Physical properties of lansoprazole orally disintegrating tablets

Matsui

Nakamura

2019

Self Cite

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.

Section: Acidoresistance Of Enteric-coated Granulesmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Effect of water temperature on a simple suspension method for lansoprazole orally disintegrating tablets

Matsui

Nakamura

2019

Self Cite

“…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.…”

Section: Acidoresistance Of Enteric-coated Granulesmentioning

confidence: 99%

“…[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.…”

Section: Introductionmentioning

confidence: 99%

Conditional examinations for pulverization of lansoprazole orally disintegrating tablets

Nakamura

Matsui

2019

Self Cite

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.

“…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.…”

Section: Introductionmentioning

confidence: 99%

Usability of theophylline extended-release dry syrups

Ishikawa

Ikeda

et al. 2018

Self Cite

Objectives: We examined the usability of theophylline extended-release dry syrups, including their powder fluidity and ingestibility using one branded and six generic formulations (formulations A, B, C, D, E, F, and G, respectively). Methods: To evaluate the ease of handling by pharmacists, powder fluidity was evaluated by measuring the repose angle, whereas to determine ingestibility, the viewpoints of patients or caregivers were evaluated using a questionnaire survey. Results and discussion: The repose angles of formulations A, B, C, D, E, and F were approximately 30-40. These formulations had sufficient powder fluidity, indicating the ease of weighing for most pharmacists. However, the repose angle of formulation G was <30. Formulation G had high fluidity, suggesting its high rolling property. Thus, powder handling for formulation G may be more difficult than that for other six formulations. The ingestibility, such as the ease of mixing the dry syrup with water and odor intensity, was different between the formulations. Conclusions: The present study provides useful information for selecting branded or generic theophylline extended-release dry syrups.