무코스타정(레바미피드 100mg)에 대한 레바미드 정의 생물학적 동등성

조혜영,정현철,오인준,문재동,이용복 한국약제학회 2001 Journal of Pharmaceutical Investigation Vol.31 No.4

Rebamipide is a novel anti-gastric ulcer agent that has been reported to increase the synthesis of mucus, to increase the mucosal concentration of prostaglandin, and to promote rapid ulcer healing. The purpose of the present study was to evaluate the bioequivalence of two rebamipide tablets, Mucosta^TM (Otsuka Korea Pharmaceutical Co., Ltd.) and Rebamide^TM (Kyung Dong Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The rebamipide release from the two rebamipide tablets in vitro was tested using KP VII Apparatus II method at pH 6.8 dissolution media. Twenty normal male volunteers, 24.20±2.26 years in age and 66.19±9.41 kg in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After one tablet containing 100 mg of rebamipide was orally administered, blood was taken at predetermined time intervals and the concentrations of rebamipide in serum were determined using HPLC method with fluorescence detector. The dissolution profiles of two rebamipide tablets were very similar at pH 6.8 dissolution media. Besides, 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. The results showed that the differences in AUC_t C_max and T_max between two tablets based on the Mucosta^TM were -2.57%, 5.77% and -1.47%, respectively. Minimum detectable differences (Δ) at α=0.05 and 1-β=0.8 were less than 20% (e.g., 12.62% and 17.63% for AUC_t and C_max respectively). The powers (1-β) at α=0.05, Δ=0.2 for AUC_t and C_max were above 99.00% and 88.56%, respectively. The 90% confidence intervals were within 20% (e.g., -9.96∼4.82 and -4.54∼16.09 for AUC_t and C_max respectively). Two parameters met the criteria of KFDA for bioequivalence, indicating that Rebamide^TM tablet is bioequivalent to Mucosta^TM tablet.

엘도스 캡슐(에르도스테인 300mg)에 대한 엘브론 캡슐의 생물학적 동등성

조혜영,이석,강현아,문재동,이용복 한국약제학회 2003 Journal of Pharmaceutical Investigation Vol.33 No.3

Erdosteine, the thiol derivatives chemically related to cysteine, is a mucolytic and mucoregulator agent which modulated mucus production and viscosity and increases mucoiliary transport. The purpose of the present study was to evaluate the bioequivalence of two erdosteine capsules, Erdos (Dae Woong Pharmaceutical Co., Korea) and Erblon (Kuhn Ⅱ Pharmaceutical Co., Korea), according to the guidelines of Korea Food and Drug Administration (KFDA). The erdosteine release from the two erodisteine capsules in vitro was tested using KP Ⅷ Apparatus Ⅱ method with various different kinds of dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty four healthy male subject, 23.33±2.06 years in age and 66.18±8.19 ㎏ in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After three capsules containing 300 ㎎ as erdostein were orally administered, blood was taken at predetermined time intervals and the concentrations of erdostein in serum were determined using HPLC method with UV detector. The dissolution profiles of two formulations were similar at all dissolution media. Besides, 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 log-arithmically transformed AUC_(t) and C_(max) and untransformed T_(max). The results showed that the differences between two formulations based on the Erdos were 0.20%, 1.10% and -9.44% 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 long(0.8) to log(1.25)(e.g., long(0.94)∼long(1.22) and log(0.92)∼log(1.20) for AUC_(t) and C_(max), respectively. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating Erblon capsule and Erdos capsule are bioequivalent.

구개열에서 비인두강의 생리해부학적 구조와 과비음과의 연관성 연구

조준희,표화영,최홍식,최병재,손흥규,심현섭 大韓小兒齒科學會 2004 大韓小兒齒科學會誌 Vol.31 No.4

비인강폐쇄란 연구개, 인두측벽 그리고 인두후벽간의 움직임이 서로 조화되어 구강과 비강을 나누어주는 괄약근 기전으로서 연하, 호흡, 발음 등의 생리적기능에 중요한 역할을 한다. 이 기능에 문제가 생긴 경우를 비인강폐쇄부전이라하며 그 원인으로는 (1) 연구개의 길이 및 움직임이상 (2) 비인두강의 해부학적 공간문제 (3) 인두 후벽과 측벽의 기능이상 등이 있다. 본 연구는 구개열 환자의 측면두부방사선계측사진을 통해 비인두강을 생리해부학적으로 분석하였으며 산출된 말소리의 과비음정도를 Nasometer로 평가하였다. 이로부터 얻은 정상군과 구개열환자군의 결과를 각각 비교하였으며, 비인강폐쇄부전과의 연관성을 알아보기 위하여 Anatomic VPI와 Nasalance score의 값을 비교분석하였다. 얻어진 결과는 다음과 같았다. 1. 측면두부방사선계측사진 결과, 연구개 길이, 연구개 두께, 비인강 깊이, 비인강 면적, Adequate ratio에서 두 그룹간 유의한 차이를 나타내었다. 2. Nasometer 결과. 모음/오/와 구강공명음문장, 구강장해음문장에서 두 그룹 간 유의한 차이를 나타내었다. 3. 구개열환자군에서 비인두강의 폐쇄부전 정도를 표현해주는 Anatomic VPI와 Nasalance score는 전반적으로 연관성이 없었다. 다만, 모음/이/와 일부 구강자음으로 이루어진 문장에서 다소의 상관성을 나타내었다. 결론적으로, 측면두부방사선계측사진과 Nasometer 각각의 검사결과에서 두 그룹간 유의한 차이를 찾아볼 수 있었으나, 구개열환자군내에서 비인강폐쇄부전을 표현하는 Anatomic VPI와 Nasalance score는 모음/이/와 구강자음을 포함한 문장을 제외하고는 전반적으로 연관성이 없었다. Velopharyngeal closure is a sphincter mechanism between the activities of the soft palate, lateral pharyngeal wall and the posterior pharyngeal wall, which divides the oral and nasal cavity. It participates in physiological activities such as swallowing, breathing and speech. It is called a velopharyngeal dysfunction when this mechanism malfunctions. The causes of this dysfunction are defects in (1) length, function, posture of the soft palate, (2) depth and width of the nasopharynx and (3) activity of the posterior and lateral pharyngeal wall. The purposes of this study are to analyze the nasopharynx of cleft palate patients using cephalometry and to evaluate the degree of hypernasality using nasometry to find its relationship with velopharyngeal dysfunction. The following results were obtained : 1. In cephalometry, there were significant differences in soft palate length, soft palate thickness, nasopharyngeal depth, nasopharyngeal area, and adequate ratio between two groups. 2. In nasometry, there were significant differences between two groups in vowel /o/ and sentences including oral consonants. 3. In cleft palate patients, though no general correlation was found between Anatomic VPI and nasalance scores, vowel /i/ and sentences including oral consonants were slightly correlated. In conclusion, cephalometry and nasometer results were significantly different between the two groups. Though in the cleft palate group. Anatomic VPI and nasalance scores, which are indices for velopharyngeal closure, excluding the vowel /i/ and sentences including oral consonants show generally no significance.

시클러 캡슐(세파클러 250㎎)에 대한 경보세파클러 캡슐의 생물학적동등성

조혜영,강현아,김세미,박찬호,오인준,임동구,문재동,이용복 한국약제학회 2005 Journal of Pharmaceutical Investigation Vol.35 No.1

The purpose of the present study was to evaluate the bioequivalence of two cefaclor capsules, Ceclor (Lilly Korea Co., Ltd.) and Kyongbocefaclor (Kyongbo Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of cefaclor from the two cefaclor 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 four healthy male subjects. 22.96±1.52 years in age and 67.03±7.90 kg in body weight, were divided into two groups and a randomized 2x2 cross-over study was employed. After one capsule containing 250 mg of cefaclor was orally administered, blood was taken at pre-determined time intervals and the concentrations of cefaclor in serum were determined using HPLC method 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 Tmaa. The results showed that the differences between two formulations based on the reference drug, Ceclor. were -1.90%, 2.68% and -7.60% for AUCt, 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 0.91-log 1.06 and log 0.92-log 1.18 for AU', and C_(max), respectively). Thus. the criteria of the KFDA bioequivalence guideline were satisfied, indicating Kyongbocefaclor capsule was bioequivalent to Ceclor capsule.

유한세프라딘 캅셀(세프라딘 500mg)에 대한 브로드세프 캅셀의 생물학적 동등성

조혜영,이석,강현아,오인준,임동구,문재동,이용복 한국약제학회 2002 Journal of Pharmaceutical Investigation Vol.32 No.3

Cephradine is a first generation cephalosporin and has broad spectrum antibacterial activity against gram-positive and gram-negative microorganisms, through inhibition of bacterial cell wall synthesis. Cephradine is useful for treatment of infections of the urinary and respiratory tract, skin and soft tissues. The purpose of the present study was to evaluate the bioequivalence of two cephradine capsules, Cefradine Yuhan(YuHan Corporation) and Broadcef (Ilsung Pharmaceuticals Co. Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The cephradine release from the two cephradine capsules in vitro was tested using KP Ⅶ Apparatus Ⅱ method with various different kinds of dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty normal male volunteers, 23.10±2.90 years in age and 67.69±8.04 ㎏ in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After one capsule containing 500㎎ as cephradine was orally administered, blood was taken at predetermined time intervals and the concentrations of cephradine in serum were determined using HPLC method with UV detector. The dissolution profiles of two cephradine capsules were very similar at all dissolution media. Besides, 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 and C_max and untransformed T_max. The results showed that the differences in AUC_t C_max and T_max between two capsules based on the Cefradine Yuhan were -2.87%, -0.96% and -4.85%, respectively. There were no sequence effects between two capsules in these parameter. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(1.25) (e.g.,log(0.93)∼log(1.02) and log(0.88)∼log(1.13) for AUC_t and C)max, respectively). The 90% confidence interval using untransformed data was within ±20% (e.g., -17.54∼7.78 for T_max). All parameters met the criteria of KFDA guideline for bioequivalence, indicating that Broadcef capsule is bioequivalent to Cefradine Yuhan capsule.

스마트폰 부재와 분실을 대비한 어플리케이션

조시현;문상수;김기환;도민균;서재현;김태공 인제대학교 2012 仁濟論叢 Vol.27 No.1

Recently, as the Smart Phone is rapidly disseminated worldwide, it is emerging as an important digital communication media changing the communication types of users. We use the Smart Phone in all aspect of daily life besides communication. The Smart Phone is indispensible tool that has a great ripple effect on our daily life. Therefore, if the Smart Phone users lose or do not bring their phones, they were troubled. In this paper, we make users available to use the Smart Phone, even if they lose or do not bring their phones. To do this end, we develop features that search the phone in case of not knowing where it is, that contact another phone in case of not bringing their phone, that lock the phone in case of losing it. We expect these features promote a expansion and a vitality of the Smart Phone market.

디푸루칸 캅셀(플루코나졸 50 mg)에 대한 플루코나 캅셀의 생물학적 동등성

조혜영,강현아,이석,오인준,임동구,문재동,이용복 한국약제학회 2003 Journal of Pharmaceutical Investigation Vol.33 No.2

Fluconazole is an orally active bis-triazole antifungal agent, which is used in the treatment of superficial and systemic candidiasis and in the treatment of cryptococcal infections in patients with the acquired immuno deficiency syndrome (AIDS). The purpose of the present study was to evaluate the bioequivalence of two fluconazole capsules, Diflucan(Pfizer Pharmaceuticals Korea Inc.) and Flucona (Korean Drug Pharmaceuticals Co., Ltd.), according to the guidelines of Korea Food and Drug Administration(KFDA). The fluconazole release from the two fluconazole capsules in vitro was tested using KP Ⅶ Apparatus Ⅱ method at 0.1M hydrochloride dissolution media. Twenty normal male volunteers, 23.60±1.88 years in age and 63.57±6.17㎏ in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After three capsules containing 50㎎ as fluconazole was orally administered, blood was taken at predetermined time intervals and the concentrations of fluconazole in serum were determined using HPLC method with UV detector. The dissolution profiles of two fluconazole capsules were very similar at 0.1M hydrochloride dissolution media. Besides, 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 and C_max and untransformed T_max. The results showed that the differences in AUC_t, C_max and T_max between two capsules based on the Diflucan were 4.96%, 5.65% and -13.76%, respectively. There were no sequence effects between two capsules 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(1.01)∼log(1.08) and log(1.00)∼log(1.12) for AUC_t and C_max respectively), indicating that Flucona capsule is bioequivalent to Diflucan capsule.

스프렌딜 지속정(펠로디핀 5㎎)에 대한 스타핀 지속정의 생물학적동등성

조혜영,강현아,이석,백승희,박은자,최후균,문재동,이용복 한국약제학회 2003 Journal of Pharmaceutical Investigation Vol.33 No.4

Felodipine is a calcium antagonist that lowers blood pressure by reducing peripheral resistance by means of a direct, selective action on smooth muscle in arterial resistance vessels. Furthermore, it have been approved for the effective in angina pectoris and cardiac failure. The purpose of the present study was to evaluate the bioequivalence of two felodipine extended release (ER) tablets, Splendil (YuHan Corporation) and Stapin (Hana Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). THe felodipine release from the two felodipine formulations in vitro was tested using KP Ⅷ Apparatus Ⅱ method at pH 6.5 buffer solution. Twenty six healthy male subjects, 22.73±1.78 years in age and 66.66±7.28 ㎏ in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After two tablets containing 5 ㎎ as felodipine were orally administered, blood sample was taken at predetermined time intervals and the concentrations of felodipine in serum were determined using column-switching HPLC method with UV detector. The dissolution profiles of two formulations were similar at pH 6.5 buffer solution. Besides, the pharmacokinetic parameters such as AUG_(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) and C_(max) and untransformed T_(max). The results showed that the differences between two formulations based on the Splendil were 2.53%, 1.32% and 18.32% for AUC_(t), C_(max) and T_(mzx), 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(0.86)∼log(1.20) and long(0.89)∼long(1.23) for AUC_(t) and C_(max), respectively). Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating Stapin ER tablet and Splendil ER tablet are bioequivalent.

리스페달 정(리스페리돈 2㎎)에 대한 리스펜 정의 생물학적 동등성

조혜영,박은자,강현아,백승희,이석,박찬호,문재동,이용복 한국약제학회 2004 Journal of Pharmaceutical Investigation Vol.34 No.2

The purpose of the present study was to evaluate the bioequivalence of two risperidone tablets, Risperdal (Janssen Korea Co., Ltd) and Rispen (Myung In Pharm. Co., Ltd), according to the guidelines of Korea Food and Drug Administration (KFDA). The risperione release from the two risperidone formulations in vitro was tested using KP Ⅷ Apparatus Ⅱ method with various of dissolution media (pH 1.2, 4.0, 6.8 butter solution and water). Twenty four healthy male subjects, 23.33±2.10 years in age and 69.24±8.05 kg in body weight, were divided into two groups and a randomized 2×2 crossover study was employed. After one tablet containing 2 ㎎ as risperidone was orally administered, blood was taken at predetermined time intervals and the concentration of risperidone in serum were determined using HPLC method with UV detector. The dissolution profiles of two formulations were similar at all dissolution media. Besides, the pharmacokinetic parameters such as AUC_(t), C_(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 Risperdal were 0.20, -1.29 and -11.09% 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(0.90)∼log(1.03) and log(0.84)∼log(1.09) for AUC_(t) and C_(max), respectively). Thus, the criteria of the KFDA guideline for the bioequivalence were satisfied, indicating Rispen tablet and Risperdal tablet were bioequivalent.

체내동태 연구를 위한 혈청 중 펜톡시필린의 HPLC 정량법 개발 및 검증

조혜영,강현아,류희두,이화정,문재동,이용복 한국약제학회 2006 Journal of Pharmaceutical Investigation Vol.36 No.2