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이미숙,남궁형욱,김영주,손인자,조남춘 한국병원약사회 1997 병원약사회지 Vol.14 No.4
The stability of a dexamethasone disodium phosphate in suspension was studied. Suspensions of dexamethasone disodium phosphate were prepared from commercially available amples (Dexamethasone suspension Ⅰ) and from bulk powder (Dexamethasone suspension Ⅱ) to yield a suspension with a theoretical dexamethasone disodium phosphate concentration of 0.5㎎/㎖. The suspension was divided into portion and stored in plastic bottles under fluorescent light or in light - protective vinyl package at room temperature (25±1℃) or refrigerated temperature(4±1℃) for 6 months. The concentration of dexamethasone disodium phosphate in the samples was determined by a stability - indicating High Performance Liquid Chromatographic (HPLC) assay at 0, 1, 2, 4 and 6 months. Also at these times, the pH of the sample was measured and the samples were inspected for evidence of the color, odor and microbial growth. The concentration of dexamethasone disodium phosphate in the samples remained more than 90% of the initial concentration throughout the study period. No important change of the color and odor in the samples were noted throughout the study period. No important change in the pH of the samples were noted for 6 months under all storage conditions. Visible evidence of microbial growth was noted in dexamethasone suspension Ⅱ stored at room temperature on 4 months. This extemporaneous suspension of dexamethasone disodium phosphate prepared form bulk powder and from commercially available injections is stable for at least 4 months when stored in light - protective vinyl package at refrigerated temperature.
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5% 포도당 용액중 Cefotaxime과 sodium bicarbonate의 혼합시 안정성
박진영,남궁형욱,김향숙,박광준,손인자 한국병원약사회 2003 병원약사회지 Vol.20 No.3
Cefotaxime is usually used for the treatment of a documented or suspected meningitis due to susceptible organisms such as H. influenzae and N.meningitidis, nonpseudomonal gram-negative rod infection. Sodium Bicarbonate is infused to treat metabolic acidosis and to alkalinize urine, to treat life-threating hyperkalemia , to stabilize the acid base status in cardiac arrest. It is generally recognized that sodium bicarbonate , which is stabilized at pH 7.0∼8.5, cannot be mixed with cefotaxime injection solution. So we did study about the stability of cefotaxime when it was mixed with sodium bicarbonate in 5% dextrose solution. The test sample was prepared in D5W infusion solution in which sodium bicarbonate and cefotaxime were mixed 1:1 in four different concentrations. Sample "A" solution was prepared with cefotaxime(1mL, 100mg/mL) and sodium bicarbonate(0.5mL/50mL D5W). Sample "B" was prepared with cefotaxime(1mL, 100mg/mL) and sodium bicarbonate(1mL/50mL D5W). Sample "C" was prepared with cefotaxime(1mL, 100mg/mL) and sodium bicarbonate(2mL/50mL D5W). Sample "D" was prepared with cefotaxime(1mL, 100mg/mL) and sodium bicarbonate(3mL/50mL D5W). The cefotaxime concentrations were determined HPLC methods at 0, 3, 6, 12, 24, 48 hours. Sample "C" was most stable among samples. The concentrations of sample "C" are 99.11%(3hr), 95.94%(6hr), 94.72%(12hr), 92.13%(24hr). So we can infuse cefotaxime injection into the line of sodium bicarbonate diluted in D5W for 24hours at room temperature without significant decay in clinical situations. If we infuse two drugs by Y site, they are contacted for a short time. So we can infuse cefotaxime and bicarbonate in D5W by Y site.
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남택종,남궁형욱,김향숙,박광준,박경호,조남춘,이근혁 한국병원약사회 1999 병원약사회지 Vol.16 No.1
Prednisolone (PD) has been used in various disease and as various doses according to disease or body weight in pediatrics. Young children (≤5 years) who cannot able to take the tablet is prescribed with pulves, but the taste of PD is so bitter that they are difficulty in taking this medicine. And it is difficult to take precise doses because of the unequalization of distribution, loss of drug when it is distibuted with pulves. So in this study, we developed PD syrups for easiness, exactness of distribution and evaluated the stability of prednisolone syrups. First, we made an preliminary experiments to evaluate the effect of exipients on the stability. We added EDTA (disodium edetate) to PD solutions (0.05%) and observed the slight changes of the contents. As a result, EDTA has an effect of stabilization. Besides, after added 40% sucrose and preservatives to PD solutions (0.05%), mixed each 10% glycerin, sorbitol, xylitol, propylene glycol (PG), and preserved for 6 days at 55℃, we analyzed the contents and compared the rate constant (k) and half-life (t_(1/2)). Because solutions added PG, glycerin is more stable, we observed the stability of the different concentrations of these exipients and established the appropriate concentrations of these exipients. We kept PD solutions containing citric acid for 7 days at 55℃ and evaluated the effect of the concentration of the citric acid. As a result, there is no difference less than 0.5% citric acid concentrations. Second, through this preliminary experiments we designed the preliminary formulations. To examine the stability of formulations which is containing alcohol and is not, formulations containing alcohol (RP1, RP2) and formulations not containing alcohol (RP3, RP4) were stored for 4 weeks at 30, 40, 60℃ and was measured by a stability-indicating HPLC. And we plotted the Arrhenius-plot. All samples were analyed in duplicate on each week of analysis. When extrapolated this straight line, we found that the shelf life (t_(90)%) of RPI was about 23.4 months, RP2 was about 2.5 months, RP3 was months and RP4 was about 7.4 months. We developed PD syrups successfully but thought that we hereafter would correct the bitter taste of prednisolone itself.
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장용성 란소프라졸 캅셀의 제조 및 생물학적 동등성 시험
박경호,남궁형욱,신완균 한국병원약사회 1997 병원약사회지 Vol.14 No.3
Iansoprazole, (H+/K+)-ATPase (proton pump) inhibitor is being widely used to gastro-intestinal peptic ulcer patients. Koryo Pharmaceutical Company tried to develope lansoprazole capsule bioeqivalent to already being marketed lansoprazole capsule, reference product, which is producted by Hanil Pharmaceutical Company. Through in vitro dissolution tests of preformulated test capsules (Test capsule A, B, C and D) compared with reference, one capsule (Test capsule D) compared with reference, one capsule (Test capsule D) was selected which had a very similar dissolution profile as reference. And bioequivalence test in human volunteers was conducted to obtain marketing approvement of test capsule D. Dissolution tests of preformulated products were conducted in dissolution solution I (acid solution, pH 1.2) by dissolution method Ⅱ(paddle method) (KP Ⅵ) for 60 minutes, and then followed in dissolution solution Ⅱ(phosphate buffer, pH 6.8) by dissolution method Ⅰ (basket method) (KP Ⅵ) for 60 minutes. The dissolution solutions was maintained at 37±0.5℃, and basket and paddle were rotated at 150± 5 rpm, respectively. Also, in bioequivalence test, 14 healthy male volunteers were administered one capsule of test capsule(30 ㎎ lansoprazole/cap, Koryo Pharm. Co.) or reference, and randomized two-period, cross-over study was applied. Bioequivalence was statistically analyzed between two products using pharmacokinetic parameters (AUC, C_(max) and T_(max)). The results showed that the differences in AUC, C_(max) and T_(max) between two products were 8.75%, 9.32% and 29.79%, respectively. Detectable (△) of AUC, C_(max) ands T_(max) were 15.79%, 18.18% and 45.17%, at α=0.1 and power (1-β)=0.8, respectively, and also confidence intervals were -1.91% ≤△≤ 19.41%, -2.96% ≤△≤21.59% and -0.70%≤△≤60.28%, respectively. Among pharmacokinetic parameters, AUC met the criteria of KFDA for bioequivalence, while T_(max) and C_(max) didn't meet exactly the criteria of KFDA. But lansoprazole is medicated for long term, and C_(max) did't meet exactly the criteria of KFDA. But lansoprazole is medicated for long term, and absorption amount is more important rather than absorption rate. So considering on clinical aspects of lansoprzole, it was concluded that test capsule, Lansid^(R), is bioequivalent to reference, Lanston^(R) capsule by KFDA.
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