• Biomolecules & Therapeutics
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• v.8 no.3
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• pp.262-268
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• 2000

The bioequivalence of two tiropramide products was evaluated in 18 health male volunteers following oral administration. Test product was Tira $m^{R}$ tablet (Shin Poong SP-102) (Shin Poong Pharm. Co., Ltd.) and reference product was Tirop $a^{R}$ tablet (Dae Woong Pharm. Co., Ltd.) One capsule of the test and reference product containing 100 mg of tropramide.hydrochloride was administered to the volunteers by randomized two period cross-over study (2 $\times$ 2 Latin square method). The drug concentration in plasma was determined by GC/MS for over a period of 12hours after administration. Analysis of variance reveal that there are no differences in AUC (area under the plasma concentration-time curve from time zero to infinity), Cmax (maximum plasma concentration) and Tmax (time to reach Cmax). The differences of mean AUC, Cmax and Tmax between two products were 3.85, 1.47 and -3.6%, respectively. Minimum detectable differences (%) at $\alpha$=0.1 were all less than 20% given as a guideline (18.07, 17.00 and 20.69% for AUC, Cmax and Tmax, respectively). From these results, the two products are bioequivalent.ent.

• Journal of Powder Materials
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• v.31 no.2
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• pp.126-131
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• 2024

The aim of this study was to improve the chemical stability of cycloserine containing organic and inorganic compounds. Composite particles were manufactured with a 1:1 weight ratio of organic/inorganic compounds and cycloserine. The influence of organic/inorganic compounds on the stability of cycloserine was investigated under accelerated stress conditions at 60℃/75% RH for 24 hours. In addition, the properties of the composite particles were evaluated using differential scanning calorimetry (DSC), scanning electron microscopy (SEM), and the dissolution of the drug was assessed by preparing it as a hard capsule. Among the organic and inorganic compounds investigated, calcium hydroxide most improved the stability of cycloserine under accelerated stress conditions (53.3 ± 2.2% vs 1.7 ± 0.2%). DSC results confirmed the compatibility between calcium hydroxide and the cycloserine, and SEM results confirmed that it was evenly distributed around the cycloserine. Calcium hydroxide also showed more than 90% cycloserine dissolution within 15 minutes. Therefore, the calcium hydroxide and cycloserine composite particles may be candidates for cycloserine oral pharmaceuticals with enhanced drug stability.

• Journal of the korean academy of Pediatric Dentistry
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• v.37 no.4
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• pp.429-437
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• 2010

The aim of this study was to evaluate the fluoride release and microhardness of Beautifil II as giomer(Group I), F2000 Compomer as compomer(Group II), GC Fuji II LC Capsule as resin-modified glass ionomer(Group III) and $Filtek^{TM}$ Z350 as composite resin(Group IV) according to time. Forty discs(5 mm diameter and 2 mm height) were prepared for each material. Each disc was immersed in 3 ml of de-ionized water within polyethylene tube and stored at $37^{\circ}C$. Evaluations were performed by pH/ISE meter for analysis of fluoride release and hardness testing machine for analysis of microhardness over 31 days. The results can be summarized as follows : 1. For all groups except group IV, the greatest fluoride release was observed after the first day of the study period and then dramatically diminished over time. On the 7th day of the study period, fluoride release level was stabilized. 2. Group III showed the highest fluoride release among test groups and then group II, group I were followed. Significant difference in cumulative fluoride release over 31 days was found between each groups. Group IV showed no fluoride release during study period. 3. Group IV showed the highest microhardness among test groups and then group I, group II, group III were followed. Significant difference in microhardness was found between each group, except between group I and group II. 4. After 31 days, microhardness was slightly diminished in every group. However, no significant difference was found.

• Journal of Periodontal and Implant Science
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• v.32 no.2
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• pp.415-428
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• 2002

Periodontal disease is a complex infectious disease caused by bacteria in the oral mucosa, which results in gingival inflammation, breakdown of periodontal tissues, bone resorption, and finally tooth loss. Mechanical plaque control methods-scaling and root planing are effective methods to stop the progression of such periodontal disease. It was reported that subantimicrobial dose of doxycycline(SDD) regimen could improve clinical conditions of periodontal tissues without causing the overgrowth of opportunistic organisms that was a typical antibiotic side effect. Therefore pharmacological therapy, used in conjunction with mechanical therapy could be considered a useful treatment modality in the treatment of chronic periodontal disease. In this study, 30 patients diagnosed as moderate to advanced chronic periodontitis were divided into 2 groups. In this double-blind, placebo-controlled study, the patients were administered 20mg doxycycline capsule or placebo capsule b.i.d. for 4months, after scaling and root planing. Clinical parameters-bleeding on probing, pocket depth and clinical attachment level were compared and evaluated between these groups at periods of first visit, 1 month, 2 months, 3 months, 4 months. The results were as follows ; 1. In case of moderate periodontitis, pocket depth showed significant reduction after treatment in both the control & experiment groups, when compared with the baseline values(p<0.01), but in case of advanced periodontitis, only the experiment group showed significant reduction after treatment when compared with the baseline values(p<0.05). Statistically significant reduction in pocket depth was observed in the experiment group compared to the control group(p<0.05). 2. In case of moderate periodontitis, clinical attachment level showed significant reduction after treatment in both the control & experiment groups, when compared with the baseline values(p<0.01), but in case of advanced periodontitis, only the experiment group showed significant reduction after treatment when compared with the baseline values(p<0.05). Statistically significant reduction in clinical attachment level was observed in the experiment group compared to the control group(p<0.05). 3. Bleeding on probing improved after treatment in both the groups. In case of moderate periodontitis, the experiment group showed statistically significant reduction of bleeding on probing when compared with the control group at 1 and 4 months after treatment(p<0.05). In case of advanced periodontitis, treatment resulted in statistically significant reduction of bleeding on probing in both the groups(p<0.05). These results indicate that the use of subantimicrobial dose of doxycycline is a useful supplement to mechanical treatment for periodontal patients in ameliorating the clinical parameters such as periodontal pocket, attachment level, and bleeding on probing.

• Journal of Pharmaceutical Investigation
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• v.35 no.2
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• pp.117-122
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• 2005

After establishing improved HPLC analytical method of cefaclor in human plasma samples, a bioavailability study of cefaclor capsules was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). The standard calibration curve using an HPLC with UV detector was constructed in a range of $0.0324{\sim}16\;{\mu}g/ml$. The 6% perchloric acid instead of 6% trichloroacetic acid was used to precipitate plasma protein. The HPLC chromatograms were precisely and accurately resolved when spiked with human plasma spiked with cefaclor and cephalexin (internal standard). Twenty healthy male Korean volunteers received two commercial cefaclor capsules, $Neocef^{\circledR}$ capsule (Jinyang Pharm. Co., Ltd) or $Ceclor^{\circledR}$ capsule (Lilly Korea. Co., Ltd.) at the 250 mg cefaclor in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. Plasma concentrations of cefaclor were monitored for 8 hours after oral drug administration. $AUC_t$ the area under the plasma concentration-time curve from time zero to 8 hr (13 points), was calculated by the linear trapezoidal rule method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the cross-over design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $Neocef^{\circledR}/Ceclor^{\circledR}$ were $0.9049{\leq}{\delta}{\leq}1.226$, respectively. These values were within the acceptable bioequivalence intervals of 0.80-1.25. Thus, our study demonstrated the bioequivalence of $Neocef^{\circledR}/Ceclor^{\circledR}$ with respect to the extent of absorption.

• Journal of Periodontal and Implant Science
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• v.48 no.3
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• pp.152-163
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• 2018

Purpose: To determine whether the swelling and mechanical properties of osmotic self-inflating expanders allow or not the induction of intraoral soft tissue expansion in dogs. Methods: Three different volumes (0.15, 0.25, and 0.42 mL; referred to respectively as the S, M, and L groups) of soft tissue expanders (STEs) consisting of a hydrogel core coated with a silicone-perforated membrane were investigated in vitro to assess their swelling behavior (volume swelling ratio) and mechanical properties (tensile strength, tensile strain). For in vivo investigations, the STEs were subperiosteally inserted for 4 weeks in dogs (n=5). Soft tissue expansion was clinically monitored. Histological analyses included the examination of alveolar bone underneath the expanders and thickness measurements of the surrounding fibrous capsule. Results: The volume swelling ratio of all STEs did not exceed 5.2. In tensile mode, the highest mean strain was registered for the L group ($98.03{\pm}0.3g/cm$), whereas the lowest mean value was obtained in the S group ($81.3{\pm}0.1g/cm$), which was a statistically significant difference (P<0.05). In addition, the S and L groups were significantly different in terms of tensile strength ($1.5{\pm}0.1g/cm$ for the S group and $2.2{\pm}0.1g/cm$ for the L group, P<0.05). Clinical monitoring showed successful dilatation of the soft tissues without signs of inflammation up to 28 days. The STEs remained volumetrically stable, with a mean diameter in vivo of 6.98 mm, close to the in vitro post-expansion findings (6.69 mm). Significant histological effects included highly vascularized collagen-rich fibrous encapsulation of the STEs, with a mean thickness of $0.67{\pm}0.12mm$. The bone reaction consisted of resorption underneath the STEs, while apposition was observed at their edges. Conclusions: The swelling and mechanical properties of the STEs enabled clinically successful soft tissue expansion. A tissue reaction consisting of fibrous capsule formation and bone loss were the main histological events.

• Journal of the Korean Society of Radiology
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• v.6 no.4
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• pp.267-273
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• 2012

Abnormal gastric emptying time of dog by alien substance, neoplasm, pyloric antrum hyperplasia, stomach surgery, electrolyte imbalance, stomach-dilated torsion is clinically important as a digestive disease. Therefore study aims to provide basic data on the clinical usefulness of gastric emptying time test which uses radiopaque Kolomark developed in Korea rather than using the existing BIPS for the dog. 9 beagles were used for this experiment and their average weight was about 10.3kg with 2.5 year-old average age. For the test, fast for 12 hours was made without chemical sedation, and just before the test, 1 capsule of Kolomark was fed with 25% of daily feed amount, and we took photographs at ventrodorsal and right lateral position after 2, 4, 8 and 12 hours. As for interested reading area, we observed entire stomach from cardia to stomach pyloric part, and as for analysis method, we counted Kolomarks remained in the stomach per time and judged only P value below 0.05 to be meaningful by using Friedman Test. After feeding Kolomark through oral cavity, it took average 7.55 hours for the Kolomark to have escaped from the stomach to small intestine. In this study of gastrointestinal tract passing time after feeding matured dog, we used Kolomark and expect that it could be a basic data for normal gastrokinetic time.

• Journal of Pharmaceutical Investigation
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• v.37 no.6
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• pp.397-402
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• 2007

To evaluate the bioequivalence of two venlafaxine formulations, a standard 2-way randomized cross-over study was conducted in twenty-four healthy male Korean volunteers. A single oral dose of 75 mg of test formulation Venfaxine $OR^{(R)}$ (tablet) or reference formulation Efexor $XR^{(R)}$ (capsule) was administered with one-week washout period. Plasma concentrations of venlafaxine were assayed for over a period of 72 hours with a well validated method using liquid chromatography coupled to tandem mass spectrometry (LC-MS-MS). The $mean{\pm}S.D$. of maximum concentration $(C_{max})$ and elimination half-life $(t_{1/2})$ were $64.7{\pm}28.5$ ng/mL, $9.2{\pm}3.0$ h, and $67.2{\pm}30.2$ ng/mL, $9.9{\pm}3.5$ h for test and reference formulations, respectively. Time to reach maximum concentration $(T_{max})$ expressed in median value (range), for the test and the reference, were 10 h (6-14) and 8h (4-12), respectively. Similarly, area under the plasma concentration-time curve, from time zero to last sampling time $(AUC_t)$ and from time zero to time infinity $(AUC_{inf})$, for test and reference formulations were $1185{\pm}755$, $1326{\pm}896$ and $1124{\pm}737$, $1185{\pm}755$ $ng{\cdot}h/mL$, respectively. The parametric 90% confidence intervals on the mean of the differences between the two formulations (test-reference) of the log transformed values of $AUC_t$, and $C_{max}$ were 0.9630 to 1.1383 and 0.8650 to 1.0446, respectively. The overall results indicate that the two formulations are bioequivalent and can be prescribe interchangeably.

• Asian Pacific Journal of Cancer Prevention
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• v.14 no.5
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• pp.2845-2850
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• 2013

Background: Breast cancer is one of the most frequent diseases in women today. Little information exists on modifiable lifestyle factors including effects of ginger supplements (as an anti-oxidant and anti-inflammatory herbal) and water-based exercise on biomarkers related to oxidative stress such as malondialdehyde (MDA), nitric oxide (NO) and glutathione peroxidase (GPx) and adiponectin in obese women with breast cancer. The aim of this study was to determine the single and concomitant effect of 6-wks water-based exercise and oral ginger supplement on the aforesaid markers in obese women with breast cancer. Materials and Methods: Forty women diagnosed with breast cancer ($48{\pm}5.4$ years, $76{\pm}9$ kg, fat mass $41.8{\pm}4%$), volunteered to participate in the study. Subjects were randomly assigned into four groups; placebo, water-based exercise, ginger supplement and water-based exercise+ginger supplement groups. Subjects in the ginger supplement group and the water-based exercise+ginger supplement group orally received 4 capsules (each capsule contained 750 mg), 7 days a week for 6 weeks. The water-based exercise program featured progressive increase in intensity and time, ranging from 50% to 75% of heart rate reserve, in a pool with 15 meters width, 4 times a week for 6 weeks. Fasting blood samples were collected at pre-test and post-test time points. Results: The ginger supplementation and or the water-base exercise resulted in an increase of adiponectin, NO and GPx and reduction MDA, as compared to pre-test values. However, the combined intervention (water-base exercise and ginger supplement) group showed significantly a far better effect on the biomarkers related to oxidative stress and adiponectin levels, as compared to the waterbase exercise or ginger supplement alone groups and the age-matched placebo group. Conclusions: Our results revealed that water-base exercise is a non-drug therapeutic strategy to reduce systemic stress in obese women suffering from breast cancer. Further, ginger supplementation alone or in combination with training, also play an important role in the pathogenesis of oxidative stress in obese women diagnosed with breast cancer.

• Journal of Pharmaceutical Investigation
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• v.31 no.1
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• pp.37-41
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• 2001

Various characteristics of polyethylene oxide (PEO) are useful for drug delivery systems. In this study, PEO was used as a sustained release matrix system containing cefatrizine propyleneglycol (Cefa-PG) which is a new semi-synthetic broad-spectrum and orally active cephalosporin. Five kinds of sustained release matrix tablets were formulated with various content of PEO and other ingredients. And three types of matrix tablets were formulated of which compositions were the same but the hardness was different. It was found that PEO content influenced drug release rate. Increasing PEO content, the drug release rate from matrix tablets was decreased. In addition, Avicel, one of the ingredients of matrix components, changed the drug release from the sustained release PEO matrix tablets. With increasing Avicel content, the rate of drug release was increased. For the effect of hardness of matrix tablets, the rate of drug release is decreased with increasing hardness. In comparison of bioavailability parameters after oral administration of Cefa-PG PEO matrix tablets and general Cefa-PG capsule in beagle dog, the sustained release PEO matrix tablets is more useful than a general dosage form. $AUC^{0-12}$ of the sustained release PEO matrix tablet and the general dosage form was 1.16 and 0.644 respectively.