Formulation Study for Orally Disintegrating Tablet Using Partly Pregelatinized Starch Binder

• Published in: Chemical & Pharmaceutical Bulletin Vol. 59; no. 8; pp. 959 - 964
• Main Authors: Mimura, Kazuki, Kanada, Ken, Uchida, Shinya, Yamada, Masaki, Namiki, Noriyuki
• Format: Journal Article
• Language: English
• Published: Japan The Pharmaceutical Society of Japan 2011; Pharmaceutical Society of Japan; Japan Science and Technology Agency
• Subjects: Administration, Oral; binder; central composite design; Chemistry, Pharmaceutical; disintegration time; Drug Compounding; Excipients - chemistry; Gelatin - chemistry; Hardness; Mannitol - chemistry; orally disintegrating tablet; partly pregelatinized starch; Solubility; Starch - chemistry; Tablets - chemistry
• ISSN: 0009-2363; 1347-5223
• DOI: 10.1248/cpb.59.959

In this study, we aimed to design orally disintegrating tablets by employing a formulation design approach that enables the production of such tablets in the same facilities used for the production of solid dosage forms on an industrial scale. First, we examined the relationships between the types of binders used in the tablets and the properties of orally disintegrating tablets prepared by the wet granulation method. Results revealed that partly pregelatinized starch is a relatively suitable binder for orally disintegrating tablets as it also serves as a disintegrant. Next, we employed a central composite design for 2 factors, namely, corn starch and partly pregelatinized starch, in order to design granules suited for orally disintegrating tablets composed of D-mannitol, corn starch or partly pregelatinized starch. The effects of these 2 factors on 3 types of responses, namely, 50% granule size, compressing index and disintegrating index, were analyzed with a software package, and responses to changes in the factors were predicted. This study investigated the effects of binder type and binder content in orally disintegrating tablets, and provided evidence that the binder exerts a strong influence on tablet properties, and is therefore an important component of orally disintegrating tablets.