• Title/Summary/Keyword: Formulations

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Bioeqivalence Study of Ketorolac Tromethomin Tablets in Human Volunteers (지원자의 케토롤락트로메타민 정제에 대한 생물학적 동등성 연구)

  • Chung, Youn Bok;Lee, Jun Seup;Han, Kun
    • Korean Journal of Clinical Pharmacy
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    • v.8 no.2
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    • pp.101-106
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    • 1998
  • A bioequivalence study of the Kerola tablets (Dongkwang Pharmaceutical Co., Korea) to the Tarasyn tablets (Roche Co., Korea), formulations of ketorolac trometamine(KTR), was conducted. Sixteen healthy Korean male subjects received each formulation at the dose of 10 mg as KTR in a $2\times2$ crossover study. There was a 1-week washout period between the dose. Plasma concentrations of KTR were monitored by an HPLC method for over a period of 12 hr after each administration. AUC (area under the plasma concentration-time curve) was calculated by the linear trapezoidal method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma drug concentration-time data. Analysis of variance (ANOVA) revealed that there are no differences in AUC, $C_{max}\;and\;T_{max}$ between the formulations. The apparent differences between the formulations in these parameters were all far less than $20\%$ (i.e., 2.31, 8.19 and $0\%$ for AUC, $C_{max}\;and\;T_{max}$, respectively). Minimum detectable differences $(\%)\;at\;\alpha=0.1\;and\;1-\beta=0.8$ were all less than $20\%$ difference in these parameters between the formulations were all over 0.8. The $90\%$ confidence intervals for these parameters were also within $20\%$. These results satisfy the bioequivalence criteria of the Korea Food and Drug Administration (KFDA) guidelines (No. 1998-86). Therefore, these results indicate that the 2 formulations of KTR are bioequivalent and, thus, may be prescribed interchangeably.

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Bioequivalence Evaluation of the Cisapride Formulation Produced by Dong Wha Pharmaceutical Co. (동화약품 시사프리드제제의 생물학적 동등성 평가)

  • 윤광희;박진영;박선주;조은희;유제만;김경식;정석재;이민화;심창구
    • Biomolecules & Therapeutics
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    • v.7 no.1
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    • pp.59-65
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    • 1999
  • A bioequivalence study of the Dong Wha Cisapril tablets(Dong Wha Pharm. Ind. Co., Ltd.) to the Prepulsid tablets(Janssen Korea Ltd.), formulations of cisapride, was conducted. Twenty four healthy Korean male subjects received each formulation at the dose of 5 mg as cisapride in a 2$\times$2 crossover study. There was a 1-week washout period between the doses. Plasma concentrations of cisapride were monitored by an LC/MS method for over a period of 36 h after each administration. AUC(area under the plasma concentration- time curve from time zero to infinity) was calculated by the linear trapezoidal and extrapolation method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma drug concentration-time data. Analysis of variance (ANOVA) revealed that there are no differences in AUC, $C_{max}$ and $T_{max}$ between the formulations. The apparent differences between the formulations in these parameters were all far less than 20% (i.e., 6.8, -6.6 and 1.8% for AUC, $C_{max}$ and $T_{max}$, respectively). Minimum detectable differences(%) at $\alpha$=0.05 and 1-$\beta$=0.8 were all less than 20% in these parameters between the formulations (i.e., 16.5, 11.4 and 16.4% for AUC, $C_{max}$ and $T_{max}$, respectively). The 90% confidence intervals for these parameters were also within 20% (i.e., -2.9~ 16.4, -13.2~0.1 and -7.8~ 11.4% for AUC, $C_{max}$ and $T_{max}$, respectively). These results satisfy the bioequivalence criteria of the Korea Food and Drug Administration (KFDA) guidelines (No. 98-51). Therefore, these results indicate that the two formulations of cisapride are bioequivalent and, thus, may be prescribed interchangeably.hangeably.y.hangeably.

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Development and Characterization of O/W Cosmetic Formulations Containing Nipa palm (Nypa fruticans Wurmb) and Finger root (Boesenbergia pandurate) Extracts (니파팜, 핑거루트 추출물을 함유한 O/W 화장품 제형 개발 및 분석)

  • Jun, Yue Jin;Kim, Jin-Hee;Jin, Byung Suk
    • Journal of the Korean Applied Science and Technology
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    • v.38 no.4
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    • pp.922-930
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    • 2021
  • This study was attempted to investigate the availability of nipa palm (Nypa fruticans Wurmb.) and finger root (Boesenbergia pandurata) extracts as natural cosmetic ingredients. For this, O/W cosmetic formulations with different compositions were prepared. The appearance of the cosmetic formulations was compared, and brightness and color values were measured using a colorimeter. Also, the pH, viscosity, and texture of the cosmetic formulations with different compositions were measured, and the effects of the extracts on the properties of the cosmetic formulations were examined. Finally, the UV transmittance and sun protection factor (SPF) index were observed, and the results confirmed the availability of finger root extract as a natural ingredient for UV protection.

Mathematical formulations for static behavior of bi-directional FG porous plates rested on elastic foundation including middle/neutral-surfaces

  • Amr E. Assie;Salwa A. Mohamed;Alaa A. Abdelrahman;Mohamed A. Eltaher
    • Steel and Composite Structures
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    • v.48 no.2
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    • pp.113-130
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    • 2023
  • The present manuscript aims to investigate the deviation between the middle surface (MS) and neutral surface (NS) formulations on the static response of bi-directionally functionally graded (BDFG) porous plate. The higher order shear deformation plate theory with a four variable is exploited to define the displacement field of BDFG plate. The displacement field variables based on both NS and on MS are presented in detail. These relations tend to get and derive a new set of boundary conditions (BCs). The porosity distribution is portrayed by cosine function including three different configurations, center, bottom, and top distributions. The elastic foundation including shear and normal stiffnesses by Winkler-Pasternak model is included. The equilibrium equations based on MS and NS are derived by using Hamilton's principles and expressed by variable coefficient partial differential equations. The numerical differential quadrature method (DQM) is adopted to solve the derived partial differential equations with variable coefficient. Rigidities coefficients and stress resultants for both MS and NS formulations are derived. The mathematical formulation is proved with previous published work. Additional numerical and parametric results are developed to present the influences of modified boundary conditions, NS and MS formulations, gradation parameters, elastic foundations coefficients, porosity type and porosity coefficient on the static response of BDFG porous plate. The following model can be used in design and analysis of BDFG structure used in aerospace, vehicle, dental, bio-structure, civil and nuclear structures.

REMARKS ON FIXED POINT THEOREMS OF DOWNING AND KIRK FOR SET-VALUED MAPPINGS IN METRIC AND BANACH SPACES

  • Park, Sehie
    • Bulletin of the Korean Mathematical Society
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    • v.21 no.2
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    • pp.55-60
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    • 1984
  • In [2], D. Downing and W.A. Kirk obtained a number of fixed point theorems for set-valued maps in matric and Banach spaces. The authors considered maps which are more general than the contractions with nonempty and closed mapping values, and obtain results for maps satisfying certain "inwardness" conditions. A key aspect of their approach is the application of a general fixed point theorem due to Caristi [1]. On the other hand, in [6], the present author obtained a number of equivalent formulations of the well-known result of I. Ekeland [3, 4] on the variational principle for approximate solutions of minimization problems. Some of such formulations include sharpened forms of the Caristi theorem. In this paper, using one of such formulations, we show that Theorems 1-3 and Corollaries 1-5 of [2] are substantially improved by giving geometric estimations of fixed points.ed points.

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Transdermal Delivery of Ceramide Using Sodium Deoxycholate-based Deformable Liposomes

  • Kim, Dong-Chan;Noh, Sang-Myoung;Kim, Young-Bong;Baek, Kwang-Hyun;Oh, Yu-Kyoung
    • Journal of Pharmaceutical Investigation
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    • v.38 no.5
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    • pp.319-323
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    • 2008
  • For transdermal delivery of ceramides, various liposomes formulations were studied and evaluated. Sodium deoxycholate (SDC), Tween 20 and Span 85 were used as edge activators. The skin permeation of ceramides was performed using a Franz cell apparatus with hairless mouse skin. Among edge activators, SDC showed the higher values of deformability index and skin permeation than did others. For optimization of formulations, we varied the ratios of lipids to edge activators and the compositions between phosphatidylcholine (PC) and ceramides. The optimal ratio of lipid to SDC was observed to be 6:1 (w:w) and that of PC and ceramide was 1:1. Our results suggest that the skin permeation of ceramides could be enhanced by optimized deformable formulations of liposomes containing SDC as a major edge activator.

Failure Modeling of Bridge Components Subjected to Blast Loading Part I: Strain Rate-Dependent Damage Model for Concrete

  • Wei, Jun;Quintero, Russ;Galati, Nestore;Nanni, Antonio
    • International Journal of Concrete Structures and Materials
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    • v.1 no.1
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    • pp.19-28
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    • 2007
  • A dynamic constitutive damage model for reinforced concrete (RC) structures and formulations of blast loading for contact or near-contact charges are considered and adapted from literatures. The model and the formulations are applied to the input parameters needed in commercial finite element method (FEM) codes which is validated by the laboratory blast tests of RC slabs from literature. The results indicate that the dynamic constitutive damage model based on the damage mechanics and the blast loading formulations work well. The framework on the dynamic constitutive damage model and the blast loading equations can therefore be used for the simulation of failure of bridge components in engineering applications.

Effect of pH on the Formation of Acylated Octreotides by Poly(lactide-co-glycolide)

  • Na, Dong-Hee
    • Journal of Pharmaceutical Investigation
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    • v.40 no.4
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    • pp.251-254
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    • 2010
  • The formation of acylated peptide impurities in poly(lactide-co-glycolide) (PLGA) formulations is one of the major challenges to the development of successful sustained-release product. Octreotide, synthetic analogue of somatostatin, has been identified to be acylated in PLGA microsphere formulations. The purpose of this study was to investigate the pH effect on the formation of acylated octreotides by PLGA. In the incubation with PLGA in 0.1 M phosphate buffer at pH 7.4, approximately 98% of octreotide adsorbed to PLGA through 14 days and 66.3% of acylated octreotides were produced after 42 days, whereas the interaction of octreotide with PLGA was significantly inhibited in the incubation at pH 4, in which the acylated octreotides were observed to be 9.2% after 42 days. In the interaction study at pH 4.1-7.4, the production of acylated octreotides was demonstrated to be dependent on environmental pH. Below pH 5.0, the acylation of octreotide was significantly inhibited. This study indicates that the pH is the major factor for the formation of acylated octreotide in PLGA formulations.

Formulation of forming limit diagram based on strain-rate potential (소성 변형률 포텐셜에 기초한 성형 한계도의 정식화)

  • Kim D.;Chung K.;Kim K. J.
    • Proceedings of the Korean Society for Technology of Plasticity Conference
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    • 2004.10a
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    • pp.156-159
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    • 2004
  • Most formulations for a forming limit diagram (FLD) have been based on yield stress potentials defined in the stress field. Nevertheless, there are formulations where potentials defined in the stain-rate field are especially convenient to formulate the rigid plastic material. Based on a strain-rate potential proposed for materials exhibiting planar anisotropic, the formulations for the forming limit diagram has been developed applying M-K theory. As verification example, the formulation is applied for anisotropic AA5182-O sheet. The good verification results show that the formulation for the forming limit diagram has been successfully developed.

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Approximate analyses of reinforced concrete slabs

  • Vecchio, F.J.;Tata, M.
    • Structural Engineering and Mechanics
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    • v.8 no.1
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    • pp.1-18
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    • 1999
  • Procedures are investigated by which nonlinear finite element shell analysis algorithms can be simplified to provide more cost effective approximate analyses of orthogonally-reinforced concrete flat plate structures. Two alternative effective stiffness formulations, and an unbalanced force formulation, are described. These are then implemented into a nonlinear shell analysis algorithm. Nonlinear geometry, three-dimensional layered stress analyses, and other general formulations are bypassed to reduce the computational burden. In application to standard patch test problems, these simplified approximate analysis procedures are shown to provide reasonable accuracy while significantly reducing the computational effort. Corroboration studies using various simple and complex test specimens provide an indication of the relative accuracy of the constitutive models utilized. The studies also point to the limitations of the approximate formulations, and identify situations where one should revert back to full nonlinear shell analyses.