Factors affecting the characteristics of rapidly disintegrating tablets in the mouth prepared by the crystalline transition of amorphous sucrose

Maltodextrin: A Novel Excipient Used in Sugar-Based Orally Disintegrating Tablets and Phase Transition Process

“…It has been reported in the studies based on conditioning that an amorphous form of the saccharide should exist and a phase transition, manifested as crystalline-amorphous transition, usually occur (13,14). In the current investigation, selected maltodextrin-based ODT formulations prepared by both direct compression and wet granulation techniques were subjected to conditions of 75% relative humidity and 40°C for 4 and 7 days, respectively.…”

“…Recently, few attempts were made to produce sugarbased ODT with the luxury of balanced hardness and disintegration characteristics (3,(12)(13)(14). These involved the use of saccharides classified by Mizumoto et al (13) into type I saccharides exhibiting low compressibility (e.g., mannitol, lactose, xylitol, and erythritol) and type II with high compressibility (e.g., maltose and trehalose).…”

“…These involved the use of saccharides classified by Mizumoto et al (13) into type I saccharides exhibiting low compressibility (e.g., mannitol, lactose, xylitol, and erythritol) and type II with high compressibility (e.g., maltose and trehalose). In most of these attempts, the concept of tablet conditioning has raised up (12)(13)(14). This concept involves the exposure of the tablets to specified conditions of temperature and humidity during which certain changes in the internal tablet structure take place.…”

“…These changes that usually involve crystalline-amorphous transition lead to improvement of tablet hardness while keeping rapid disintegration. Nevertheless, many of the reported methods of preparation of sugar-based ODT with balanced hardness and disintegration characteristics involved a pre-compression treatment such as lyophilization or fluidized bed granulation usually to prepare the amorphous form of the saccharide (13,14). These are time-consuming and expensive processes that require special equipment.…”

Development of a Novel and Simple Method to Evaluate Disintegration of Rapidly Disintegrating Tablets

“…Among them, rapidly disintegrating tablets (RDTs) are a convenient dosage form for elderly people or children who have difficulty swallowing conventional tablets or capsules, as RDTs are disintegrated within several tens of seconds with a small amount of saliva in the oral cavity. [1][2][3][4][5] RDTs are also applicable for drug administration through an enteral feeding tube without crushing the tablets, since RDTs are easily dispersible into an aqueous solution.Two main factors are important for disintegration of RDTs in the oral cavity: the absorption of saliva and the destruction by external pressure between the tongue and the upper palate. Evaluating the disintegration profile of RDTs is important in their development and quality assurance.…”