orally disintegrating tablets disintegration time

10.1371/journal.pone.0244646

Improved disintegration of ODTs has been achieved by increasing the porosity to let the liquid penetrate the tablet easily, and by using disintegrants that have excellent water absorption and wetting capacities.12) Thus, the hardness, diameter, thickness, and weight of ODTs are not likely to be major factors that influence disintegration time. These results have shown that development of novel biorelevant methods of ODTs disintegration time determination is eligible and scientifically justified.

endobj In this study, the clinical disintegration time of 17 clinically available ODTs in Japan was measured, and the correlation between the clinical disintegration time and the in vitro disintegration time of ODTs was evaluated. endobj H\Mn09em@PFjEn_. The volunteers were randomly assigned to 3 groups (A, B and C), and clinical disintegration times were measured. Disintegration time is an important characteristic of orally disintegrating tablets (ODTs), and evaluation of disintegration time is a key step in formulation development, manufacturing, and clinical practice. 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. In these patients, medication is often controlled and administered by nurses and caregivers, and a greater burden of medication assistance is placed on health care providers and the patients families. Amlodipine 5mg, 8. doi:10.1371/journal.pone.0244646 0000017151 00000 n endobj disintegrating orally dentagama 0000001511 00000 n Recent trend of fast dissolving tabletAn overveiw of fomulation technology. omeprazole disintegrating ibotta orally <>/Border[0 0 0]>> endobj The clinical disintegration time was measured for 17 ODT products (Nos. Patients with dementia or schizophrenia have difficulty in managing their medication by themselves due to cognitive impairment and psychiatric disorders, and sometimes refuse medication. In addition, we attempted to evaluate the correlation between the clinical disintegration time and the in vitro disintegration time of ODTs which was measured using Tricorptester, a newly developed disintegration testing apparatus. allergy Production and hosting by Elsevier B.V. https://doi.org/10.1016/j.jsps.2015.01.015. endobj endobj Peer review under responsibility of King Saud University. endobj 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. 0000021297 00000 n <>/Border[0 0 0]>> 0000014078 00000 n All other chemicals were of reagent grade. 2. ScienceDirect is a registered trademark of Elsevier B.V. ScienceDirect is a registered trademark of Elsevier B.V. H\j0z Liquid penetrates through pores deep into the tablet, and the disintegrant exerts its disintegrating function by absorbing the water that reached into the tablet. V )H(Od]|.!KA \)_Q mta2]\},fbN$pA/-/.wfe}{E,T};o7]^W~x"X=I?^oHO[Tf~ssq~0WvY-vbL{i~ _O';f_M]5slF/=tn~Ehjn@*Po[+/d, Shahinaze A. Fouad, Fady A. Malaak, Mohamed A. El-Nabarawi, Khalid Abu Zeid, Development of orally disintegrating tablets containing solid dispersion of a poorly soluble drug for enhanced dissolution: In-vitro optimization/in-vivo evaluation. Similarly, the in vitro disintegration times of the 26 clinically used ODT products ranged between 4.4 and 30.4s. Currently, there are couples of apparatus for measuring disintegration time of ODTs. endobj 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. A significant positive correlation was observed between in vitro and clinical disintegration times of 17 ODT products (r=0.79; p<0.001, Fig. Development of orally disintegrating tablets containing solid dispersion of a poorly soluble drug for enhanced dissolution: In-vitro optimization/in-vivo evaluation 33 0 obj 31 0 obj ODTs have various merits as listed above, and are expected to improve compliance because of the ease with which they can be swallowed. 17 0 obj

10.1371/journal.pone.0244646 hbbg`b``3 endstream endobj 241 0 obj <>/Metadata 37 0 R/PageLabels 34 0 R/Pages 36 0 R/StructTreeRoot 39 0 R/Type/Catalog/ViewerPreferences<>>> endobj 242 0 obj <>/Font<>/ProcSet[/PDF/Text]>>/Rotate 0/StructParents 0/TrimBox[0.0 0.0 552.756 793.701]/Type/Page>> endobj 243 0 obj <>stream

endobj 36 0 obj Each tablet was placed on their tongues and disintegrated in their oral cavities. 1 0 obj http://dx.doi.org/10.1371/journal.pone.0244646 In contrast, there were no relationship between in vitro disintegration time and tablet hardness, diameter, weight, and thickness. Therefore, it is likely that the easier water penetrates the tablet, the faster the tablet disintegrates. (2) Orally disintegrating tablets have appropriate disintegration properties. Tablet diameter, weight, and thickness were obtained from the package insert or interview form for each product. 0000006291 00000 n 0000016644 00000 n <>/Border[0 0 0]>> Copyright 2015 The Authors. 6 0 obj 117) listed as follows: 1.

On the other hand, the compendial disintegration test does not seem to accurately reproduce the disintegration behavior of ODTs in the oral cavity as the test is carried out in a large volume of test solution (i.e., 900mL). ). 3 0 obj 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. 24 0 obj endobj <>/Border[0 0 0]>> endobj endobj A tablet was put on the paper, and the time for complete wetting was measured using 3 tablets for each product. 3). endobj <>/Border[0 0 0]>> Therefore, an appropriate method is required to evaluate the disintegration time of ODTs. <>/Border[0 0 0]>> Clinical Disintegration Times of Clinically Available ODTs, 2013 The Pharmaceutical Society of Japan, Edited and published by The Pharmaceutical Society of Japan, Validation of the Method for the Measurement of Clinical Disintegration Time, Measurement of Clinical Disintegration Time in Clinically Available ODTs. endobj 0000010052 00000 n 2) for each ODT product (Nos. 240 0 obj <> endobj xref 240 41 0000000016 00000 n The placebo ODTs were prepared by direct compression method using a single-station tableting machine (HANDTAB-100; Ichihashi-seiki Co., Ltd., Kyoto, Japan). On the other hand, wetting time of ODTs correlated significantly with in vitro disintegrating time (r=0.718; p<0.001, Fig. 0000015465 00000 n Shibata Y, Yamamoto Y, Fujii M, Kondoh M, Watanabe Y. Narazaki R, Harada T, Takami N, Kato Y, Ohwaki T. A new method for disintegration studies of rapid disintegrating tablet. false -EO,chLE0DOcPE_wfIx,Ioy^eNzu?EiRY=>.{.yA~ezphtQ>]J.69/VE#M,K,[2~_='EUB*%xE^+rd~!_8Zd-YE2kltp~"?oo5% y=Zux>>bOKn[, $1qO3iG%` t[ endstream endobj 244 0 obj <> endobj 245 0 obj <> endobj 246 0 obj <>stream 0000012572 00000 n <>stream for 10 determinations. Khan S, Kataria P, Nkhat P, Yeole P. Taste masking of ondansetron hydrochloride by polymer carrier system and formulation of rapid-disintegrating tablets. 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.

endobj 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. endobj Copyright 2022 Elsevier B.V. or its licensors or contributors. 2020-12-31 <>/Border[0 0 0]>> 2). 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. Gaslon NOD Tablets 2mg, and 17.

Determination of the. This measurement was performed on 10 tablets of each type of ODT and the mean disintegration time was calculated. <>/Border[0 0 0]>> The authors thank Mr. Ryouichi Takenaka and Mr. Kenjirou Yamada for their excellent technical assistance. Therefore, the actual disintegration time of ODTs in the oral cavity does not often correlate with the in vitro disintegration time measured by disintegration tests of USP or JP.58). % A similar issue seems to be present with children who are not good at swallowing and require caregivers for controlling and administering their medication. 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.

In addition, standard deviation (S.D.) Pages 1488-1493, (compatible with EndNote, Reference Manager, ProCite, RefWorks). 0000057569 00000 n <>/Border[0 0 0]>> Interestingly, a significant correlation was observed between the in vitro disintegration times of the tested ODTs and the wetting times of the corresponding tablet. The in vitro disintegration time represents meanS.D. 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. 117). 18 0 obj 5 0 obj 0000002312 00000 n 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.

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