orally disintegrating tablets disintegration time

Tablet diameter, weight, and thickness were obtained from the package insert or interview form for each product. 23 0 obj [16 0 R 17 0 R 18 0 R 19 0 R 20 0 R 21 0 R 22 0 R 23 0 R 24 0 R 25 0 R 26 0 R 27 0 R 28 0 R 29 0 R 30 0 R 31 0 R 32 0 R 33 0 R 34 0 R 35 0 R 36 0 R]

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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. endobj <>/Border[0 0 0]>> Several methods have been reported for the measurement of ODT disintegration. 8*qTEYZccld".Y)&:.Ye1Kt'ra,'r.0%)EH}`EYd$q`\ hQr"*K0Xi/$ 7> gq$ersOdAbl(1C_7 '2a cfL3}bFQ8 ':,@Lb} [-b (O@4r EQ 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. ), Takepron OD Tablets 15 (Takeda Pharmaceutical Co., Ltd.), RISPERDAL OD Tablets 2mg (Janssen Pharmaceutical K.K. 0000007844 00000 n The highest correlation with oral disintegration time was found in the case of own-construction apparatus with additional weight and the employment of the method proposed by Narazaki et al.

Patients with dementia or schizophrenia have difficulty in managing their medication by themselves due to cognitive impairment and psychiatric disorders, and sometimes refuse medication. Harnal D Tablets 0.2mg, 7. <>/Border[0 0 0]>> 0000010052 00000 n endobj

endobj 25 0 obj In this study, we aimed to clarify the clinical disintegration time of ODTs that are currently used clinically, and to evaluate its correlation with the in vitro disintegration time of ODTs which was measured using Tricorptester, a newly developed disintegration testing apparatus. Clinical Disintegration Times of ODT-A (A) and ODT-B (B) in 3 Groups of Healthy Volunteers, Fig. <>/Border[0 0 0]>> 0000001511 00000 n Gaster D Tablets 10mg, 5. Copyright 2015 The Authors. 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. Here, ODTs are described as follows: (1) Orally disintegrating tablets are tablets that are administered by rapidly dissolving or disintegrating in the mouth. 1. Recent trend of fast dissolving tabletAn overveiw of fomulation technology. Watanabe Y, Koizumi K, Zama Y, Kiriyama M, Matsumoto Y, Matsumoto M. New compressed tablet rapidly disintegrating in saliva in the mouth using crystalline cellulose and a disintegrant. 17 0 obj The clinical disintegration time of 17 ODT products was measured in healthy volunteers (n=910; age range, 2128 years). Healthy volunteers (n, 910; age range, 2128 years) participated in this randomized crossover trial. Statistical analysis was performed using Graphpad Prism v.5.02 (Graphpad Software, San Diego, U.S.A.). 0000013186 00000 n www.plosone.org 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. -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 The clinical disintegration time of each ODT was measured by an investigator with a stopwatch. x\YFr~"Z&C I#owXpD7 H?/++

0000021297 00000 n

27 0 obj 16 0 obj Copyright 2022 Elsevier B.V. or its licensors or contributors. 0000002807 00000 n Participants took a 15-min interval between tests of ODT-A and ODT-B. The result of this study showed that a significant positive correlation was found between in vitro and clinical disintegration times, which showed that the in vitro disintegration time of ODTs measured using Tricorptester is a good reflection of the disintegration time in the oral cavity. <>stream 35 0 obj endobj

endobj 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. 3 to 5s) indicated that 7 to 17 subjects are required to detect a 5-s difference in the disintegration time of 2 ODTs, with 5% alpha error and 80% power at a two-sided 5% significance level. Interestingly, a significant correlation was observed between the in vitro disintegration times of the tested ODTs and the wetting times of the corresponding tablet. Determination of the. 0000007408 00000 n 32 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. 330mg, 3. <>/Border[0 0 0]>> 2. Pages 1488-1493, (compatible with EndNote, Reference Manager, ProCite, RefWorks). In addition, standard deviation (S.D.) for 10 determinations. Shibata Y, Yamamoto Y, Fujii M, Kondoh M, Watanabe Y. The correlation coefficients were 0.9994 (p<0.001), and 0.9907 (p<0.001) respectively.

However, there is no specific description of the disintegration time or method for measuring disintegration time. 2020-12-31 H\Mn09em@PFjEn_. 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 practical approach to the evaluation of methods used to determine the disintegration time of orally disintegrating tablets (ODTs). In addition, the in vitro disintegration time of ODTs measured using Tricorptester is a good reflection of the disintegration time in the oral cavity. 4e). Recent technological advances in oral drug deliveryA review. 117). Basen OD Tablets 0.2mg, 15. 0000006291 00000 n Orally disintegrating tablets (ODTs) have the superior physical property of excellent disintegration that allows them to be taken with little or no water, and are well proven to be easily taken.13) The biggest benefit of ODTs is their use in rescuing patients who are incapable of taking oral medication, but there may be other benefits depending on the patient. We added other 9 ODT products (Nos. <>/Border[0 0 0]>> 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. The clinical disintegration time was measured for 17 ODT products (Nos. Suzuki H, Onishi H, Takahashi Y, Iwata M, Machida Y. Department of Pharmacy Practice and Science, School of Pharmaceutical Sciences University of Shizuoka, 2013 <> 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. 0000069958 00000 n ODTs, which can be taken without water, can be taken even when water is not readily available at work, or when the patient does not want his/her disease known to people in the workplace. <>/ProcSet 14 0 R/XObject<>>> Tukeys test was performed to examine the significance at p<0.05. Promac D tablets 75, 2. The drugs used in this study are listed in Table 1, including 26 ODT products that are currently available for clinical use. A tablet was put on the paper, and the time for complete wetting was measured using 3 tablets for each product. Tamslon-OD Tablets 0.1mg, 9. Mizumoto T, Tamura T, Kawai H, Kajiyama A, Itai S. Formulation design of taste-masked particles, including famotidine, for an oral fast-disintegrating dosage form. Volume 36 Tamslon-OD Tablets 0.2mg, 14.

All volunteers who provided written informed consent participated in the study.

(2) Orally disintegrating tablets have appropriate disintegration properties. <>/Border[0 0 0]>> Bi Y, Sunada H, Yonezawa Y, Danjo K, Otsuka A, Iida K. Preparation and evaluation of a compressed tablet rapidly disintegrating in the oral cavity. 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. The same applies to ODT disintegration time. endobj 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. Six series of ODTs were prepared by direct compression. 37 0 obj endobj <>/Border[0 0 0]>> By continuing you agree to the use of cookies. 5 0 obj 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. 0000012572 00000 n endobj 20 0 obj 0000004167 00000 n 21 0 obj 1). Before the test, the oral cavity of participants was rinsed with a cup of water (120mL). 250mg, 4.

Magmitt Tab.

We use cookies to help provide and enhance our service and tailor content and ads. In this study, we have selected Tricorptes, which is a newly developed disintegration testing apparatus, because it has not been reported the relationship of the in vitro disintegration time measured of ODTs by this apparatus with the clinical disintegration time which were evaluated from a validated clinical trial. 126) was measured by Tricorptester (Okada Seiko Co., Ltd., Tokyo, Japan). doi:10.1371/journal.pone.0244646 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. hb```b`` * @QcSZ47(Z00<5_ $.Q C)qYbEGD9y(.liek2NFE"$9LYaq nKGGc fqE8P L*@Z5!Nd`LgctjOddfdbRe4qg?X6010dRa8b@oRp)101443*5 : ?C endstream endobj 279 0 obj <>/Filter/FlateDecode/Index[39 201]/Length 30/Size 240/Type/XRef/W[1 1 1]>>stream 18 0 obj Development of oral acetaminophen chewable tablets with inhibited bitter taste. 0000001856 00000 n The pharmacopoeial method correlated with the in vivo data much worse (r=0.8925, p<0.05). Therefore, it is likely that the easier water penetrates the tablet, the faster the tablet disintegrates. endobj $8fB_Yr,x,D`"MEPDqxR,$'QR.Je9F"R}b1f In contrast, there were no relationship between in vitro disintegration time and tablet hardness, diameter, weight, and thickness. The clinical disintegration time was measured for 17 ODT products (Nos. 30 0 obj endobj 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 <>/Border[0 0 0]>> 26 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. <> 0000003773 00000 n endobj The hardness of ODT was determined by a load cell-type hardness tester, PC-30 (Okada Seiko Co., Ltd., Tokyo, Japan) using 10 tablets for each product. 0000003323 00000 n Amlodipine-OD Tablets 5mg TOWA, 10. <>/Border[0 0 0]>> Kakutani R, Muro H, Makino T. Development of a new disintegration method for orally disintegrating tablets. Gaslon NOD Tablets 2mg, and 17. 3 0 obj 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 clinical disintegration time of 17 ODT products was between 17.6s and 33.8s. The 16th edition of the Japanese Pharmacopoeia describes the optimum characteristics of ODTs, but there is no specific description about the disintegration time. <>/Border[0 0 0]>> 0000004982 00000 n

0000061895 00000 n All compressed conventional and ODTs weighed 250mg and had a diameter of 9.0mm. false This measurement was performed on 10 tablets of each type of ODT and the mean disintegration time was calculated. 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. endobj Magmitt Tab. endobj 31 0 obj Clinical Disintegration Time of Orally Disintegrating Tablets Clinically Available in Japan in Healthy Volunteers, Fig. 24 0 obj This result indicates the reproducibility of our method for measuring the clinical disintegration time. Amlodipine 5mg, 8. In this study, we aimed to evaluate the clinical disintegration time of 17 ODTs that are currently available for clinical use in Japan. ScienceDirect is a registered trademark of Elsevier B.V. ScienceDirect is a registered trademark of Elsevier B.V. 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. 3). 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 <>/Border[0 0 0]>> The aim of this study was to compare these methods and correlate them with in vivo results. 0000015465 00000 n 0000001691 00000 n Production and hosting by Elsevier B.V. https://doi.org/10.1016/j.jsps.2015.01.015. 1 0 obj 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. 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. 0000006193 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). 0000013805 00000 n 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. Gaster D Tablets 20mg, 11. endobj 2020-12-31 The hardness of ODTs used in this study ranged between 26.8N (Takepron OD Tablets 15) and 110.1N (Magmitt Tab. 0000008554 00000 n 0000014687 00000 n Gaslon NOD Tablets 4mg, 16. ODTs have various merits as listed above, and are expected to improve compliance because of the ease with which they can be swallowed. 0000005628 00000 n 36 0 obj All other chemicals were of reagent grade.

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. Development of orally disintegrating tablets containing solid dispersion of a poorly soluble drug for enhanced dissolution: In-vitro optimization/in-vivo evaluation endobj They were allowed to move the tablet gently against the upper palate of the mouth with their tongue without biting. No significant difference was observed in the clinical disintegration time of ODT-A and ODT-B among the 3 groups. <>/Border[0 0 0]>> Amlodin OD Tablets 2.5mg, 13. A significant positive correlation was observed between in vitro and clinical disintegration times of 17 ODT products (r=0.79; p<0.001, 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. On the other hand, wetting time of ODTs correlated significantly with in vitro disintegrating time (r=0.718; p<0.001, Fig. 0000011971 00000 n Therefore, an appropriate method is required to evaluate the disintegration time of ODTs. 0000016110 00000 n endobj The remnants of each ODT were removed and rinsed from the mouth with water after each test. ODT-A contained Ludiflash (BASF, Ludwigshafen, Germany), and ODT-B contained Ludiflash and cocoa powder (NF-15, Morinaga Shoji Co., Ltd., Yokohama, Japan).

0000014078 00000 n 0000016644 00000 n However, when ODT disintegration time is to be evaluated in humans, ethical issues arise because tablets containing active pharmaceutical ingredients are administered to humans. 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. <>/Border[0 0 0]>> 19 0 obj 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. 6 0 obj endobj <>/Border[0 0 0]>> 0000006711 00000 n 117) listed as follows: 1. 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. 2 0 obj 250mg). http://dx.doi.org/10.1371/journal.pone.0244646 % Amlodipine 2.5mg, 6. 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. 0000011365 00000 n www.plosone.org 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. endobj Issue 9 A randomized single-blind trial was performed; each tablet was placed on the tongues of the participants, and it disintegrated in their oral cavities. <>/Border[0 0 0]>> H\j0z 22 0 obj No significant difference was observed in the clinical disintegration time of each ODT among the 3 groups to which the subjects were randomly assigned.

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