ABSTRACT
This chapter provides an overview of the manufacturing methods, formulation of the content medicament, composition of the shell, quality control procedures, stability, and shelf-life testing. It also discusses in some detail examples of the products formulated in softgel dosage form. The chapter provides brief description of the various processing technologies for production of soft gelatin capsules: plate process, rotary die process, the rotary die encapsulating machine, accogel process, and seamless process. Important consideration in the development of soft gelatin capsules is the composition of the fill content, be it solution, suspension, or solid. The compounds that are difficult to formulate in soft gelatin capsules are fairly water-soluble small organic molecules, acids, and bases. Quality control of the in-process and final product is critical for the overall presentation of any dosage form, and production of soft gelatin capsules is no exception. Most of the soft gelatin capsules' shell compositions contain parabens as preservatives since gelatin is intrinsically subject to microbial degradation.
