Application Studies / Determining CDI and DTS of Chewable Tablets

Determining CDI and DTS of Chewable Tablets

Industry:

Pharmaceutical

Attributes measured:

force

breaking point

hardness

diametral tensile strength

chewing difficulty index

Background

Chewable tablets are designed for consumers who have difficulty swallowing pills or who prefer them over traditional hard dosage tablets. Reports of adverse health experiences associated with chewable tablets, such as intestinal obstruction due to incomplete chewing or tooth damage from hard tablets, caused the FDA (CDER) to develop a standardized metric to quantify a Chewing Difficulty Index (CDI)1,2. This metric multiplies the force to break tablets with the thickness of a tablet. Diametral tensile strength (DTS) is another recommended index that takes a multiple of the tablet breaking strength under diametral compression and normalizes it by several dimensional elements of a tablet. This study determines CDI and DTS using the TA.XTPlus Texture Analyzer, Exponent software, TA-019 Kobe cylinder and various over the counter, chewable tablets. This study also investigates the effects of brief exposure to a saline solution on chewable tablets.