Formulation Study for Lansoprazole Fast-disintegrating Tablet. III. Design of Rapidly Disintegrating Tablets

Shimizu, Toshihiro; Sugaya, Masae; Nakano, Yasuhiko; Izutsu, Daisuke; Mizukami, Yoshio; Okochi, Kazuhiro; Tabata, Tetsuro; Hamaguchi, Naoru; Igari, Yasutaka

doi:10.1248/cpb.51.1121

Cited by 49 publications

(33 citation statements)

References 23 publications

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“…8 RDTs are also applicable when local action in the mouth is desirable such as local anesthetic for toothaches, oral ulcers, cold sores, or teething, 9 and to deliver sustained release multiparticulate system to those who cannot swallow intact sustained action tablets/capsules. 10 Ondansetron HCl is a potent antiemetic drug 11 indicated for the treatment and/or prophylaxis of postoperative or chemotherapy-or radiotherapy-induced emesis and also used in the early onset of alcoholism. 12 In general, emesis is preceded with nausea and in such condition it is difficult to administer drug with a glass of water; hence it is beneficial to administer such drugs as RDTs.…”

Section: Introductionmentioning

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: Introductionmentioning

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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“…Tablets A and E are also formulated with low-stickiness additives during water absorption, and have a dense structure from their manufacture by direct compression. 14,15) On the other hand, the disintegration time of the other tablets (2, 5, 6, B, C, D) decreased with an increase in weight. Tablets 2 and 6 contain erythritol, and tablets 5 and 6 contain micronized crospovidone.…”

Section: Determination Of the Test Condition In The New Disintegratiomentioning

confidence: 98%

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

Hoashi

Tozuka

Takeuchi

2013

CHEMICAL & PHARMACEUTICAL BULLETIN

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The purpose of this study was to develop and test a novel and simple method for evaluating the disintegration time of rapidly disintegrating tablets (RDTs) in vitro, since the conventional disintegration test described in the pharmacopoeia produces poor results due to the difference of its environmental conditions from those of an actual oral cavity. Six RDTs prepared in our laboratory and 5 types of commercial RDTs were used as model formulations. Using our original apparatus, a good correlation was observed between in vivo and in vitro disintegration times by adjusting the height from which the solution was dropped to 8 cm and the weight of the load to 10 or 20 g. Properties of RDTs, such as the pattern of their disintegrating process, can be assessed by verifying the load. These findings confirmed that our proposed method for an in vitro disintegration test apparatus is an excellent one for estimating disintegration time and the disintegration profile of RDTs. Key words rapidly disintegrating tablets; disintegration test; disintegration time; disintegrating profileIn recent years, several types of dosage forms have been developed for a variety of demands such as improvement in patient compliance. 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. Many studies have recorded disintegration times in the human mouth.6,7) However, evaluating the disintegration time in the human mouth entails the following problems: 1) the disintegration time in the mouth tends to depend on oral environments and conditions, and thus, results are scattered; and 2) the human sensory test has risks for healthy volunteers. Many other disintegration test methods have been proposed such as a modified disintegration test and a modified dissolution test.8,9) However, the evaluation of various RDTs using these methods is ultimately flawed because their environments differ from that of the oral cavity. Some researchers reported disintegration test for RDTs using a loading apparatus.10-12) These apparatuses still have some problems, such as wetting of the tablet only on one side and the requirement of a special apparatus such as a texture analyzer to load.The purpose of this study was to develop a novel and simple method to simulate the disintegration time and profiles of RDTs in the oral cavity. The developed method has several advantages: 1) it invo...

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“…Many pharmaceutical companies have developed various types of ODTs. A freeze-dried porous wafer known as Zydis, 4,5) a molding tablet known as EMP, 6) an effervescent tablet known as OraSolve, 7) and a disintegrative addition 8,9) have been developed, consisting of high and low-compressibility saccharide tablets known as WOWTAB-DRY. 10) In addition, new ODTs have been developed, consisting of rapid disintegration granules (RDGs) spray-coated with a suspension of wicking agents using a fluidized-bed granulator known as RACTAB.…”

mentioning

confidence: 99%

Taste-Masking Effect of Physical and Organoleptic Methods on Peppermint-Scented Orally Disintegrating Tablet of Famotidine Based on Suspension Spray-Coating Method

Sugiura

Uchida

Namiki

2012

CHEMICAL & PHARMACEUTICAL BULLETIN

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Orally disintegrating tablets (ODTs) are useful for improving benefits for patients of various ages. Masking the unpleasant taste of a drug is an important factor in the compliance of patients who take ODTs. We evaluated the taste acceptability effects of various taste-masking methods on bitter famotidine ODTs as a clinical pharmacological study. The following methods were tested to compare taste-masking effects: physical masking by spray-coating famotidine with ethyl cellulose versus organoleptic masking with added sweetener and flavor. The ODT samples were prepared as single or combinations of each taste-masking method using a novel suspension spray-coating method including a placebo. A total of 31 healthy volunteers were enrolled in this randomized, double-blind study and asked to score their bitterness, sweetness and total palate impressions by 100 mm visual analogue scale (VAS). VAS scores were significantly improved by the physical and organoleptic methods as compared to without taste-masked ODTs. Furthermore, the combination of both taste-masking methods was most effective for improving palatability and VAS scores were similar to those of placebo ODTs. The results of this study suggest that different taste-masking mechanisms function cooperatively.

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Formulation Study for Lansoprazole Fast-disintegrating Tablet. III. Design of Rapidly Disintegrating Tablets

Cited by 49 publications

References 23 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

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

Taste-Masking Effect of Physical and Organoleptic Methods on Peppermint-Scented Orally Disintegrating Tablet of Famotidine Based on Suspension Spray-Coating Method

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