Softgel formulations, development

Patel M. S., F. S. Morton, H. Seager, and D. Howard. 1992. Factors affecting the chemical stability of carboxylic acid drugs in enhanced solubility system (ESS) softgel formulations based on polyethylene glycol (PEG).Drug Development and Industrial Pharmacy, 18 1-19. 

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. 

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. 

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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