Further improvement of orally disintegrating tablets using micronized ethylcellulose

Okuda, Yutaka; Irisawa, Yosuke; Okimoto, Kazuto; Ôsawa, Takashi; Yamashita, Shinji

doi:10.1016/j.ijpharm.2011.10.050

Cited by 25 publications

(10 citation statements)

References 19 publications

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“…In our previous report, we demonstrated that the compaction force between RDGs was completely transmitted and related to matrix formation because MEC worked as a dry-binder in ODTs. 17) MEC increased the contact frequency between RDGs in the tablet and led to the high hardness of the tablet with a relatively low compression force. Thus, plastic deformation in ODT RAC was considered to be smaller than that in ODT ref .…”

Section: Discussionmentioning

confidence: 99%

“…2. Figure 2a shows the preparation method of ODTs using RACTAB ® technology (ODT RAC ) developed in Towa Pharmaceutical Co., Ltd. 16,17) Rapidly disintegrating granules (RDGs) were initially prepared using the suspension spray-coating method with a fluidized-bed granulator (MP-01, Powrex, Japan) at a 1 kg size scale. Briefly, D-mannitol (D 50 : 64.3 µm) was spray-coated with a suspension of corn starch and crospovidone (9 : 1 w/w ratio).…”

Section: Methodsmentioning

confidence: 99%

“…Furthermore, by applying micronized ethylcellulose (MEC), the ODT acquired high resistance to humidity and high physical strength. 17) When RDGs containing MEC were tableted at an appropriate compression force (6 kN), the ODTs exhibited adequate hardness and friability for clinical use. This newly developed technology, named RACTAB ® technology, is now widely used for the marketed products of ODTs.…”

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confidence: 99%

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Formulation Design for Orally Disintegrating Tablets Containing Enteric-Coated Particles

Okuda

Okamoto

Irisawa

et al. 2014

CHEMICAL & PHARMACEUTICAL BULLETIN

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The purpose of this study was to investigate the applicability of our newly developed technology (RACTAB ® technology) for preparing orally disintegrating tablets (ODTs) containing enteric-coated particles. Tamsulosin hydrochloride (TAM) was used as a model drug contained in the enteric-coated particles. Enteric-coated particles containing TAM (ECP-T) were prepared by spray coating a mixture of TAM with controlled-release materials. ECP-T was then mixed with rapidly disintegrating granules (RDGs), which were prepared using the suspension spray-coating method, and was tableted to form ODTs (ODT RAC ). ODT RAC was evaluated for its hardness, thickness, internal structure (X-ray-CT scanning), functional properties (controlled-release profile), and in vivo disintegration time. Since RDGs with micronized ethylcellulose (MEC) increased tablet hardness by increasing the contact frequency between granules, ODT RAC containing ECP-T exhibited high hardness (>50 N) and low friability (<0.5%) with a relatively low compression force. After tableting, the structure of ECP-T in ODT RAC remained intact and no damage was observed on the surface. ECP-T recovered from ODT RAC showed the same dissolution profile of TAM in Japanese Pharmacopoeia (JP) 1st and JP 2nd media as that of intact ECP-T, which indicated that the tableting process did not affect the acid-resistibility of the particle. In addition, ODT RAC rapidly disintegrated in vivo (< 30 s), even at a high compression force (at 9 kN). These findings clearly suggest that RACTAB ® technology is a useful approach to prepare ODTs containing enteric-coated particles.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

mentioning

confidence: 99%

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Formulation Design for Orally Disintegrating Tablets Containing Enteric-Coated Particles

Okuda

Okamoto

Irisawa

et al. 2014

CHEMICAL & PHARMACEUTICAL BULLETIN

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“…On the basis of requests from patients to enhance their quality of life (QOL), new types of FDTs have been developed and then released globally by many pharmaceutical companies (Okuda et al, 2011). These tablets display a fast and spontaneous de-aggregation in the mouth, soon after coming into contact with saliva, dissolving the active ingredient and allowing absorption through all possible membranes it comes into contact with during deglutition (Puttewar et al, 2010).…”

Section: Introductionmentioning

confidence: 99%

Formulation and in vitro evaluation of fast dissolving tablets of metoprolol tartrate

Satpute

Tour

2013

Braz. J. Pharm. Sci.

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The demand for fast dissolving tablets has been growing during the last decade, especially for elderly and children who have swallowing difficulties. In the present work, fast dissolving tablets of metoprolol tartrate, were prepared using sodium starch glycolate, sodium croscarmellose and crospovidone as superdisintegrants, by the direct compression method. The tablets prepared were evaluated for various parameters including weight variation, hardness, friability, in vitro dispersion time, drug-polymer interaction, drug content water absorption ratio, wetting time, in vitro drug release, FTIR and DSC studies. The tablets prepared by the direct compression method had a weight variation in the range of 145 mg to 152 mg, which is below ± 7.5%, a hardness of 3.6 kg/cm 2 to 4.5 kg/cm², percentage friability of 0.46% to 0.73%, in vitro dispersion time of 18 s to 125 s, drug content uniformity of between 98.12% and 100.03%, a water absorption ratio of 67% to 87%, wetting time of 32 sec. to 64 sec., and an in vitro drug release of 53.92% -98.82% within 15 min. The IR spectral analysis and DSC study showed no drug interaction with formulation additives of the tablet, and the formulations indicated no significant changes in hardness, friability, drug content or in vitro drug release. Fast dissolving tablets of metoprolol tartrate have enhanced dissolution and will lead to improved bioavailability and more effective therapy. Uniterms:Fast dissolving tablets/in vitro evaluation. Fast dissolving tablets/formulation. Metoprolol tartrate/fast dissolving tablets/formulation. Metoprolol tartrate/in vitro evaluation. Sodium croscarmellose. Sodium starch glycolate. Crospovidone. In vitro dispersion time/tablets evaluation.A exigência por comprimidos de dissolução rápida aumentou durante a última década, especialmente para idosos e crianças, com dificuldades de deglutição . No presente trabalho prepararam-se, pelo método de compressão direta, comprimidos de tartarato de metoprolol de rápida dissolução, utilizando glicolato sódico de amido, croscarmellose sódica e crospovidona como superdisintegrantes. Os comprimidos preparados foram avaliados em relação a diferentes parâmetros, como variação de peso, dureza, friabilidade, tempo de dispersão in vitro, interação fármaco-polímero, taxa de absorção de água pelo fármaco, tempo de umedecimento, liberação do fármaco in vitro,, FTIR e estudos de DSC. Os comprimidos preparados por compressão direta apresentaram variação de peso de 145 mg a 152 mg, abaixo de ±7,5%, dureza de 3,6 kg/cm² a 4,5 kg/cm² , porcentagem de friabilidade de 0,46% a 0,73%, tempo de dispersão in vitro de 18 s a 125 s, uniformidade de conteúdo de fármaco entre 98,12% e 100,03%, taxa de absorção de água de 67% a 87%, tempo de umidificaçãode 32 s a 64 s liberação do fármaco in vitro entre 53,92% e 98,82%, em 15 min. A análise no IV e de DSC mostrou que não houve interação de fármacos com os aditivos de formulação do comprimido e as formulações indicaram que não houve mudança significativa na dureza, friabilidade, s uniform...

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“…Bu yöntemle, kötü tada sahip etken maddelerin tatlarının maskelenerek, ADT formülasyonlarının hazırlanabileceği ve uzatılmış salım elde edilerek etken maddeden kontrollü salım elde edilebileceği belirtilmiştir. 8 Bu çalışmada, ADT formülasyonlarının avantaj ve dezavantajlarından, formülasyonlarında kullanılan etken ve yardımcı madde gruplarından, hazırlama yöntemlerinden, in vitro ve in vivo kalite kontrol parametrelerinden söz edilmesi amaçlanmıştır.…”

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Overview on the Orally Disintegrating Tablet Formulations

Özyilmaz¹,

Çomoğlu²

2019

J Lit Pharm Sci

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Further improvement of orally disintegrating tablets using micronized ethylcellulose

Cited by 25 publications

References 19 publications

Formulation Design for Orally Disintegrating Tablets Containing Enteric-Coated Particles

Formulation Design for Orally Disintegrating Tablets Containing Enteric-Coated Particles

Formulation and in vitro evaluation of fast dissolving tablets of metoprolol tartrate

Overview on the Orally Disintegrating Tablet Formulations

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