• Title/Summary/Keyword: biopharmaceutical studies

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Biopharmaceutical Studies of 1,2-Ethanediolester and 1,4- Butanediolester of Flurbiprofen (플루비푸로펜의 1,2-에탄디올에스테르와 1,4-부탄디올에스테르의 생물 약제학적 연구)

  • Rho, Jae-Il;Lee, Wan-Ha
    • Journal of Pharmaceutical Investigation
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    • v.21 no.2
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    • pp.85-90
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    • 1991
  • Prodrugs of flurbiprofen, 1,2-ethanediolester(FE) and 1,4-butanediolester(FB) were prepared and their biopharmaceutical studies were performed. The prodrugs showed high stability in simulated gastric fluid, simulated intestinal fluid and pancreatin-saturated solution. Pharmacokinetic parameters of the prodrugs were similar to those of their parent drug. However they showed less acute toxicity and gastric irritation and higher anti-inflammatory and analgesic effects.

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Biopharmaceutical Studies on the Alkanol Esters of Naproxen (II) -Pharmaceutical Characteristics of 3 Kinds of the Alkanol Esters of Naproxen- (나프록센의 Alkanol 에스테르류에 관한 생물약제학적 연구 II -3종의 Alkanol 에스테르의 약제학적 특성-)

  • 백우현;김종갑
    • YAKHAK HOEJI
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    • v.30 no.3
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    • pp.128-138
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    • 1986
  • Three newly synthesized alkanol esters of d-2-(6-methoxy-2-naphthyl) propionic acid, NAPROXEN were examined for physicochemical properties and biopharmaceutical characteristics. These esters were very stable in solid state, but more than 90% of these esters were hydrolysed to the parent, naproxen in rabbit's liver hornogenates. They showed higher dissolution rate in the artificial gastric and intestinal juice, and significantly greater partition coefficient in n-octanol, when compared with naproxen. The absorption rate constants of these esters were increased, while the elimination rate constants were decreased, comparing with naproxen. The ulcerogenic doses on gastric and intestinal mucosa were increased remarkably, and the antiinflammatory dose against carrageenininduced edema on rat hind paw was decreased markedly in these esters, and thus the safety indexes of these esters were higher than that of naproxen.

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Biopharmaceutical Studies of Lonazolac Acetic Acid Ester and Lonazolac Argininate (로나졸락 초산에스테르 및 로나졸락 알지니네이트의 생물약제학적 연구)

  • Ham, Kwang-Su;Lee, Wan-Ha;Yang, Jae-Heon
    • Journal of Pharmaceutical Investigation
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    • v.21 no.2
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    • pp.103-110
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    • 1991
  • Two new prodrugs of lonazolac, lonazolac acetic acid ester and lonazolac argininate, were prepared and examined for physicochemical properties and biopharmaceutical characteristics. The prodrugs were stable in solid state and lonazolac argininate showed higher dissolution rate than lonazolacca in both artificial gastric and intestinal juices. These prodrugs have higher analgegic effect than that of lonazolac-Ca in mice, and increased anti-inflammatory activities in rats. In addition, ulcerogenic effects and acute toxicity of these prodrugs were lower than those of lonaaolac-Ca. Lonazolac acetic acid ester showed larger area under the plasma concentration-time curves (AUC) than that of lonazolac. Therefore, it was suggested that these prodrugs of lonazolac have advantages over lonzolac-Ca for not only enhanced bioavailability but also decreased ulcerogenic and toxic effects.

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Biopharmaceutical Studies on the Alkanol Esters of Naproxen(I) -Studies of 3 Kinds Alkanol Esters of Naproxen- (나프록센의 Alkanol 에스테르류에 관한 생물약제학적 연구 I -3종의 Alkanol 에스테르의 합성-)

  • 백우현;김종갑
    • YAKHAK HOEJI
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    • v.30 no.3
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    • pp.121-127
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    • 1986
  • Three new alkanol esters of d-2-(6-methoxy-2-naphthyl)propionic acid, NAPROXEN were synthesized by esterification of sodium naproxen with chloralcohols, such as 2-chloroethanol, 3-chloro-1, 2-propanediol and $\beta$-chloroethoxyethanol in dimethylformamide. These new esters were obtained with comparably high yield and identified by elemental analysis, UV, IR and NMR techniques.

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Technology Trends of Growth Hormone and Development Strategies for Growtropin

  • Seo, Kwang-Seok
    • Journal of mucopolysaccharidosis and rare diseases
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    • v.1 no.1
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    • pp.23-27
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    • 2015
  • Recent research trends of human growth hormone (hGH) are divided into improved first-generation products, long-acting second-generation products, and biosimilar products. Among the improved first-generation products studies, studies of injection devices are being actively conducted. The long-acting second-generation products are focused on extending the half-life of hGH, and depending on the results of the clinical trials, the candidates are expected to lead the future hGH market. Finally, biosimilar has had less impact on the hGH market before now; however, expectations of low-cost products still remainas an opportunity.

The Biopharmaceutical Studies on the Some Compunding Drugs( III ) -Antipyritic Analgesic Effect on the Aminopyrine Combined with Atropine Sulfate by Writhing Method- (배합약물(配合藥物)의 생물약제학적(生物藥劑學的) 연구(硏究) ( III ) -Aminopyrine의 해열진통작용(解熱鎭通作用)에 미치는 Atropine Sulfate의 배합효과(配合效果))

  • Park, Young-Ock;Chung, Ki-Hwa;Kim, Jae-Wan
    • Journal of Pharmaceutical Investigation
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    • v.4 no.1_2
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    • pp.19-24
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    • 1974
  • The comparative studies were made on the analgesic antipyretic effects of aminopyrine used individually and combined with parasympathetic agents (atropine sulfate). The analgesic antipyretic effects were eximined by Writhing's method to the experimental groups(mouse), and the following effects were found : 1) The active intensity of aminopyrine by it's oral administration combined with atropine sulfate is as follows. Amiinopyrine 80 mg/kg combided with Atropine sulfate 0.005 mg/kg=Aminopyrine 100 mg/kg 2) The most active range of intensity of Atropine sulfate(adjuvant) by it's oral administration is as follows. Atropine sulfate $0.004{\sim}0.005\;mg/kg$.

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Cleaning Validation Studies for Multi-Purpose Facility : Vial Filling Machine (다품목 공용 제약설비인 바이알 충전기에 대한 세척공정 밸리데이션)

  • Choi, Han-Gon;Yang, Ho-Joon;Kim, Young-Ran;Sung, Jun-Ho;Hwang, Ma-Ro;Kim, Jong-Oh;Yong, Chul-Soon
    • Journal of Pharmaceutical Investigation
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    • v.39 no.4
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    • pp.263-267
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    • 2009
  • The purpose of this study is to evaluate the efficacy of stipulated cleaning process, and the prohibition of cross-contamination and microbiological contamination, which inadequate cleaning in multi-production could occur, through cleaning validation of multi-purpose facility used to produce five biopharmaceutical products as sterile injection. After production of five biopharmaceutical products such as hGH, rhGCSF, rhEPO, rhFSH and rhIFN using vial filling machine, the cleaning validation such as residual analysis of active ingredients or human serum albumin, measurement of total organic carbon (TOC), residual analysis of detergent and microbiological contamination were carried out. In the case of rhGH and rhGCSF clean validations, drug residues were not detected. Furthermore, in the case of rhEPO, rhFSH and rhIFN clean validations, human serum albumin residues were not detected. At TOC (total organic carbon) analysis, all clean validations gave the TOC of about average 137.93%, not more than 150% of acceptance criteria. At sodium analysis for the checking of residues of cleaning agent, sodium residues were not detected. In sterility test, they showed no microbiological contamination of bacteria and fungi. Thus, this cleaning validation was determined as successful in protection of cross-contamination and induction of safety in multi-purpose facility.

A Biopharmaceutical Study on the Absorption of Some Compounding Drugs (배합약물(配合藥物)의 흡수(吸收)에 관(關)한 생물약제학적(生物藥劑學的) 연구(硏究) 1. Salicylamide에 항(抗) Histamine제(劑)를 배합(配合)하였을 때의 흡수효과에 관(關)하여)

  • Kim, Jae-Wan
    • Journal of Pharmaceutical Investigation
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    • v.1 no.1
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    • pp.78-84
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    • 1971
  • The comparative studies were made on Salicylamide, used individually and compounded with antihistaminics as regards. (1) the absorption rate through isolated rat small intestine (in vitro) (2) the absorption rate through rat small intestine (in vivo), and the following effects were found. 1. The Absorption velosity of 2 m Mole gm. of salicylamide in the small intestine were decreased, when the agents compounded with tripelennamine indicating the greatest absorption inhibition in the case of m Mole gm. of tripelennamine. 2. The Absorption velosity of 2m Mole gm. of salicylamide in the small intestine were decreased, when the agents compounded with diphenhydramine indicating the greatest absorption inhibition in the case of 2m Mole gm. of diphenhydramine. 3. The Absorption velosity of 2m Mole gm. of salicylamide in the small intestine were increased, when the agents compounded with chlorpheniramine indicating the greatest absorption augmentation in the case of 0.2m Mole gm. of chlorpheniramine.

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Statistical Consideration of Vaccine Clinical Trials (백신임상시험에 대한 통계적 고찰)

  • Nam, Ju-Sun;Kang, Seung-Ho
    • The Korean Journal of Applied Statistics
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    • v.24 no.4
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    • pp.633-646
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    • 2011
  • Clinical vaccines studies (that include cancer prevention vaccines and therapeutic vaccines) are ongoing to improve the quality of life and lengthen the human lifespan. Recently clinical trials and research on vaccines have become more active due to the prevalence of new viruses such as the A(H1N1) virus that freighted the whole word in 2009. In this paper we will describe the statistical aspects of clinical vaccine trials and outline the current situation of domestic and international vaccine development.

Fluorescently Labeled Nanoparticles Enable the Detection of Stem Cell-Derived Hepatocytes

  • Ha, Young-Eun;Shin, Jin-Sup;Lee, Dong-Yun;Rhim, Tai-Youn
    • Bulletin of the Korean Chemical Society
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    • v.33 no.6
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    • pp.1983-1988
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    • 2012
  • Stem cell transplantation is emerging as a possible new treatment for liver cirrhosis, and recent animal studies have documented the benefits of stem cell therapy in a hepatic fibrosis model. However, the underlying mechanism of stem cell therapy is still unclear. Among the proposed mechanisms, the cell replacement mechanism is the oldest and most important, in which permanently damaged tissue can be replaced by normal tissue to restore function. In the present study, Cy5.5-labeled superparamagnetic iron oxide (SPIO) was used to label human mesenchymal stem cells. The uptake of fluorescently labeled nanoparticles enabled the detection and monitoring of the transplanted stem cells; therefore, we confirmed the direct incorporation and differentiation of SPIO into the hepatocyte-like transplanted stem cells by detecting human tyrosine aminotransferase (TAT), well-known enzymatic marker for hepatocyte-specific differentiation.