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고체분산체에 의한 펠로디핀의 용출율 개선과 서방성 경구제제
길영식,홍석천,유창훈,신현종,김종성,Gil, Young-Sig,Hong, Seok-Cheon,Yu, Chang-Hun,Shin, Hyun-Jong,Kim, Jong-Sung 한국약제학회 2002 Journal of Pharmaceutical Investigation Vol.32 No.3
To improve the solubility of poorly water-soluble drug and to develop a sustained release tablets, the need for the technique, the formation of solid dispersion with polymeric materials that can potentially enhance the dissolution rate and extent of drug absorption was considered in this study. The 1:1, 1:4, and 1:5 solid dispersions were prepared by spray drying method using PVP K30, ethanol and methylene chloride. The dissolution test was carried out at in phosphate buffer solution at $37^{\circ}C$ in 100 rpm. Solid dispersed drugs were examined using differential scanning calorimetry and scanning electron microscopy, wherein it was found that felodipine is amorphous in the PVP K30 solid dispersion. Felodifine SR tablets were prepared by direct compressing the powder mixture composed of solid dispersed felodipine, lactose, Eudragit and magnesium stearate using a single punch press. In order to develop a sustained-release preparation containing solid dispersed felodipine, a comparative dissolution study was done using commercially existing product as control. The dissolution rate of intact felodipine, solid dispersed felodipine and its physical mixture, respectively, were compared by the dissolution rates for 30 minutes. The dissolution rates of felodipine for 30 minutes from 1:1, 1:4, 1:5 PVP K30 solid dispersion were 70%, 78% and 90%. However, dissolution rate offelodipine from the physical mixture was 5% of drug for 30 minutes. Our developed product Felodipine SR Tablet showed dissolution of 17%, 50% and 89% for 1, 4, and 7 hours. This designed oral delivery system is easy to manufacture, and drug releases behavior is highly reproducible and offers advantages over the existing commercial product. The dissolution rate of felodipine was significantly enhanced, following the formation of solid dispersion. The solid dispersion technique with water-soluble polymer could be used to develop a solid dispersed felodipine SR tablet.
권지윤,윤성도,조동현,길영식,김수경,Kwon, Gee-Youn,Yoon, Sung-Do,Cho, Dong-Hyun,Gil, Young-Sig,Kim, Soo-Kyung 대한임상약리학회 2003 Translational and Clinical Pharmacology Vol.11 No.2
Background: This study was conducted to evaluate the bioavailability of Fluconazole formulation in healthy Korean volunteers. Furthermore, the bioequivalence of $Flukan^{\circledR}$ capsule, a fluconazole preparation from Korea United Pharm, Inc., was determined. Methods: The study employed a randomized, two-way crossover Latin square design with a two-week washout period. The test product was $Flukan^{\circledR}$ capsule (Korea United Pharm Inc., South Korea) and the reference was $Diflucan^{\circledR}$ capsule (Pfizer Inc.). The two products were administered in 150 mg single oral doses into 26 healthy Korean volunteers. Serial blood samples were collected for a period of 120 hours. Plasma fluconazole concentrations of the two brands were measured by HPLC using UV detector, and the pharmacokinetic parameters including $AUC_t,\;C_{max},\;T_{max}$, and half-life were determined from plasma concentrations of both formulations. Results: Both formulations were well tolerated in 26 volunteers. Mean $AUC_t,\;C_{max}$ of $Flukan^{\circledR}$ capsule were 1.068 $(90%\;confidence\;interval:\;1.0057{\leq\delta\leq}1.1349)$ and 1.017 $(90%\;confidence\;interval:\;0.9633{\leq\delta\leq}1.0749)$ compared to those of $Diflucan^{\circledR}$ capsule. Mean half-life of $Flukan^{\circledR}$ capsule was $30.41{\pm}5.44$ and that of $Diflucan^{\circledR}$ capsule was $30.74{\pm}5.86$ hr. The powers $(1-{\beta})$ for $AUC_t\;and\;C_{max}$ were above 90%. The pharmacokinetic parameters $(AUC_t,\;C_{max},\;T_{ max})$ were analyzed statistically with K-BE test 2002 (KFDA). Conclusion : No significant differences between two formulations were observed in terms of $AUC_t\;and\;C_{max}$, the main pharmacokinetic parameters used for bioequivalence evaluation. The results satisfied the bioequivalence criteria of KFDA guidelines, and $Flukan^{\circledR}$ capsule was determined to be bioequivalent to $Diflucan^{\circledR}$ capsule.
정석현(Suk Hyun Jung),정상영(Sang Young Jeong),길영식(Young Sig Gil),조선행(Sun Hang Cho),신병철(Byung Cheol Shin) 한국생산제조학회 2011 한국생산제조시스템학회 학술발표대회 논문집 Vol.2011 No.4
Bisphosphonates are an important group of therapeutic agents for the management of osteoporosis, as they inhibit bone resorption and increase bone density, thereby potentially decreasing fracture risk. In this study, risedronate was transdermally delivered by iontophoresis. Effects of polarity, pH, current density, drug concentration and enhances were studied using a side-by-side diffusion cell including the hairless mice skin. The amount of transported drug under iontophoretic delivery was about 186 fold higher than that under passive delivery. Results indicated that iontophoresis is an effective method for transdermal administration of risedronate sodium.
자가미세유화시스템을 이용한 매스틱의 헬리코박터파일로리 대한 In vitro 및 In vivo 활성 연구
김수지(Su Ji Kim),정상영(Sang-Young Jeong),길영식(Young Sig Gil),신병철(Byung-Cheol Shin),황성주(Sung-Joo Hwang),조선행(Sun Hang Cho) 대한약학회 2011 약학회지 Vol.55 No.1
Mastic is a bleed resin formed in pistacia lentiscus tree extract form the anacatdiaceae family. Mastic is used as a food ingredient in the Mediteraanean resin, and has been used by local inhabitants as a traditional medicine for relief of upper abdominal discomfort, dyspepsiaand peptic ulcer. Clinically, mastic has been effective in the treatment of benign gastric and duodenal, ulcers, giving symptomatic relief and endoscopically proven healing. In this study, to enhance activiteies of poorly water soluble Mastic with oils, surfactants and cosurfactants and then the mixure was microemulsified in aqueous media under condition of gentle agitation and digestive motility that would be encountered in the gastrointestinal tract. Formulation development and screening were based on phase diagrams and characteristics of resultant microemulsion. For optimum mastic formulation, microemulsions with various ratio (w/w%) of mastics, oils, surfactants and cosurfactants were prepared and their solubility was evaluated by monitoring particles size in their buffer through visual asessment and electrophoretic light scattering spectrophotomerter (ELS). In vitro activity of self microemulsified mastic (SME mastic) was determined by minimum ingibition concentration (MIC) test against a panel of Helicobacter pylori (H.pylori) clinical strains. Additionally, in vivo activity of SME masitc was investigated us mouse infected by CH275 of H. pylori. The mean diameter of SME mastic was less then 100 nm in water and SME mastic was showed similar antiboisis effect compared to tometronidazole, clarithromycin and omeproazole. Consequently, SME mastic would be effective system to exterminate H. pylori. If mastic were dose with combined treatment, mastic might augur well for effect of H. pylori eradication as good remedy.
연구논문 : 생명과학 ; 인간에서의 경구흡수를 촉진하는 투명 아세클로페낙 연질캅셀의 개발
용철순 ( Chul Soon Yong ),오유경 ( Yu Kyoung Oh ),이경희 ( Kyung Hee Lee ),박상만 ( Sang Man Park ),길영식 ( Young Sig Gil ),유창훈 ( Chang Hun Yu ),김종오 ( Jong Oh Kim ),유봉규 ( Bong Kyu Yoo ),이종달 ( Jong Dal Rhee ),김종국 ( 영남대학교 약품개발연구소 2005 영남대학교 약품개발연구소 연구업적집 Vol.15 No.-
고체분산체에 의한 펠로디핀의 용출을 개선과 서방성 경구제제
길영식,홍석천,유창훈,신현종,김종성 한국약제학회 2002 Journal of Pharmaceutical Investigation Vol.32 No.3
To improve the solubility of poorly water-soluble drug and to develop a sustained release tablets, the need for the technique, the formation of solid dispersion with polymeric materials that can potentially enhance the dissolution rate and extent of drug absorption was considered in this study. The 1:1, 1:4, and 1:5 solid dispersions were prepared by spray drying method using PVP K30, ethanol and methylene chloride. The dissolution test was carried out at in phosphate buffer solution at 37℃ in 100 rpm. solid dispersed drugs were examined using differential scanning calorimetry and scanning electron microscopy, wherein it was found that felodipine is amorphous in the PVP K30 solid dispersion. Felodifine SR tablets were prepared by direct compressing the powder mixture composed of solid dispersed felodipine, lactose, Eudragit and magnesium stearate using a single punch press. In order to develop a sustained-release preparation containing solid dispersed felodipine, a comparative dissolution study was done using commercially existing product as control. The dissolution rate of intact felodipine, solid dispersed felodipine and its physical mixture, respectively, were compared by the dissolution rates for 30 minutes. The dissolution rates of felodipine for 30 minutes from 1:1, 1:4, 1:5 PVP K30 solid dispersion were 70%, 78% and 90%. However, dissolution rate offelodipine from the physical mixture was 5% of drug for 30 minutes. Our developed product Felodipine SR Tablet showed dissolution of 17%, 50% and 89% for 1, 4, and 7 hours. This designed oral delivery system is easy to manufacture, and drug releases behavior is highly reproducible and offers advantages over the existing commercial product. The dissolution rate of felodipine was significantly enhanced. following the formation of solid dispersion. The solid dispersion technique with water-soluble polymer could be used to develop a solid dispersed felodipine SR tablet.
L-아르기닌 복합체를 이용한 피록시캄의 용해도 및 생체이용률의 증가
홍석천,유창훈,조동현,신현종,길영식 한국약제학회 2003 Journal of Pharmaceutical Investigation Vol.33 No.2
Piroxicam-arginine complex was prepared to improve the solubility and dissolution rate of poorly water-soluble piroxicam. Its formation was identified by infrared spectrophotometry, differential thermal analysis and dissolution rate. Piroxicam complex dispersible tablets, commercial Feldene^?? dispersible tablets and piroxicam physical mixture hard capsules were prepared to compare dissolution rate in water. Dissolved amounts (%) after 15 mins of piroxicam complex dispersible tablets, commercial Feldene^?? dispersible tablets and piroxicam physical mixture hard capsules were 98%, 45% and 10%, respectively. The solubility of complex in water was significantly higher than that of piroxicam itself. In vivo, pharmacokinetic parameters were obtained after oral administrations of piroxicam complex and physical mixture at a does of 2㎎ to New Zealand White Rabbit. The C_max of piroxicam complex was similar to that of piroxicam. However, there were much difference between the two formulations with regard to T_max and AUC. The T_max of piroxicam alone was 4 hours, but that of piroxicam complex was 0.8 hours. In addition, the AUC of piroxicam complex was 1.38 times greater than that of piroxicam alone.