Ingestibility and Formulation Quality of Lansoprazole Orally Disintegrating Tablets

Abstract

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.

Conditional examinations for pulverization of lansoprazole orally disintegrating tablets

“…The absorbance of these samples at 284 nm was measured using a spectrophotometer (UV1280, Shimadzu Corporation, Kyoto, Japan), and the drug retention (%) of the enteric-coated granules was calculated as an acidoresistance index. 9,10 For those formulations for which the drug retention (%) just after pulverization was more than 90%, the pulverized substance equivalent to one tablet was wrapped in pharmaceutical paper used for wrapping individual doses of powdered medicine, followed by storage at 25 C and 50% humidity for one week. Then, the drug retention (%) of the enteric-coated granules was obtained as described above to evaluate acidoresistance after storage.…”

“…Lansoprazole orally disintegrating (OD) tablets are frequently used to treat gastric ulcers, duodenal ulcers, and reflux esophagitis in the clinical setting. 1 In addition to the branded Takepron V R OD tablets, 2 several generic formulations are also available. Both branded and generic formulations of lansoprazole OD tablets are composed of compressed spastab-type tablets consisting of enteric-coated granules (because lansoprazole is unstable in gastric acid) and other additives.…”

“…[2][3][4][5][6][7] We have examined previously the physical properties and ingestibility of branded and several generic lansoprazole OD tablets, and have demonstrated that their physical properties (such as dissolution behavior) and ingestibility (such as usability and flavor) differ among these formulations. [8][9][10] Furthermore, we have provided previously the applicable conditions of the simple suspension method (that is, administration method via a nasogastric tube) for branded and several generic lansoprazole OD tablets. 11,12 OD tablets are rapidly disintegrated in the oral cavity.…”

Taste and dissolution of theophylline extended-release dry syrups

“…We reported similar findings in our previous studies using branded and generic orally disintegrating tablets containing tamsulosin, lansoprazole, and amlodipine. [12][13][14] The difference in taste can likely be attributed to the presence of different pharmaceutical additives between formulations. For the sweetness (panel A), the medians of formulations F and G were less than 2.…”

Usability of theophylline extended-release dry syrups

“…The wholesale product cost is not an optimal criterion for selecting formulations; selection based on scientific assessments of usability is more favorable. We previously examined the usability of branded and generic orally disintegrating tablets, such as amlodipine, 8 lansoprazole, [9][10][11] and tamsulosin, 12 and it provided useful information for selecting branded or generic formulations. Here, we evaluated the usability of seven theophylline extended-release dry syrup formulations (one branded and six generic) using a similar scientific approach.…”