Pharmaceutical Manufacturing Handbook: Production and

236 SOLID DOSAGE FORMS
4.1.9 Chewable Tablets
4.1.9.1 Testing of Chewable Tablets
4.1.10 Chewing Gums
4.1.10.1 Composition of Chewing Gum
4.1.10.2 Manufacture of Chewing Gum
4.1.10.3 Drug Release from Chewing Gums
4.1.10.4 Applications for Chewing Gums
4.1.11 Orally Disintegrating Tablets
4.1.11.1 Dissolution Testing of ODTs
4.1.12 Solid Dosage Forms for Nonoral Routes
References
Drug substances are most frequently administered as solid dosage formulations,
mainly by the oral route. The drug substance ’ s physicochemical characteristics, as
well the excipients added to the formulations, all contribute to ensuring the desired
therapeutic activity. Tablets and capsules are the most frequently used solid dosage
forms, have been in existence since the nineteenth century, and are unit dosage
forms, comprising a mixture of ingredients presented in a single rigid entity, usually
containing an accurate dose of a drug. There are other types of solid dosage forms
designed to fulfi ll specifi c delivery requirements, but they are generally intended for
oral administration and for systemic delivery. The major solid oral dosage form is
the tablet, and these can range from relatively simple, single, immediate - release
dosage forms to complex modifi ed - release systems. Tablets offer advantages for
both patients and manufacturers (Table 1 ). Most tablets are intended to be swallowed
whole and to rapidly disintegrate and release drug in the gastrointestinal
tract. Tablets are classifi ed by their route of administration or their function, form,
or manufacturing process. For example, some tablets are designed to be placed in
the oral cavity and to dissolve there or to be chewed before swallowing, and
there are many kinds of formulation designed for sustained or controlled release
(Table 2 ).
Solid dose formulations, including tablets, must have the desired release properties
coupled with manufacturability and aesthetics and must involve rational formulation
design. The dose of the drug and its solubility are important considerations
TABLE 1 Advantages of Tablets as a Dosage Form
Easy to handle
Variety of manufacturing methods
Can be mass produced at low cost
Consistent quality and dosing precision
Can be self - administered
Enhanced mechanical, chemical, and microbiological stability compared to liquid dosage
forms
Tamperproof
Lend themselves to adaptation for other profi les, e.g., coating for sustained release