Formulation Study for Orally Disintegrating Tablet Using Partly Pregelatinized Starch Binder

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 o...

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Bibliographic Details
Published inChemical & Pharmaceutical Bulletin Vol. 59; no. 8; pp. 959 - 964
Main Authors Mimura, Kazuki, Kanada, Ken, Uchida, Shinya, Yamada, Masaki, Namiki, Noriyuki
Format Journal Article
LanguageEnglish
Japanese
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
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Summary: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.
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content type line 23
ISSN:0009-2363
1347-5223
DOI:10.1248/cpb.59.959