In vitro disintegration time of 26 ODT products (Nos. The clinical disintegration time was measured for 17 ODT products (Nos. <>stream ODT-A contained Ludiflash (BASF, Ludwigshafen, Germany), and ODT-B contained Ludiflash and cocoa powder (NF-15, Morinaga Shoji Co., Ltd., Yokohama, Japan). ), Takepron OD Tablets 15 (Takeda Pharmaceutical Co., Ltd.), RISPERDAL OD Tablets 2mg (Janssen Pharmaceutical K.K. 1. endobj Amlodipine-OD Tablets 5mg TOWA, 10. 250mg). 0000016110 00000 n
No significant difference was observed in the clinical disintegration time of placebo ODT-A and ODT-B, which had different disintegration times. 0000001511 00000 n
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We added other 9 ODT products (Nos. 24 0 obj 0000017151 00000 n
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. 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. 18 0 obj Magmitt Tab. Gaster D Tablets 20mg, 11. Interestingly, a significant correlation was observed between the in vitro disintegration times of the tested ODTs and the wetting times of the corresponding tablet. Shahinaze A. Fouad, Fady A. Malaak, Mohamed A. El-Nabarawi, Khalid Abu Zeid Copyright 2022 Elsevier B.V. or its licensors or contributors. However, there is no specific description of the disintegration time or method for measuring disintegration time. Production and hosting by Elsevier B.V. https://doi.org/10.1016/j.jsps.2015.01.015. 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. 0000005628 00000 n
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Several methods have been reported for the measurement of ODT disintegration. endobj <>/Border[0 0 0]>> 30 0 obj 330mg, 3. Tamslon-OD Tablets 0.1mg, 9. ). 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. 17 0 obj No significant difference was observed in the clinical disintegration time of ODT-A and ODT-B among the 3 groups. Six series of ODTs were prepared by direct compression. 0000008554 00000 n
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. <>/Border[0 0 0]>> These results have shown that development of novel biorelevant methods of ODTs disintegration time determination is eligible and scientifically justified. Each point represents a value for the volunteers, while the horizontal line indicates the mean value of the group. 16 0 obj 0000021297 00000 n
117). <> (2) Orally disintegrating tablets have appropriate disintegration properties. Liquid penetrates through pores deep into the tablet, and the disintegrant exerts its disintegrating function by absorbing the water that reached into the tablet. endobj The remnants of each ODT were removed and rinsed from the mouth with water after each test. 10.1371/journal.pone.0244646 Patients with dementia or schizophrenia have difficulty in managing their medication by themselves due to cognitive impairment and psychiatric disorders, and sometimes refuse medication. 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. % 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. 4e). 0000001116 00000 n
2. All volunteers who provided written informed consent participated in the study. Recent trend of fast dissolving tabletAn overveiw of fomulation technology. No significant difference was observed in the clinical disintegration time of each ODT among the 3 groups to which the subjects were randomly assigned. 6 0 obj 0000069958 00000 n
Development of oral acetaminophen chewable tablets with inhibited bitter taste. 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. Tamslon-OD Tablets 0.2mg, 14. endobj The authors thank Mr. Ryouichi Takenaka and Mr. Kenjirou Yamada for their excellent technical assistance. Amlodin OD Tablets 5mg, 12. <>/Border[0 0 0]>> 21 0 obj 36 0 obj <>/Border[0 0 0]>> By continuing you agree to the use of cookies. The same applies to ODT disintegration time. hb```b`` * @QcSZ47(Z00<5_
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<>/Border[0 0 0]>> The disintegration time is measured as the time elapsed until the tablet completely disintegrates and the 2 meshes touch each other. www.plosone.org All protocols of the clinical trials were approved by the Ethics Committee of the University of Shizuoka. The placebo ODTs were prepared by direct compression method using a single-station tableting machine (HANDTAB-100; Ichihashi-seiki Co., Ltd., Kyoto, Japan). 25 0 obj 0000014687 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. 10.1371/journal.pone.0244646 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]>> endobj <>/Border[0 0 0]>> 0000010648 00000 n
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We first validated the methods for measuring the disintegration time in oral cavity (the clinical disintegration time) to develop the methods. 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 0000004627 00000 n
The clinical disintegration time of each ODT was measured by an investigator with a stopwatch. 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. http://dx.doi.org/10.1371/journal.pone.0244646 0000004167 00000 n
Promac D tablets 75 (Zeria Pharmaceutical Co., Ltd.), Magmitt Tab 330mg (Kyowa Chemical Industry Co., Ltd.), Magmitt Tab. <> Copyright 2015 The Authors. 31 0 obj In this study, we aimed to evaluate the clinical disintegration time of 17 ODTs that are currently available for clinical use in Japan. endobj endstream x\YFr~"Z&C
I#owXpD7 H?/++ Kakutani R, Muro H, Makino T. Development of a new disintegration method for orally disintegrating tablets. <>/Border[0 0 0]>> The correlation coefficients were 0.9994 (p<0.001), and 0.9907 (p<0.001) respectively. They were allowed to move the tablet gently against the upper palate of the mouth with their tongue without biting. 250mg, 4. ODTs have various merits as listed above, and are expected to improve compliance because of the ease with which they can be swallowed. <>/Border[0 0 0]>> endobj 0000002312 00000 n
endobj Basen OD Tablets 0.2mg, 15. Their mechanical properties and disintegration times were measured with pharmacopoeial and alternative methods and compared with the in vivo results. 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. Harnal D Tablets 0.2mg, 7. We use cookies to help provide and enhance our service and tailor content and ads. 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. The test solution (NaCl, 1.44g/L; KCl, 1.47g/L; and Tween 80, 0.3%) was warmed to 37C and dripped from a height of 80mm at a flow rate of 6.0mL/min. 0000007844 00000 n
Gaster D Tablets 10mg, 5. Healthy volunteers (n, 910; age range, 2128 years) participated in this randomized crossover trial. <>/ProcSet 14 0 R/XObject<>>> 28 0 obj <>/Border[0 0 0]>> <>stream 0000014078 00000 n
The pharmacopoeial method correlated with the in vivo data much worse (r=0.8925, p<0.05). 2). 0000009307 00000 n
Development of orally disintegrating tablets containing solid dispersion of a poorly soluble drug for enhanced dissolution: In-vitro optimization/in-vivo evaluation In addition, standard deviation (S.D.) endobj $8fB_Yr,x,D`"MEPDqxR,$'QR.Je9F"R}b1f Volume 36 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. Amlodipine 5mg, 8. Statistical analysis was performed using Graphpad Prism v.5.02 (Graphpad Software, San Diego, U.S.A.). All compressed conventional and ODTs weighed 250mg and had a diameter of 9.0mm. 26 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 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. 240 0 obj
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The drugs used in this study are listed in Table 1, including 26 ODT products that are currently available for clinical use. <>/Border[0 0 0]>> The mean in vitro disintegration times of the 26 clinically used ODT products, measured using Tricorptester, ranged from 4.40 to 30.4s (Table 1). A significant positive correlation was observed between in vitro and clinical disintegration times of 17 ODT products (r=0.79; p<0.001, Fig. endobj 35 0 obj 0000011365 00000 n
Each point represents a value for the volunteers, while the horizontal line indicates the mean value of the group. 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. 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. Recent technological advances in oral drug deliveryA review. <>/Border[0 0 0]>> 0000057569 00000 n
<>/Border[0 0 0]>> 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. <>/Border[0 0 0]>> 117) listed as follows: 1. The volunteers were randomly assigned to 3 groups (A, B and C), and clinical disintegration times were measured. 5 0 obj Each tablet was placed on their tongues and disintegrated in their oral cavities. <>/Border[0 0 0]>> These guidelines recommend the United States Pharmacopeia (USP) disintegration test as the method for measuring disintegration time, while allowing any alternative method that provides equivalent results. 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. In addition, the in vitro disintegration time of ODTs measured using Tricorptester is a good reflection of the disintegration time in the oral cavity. 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. Suzuki H, Onishi H, Takahashi Y, Iwata M, Machida Y. Magmitt Tab. Each point represents a value for each ODT product listed in Table 1. 0000006291 00000 n
On the other hand, wetting time of ODTs correlated significantly with in vitro disintegrating time (r=0.718; p<0.001, Fig. However, when ODT disintegration time is to be evaluated in humans, ethical issues arise because tablets containing active pharmaceutical ingredients are administered to humans. The wetting time of each ODT product was measured as described previously with minor modification.8,9) In brief, a piece of paper tissue folded twice was placed in a culture dish containing 6mL of the test solution (NaCl, 1.44g/L; KCl, 1.47g/L; and Tween 80, 0.3%) at 37C. 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. 1 0 obj The aim of this study was to compare these methods and correlate them with in vivo results. endobj 0000007408 00000 n
Tricorptester is a test device composed of 2 meshes; a lower mesh, on which an ODT is placed, and an upper mesh, which is attached to holders and is in contact with the ODT, on which artificial saliva is dripped from above. <>/Border[0 0 0]>> endobj endobj 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. %PDF-1.6 34 0 obj hbbg`b``3
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Clinical Disintegration Time of Orally Disintegrating Tablets Clinically Available in Japan in Healthy Volunteers, Fig. 0000003323 00000 n
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. 3). 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 In contrast, there were no relationship between in vitro disintegration time and tablet hardness, diameter, weight, and thickness. for 10 determinations. 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. 2) for each ODT product (Nos. Khan S, Kataria P, Nkhat P, Yeole P. Taste masking of ondansetron hydrochloride by polymer carrier system and formulation of rapid-disintegrating tablets. 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). 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. A novel method for predicting disintegration time in the mouth of rapidly disintegrating tablet by compaction analysis using TabAll. Therefore, it is likely that the easier water penetrates the tablet, the faster the tablet disintegrates. 23 0 obj %PDF-1.4
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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. 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. Therefore, several alternative tests more relevant to in vivo conditions were described by different researchers. 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. 1). 32 0 obj 29 0 obj 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. 20 0 obj trailer
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The hardness of ODTs used in this study ranged between 26.8N (Takepron OD Tablets 15) and 110.1N (Magmitt Tab. Each ODT was placed on their tongues, and it disintegrated in their oral cavities. Here, ODTs are described as follows: (1) Orally disintegrating tablets are tablets that are administered by rapidly dissolving or disintegrating in the mouth. 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. Gaslon NOD Tablets 2mg, and 17. The relationships of the measured in vitro disintegration time to tablet hardness, diameter, weight, and thickness were evaluated. endobj 0000002807 00000 n
ScienceDirect is a registered trademark of Elsevier B.V. ScienceDirect is a registered trademark of Elsevier B.V. false <>/Border[0 0 0]>> 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. <>/Border[0 0 0]>> Gupta A, Mishra AK, Gupta V, Bansal P, Singh R, Singh AK. 126) was measured by Tricorptester (Okada Seiko Co., Ltd., Tokyo, Japan). H\Mn09em@PFjEn_. 4). 0000016644 00000 n
Comoglu T, Dogan A, Comoglu S, Basci N. Formulation and evaluation of diclofenac potassium fast-disintegrating tablets and their clinical application in migraine patients. 33 0 obj 3 0 obj 0000006193 00000 n
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Takepron OD Tablets 30mg. Each point represents the mean value of the in vitro or clinical disintegrating times (Table 1, Fig. H\j0z calculated from results of our study (ca. A similar issue seems to be present with children who are not good at swallowing and require caregivers for controlling and administering their medication. Promac D tablets 75, 2. Shibata Y, Yamamoto Y, Fujii M, Kondoh M, Watanabe Y. endobj endobj Issue 9 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). 2020-12-31 A tablet was put on the paper, and the time for complete wetting was measured using 3 tablets for each product. 2 0 obj Amlodipine 2.5mg, 6. false 0000001691 00000 n
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). 10.1371/journal.pone.0244646 19 0 obj 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. 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. <>/Border[0 0 0]>> endobj 0000013186 00000 n
endobj 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. endobj 117). 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. Gaslon NOD Tablets 4mg, 16. <>/Border[0 0 0]>> Peer review under responsibility of King Saud University. Pages 1488-1493, (compatible with EndNote, Reference Manager, ProCite, RefWorks). Narazaki R, Harada T, Takami N, Kato Y, Ohwaki T. A new method for disintegration studies of rapid disintegrating tablet. 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. 0000003773 00000 n
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. 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 0000009525 00000 n
The clinical disintegration time of 17 ODT products was measured in healthy volunteers (n=910; age range, 2128 years). -EO,chLE0DOcPE_wfIx,Ioy^eNzu?EiRY=>.{.yA~ezphtQ>]J.69/VE#M,K,[2~_='EUB*%xE^+rd~!_8Zd-YE2kltp~"?oo5%
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endobj Clinical Disintegration Times of ODT-A (A) and ODT-B (B) in 3 Groups of Healthy Volunteers, Fig. Participants took a 15-min interval between tests of ODT-A and ODT-B. 37 0 obj Tablet diameter, weight, and thickness were obtained from the package insert or interview form for each product. 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. 27 0 obj 0000003226 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. Amlodin OD Tablets 2.5mg, 13. Sastry SV, Nyshadham JR, Fix JA. 0000006711 00000 n
Before the test, the oral cavity of participants was rinsed with a cup of water (120mL). Determination of the. 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. 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. 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. 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. This measurement was performed on 10 tablets of each type of ODT and the mean disintegration time was calculated.
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