Selecting Superdisintegrants for Orally Disintegrating Tablet Formulations

During the past several years, there has been rapid growth in the number of orally disintegrating tablets (ODT) available on the market. An ODT is generally recognized as a solid dosage form containing a medicinal substance that disintegrates rapidly and dissolves in the mouth without water within 60. ODTs are also known as quick dissolves, fast melts, or fast-dissolving, rapid-dissolve, or orally dissolving tablets. Today, ODTs are available in a range of sizes and shapes, with some requiring special packaging. To achieve rapid disintegration, direct-compression ODT formulations typically contain high levels of a superdisintegrant. Because ODT formulations typically use high levels of superdisintegrants to achieve rapid disintegration in the mouth, it is important to select a disintegrant that provides optimal performance. The disintegrant should produce rapid disintegration, a smooth mouth feel, good flow, and high compactability. Results show that crospovidone A2 has the best combination of properties for producing physically robust ODTs with the best performance and highest potential consumer appeal.