A New Method for Disintegration Studies of Rapid Disintegrating Tablet

Narazaki, Ryuichi; Harada, Tsutomu; Takami, Norishige; Kato, Yoshiteru; Ohwaki, Takayuki

doi:10.1248/cpb.52.704

Cited by 77 publications

(42 citation statements)

References 12 publications

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“…During this study we made an attempt to develop a more suitable apparatus for RDT ( Figure 3) because many reports [17][18][19][20] indicated the unsuitability of the conventional disintegration test apparatus for RDT. Briefly, the apparatus consisted of a glass beaker …”

Section: In Vitro Disintegration Studymentioning

confidence: 99%

Taste masking of ondansetron hydrochloride by polymer carrier system and formulation of rapid-disintegrating tablets

Khan¹,

Kataria²,

Nakhat³

et al. 2007

AAPS PharmSciTech

114

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The purpose of this research was to mask the intensely bitter taste of ondansetron HCl and to formulate a rapiddisintegrating tablet (RDT) of the taste-masked drug. Taste masking was done by complexing ondansetron HCl with aminoalkyl methacrylate copolymer (Eudragit EPO) in different ratios by the precipitation method. Drug-polymer complexes (DPCs) were tested for drug content, in vitro taste in simulated salivary fluid (SSF) of pH 6.2, and molecular property. Complex that did not release drug in SSF was considered taste-masked and selected for formulation RDTs. The complex with drug-polymer ratio of 8:2 did not show drug release in SSF; therefore, it was selected. The properties of tablets such as tensile strength, wetting time, water absorption ratio, in vitro disintegration time, and disintegration in the oral cavity were investigated to elucidate the wetting and disintegration characteristics of tablets. Polyplasdone XL-10 7% wt/wt gave the minimum disintegration time. Tablets of batch F4 containing spray-dried mannitol and microcrystalline cellulose in the ratio 1:1 and 7% wt/wt Polyplasdone XL-10 showed faster disintegration, within 12.5 seconds, than the marketed tablet (112 seconds). Good correlation between in vitro disintegration behavior and in the oral cavity was recognized. Taste evaluation of RDT in human volunteers revealed considerable taste masking with the degree of bitterness below threshold value (0.5) ultimately reaching to 0 within 15 minutes, whereas ondansetron HCl was rated intensely bitter with a score of 3 for 10 minutes. Tablets of batch F4 also revealed rapid drug release (t 90 , 60 seconds) in SGF compared with marketed formulation (t 90 , 240 seconds; P G .01). Thus, results conclusively demonstrated successful masking of taste and rapid disintegration of the formulated tablets in the oral cavity.

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Section: In Vitro Disintegration Studymentioning

confidence: 99%

Taste masking of ondansetron hydrochloride by polymer carrier system and formulation of rapid-disintegrating tablets

Khan¹,

Kataria²,

Nakhat³

et al. 2007

AAPS PharmSciTech

114

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“…This is due to dosage form specifications for which a dissolution test might not be the best fit, as shown by Han et al for dosage forms like liquid-filled capsules (2) or fastdissolving tablets (3,4).…”

Section: Introductionmentioning

confidence: 99%

“…Now the harmonized monograph specifies the beaker size from 97 to 115 mm (3,12). No data exist which demonstrate that these changes do not affect the performance of the disintegration test.…”

Section: Introductionmentioning

confidence: 99%

Investigation of the Performance of the Disintegration Test for Dietary Supplements

Almukainzi

Salehi

Bou‐Chacra

et al. 2010

AAPS J

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Abstract. The aim of this study was to investigate how beaker size, basket assembly, use of disk, and immersion medium impact the disintegration time of dietary supplements. The disintegration times were determined for five tablet and two capsule products. A two-station disintegration tester was used with Apparatus A or Apparatus B as described in the United States Pharmacopeia (USP) chapters, <701> and <2040>. Two beakers complying with the harmonized specifications were used, one with a volume of 1,000 mL and one with a 1,500-mL volume. The disintegration data were analyzed using ANOVA for the following factors: beaker size, equipment (App A and B) and condition (with/without disk). Two tablet products were not sensitive to any changes in the test conditions or equipment configurations. One product was only partially sensitive to the test conditions. The other products showed impact on the disintegration time for all test conditions. The results revealed that these tablet products might pass or fail current USP disintegration requirements depending on the equipment configuration. Similar results were obtained for the two investigated capsule formulations. One product might fail current USP disintegration requirements if the large beaker was used, but might pass the disintegration requirements when the small beaker was used. Hydroxy propyl methyl cellulose capsules were mostly influenced if sodium instead of a potassium buffer was used as the immersion medium. The results demonstrate that the current harmonized ICH specifications for the disintegration test are insufficient to make the disintegration test into reliable test for dietary supplements.

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“…Multiple laboratories have employed a texture analyzer which allows a constant force to be applied to a tablet using a solid probe. The disintegration time is determined from a plot of distance traveled by the probe as a function of time (8)(9)(10)(11)(12).…”

Section: Dosage Forms For Which a Specific Methods Can Be Recommended mentioning

confidence: 99%

Meeting Report: FIP/AAPS Joint Workshop Report: Dissolution/In Vitro Release Testing of Novel/Special Dosage Forms

Brown¹,

Friedel²,

Barker³

et al. 2011

Dissolution Technol.

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In 2003, the FIP Dissolution Working group published a position paper on dissolution/drug release testing for special/ novel dosage forms that represented the scientific opinions of many experts in the field at that time (1). The position paper has supported activities, programs, and decisions in the scientific, technical, and regulatory community. Due to the rapid evolution of new practices and techniques for in vitro testing, the FIP Special Interest Group (SIG) on Dissolution/ Drug Release decided to revise the previous paper and added proposals for further harmonization of in vitro release testing practices for different pharmaceutical dosage forms. This article represents the current updates to the previously published paper. This revision has been aligned to coincide with the USP taxonomy including route of administration, intended site of drug release, and dosage form. The revised paper includes information from current literature, expert discussions, and presentations from recent workshops (2, 3).

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A New Method for Disintegration Studies of Rapid Disintegrating Tablet

Cited by 77 publications

References 12 publications

Taste masking of ondansetron hydrochloride by polymer carrier system and formulation of rapid-disintegrating tablets

Taste masking of ondansetron hydrochloride by polymer carrier system and formulation of rapid-disintegrating tablets

Investigation of the Performance of the Disintegration Test for Dietary Supplements

Meeting Report: FIP/AAPS Joint Workshop Report: Dissolution/In Vitro Release Testing of Novel/Special Dosage Forms

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