orally disintegrating tablets disintegration time

All compressed conventional and ODTs weighed 250mg and had a diameter of 9.0mm. No significant difference was observed in the clinical disintegration time of placebo ODT-A and ODT-B, which had different disintegration times. endobj 27 0 obj

Each point represents a value for each ODT product listed in Table 1. 0000017151 00000 n The clinical disintegration time was measured for 17 ODT products (Nos. Amlodipine 5mg, 8. To evaluate the intra-assay precision, we randomly divided 18 healthy volunteers (age range, 2128 years) into 3 groups and performed a randomized crossover trial to determine the clinical disintegration time for placebo ODT-A and ODT-B. These include the following: a method using a compendial disintegration test device equipped with an adaptation of the JP dissolution test method for use with ODTs,12,13) dissolution test measurement of disintegration time using CCD camera imaging,10) utilization of a tablet compaction analysis system,14) application of a texture analyzer from the field of food science,11) tablet disintegration with upward water penetration from beneath the tablet and applying spindle rotation from above,15) and the Kyoto-model disintegration test.16) Although each of these test methods has been reported to show a correlation with disintegration time in the mouth as for the tested ODTs in this study, ODT products are currently manufactured and marketed by many manufacturers in various sizes using various formulation technologies.12,17) Therefore, the oral disintegration behavior may vary by product; some ODTs are designed to disintegrate while leaving the core intact and others are formulated to quickly disintegrate and spread in the mouth. Sastry SV, Nyshadham JR, Fix JA. 117). When the relationships of the measured in vitro disintegration time with tablet hardness, diameter, weight, and thickness were evaluated for each ODT product, there was no significant correlation between the in vitro disintegration time and any of the parameters (Fig. The results of this study suggest that in vitro disintegration time measured by Tricorptester may reflect the mechanism for the disintegration of ODTs in the oral cavity. <>/Border[0 0 0]>> 0000011971 00000 n 0000004627 00000 n 34 0 obj Determination of the. The correlation coefficients were 0.9994 (p<0.001), and 0.9907 (p<0.001) respectively. Tamslon-OD Tablets 0.2mg, 14. false www.plosone.org

0000021297 00000 n In conclusion, this study shows that all the tested products, which are clinically available in Japan, showed good disintegration and that the disintegration time varied according to the product. Even that orodispersible tablets (ODTs) have been successfully used in therapy for more than 20years, there is still no compendial method of their disintegration time evaluation other than the pharmacopoeial disintegration test conducted in 800900mL of distilled water. Shibata Y, Yamamoto Y, Fujii M, Kondoh M, Watanabe Y. www.plosone.org 0000001691 00000 n In vitro disintegration time of 26 ODT products (Nos. endstream 0000077986 00000 n endobj 17 0 obj Furthermore, medication should be well suited to the lifestyles of individual patients to encourage compliance in those with lifestyle-related diseases such as hypertension, dyslipidemia, and diabetes. To validate the method for measuring the clinical disintegration time of ODTs, the subjects were randomly assigned to 3 groups, and the clinical disintegration time was measured. 2). 18 0 obj Their mechanical properties and disintegration times were measured with pharmacopoeial and alternative methods and compared with the in vivo results. <>/Border[0 0 0]>> FDA guidelines indicate that the disintegration time of ODTs should be approximately within 30s.4) Our result indicated that ODT products, which are clinically used in Japan, have good disintegration (within approximately 30s) and that the disintegration time varies according to the product. endobj The in vitro disintegration time represents meanS.D. The relationships of the measured in vitro disintegration time to tablet hardness, diameter, weight, and thickness were evaluated. 3 0 obj Disintegration time is an important quality attribute of ODTs, and the evaluation of disintegration time is positioned as a key step in formulation development, manufacturing, and clinical practice. %PDF-1.4 % endobj endobj Production and hosting by Elsevier B.V. https://doi.org/10.1016/j.jsps.2015.01.015. The clinical disintegration time of each ODT was measured. <>stream Clinical Disintegration Time of Orally Disintegrating Tablets Clinically Available in Japan in Healthy Volunteers, Fig. Amlodipine 2.5mg, 6. 23 0 obj Shahinaze A. Fouad, Fady A. Malaak, Mohamed A. El-Nabarawi, Khalid Abu Zeid 0000014078 00000 n Interestingly, a significant correlation was observed between the in vitro disintegration times of the tested ODTs and the wetting times of the corresponding tablet. 24 0 obj 21 0 obj Magmitt Tab. 20 0 obj The clinical disintegration time of 17 ODT products, measured as the time required for oral disintegration in a clinical trial, was between 17.6 and 33.8s (Fig. trailer <<9CB92B2296E64E8D9AF47ED9F6041774>]/Prev 353306/XRefStm 1511>> startxref 0 %%EOF 280 0 obj <>stream <>/Border[0 0 0]>> The placebo ODTs were prepared by direct compression method using a single-station tableting machine (HANDTAB-100; Ichihashi-seiki Co., Ltd., Kyoto, Japan). <>/Border[0 0 0]>> In this study, a significant positive correlation was observed between the measured and clinical disintegration times, demonstrating that ODT disintegration time measured by Tricorptester is a good reflection of the oral disintegration time, regardless of manufacturer, formulation technology, and size of tablet. Amlodin OD Tablets 2.5mg, 13. Morita Y, Tsushima Y, Yasui M, Termoz R, Ajioka J, Takayama K. Evaluation of the disintegration time of rapidly disintegrating tablets, Abdelbary G, Eouani C, Prinderre P, Joachim J, Reynier J, Piccerelle P. Reynier Jp., Piccerelle Ph. 26 0 obj A description of the handling of ODTs has been added in the general guidelines for the preparation of Japanese Pharmacopoeia (JP) upon the 16th revision. <>stream Peer review under responsibility of King Saud University. endobj 240 0 obj <> endobj xref 240 41 0000000016 00000 n Gaslon NOD Tablets 2mg, and 17. ODT-A contained Ludiflash (BASF, Ludwigshafen, Germany), and ODT-B contained Ludiflash and cocoa powder (NF-15, Morinaga Shoji Co., Ltd., Yokohama, Japan). In this study, we aimed to evaluate the clinical disintegration time of 17 ODTs that are currently available for clinical use in Japan. 0000009525 00000 n All other chemicals were of reagent grade. Healthy volunteers (n, 910; age range, 2128 years) participated in this randomized crossover trial. endobj Statistical analysis was performed using Graphpad Prism v.5.02 (Graphpad Software, San Diego, U.S.A.). 2) for each ODT product (Nos. 0000001511 00000 n 0000010052 00000 n While swelling, particle deformation, capillary action, and interparticle repulsion are proposed as mechanisms for tablet disintegration, most cases have been explained by swelling and capillary action. Recent technological advances in oral drug deliveryA review. Harada T, Narazaki R, Nagira S, Ohwaki T, Aoki S, Iwamoto K. Evaluation of the disintegration properties of commercial famotidine 20mg orally disintegrating tablets using a simple new test and human sensory test. Comoglu T, Dogan A, Comoglu S, Basci N. Formulation and evaluation of diclofenac potassium fast-disintegrating tablets and their clinical application in migraine patients. Development of orally disintegrating tablets containing solid dispersion of a poorly soluble drug for enhanced dissolution: In-vitro optimization/in-vivo evaluation The use of ODTs will not only improve compliance but also ease the burden of medication assistance, because ODTs can address issues such as the patient spitting out the medication or taking a long time to swallow it. 0000010648 00000 n The clinical disintegration time of ODT-A in the 3 groups was 13.83.8s, 16.63.4s, and 16.62.5s, and that for ODT-B was 30.83.6s, 31.52.6s, and 28.45.6s (Fig. Randale S, Dabhi C, Tekada A, Belgamwar V, Gattani S, Surana S. Rapidly disintegrating tablets containing taste masked metoclopramide hydrochloride prepared by extrusion-precipitation method. Gupta A, Mishra AK, Gupta V, Bansal P, Singh R, Singh AK. Issue 9 (2) Orally disintegrating tablets have appropriate disintegration properties. 0000003773 00000 n 25 0 obj We added other 9 ODT products (Nos. Each point represents a value for the volunteers, while the horizontal line indicates the mean value of the group. 19 0 obj 1. 2020-12-31 0000014687 00000 n 0000012572 00000 n Harnal D Tablets 0.2mg, 7.

Here, ODTs are described as follows: (1) Orally disintegrating tablets are tablets that are administered by rapidly dissolving or disintegrating in the mouth. 126) was measured by Tricorptester (Okada Seiko Co., Ltd., Tokyo, Japan). 2020-12-31 endobj <>/Border[0 0 0]>> 1826) to 17 ODTs in order to perform the further evaluation of relationships between the in vitro disintegration time and tablets characteristics, after the evaluation of the in vitro disintegration time by using Tricorptester. The tablet diameter was between 6.0 and 11.5mm, weight was between 80 and 570mg, and thickness was between 2.4 and 4.9mm. endobj 250mg (Kyowa Chemical Industry Co., Ltd.), Gaster D Tablets 10mg (Astellas Pharma Inc.), Amlodipine 2.5mg (Nippon Chemiphar Co., Ltd.), Harnal D Tablets 0.2mg (Astellas Pharma Inc.), Amlodipine 5mg (Nippon Chemiphar Co., Ltd.), TAMSLON-OD TABLETS 0.1mg (Towa Pharmaceutical Co., Ltd.), AMLODIPINE-OD TABLETS 5mg TOWA (Towa Pharmaceutical Co., Ltd.), Gaster D Tablets 20mg (Astellas Pharma Inc.), Amlodin OD Tablets 5mg (Dainippon Sumitomo Pharma Co., Ltd.), Amlodin OD Tablets 2.5mg (Dainippon Sumitomo Pharma Co., Ltd.), TAMSLON-OD TABLETS 0.2mg (Towa Pharmaceutical Co., Ltd.), BASEN OD Tablets 0.2mg (Takeda Pharmaceutical Co., Ltd), Gaslon NOD Tablets 4mg (Nippon Shinyaku Co., Ltd.), Gaslon NOD Tablets 2mg (Nippon Shinyaku Co., Ltd.), Takepron OD Tablets 30mg (Takeda Pharmaceutical Co., Ltd.), Aricept D Tablets 5mg (Eisai Co., Ltd./Pfizer Japan Inc.), Harnal D Tablets 0.1mg (Astellas Pharma Inc.), Lendormin D Tablets 0.25mg (Boehringer Ingelheim Japan, Inc.), AMLODIPINE-OD TABLETS 2.5mg TOWA (Towa Pharmaceutical Co., Ltd.), EBASTEL (Dainippon Sumitomo Pharma Co., Ltd.), RISPERDAL OD Tablets 1mg (Janssen Pharmaceutical K.K. endobj In other words, wetting by liquid is the first requisite for tablet disintegration, even though swelling, wetting, liquid surface tension, viscosity, and capillary action may all be involved. 4e). They were allowed to move the tablet gently against the upper palate of the mouth with their tongue without biting. The clinical disintegration time of the 17 ODT products was between 17.6s and 33.8s. The in vitro disintegration time of 26 clinically used ODT products measured using Tricorptester ranged between 4.40s and 30.4s. A significant positive correlation was observed between in vitro and clinical disintegration times (r=0.79; p<0.001). Development of oral acetaminophen chewable tablets with inhibited bitter taste. 117). Each tablet was placed on their tongues and disintegrated in their oral cavities. In addition, standard deviation (S.D.) 29 0 obj To date, no studies have described validation of the method for measuring the clinical disintegration time of ODTs although a few studies have reported the disintegration time in the oral cavity.7,10,11) Thus, we first validated the method for measuring the clinical disintegration time of ODTs in healthy volunteers who were randomly assigned to 3 groups. The clinical disintegration time was measured for 17 ODT products (Nos. It also states that the disintegration time should be within approximately 30s, which is presented only as a recommended time to express the rapid disintegration of ODTs in the oral cavity. Promac D tablets 75, 2. Each ODT was placed on their tongues, and it disintegrated in their oral cavities. <>/Border[0 0 0]>> Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Guidance for Industry: Orally Disintegrating Tablets, U.S. Department of Health and Human Services, U.S.A., December, 2008. endobj On the other hand, guidance regarding ODTs has been issued by the United States Food and Drug Administration (FDA) in 2008.4) The guidance provides a definition of ODTs, stating that ODTs should rapidly disintegrate in saliva without the need for chewing or liquids.

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