Widely used two-piece empty gelatin capsules offer the best combination of in vivo performance, excellent handling in high-speed filling machines, and shelf life stability. Here are some of the many reasons why this drug delivery system has stood the test of time and remains the preferred choice of the global pharmaceutical industry.
Cost-effective - Because the raw materials are cheaper and the manufacturing process is simpler, gelatin capsules are more economical than two-piece capsules made from HPMC.
Safety - Gelatin has a Generally Recognized As Safe (GRAS) status in pharmaceutical applications by most regulatory agencies worldwide. It is non-allergenic, natural, and free of genetically modified organisms (GMOs).
Flexibility - Gelatin capsules can be used in a variety of formulations and applications, including encapsulating large doses of active substances and heat-sensitive drugs that cannot be tableted. They can be filled with powders, granules, beads, liquids, and tablets – or a combination of filling types.
Customizability - Two-piece gelatin capsules can be customized in a variety of ways, including size, color, strips, finishes, printing options, and even flavors. This is important because FDA guidelines encourage drug companies to make it easier for consumers to distinguish one drug from another.
API Immediate Release - Dosage is an important factor in evaluating capsule performance. The sooner the capsule is opened in the stomach, the sooner the active pharmaceutical ingredient (API) is available for absorption by the body. Gelatin capsules dissolve quickly and reliably as expected.
Low Oxygen Permeability - Due to the low oxygen permeability of gelatin capsules, they are an excellent choice for oxygen-sensitive APIs.
Excellent mechanical resistance - gelatin capsules can withstand the heat of the filling machine without affecting its function.
Consumer preference - Research shows that consumers prefer all types of capsules over tablets. Capsules are easier to swallow and can mask unpleasant tastes and odors. Additionally, capsules can be made without binders or other excipients, which can make them easier to digest.