and sealed in a single operation. Once production for a specific product begins, the manufacturing process normally continues 24 hr per day until the lot of product is completed. This results in a manufacturing environment that operates around the clock, up to seven days a week. 

Softgels can be easily manufactured in any shape with a plane of symmetry and any size (to contain up to 25 ml) via appropriate die design. A recent survey has shown that smaller sized Softgels are preferred within each shape category, with oval being the most popular shape. 

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. 

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. 

Eerdinando, J.C Eormulation solutions—softgels. Pharmaceutical Manufacturing and Packaging 2000, 69-73. 

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