• Biomolecules & Therapeutics
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• 제7권2호
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• pp.191-197
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• 1999

The effects of various drugs on the alleviation of the symptoms of chemical bums were evaluated in mice to formulate topical antiblister preparations. After a chemical bum was induced on the mouse dorsal skin with 2-chloroethylethyl sulfide, the drug was applied on the disease site. The effectiveness of the drug was evaluated by determining blister size, necrosis score of skin and appearance of the chemical burns induced. It showed that steroids and aminoglycoside antibiotics had a tendency to protect skin cell, and antihistamines decreased the size of chemical bums. While oleaginous base resulted in deleterious effect, hydrophilic base didn't show a significant difference on the alleviation of the chemical burn symptoms compared to the control.

• Journal of Pharmaceutical Investigation
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• 제40권6호
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• pp.339-345
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• 2010

Fenofibrate has been used for many years to lower cholesterol levels and its pharmacokinetic profile is well understood. However, due to its low solubility in water, it has low bioavailability after oral administration. In order to improve the dissolution rate, fenofibrate was formulated into a self-microemulsifying drug delivery systems (SMEDDS). We used pseudo-ternary phase diagrams to evaluate the area of microemulsification, and an in vitro dissolution test was used to investigate the dissolution rate of fenofibrate. The optimized formulation for in vitro dissolution assessment consisted of Lauroglycol FCC (60%), Solutol HS 15 (27%), and Transcutol-P (13%). The mean droplet size of the oil phase in the microemulsion formed from the SMEDDS was about 130 nm. The dissolution rate of fenofibrate from SMEDDS was significantly higher than that of the reference tablet. Our studies suggested that the fenofibrate containing SMEDDS composition can effectively increase the solubility and oral bioavailability of poorly water-soluble drugs.

• Journal of Pharmaceutical Investigation
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• 제40권spc호
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• pp.33-43
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• 2010

Hyaluronic acid (HA) is a biodegradable, biocompatible, non-toxic, non-immunogenic and non-inflammatory linear polysaccharide, which has been used for various medical applications including arthritis treatment, wound healing, ocular surgery, and tissue augmentation. Because of its mucoadhesive property and safety, HA has received much attention as a tool for drug delivery system development. It has been used as a drug delivery carrier in both nonparenteral and parenteral routes. The nonparenteral application includes the ocular and nasal delivery systems. On the other hand, its use in parenteral systems has been considered important as in the case of sustained release formulation of protein drugs through subcutaneous injection. Particles and hydrogels by various methods using HA and HA derivatives as well as by conjugation with other polymer have been the focus of many studies. Furthermore, the affinity of HA to the CD44 receptor which is overexpressed in various tumor cells makes HA an important means of cancer targeted drug delivery. Current trends and development of HA as a tool for drug delivery will be outlined in this review.

• 폴리머
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• 제34권3호
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• pp.269-273
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• 2010

본 연구는 염산 알푸조신의 서방화를 위한 과립제의 최적 구성을 찾기 위해 수행되었으며, 이에 따라 고분자의 점도에 따른 염산 알푸조신 과립정제를 제조하였다. 사용된 고분자는 경구를 통한 약물전달 시스템 설계에 가장 널리 사용되는 하이드록시프로필메틸셀룰로오스(HPMC)이며, HPMC의 팽윤성은 가장 중요한 특성으로 약물의 방출에 큰 영향을 미친다. 염산 알푸조신 과립정제의 구조변화를 확인하기 위하여 적외선분광법(FTIR)을 분석하였으며, 결정학적 특성을 알아보기 위해 X선 회절분석법(XRD)을 이용하여 분석하였다. 과립정제를 제조하여 인공장액에서의 방출거동을 알아보았으며, 본 연구를 통해 첨가제로 사용된 HPMC의 점도에 따라 모델약물인 염산 알푸조신의 방출거동을 조절할 수 있었다.

• 한국임상약학회지
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• 제19권1호
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• pp.50-60
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• 2009

Highly variable drugs (within-subject variability greater than 30%) have been difficult to meet current regulatory acceptance criteria using a reasonable number of study subjects. In this study, we reviewed previous studies presenting alternative approaches for bioequivalence evaluation of highly variable drugs, and focused on an approach for widening the bioequivalence acceptance limits using within-subject variability. We discussed the suggested five solutions for highly variable drug including the deletion of $C_{max}$ of the bioequivalence criteria, direct expansion of bioequivalence limit, multiple dose studies in steady state, bioequivalence assessment on the metabolite, add-on study, and widening the bioequivalence acceptance limits based on reference variability. The methods for widening of bioequivalence limits based on reference variability are scaled average bioequivalence containing within-subject variability on reference drug (${\sigma}_{WR}$), population bioequivalence derived from total variability on reference drug (${\sigma}_{TR}$) and test drug (${\sigma}_{TT}$), and individual bioequivalence derived from subject by formulation interaction variability (${\sigma}_D$) and within subject variability on reference drug (${\sigma}_{WR}$) and test drug (${\sigma}_{TR}$). To apply these methods, the switching variability (${\sigma}_0$) will have to be set by the regulatory authorities. The proposals of bioequivalence evaluation approach for the highly variable in Korea are presented for both of new drug and reevaluation drug.

• 산업융합연구
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• 제21권6호
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• pp.13-21
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• 2023

본 연구의 목적은 마약 범죄와 관련된 언론보도량과 실제 마약사범 검거 건수 간의 관계를 탐구하고, 이 관계가 경찰이 마약 범죄 대응 정책을 수립하는 데 있어 시사하는 바를 확인하는 것이다. 이를 위해, 2001년부터 2022년까지의 국내 온라인 언론보도 데이터 50,355건과 경찰청이 집계한 마약사범 검거 건수 데이터를 수집하고 분석하였다. 분석결과, 마약 범죄 온라인 언론보도량과 실제 마약사범 검거 건수 간에는 유의미한 인과관계가 있음을 확인할 수 있었다. 이 관계는 지배적 이슈의 존재 및 유명 사건 관련 여부에 영향을 받는데, 언론보도량은 마약 범죄 검거 수 외 대중적 관심에도 영향을 받는 것으로 판단되었다. 이러한 결과를 통해 경찰은 국민의 신뢰를 얻기 위하여 범죄 관련 언론보도량을 모니터링하고, 국민적 관심을 받는 범죄에 대한 치안역량을 강화해야 한다고 제안하였다.

• 한국임상약학회지
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• 제15권1호
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• pp.27-33
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• 2005

This study was intended to contribute towards the development of proper drug use system for pediatric patients by investigationg problems related to their medication and identifying drugs that need to be developed into low dosage tab-lets or syrups for pediatric use based on our analysis on the prescriptions for pediatric inpatients from 22 hospitals in South Korea on a day of Feb. 2003. The usage rates in the proportion of less than 0.5 and 1 per unit of oral solid formulation were $29.9{\%}$ and $54.3{\%}$ in hospitals with 1000 beds or more, 36.5 and $60.6{\%}$ in hospitals with 500 to less than 1000 beds, $60.8{\%}$ and $81.6{\%}$ in hospitals with less than 500 beds. Of the 63 oral solid formulation products that were used two or more times in the proportion oi less than 0.5 units, 34 products ($54.0{\%}$) were used as such despite the fact that syrups and lower dosage tablets or capsules were available in the market, and 24 products ($38.1{\%}$) so even when syrup formulations were available. Therefore, it would be desirable that pharmacist communities in charge of dispensing identify the most frequently crushed drugs or those that require special attention in choosing dispensing powders or solutions and develop dispensing guidelines that can be adopted by pharmacists in practice. Moreover government-led policies are needed to encourage development and manufacture of the formulations for pediatrics and to correct unsound prescription and dispensing practices such as using crushed forms of certain oral solid formulations although alternative formulations are available in the market.

• Journal of Pharmaceutical Investigation
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• 제33권4호
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• pp.319-322
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• 2003

Many studies have been attempted to overcome the problems of paclitaxel related to the extremely low aqueous solubility of paclitaxel and the unexpected side-effects caused by $Cremophor^{\circledR}$ EL in a commercial paclitaxel formulation, $Taxol^{\circledR}$. In order to formulate a new delivery system suitable for intravenous administration without toxic excipients, in this study, paclitaxel was incorporated into solid lipid nanoparticles (Px-SLN) by hot homogenization technique using a microfluidizer. Particle size and zeta potential were measured by a Zetasizer. In vitro drug release experiment was performed by a dialysis diffusion method. Each Px-SLN or $Taxol^{\circledR}$ was intravenously administered to the male Sprague-Dawley rats at a dose of 5 mg/kg as paclitaxel. Blood samples were deproteinated with acetonitrile and assayed for paclitaxel by the validated HPLC/MS/MS method. Mean particle size and zeta potential were measured as 72.1 nm (< Polydispersity 0.3) and -41.5 mV, respectively. The content of paclitaxel in SLN was 1.42 mg/ml and the drug loading efficiency was $71.2{\pm}4.3%$. The $AUC_t$ of Px-SLN was 3.4-fold greater than that of $Taxol^{\circledR}$. The Px-SLN might be a promising candidate for an alternative formulation for the parenteral delivery of paclitaxel.

• 대한예방한의학회지
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• 제23권1호
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• pp.83-94
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• 2019

Objective : This study investigated the effects of concentrated and lyophilized blue honeysuckle powders (BH) on the pharmacokinetics (PK) of sorafenib were observed. Method : The blood was collected at 0.5 hr before single oral treatment of sorafenib (40 mg/kg) or sorafenib with BH (400, 200 and 100 mg/kg) mixed formulas administration, and 0.5, 1, 2, 3, 4, 6, 8 and 24 hrs after the end of single or mixed formula administration. Plasma concentrations of sorafenib were analyzed using LC-MS/MS methods. Tmax, Cmax, AUC, $t_{1/2}$ and $MRT_{inf}$ of sorafenib were analysis as compared with sorafenib single treatment. Results : Single oral administration of mixed formulas induced significant increases of plasma sorafenib concentrations from 0.5 hr after end of administration throughout all blood collected time points, as compared with sorafenib single formula treated rats, and significant decreases of sorafenib Tmax with increases of Cmax, $AUC_{0-t}$ and $AUC_{0-inf}$ were detected in sorafenib and BH 400 mg/kg mixed formulation treated rats as compared with sorafenib single formula treated rats, respectively. Inaddition, sorafenib and BH 200 or 100 mg/kg mixed formula treated rats also showed significant increases of sorafenib Cmax, $AUC_{0-t}$ and $AUC_{0-inf}$, respectively. Conclusions : According to these results, mixed formulation of BH with sorafenib increased the bioavailability of sorafenib through the increment of the absorptions.

• 분석과학
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• 제36권4호
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• pp.180-190
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• 2023

The presence of process related impurities in any drug or the drug product was associated with its safety, stability and efficacy. The overall literature survey proved that there is no method published on the assessment of process related impurities in brigatinib. In this study, a simple, reliable and stable HPLC qualitative method was reported for quantification of process related impurities with easy and quick extraction procedure. The impurities along with standard brigatinib was resolved on Lichrospher^® C18 (250 mm × 4.6 mm; 5 ㎛ particle size) column in room temperature using methanol, acetonitrile, pH 4.5 phosphate buffer in 55:25:20 (v/v) at 1.0 mL/min as mobile phase and UV detection at 261 nm. The method produces well resolved peaks at retention time of 4.60 min, 12.28 min, 3.37 min, 7.34 min and 8.39 min respectively for brigatinib, impurity A, B, C and D. The method produces a very sensitive detection limit of 0.0065 ㎍/mL, 0.0068 ㎍/mL, 0.0053 ㎍/mL and 0.0058 ㎍/mL for impurity A, B, C and D respectively with calibration curve linear in the concentration range of 22.5-135 ㎍/mL for brigatinib and 0.0225-0.135 ㎍/mL for impurities. The method produces all the validation parameters under the acceptable level and doesn't produces any considerable changes in peak area response while minor changes in the developed method conditions. The method can effectively resolve the unknown stress degradation products along with known impurities with less % degradation. The method can efficiently resolve and quantify the impurities in formulation and hence can suitable for the routine quality analysis of brigatinib in raw material and formulation.