• Title/Summary/Keyword: Tablet-Based

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Bioequivalence of pioglitazone tablet to Actos® tablet (Pioglitazone 30 mg) (액토스정®(피오글리타존 30 mg)에 대한 염산피오글리타존정의 생물학적동등성)

  • Yeom, Hyesun;Lee, Tae Ho;Youm, Jeong-Rok;Song, Jin-Ho;Han, Sang Beom
    • Analytical Science and Technology
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    • v.22 no.1
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    • pp.101-108
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    • 2009
  • The bioequivalence of two pioglitazone tablets, Actos$^{(R)}$ tablet (Takeda Chemical Industries, reference drug) and Pioglitazone tablet (Boryung Company, test drug) was evaluated according to the guidelines of Korea Food and Drug Administration. Twenty-eight healthy male Korean volunteers received each medicine (pioglitazone dose of 30 mg) in a $2{\times}2$ crossover study with one week washout interval. After drug administration, blood samples were collected at specific time intervals from 0-36 hours. The plasma concentrations of pioglitazone were determined by high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS). The total chromatographic run time was 5 min and calibration curves were linear over the concentration range of 5-2000 ng/mL for pioglitazone. The method was validated for selectivity, sensitivity, linearity, accuracy and precision. The pharmacokinetic parameters were determined from the plasma concentration-time profiles of both formulations. The primary calculated pharmacokinetic parameters were compared statistically to evaluate bioequivalence between the two preparations. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for Pioglitazone tablet and Actos$^{(R)}$ tablet were log0.9422~log1.1040 and log0.9200~log1.1556, respectively. Based on the statistical considerations, we can conclude that the test drug, Pioglitazone tablet was bioequivalent to the reference drug, Actos$^{(R)}$ tablet.

Satisfaction Evaluation for Tablet-based Smart AAC Device (태블릿 기반 스마트 AAC 기기 만족도 평가)

  • Kong, Jin-Yong;An, Na-Yeon
    • Journal of Digital Contents Society
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    • v.19 no.2
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    • pp.251-257
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    • 2018
  • The purpose of this study is to analyze the satisfaction and requirements of users' devices after development of tablet based AAC(Augmentative and Alternatice Communication) application for Android. The purpose of this study is to evaluate the satisfaction and the requirement of tablet - based AAC application, Were assessed using the Korea Assistive Technology Assessment Tool (KAAT). As a result of satisfaction evaluation of tablet-based smart AAC device, all the items including device, service, and everyday life showed positive response satisfying from 5 point scale to more than 4 point scale. However, it was relatively low in the items of effectiveness, manipulation and convenience. Some of the improvements in the application include the enlargement of the symbol sound and the simplicity of symbol editing. The results of the study suggest that continual updates of m Smart AAC applications, the simplicity of symbolic editing, application usage and training should be improved. The satisfaction evaluation results of this study and the feedback of potential users will be the guidelines for improving and complementing the functions of existing smart AAC devices.

Dynamic Modeling of a Novel ATC Mechanism based on 4-bar Linkage (4절링크를 기반으로 하는 신개념 ATC 메커니즘의 동역학 해석)

  • Lee, Sangho;Kim, Jong-Won;Seo, TaeWon;Kim, Jongwon
    • Journal of Institute of Control, Robotics and Systems
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    • v.22 no.4
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    • pp.307-314
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    • 2016
  • Recently, demands on the tapping machine are increased due to the case of a cell phone is changed to metal such as aluminum. The automatic tool changer (ATC) is one of the most important devices for the tapping machine related to the speed and energy consumption of the machine. To reduce the consumed energy and vibration, the dynamic modeling is essential for the ATC. In this paper, inverse dynamic modeling of a novel ATC mechanism is introduced. The proposed ATC mechanism is composed of a double four-bar mechanism with a circular tablet to generate continuous rotation of the tablet. The dynamic modeling is performed based on the Lagrange equation with a modeling for the contact between the four-bar and the tablet. Simulation results for various working conditions are proposed and analyzed for the prototype design. The dynamic modeling can be applied to determine the proper actuator and to reduce the vibration and consumed energy for the ATC machine.

Bioequivalence of Mycosil Tablet to Lamisil Tablet (Terbinafine 125 mg) (라미실 정(테르비나핀 125 mg)에 대한 미코실 정의 생물학적 동등성)

  • Cho, Hea Young;Park, Hyun Jin;Jeong, Kyung Hee;Cho, Haeng Nam;Moon, Jai Dong;Lee, Yong Bok
    • Korean Journal of Clinical Pharmacy
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    • v.10 no.2
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    • pp.62-67
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    • 2000
  • Terbinafine has a primary fungicidal action mediated by squalene epoxidase inhibition. Treated fungi accumulate squalene while becoming deficient in ergosterol, an essential component of fungal cell membranes. Bioequivalence of two terbinafine tablets, $Lamisil^{TM}$ (Novartis Korea Ltd., Seoul, Korea) and $Mycosil^{TM}$ (Daewon Pharmaceutical Co., Ltd., Seoul, Korea), was evaluated according to the guidelines of Korea Food and Drug Administration (KFDA). Sixteen normal male volunteers ($20\sim29$ years old) were randomly divided into two groups and a randomized $2\times2$ cross-over study was employed. After oral administration of $Mycosil^{TM}\;or\;Lamisil^{TM}$ (125 mg terbinafine), blood samples were taken at predetermined time intervals and the serum terbinafine concentrations were determined using an HPLC method with UV/VIS detector. The pharmacokinetic parameters $(AUC_t,\;C_{max}\;and\;T_{max})$ were calculated and ANOVA was utilized for the statistical analysis. The results showed that the differences in $AUC_t,\;C_{max}\;and\;T_{max}$ between two tablets based on the $Lamisil^{TM}$ tablet were $-2.24\%,\;-7.68\%\;and\;2.92\%$, respectively. The powers %(1-\beta)\;for\;AVC_t,\;C_{max}\;and\;T_{max}\;were\;87.11\%,\;95.36\%\;and\;99.99\%$, respectively. Minimum detectable differences $(\Delta)\;and\;90\%$ confidence intervals were all less than $\pm20\%$. All these parameters met the criteria of KFDA for bioequivalence, indicating that $Mycosil^{TM}$ tablet is bioequivalent to $Lamisil^{TM}$ tablet.

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Evaluation of antibacterial activity against Candida albicans according to the dosage of various denture cleansers

  • Bae, Cha-Hwan;Lim, Yun-Kyong;Kook, Joong-Ki;Son, Mee-Kyoung;Heo, Yu-Ri
    • The Journal of Advanced Prosthodontics
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    • v.13 no.2
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    • pp.100-106
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    • 2021
  • PURPOSE. The purpose of this study is to compare the antibacterial activity of currently purchasable denture cleansers against Candida albicans. Materials and methods: This study used tablet-type denture cleansers, PolidentⓇ, CoolingdentⓇ and FittydentⓇ, along with liquid denture cleansers, HexamedineⓇ, ListerineⓇ and Apple vinegarⓇ. The antibacterial activities of denture cleansers were evaluated based on the number of C. albicans and concentrations of the denture cleansers. Results. In the 0.5 × 106 cfu/㎖ culture medium, the C. albicans' death rate of PolidentⓇ was significantly lower than those of FittydentⓇ, HexamedineⓇ, ListerineⓇ, and Apple vinegarⓇ(P<.05). In the 0.5 × 107 cfu/, the C. albicans' death rates of PolidentⓇ and CoolingdentⓇ were significantly lower than those of FittydentⓇ, HexamedineⓇ, ListerineⓇ and Apple vinegarⓇ(P<.05). The C. albicans' death rates of PolidentⓇ and CoolingdentⓇ were significantly decreased at 0.02 g and 0.01 g. The C. albicans' death rate of FittydentⓇ was significantly decreased at 0.005 g (P<.05). The C. albicans' death rate of HexamedineⓇ was significantly decreased at 1/16 dilution. The C. albicans' death rate of ListerineⓇ was decreased at 1/8 dilution, and the antibacterial activity of Apple vinegarⓇ was decreased at 1/4 dilution (P<.05). Conclusion. As the number of C. albicans increased, the antibacterial activities of the denture cleansers decrease. In the tablet-type denture cleanser, all denture cleansers showed 100% C. albicans' death rate when used at a dose of 1 tablet. One denture cleanser showed the same antibacterial effect with only 1/3 of a tablet. In the liquid type denture cleanser, the level of dilution required was different for each denture cleanser.

Comparative Study of Dissolution Properties of Immediate-release and Controlled-release Type Vitamin C Tablets (속방형 및 용출조절형 비타민 C 정제의 용출 특성 비교 분석)

  • Yang, Hyo-Jin;Ryu, Na-Hee;Yang, Joo-Hong;Hong, Sun-Ho;Lee, Yeonkyung;Cho, Yang-Hee
    • Journal of Food Hygiene and Safety
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    • v.37 no.2
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    • pp.114-120
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    • 2022
  • In this study, a comparative dissolution experiment was conducted between an immediate-release and a controlled-release vitamin C tablet applied with a technology to control the dissolution of vitamin C to maintain the vitamin C level in the human body. In order to confirm the dissolution rate (%) of vitamin C tablets, HPLC determination was conducted based on the dissolution test methods in the 'Korean Pharmacopoeia (No. 2020-88),' 'Guidelines on Specifications of Dissolution Tests for Oral dosage Forms,' and 'Standard and Specifications for Health Functional Foods (No. 2020-63)' from Ministry of Food and Drug Safety (MFDS). In addition, the dissolution pattern between the immediate-release tablet and the controlled-release tablet was comparatively analyzed. The analysis result confirmed that the immediate-release vitamin C tablet was 100% dissolved after 45 minutes, while the controlled-release vitamin C tablet was 100% dissolved after 480 minutes (8 hours). Furthermore, the dissolution rate (%) at 60 minutes was slower than that of the immediate-release vitamin C tablet. Based on these results, this study confirmed that the dissolution rate (%) test and development of controlled-release tablets containing vitamin C as the main component a re possible.

Tablet PC based Convergence Educational Serious Game for Children (태블릿 PC 기반의 융합형 아동 교육용 기능성 게임)

  • Ko, Jeong-Won;Lee, Ji-Won;Kim, Mi-Hye;Jung, Hye-Kyung;Park, Sung-Jun
    • Journal of Korea Game Society
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    • v.14 no.1
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    • pp.59-68
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    • 2014
  • As the prevalence of mobile platforms, expanding digital content production and also increasing interest about the serious game. However, existing educational serious games are short of application of educational function and lower effectiveness that not linked with off-line education. In this paper, we developed an educational serious game 'Rice-Mimi Adventure' for children based Tablet PC. The Games are designed five steps by four elements that storytelling, playing, music and cooking. Specially, players interaction between characters should be increase their own concentration and interest. For the effectiveness verification that linked education of on/off-line, experiment to 126 students of 3,4th grade in Choenan. A result shows positive data that on/off-line linked education using Tablet PC and effectiveness of game contents applied design factors. For this work, we should find effective class and teaching method using digital contents in off-line education for children.

Validation of Electronic Foot Function Index in Patients with Foot and Ankle Disease: A Randomized, Prospective Multicenter Study (족부 족관절 질환 환자에서 전자식 족부 기능 지수의 인증: 임의 배정, 전향적, 다기관 연구)

  • Lee, Dong Yeon;Kim, Yu Mi;Lee, Jun Hyung;Kim, Jin;Kim, Ji-Beom;Kim, Bom Soo;Choi, Gi Won;Seo, Sang Gyo;Kim, Jun Beom;Park, Se-Jin;Kim, Yoon-Chung;Choi, Young Rak;Lee, Dong-Oh;Cho, Jae-Ho;Chun, Dong-Il;Kim, Hyong Nyun;Park, Jae-Yong
    • Journal of Korean Foot and Ankle Society
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    • v.23 no.1
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    • pp.24-30
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    • 2019
  • Purpose: To evaluate the efficiency of the electronic foot function index (eFFI) through a prospective, random based, multi-institutional study. Materials and Methods: The study included 227 patients ranging in age from 20 to 79 years, visited for surgery in different 15 institutes, and agreed to volunteer. The patients were assigned randomly into a paper-based evaluated group (n=113) and tablet-based evaluated group (n=114). The evaluation was done on the day of hospital admission and the method was changed on the second day of surgery and re-evaluated. PADAS 2.0 (https://www.proscore.kr) was used as an electronic evaluation program. Results: There were no differences in age and sex in both groups. The intraclass correlation coefficient (ICC) evaluation revealed an eFFI ICC of 0.924, showing that both results were similar. The evaluation time was shorter in the tablet-based group than the paper-based group (paper vs tablet, $3.7{\pm}3.8$ vs $2.3{\pm}1.3minutes$). Thirty-nine patients (17.2%) preferred to use paper and 131 patients (57.7%) preferred the tablet. Fifty-seven patients (25.1%) found both ways to be acceptable. Conclusion: eFFI through tablet devices appears to be more constant than the paper-based program. In addition, it required a shorter amount of time and the patients tended to prefer the tablet-based program. Overall, tablet and cloud system can be beneficial to a clinical study.

Bioequivalence of S-napine Tablet 10 mg to Alesion Tablet(Epinastine HCl 10 mg) (알레지온 정(염산에피나스틴 10mg)에 대한 에스나핀 정 10밀리그람의 생물학적동등성)

  • Kang, Hyun-Ah;Cho, Hea-Young;Yoon, Hwa;Kim, Se-Mi;Kim, Dong-Ho;Park, Sun-Ae;Kim, Hwan-Ho;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.36 no.6
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    • pp.405-411
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    • 2006
  • Epinastine is an antiallergic drug effective for bronchial asthma, allergic rhinitis, urticaria and dermatitis. Epinastine is topically active, direct H1-receptor antagonist and an inhibitor of the release of histamine from the mast cell. The purpose of the present study was to evaluate the bioequivalence of two epinastine hydrochloride tablets, Alesion Tablet (Boehringer Ingelheim Korea Ltd.) and S-napine tablet 10 mg(Sam Chun Dang Pharm. Co., Ltd), according to the guidelines of the Korea Food and Drug Administration(KFDA). The release of epinastine from the two epinastine formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media(pH 1.2, 4.0, 6.8 buffer solution and water). Twenty six healthy male subjects, $23.35{\pm}1.57$ years in age and $66.29{\pm}10.61kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After two tablets containing 20 mg as epinastine hydrochloride was orally administered, blood was taken at predetermined time intervals and the concentrations of epinastine in serum were determined using HPLC with UV detector. The dissolution profiles of two formulations were similar at all dissolution media. In addition, the pharmacokinetic parameters such as $AUC_t,\;C_{max}\;and\;T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t.\;C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, Alesion tablet, were 1.50, 1.46 and -13.48% for $AUC_t,\;C_{max}\;and\;T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25(e.g., log 0.95$\sim$log 1.12 and log 0.93$\sim$log 1.10 for $AUC_t\;and\;C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating S-napine tablet 10 mg was bioequivalent to Alesion tablet.

Bioequivalence Test of Gabapentin 800 mg Tablets (가바펜틴 800밀리그람 정제의 생물학적동등성시험)

  • Kim, Se-Mi;Shin, Sae-Byeok;Kang, Hyun-Ah;Cho, Hea-Young;Lee, Yong-Bok
    • YAKHAK HOEJI
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    • v.52 no.4
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    • pp.299-305
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    • 2008
  • Gabapentin, 1-(aminomethyl) cyclohexaneacetic acid, is a amino acid derivative, and is clinically effective in the treatment of neuropathic pain and partial seizures of epilepsy as a complementary therapy. The purpose of the present study was to evaluate the bioequivalence of two gabapentin tablets, $Neurontin^{R}$ tablet 800 mg (Pfizer Pharmaceuticals Co., Ltd.) and Gabapenin tablet 800 mg (Hanmi Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of gabapentin from the two gabapentin formulations in vitro was tested using KP VIII Apparatus II method with 0.06 M HCI dissolution media. Twenty six healthy male subjects, $23.85{\pm}2.24$ years in age and $69.40{\pm}11.11$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ crossover study was employed. After a single tablet containing 800 mg as gabapentin was orally administered, blood samples were taken at predetermined time intervals and the concentrations of gabapentin in serum were determined using HPLC with fluorescence detector. The dissolution profiles of two formulations were similar in the tested dissolution media. The pharmacokinetic parameters such as $AUC_{t}$, $C_{max}$ and $T_{max}$ were calculated, and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_{t}$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Neurontin^{R}$, were 1.28%, 0.63% and 0.62% for $AUC_{t}$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., $log0.9097{\sim}log1.1598$ and $log0.8919{\sim}log1.1262$ for $AUC_{t}$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Gabapenin tablet 800 mg was bioequivalent to $Neurontin^{R}$ tablet 800 mg.