• Title/Summary/Keyword: Reference capsule

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Improved Dissolution Characteristics of Ibuprofen Employing Self-Microemulsifying Drug Delivery System and Their Bioavailability in Rats (자가유화 약물전달시스템을 이용한 이부프로펜의 용출개선 및 흰쥐에서의 생체이용률 평가)

  • Kim, Hyung-Soo;Lee, Sang-Kil;Choi, Sung-Up;Park, Hye-Sook;Jeon, Hyun-Joo;Choi, Young-Wook
    • Journal of Pharmaceutical Investigation
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    • v.32 no.1
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    • pp.27-33
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    • 2002
  • A self-microemulsifying drug delivery system(SMEDDS) composed of Cremophor $EL^{\circledR},\;Labrasol^{circledR}$, and Lauroglycol $FCC^{circledR}$ was prepared for the enhancement of solubility, dissolution rate and bioavailability of ibuprofen(IBP), which is water-insoluble but soluble in oils and surfactants. Phase diagram with various regions including microemulsion area was depicted. The SMEDDS was encapsulated in soft gelatin capsules and their dissolution characteristics in various media were observed in comparison to the generic products commercially available in the market. Soft capsules of SMEDDS formulation showed better dissolution profiles, especially in acidic condition, than the others. For the period of 1 hr dissolution in pH 1.2 medium, it reached over 70% dissolution from soft capsules, compared to less than 40% dissolution from commercial reference tablets. On the other hand, in vivo pharmacokinetic parameters were obtained after oral administrations of different IBP preparations to Sprague Dawley rats. SMEDDS formulation showed higher $C_{max}$ and greater $AUC_{0-5hr}$ than the suspension of reference tablet or IBP powder. Therefore, it is possible to conclude that a newly developed soft capsules employing SMEDDS provides an alternative preparation to improve oral bioavailability of IBP.

Spontaneous ophthalmic diseases of Beagles in Korea (국내 Beagle견의 안과질환)

  • Kim, Bong-kyeong;Yun, Young-min;Seong, Je-kyung;Seo, Kang-moon
    • Korean Journal of Veterinary Research
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    • v.41 no.1
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    • pp.113-121
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    • 2001
  • Beagle is one of the most popular laboratory animal in a dog. We investigated the incidence of spontaneous ophthalmic disease in Beagles in order to make basic data for quality control of Beagles in Korea. We surveyed 389 beagles from 3 different farms. The average prevalence rate of ophthalmic diseases was 19.3%. The prevalence rate of cataracts was higher than any other ophthalmic diseases, 7.5% and then in order of corneal scar(2.1%), retinal hemorrhage(1.5%), post-inflammatory retinal change(1.5%), cherry eye(1.0%), distichiasis(0.8%), entropion(0.8%), hypoplastic optic disc(0.8%), conjunctivitis(0.5%), retinal dysplasia(0.5%), asteroid hyalosis(0.3%), congenital eye anomaly(0.3%), corneal lipidosis(0.3%), conjunctival hemorrhage(0.3%), lens capsule pigmentation(0.3%), persistent hyperplastic primary vitreous (0.3%), posterior synechia(0.3%), eyelid tumor(0.3%) and uveal cyst(0.3%) were diagnosed. There was a slight difference between male(24.8%) and female(17.4%) in prevalence rate of ophthalmic disease. The incidence of spontaneous ophthalmic disease was increased with age. These data would be useful for using Beagles as laboratory animals and standard reference for quality control of dogs.

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Profound Sensorineural Deafness Following the Application of Terramycin Powder Intratympanically (중이강내 Terramycin산포로 초래된 심한 감각신경성난청)

  • 박옥희;김기주;이태정;조중환
    • Proceedings of the KOR-BRONCHOESO Conference
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    • 1981.05a
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    • pp.37.2-38
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    • 1981
  • Recently the efficacy of all ear drops in perforated tympanic membranes has been questioned and the safety of using the drugs intratympanically has been challanged. Many drugs not normally ototoxic when given systemically become ototoxic when administered via the middle ear. According to Stupp and others (1973) among neomycin, polymyxin-G, gentamycin, erythr omycin, tetracycline and penicillin, only penicillin was found to be free of toxic effects. The ototoxic antibiotics probably reach the inner ear by permeating the round window membrane, into the perilymph and then through Reissner's membrane to the endolymph. The main pathological changes are degeneration of stria vascularis, degeneration of sensory epithelia and degeneration of ganglion cells. We report with reference, a case of profound sensorineural deafness following the application of Terramycin powder intratympanically, in a 63 year old woman.

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CHARACTERISTICS OF A NEW PNEUMATIC TRANSFER SYSTEM FOR A NEUTRON ACTIVATION ANALYSIS AT THE HANARO RESEARCH REACTOR

  • Chung, Yong-Sam;Kim, Sun-Ha;Moon, Jong-Hwa;Baek, Sung-Yeol;Kim, Hark-Rho;Kim, Young-Jin
    • Nuclear Engineering and Technology
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    • v.41 no.6
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    • pp.813-820
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    • 2009
  • A rapid pneumatic transfer system (PTS) for an instrumental neutron activation analysis (INAA) is developed as an automatic irradiation facility involving the measurement of a short half-life nuclide and a delayed neutron counting system. Three new PTS designs with improved functions were constructed at the HANARO research reactor in 2006. The new system is composed of a manual system and an automatic system for both an INAA and a delayed neutron activation analysis (DNAA). The design and basic conception of a modified PTS are described, and the functions of system operation and control, radiation protection and emissions of radioactive gas are improved. In addition, a form of capsule transportation of these systems is tested. The experimental results pertaining to the irradiation characteristics with variation of the neutron flux and the temperature of the irradiation position with the irradiation time are presented, as is an analysis of the reference material for analytical quality control and uncertainty assessments.

Bioequivalence of Burophil Capsule to Surfolase Capsule (Acebrophylline 100 mg) (설포라제 캡슐(아세브로필린 100 mg)에 대한 부로필 캡슐의 생물학적 동등성)

  • Cho, Hea-Young;Park, Eun-Ja;Kang, Hyun-Ah;Kim, Se-Mi;Park, Chan-Ho;Oh, In-Joon;Lim, Dong-Koo;Lee, Myung-Hee;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.35 no.3
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    • pp.179-185
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    • 2005
  • Acebrophylline is a compound produced by salifying ambroxol with theophylline-7 -acetic acid. After acebrophylline administration, the salt splits into these two components which feature a peculiar pharmacokinetic behavior, an adequate ambroxol and a low theophylline-7-acetic acid serum levels. The purpose of the present study was to evaluate the bioequivalence of two acebrophylline capsules, Surfolase (Hyundai Pharm. lnd. Co., Ltd.) and Burophil (Kuhnil Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of ambroxol from the two acebrophylline 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 eight healthy male subjects, $23.25{\pm}1.43$ years in age and $64.82{\pm}6.77$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After two capsules containing 100 mg as acebrophylline were orally administered, blood was taken at predetermined time intervals and the concentrations of ambroxol in serum were determined using HPLC with electrochemical detector (ECD). 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 Surfolase, were -1.64, -3.33 and -0.92% 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 $(e.g., \;log\;0.93{\sim}log\;1.05\;and\;log\;0.88{\sim}log\;1.05$ for $AUC_t$, and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Burophil capsule was bioequivalent to Surfolase capsule.

The Bioequivalence of Plunazol Tablet (Fluconazole 150 mg) to Three capsules of Diflucan 50 mg (디푸루칸 캡슐 50 mg (3 캡슐, 플루코나졸 150mg)에 대한 푸루나졸 정 150mg의 생물학적 동등성)

  • Chang, Hee-Chul;Lee, Min-Suk;Ryu, Chong-Hyon;Lyu, Seung-Hyo;Cho, Sang-Heon;Choi, Yeon-Jin;Hwang, Ae-Kyung;Kim, Yun-Ah;Park, Si-Hyun;Yoon, Ji-Won;Bae, Kyun-Seop
    • Journal of Pharmaceutical Investigation
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    • v.39 no.3
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    • pp.207-216
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    • 2009
  • Fluconazole is used as an orally administrated antifungal drug for the treatment of tinea corporis, candidiasis including skin mycotic pneumonia infections. The dosage of fluconazole varies with indication ranging from 50 mg/day to 400 mg/day. The fluconazole capsule 50 mg (3 capsules daily) is already available in Korean market. To improve the patient compliance, a fluconazole tablet 150 mg (once a day administration) was developed recently. The purpose of this study was to evaluate the bioequivalence of three doses of fluconazole capsule 50 mg (Diflucan 50 mg, Pfizer Korea Inc., as a reference drug) and a single dose of fluconazole tablet 150 mg (Plunazol 150 mg, Daewoong Pharm. Co., Korea) according to the guidelines of the Korea Food and Drug Administration (KFDA). The bioequivalence for three capsules of Diflucan 50 mg and a single tablet of Plunazol 150 mg was investigated in twenty-four healthy male volunteers under a randomized 2${\times}$2 crossover trial design. The average age of twenty-four volunteers was 24.78${\pm}$3.27 year-old, average height was 175.56${\pm}$5.45 cm and average weight was 67.24${\pm}$6.86 kg. After three capsules of Diflucan 50 mg or a single tablet of Plunazol 150 mg were orally administered, blood was taken at predetermined time intervals and the plasma concentrations of fluconazole in plasma were determined using LC-MS-MS. The 90% confidence intervals for the main parameters of statistical results after logarithmic transformation were AUCt 0.9272-1.0084 and Cmax 0.8423-0.9544 respectively, which are in the range of log 0.8 to log 1.25 and the statistical results of additional parameters (AUClast, t1/2 and MRT) were also in the 90% confidence interval that is in the range of log 0.8 to log 1.25. Therefore, the results of this study confirm the bioequivalence of three capsules of Diflucan 50 mg to one tablet of Plunazol 150 mg.

A simple method to determine lycopene in solid supplementary food preparations using saponification and liquid chromatography (비누화 및 액체크로마토그래프를 활용한 고상 건강기능식품 중 라이코펜 분석법 개발)

  • Young Min Kim;Ye Bin Shin;Min Kyeong Kwon;Jin Hwan Kim;Ji Seong Kim;Dong-Kyu Lee;Myung Joo Kang;Yong Seok Choi
    • Analytical Science and Technology
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    • v.36 no.3
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    • pp.105-112
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    • 2023
  • Lycopene, a carotenoid hydrocarbon is known to have effects on reducing cardiovascular risk factors, blood lipids, and blood pressure. Thus, a lot of supplementary foods with lycopene in several dosage forms like soft capsule filled with liquid and hard capsule filled with powder are available in a market. Recently, however, our research group found that the lycopene assay in Supplementary Food Code of South Korea is only valid for oily lycopene preparation. Thus, here, we developed a simple method to determine lycopene in solid preparations for Supplementary Food Code of South Korea using saponification and liquid chromatography with an absorbance detector. The method was validated following Ministry of Food and Drug Safety guidelines. All validation parameters observed in this study were within acceptable criteria of the guidelines (selectivity, linearity of r2 ≥ 0.991, lower limit of quantification of 0.0149 mg/mL, accuracy as recovery (R) between 92.70 and 97.18 %, repeatability as relative standard deviation (RSD) values of R between 0.85 and 1.59 %, and reproducibility as the RSD value of interlaboratory R of 3.70 %). Additionally, the practical sample applicability of the validated method was confirmed by accuracy between 98.81 and 101.59 % observed from its lycopene certified reference material (CRM) analyses. Therefore, the present method could contribute to fortify the supplementary food safety management system in South Korea.

Bionomics of larger Black Chafer (Holotrichia morosa Waterhouse) and Korean Black Chafer( H. diomphalia Bates) with Special Reference to Their Morphological Characteristics and Life Histories (큰검정풍뎅이와 참검정풍뎅이의 형태 생활사)

  • 김기황;현재선
    • Korean journal of applied entomology
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    • v.27 no.1
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    • pp.21-27
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    • 1988
  • A study was carried out to investigate the morphological characteristics and life histories of H. morosa and H. diomPhalia during the period from 1984 to 1986. The head capsule width and bOdy length of H. Morosa larvae were slightly greater than those of H. diomPhalia. Otherwise, the two species looked very similar and were hard to be differentiated from each other in all life stages. H. morosa adults emerged in late June and laid eggs in soil during the period between mid July and mid August. Larvae developed by September to the last(3rd) instar which overwintered to pupate in late May. H. diomPhalia adults emerged from mid August but remained under the soil until next spring after which females laid eggs in soil from late May to early July. Larvae developed in most cases to the last instar by September and overwintered thereafter. Unlike H. morosa, they resumed feeding next April and began to pupate in late July. The egg periods of H. morosa and H. diomPhalia did not significantly differ but the larval and pupal periods of the latter were longer than those of the former.

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The Effect of Stress Reduction on Color Stimulus Using Healing Bed in Cypress Tree (편백나무로 제작된 힐링 침대에서의 색체 자극이 스트레스 완화에 미치는 효과)

  • Shin, Sun-Hye;Yu, Mi;Oh, Seung-Yong;Kim, Ju-Ri;Song, Eui-Sun;Moon, Myoung-Chul;Lim, Seung-Taek;Park, Hee-Jun;Kwon, Tae-Kyu
    • Journal of rehabilitation welfare engineering & assistive technology
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    • v.10 no.2
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    • pp.163-170
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    • 2016
  • The purpose of this study was to verify the emotional response of user to LED light colors in healing bed system in cypress tree. Eight colors of LED light were provided including red, orange, yellow, green, blue, indigo, violet and white. And three illumination color temperature were provided including 3,000K, 5,000K, 8,000K. Seven subjects in their twenties were involved without the medical history of eyes and heart disorders. The subjects were exposed to LED lighting during 5 minutes and their emotional response was evaluated through the following: first, at the physiological effect heart rate variability(HRV) was measured during the stimulation; second, at the emotion level the subjects were asked about lighting color and color temperature through a survey. Results, lower color temperature of 3,000K and green color shows high value on HRV. We have found that there is a difference of physiological and emotion level effect depending on color stimulus. This study could be applied to reference data to analysis of a decrease in fatique and charges of brain waves for color stimulus.

Investigations of the External Dose Rate (${\mu}Sv/h$), the Residual Activity (mCi) and the Excretion Rate (%) of Thyroid Cancer Patients Hospitalized for 3700 MBq (100 mCi) $^{131}I$ Radioiodine Treatment ($^{131}I$ 3700 MBq (100 mCi) Therapy 입원 환자의 선량률(${\mu}Sv/h$), 잔류량(mCi), 배설률(%) 측정)

  • Bae, Gi-Han;Kim, Hwa-Joong;Choi, Jae-Jin;Lee, Won-Guk
    • The Korean Journal of Nuclear Medicine Technology
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    • v.13 no.3
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    • pp.48-55
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    • 2009
  • Purpose: As Korean nuclear law doesn't have any clear guideline about the dose and the external dose rate(uSv/h) requiring hospitalization in radioactive iodine treated patients, the patients are discharged when they meet the guideline of IAEA Basic Safety Standards(BSS). We measured external dose rate(${\mu}Sv/h$) of inpatient underwent 3700MBq (100 mCi) $^{131}I$ radioiodine treatment and considering external dose rate(${\mu}Sv/h$), residual activity(mCi) and excretion rate(%) we found the time for RA to be lowered from 3700MBq (100 mCi) to 1110 MBq (30 mCi) to give reference to set a guideline for discharge. Materials and Methods: Forty-two patients underwent thyroidectomy and scheduled for radioiodine treatment, who received 3700MBq (100 mCi) of $^{131}I$ orally and had no renal disease were examined. After 1, 2, 4, 8, and 20, 24, 40 hours iodine uptake and before/after the urination, the external dose rate(${\mu}Sv/h$) measured using FH40G-L(Thermo Fisher Scientific Inc., MA) at a distance and a height of 1 m for 20 sec on the average. Results and Conclusions: At 20 hours, the external dose rate was decreased to $49{\pm}13\;{\mu}Sv$/h, namely, 78% of administrated radioactivity was excreted and 814 MBq (30 mCi) was residual, and it met the accepted limit for discharge of (IAEA, BSS) under 1110 MBq (30 mCi) (1 m at 66 uSv/h).

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