Objectives. We evaluated the ingestibility and formulation quality of one branded (formulation A) and five generic (formulations B, C, D, E, and F) lansoprazole orally disintegrating (OD) tablets. Methods. Ingestibility, including the oral disintegrating time, taste, mouth feeling, and palatability, was examined by sensory testing in healthy subjects. Formulation qualities, including salivary stability, gastric acid resistance, and intestinal dissolution behavior, were examined. Results and Discussion. The oral disintegration time of formulation F (52 s) was significantly longer than that of other formulations (32–37 s). More than 90% of subjects did not experience bitterness with formulations A, E, and F, whereas 50% of subjects felt rough and powdery sensations with formulations B, C, and D. More than 80% of subjects suggested that formulations A, E, and F had good palatability. Ingestibility was different between formulations. OD tablets consist of enteric granules containing lansoprazole, which is unstable in gastric acid. Enteric granules of each formulation were stable in artificial saliva and gastric juice. No differences were observed in dissolution behaviors among the formulations, indicating that the formulation quality of the formulations was almost equivalent. Conclusions. This study provides useful information for selecting branded or generic lansoprazole OD tablets for individualized treatments.

Here we examined the physical properties of one branded and five generic lansoprazole orally disintegrating tablets (formulations A and B, C, D, E, and F, respectively), including their hydrophilia and tablet strength and the strength required to push the tablets out of a press through package. The wetting time of formulation F (38 AE 4 s) was approximately 1.5-2.7 fold of that of formulations A, B, C, D, and E (25 AE 2, 14 AE 1, 14 AE 1, 16 AE 1, and 22 AE 1 s, respectively). Formulations B, C, D, E, and F had hardness (>3 kgf) and friability (<1%) that could endure impact and vibration of the manufacturing process and transporting. However, formulation A did not have enough tablet strength. The press through package pushing out strength of formulation C (34.4

In this study, we examined the physical properties, including disintegration, passage through a nasogastric administration tube, and acidoresistance, of one branded and five generic formulations of lansoprazole orally disintegrating (OD) tablets containing enteric-coated granules to examine the feasibility of a simple suspension method. The generic tablets immediately disintegrated in warm (55 C) and lukewarm water (35 C) and released the enteric-coated granules, which passed through an administration tube. Moreover, the released enteric-coated granules were stable under a simulated gastric acid environment. However, although the branded tablet disintegrated in warm water, the released enteric-coated granules formed aggregates that did not pass through the administration tube. Meanwhile, the granules released from the branded tablet in lukewarm water did not form aggregates. The present study demonstrated the applicability of a simple suspension method using warm or lukewarm water for generic lansoprazole OD tablets. Additionally, the method is applicable to branded lansoprazole OD tablets using lukewarm water.

Lansoprazole orally disintegrating tablets are produced as a spastab-type formulation containing entericcoated granules. We examined the acidoresistance of these enteric-coated granules following pulverization of lansoprazole orally disintegrating tablets. One branded and five generic tablets were pulverized by tapping, grinding, or mechanical milling. The enteric-coated granules of the branded and generic tablets pulverized via tapping, mild mechanical milling at low speed for 5 s, and slightly mild mechanical milling at high speed for 5 s retained acidoresistance. Moreover, acidoresistance was maintained during storage for one week following pulverization, except for one kind of generic tablets. The granules from the branded tablets also maintained acidoresistance for one week following severe mechanical milling at low speed for 30 s. Grinding and very severe mechanical milling at high speed for 30 s damaged the acidoresistance of all tablets. The results of the present study reveal the pulverization conditions under which the enteric-coated granules for the branded and generic tablets tested retain their acidoresistance.