Soft-gelatin capsule (SGC) formulations are becoming more popular. These unique capsules are elastic and soft; can mask odors or unpleasant tastes; and are easy to swallow, which provides some distinct advantages over more traditional oral dosage forms such as tablets, hard-shell capsules and even liquids. They are suitable for encapsulation of non-aqueous or lipid formulations (solutions, suspensions or pastes). They are formed, filled and closed off in a single process. Any formulation in softgel can enhance absorption and bioavailability, or produce a quicker onset.
The finished product gelatin shell is primarily composed of gelatin, plasticizer, water and sometimes a colorant. The two types of capsules being produced today are animal-sourced gelatin (i.e., bovine, porcine, piscine) or vegetarian-sourced gelatin replacements (i.e., carrageenans and modified forms of starch and cellulose). The other ingredients used are a polyol plasticizing agent (e.g., glycerin, sorbitol, etc.), water and colors (natural or FD&C). Soft capsules used for oral use are typically round (spherical), oval or oblong in shape.
Products or compounds delivered in tablets or regular two-piece hard-shell capsules first need to dissolve before they can be absorbed, a process that can take as long as 45 minutes; softgels typically will disintegrate within 15 minutes, much faster than other dosage forms. Also, several softgel techniques can considerably improve drug/nutrient absorption and bioavailability.
Solublization
Solubility enhancement is one of the challenges in the formulation of pharmaceuticals and dietary supplements. According to industry statistics, almost 40 percent of all new pharmacologically potent molecules show poor aqueous solubility, leading to their low-effective concentration in biofluids, causing poor bioavailability that directly impacts its therapeutic action. Solublizing poorly absorbed ingredients, such as fat-soluble vitamins, nutrients and drugs (both water-insoluble and lipid-soluble compounds), is a useful option when formulating to enhancing bioavailability of both insoluble and lipid-soluble compounds.
