ABSTRACT

GELATIN capsules are small, usually oblong, containers used to enclose a va-riety of substances. They are classified as solid dosage forms and are generally intended for oral use but may also be used vaginally and rectally. Gelatin is the main ingredient used to prepare capsules because it produces relatively strong films at room temperature and readily dissolves after ingestion or insertion. Depending upon their gelatin composition, capsules may be classified as soft or hard. Soft gelatin capsules (SGC) are one-piece containers, which contain plasticizers to make them flexible. On the other hand, hard gelatin capsules (HGC) are comprised of two pieces that combine to form a closed container and do not contain any plasticizers, which gives them a rigid structure. This chapter will cover the raw materials used to make HGC, the techniques used for both preparing and filling HGC, and the release of drugs from HGC (Ansel, 1985; Jones, 1990; Rudnic and Schwartz, 1990; Augsburger, 1996).