• Title, Summary, Keyword: Formulation changes

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Physicochemical Analysis according to Temperature Changes of Iopamidol and Ioversol Formulation Contrast Agents (Iopamidol과 Ioversol 제제 조영제의 온도변화에 따른 물리화학적 분석)

  • Han, Beom-Hee
    • Journal of radiological science and technology
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    • v.43 no.4
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    • pp.273-280
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    • 2020
  • In this study, the P contrast agent of Iopamidol, which is a nonionic iodide contrast agent most commonly used as a vascular contrast agent in medical institutions, and the O contrast agent of Ioversol, were studied. The physicochemical changes according to the temperature change were compared and analyzed using the Bruker Avance 500MHz Nuclear Magnetic Resonance Spectrometer owned by the Korea Basic Science Institute (KBSI). There was no physical or chemical change in the O contrast medium of Ioversol formulation in temperature change. However, in the P contrast agent of Iopamidol, a doublet peak began to appear in the 1.1 ppm region of the sample at 60℃, and the doublet peak was clearly observed in the sample at 80℃. As a result of this study, 1H-NMR analysis revealed that the P contrast agent of the Iopamidol formulation was dissociated from chemical bonds as it rose to a high temperature of 60℃ or higher, resulting in the formation of foreign substances. It was evaluated that the O contrast agent of Ioversol formulation had physico-chemical stability than the P contrast agent of Iopamidol formulation. As shown in this study, it is necessary to analyze the physical and chemical changes of contrast agents according to various environmental factors.

Investigation of Pharmacological Stability of Hyeonggaeyeongyotang Gagambang by Formulation Changes for Foaming Tablet (형개연교탕(荊芥連翹湯) 가감방(가감방)의 발포정 제형 변화에 따른 약리학적 안정성 연구)

  • Cho, Nam Joon;Gang, Seong Gu;Kim, Ji Young;Han, Hyo Sang;Kim, Kee Kwang
    • The Korea Journal of Herbology
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    • v.33 no.5
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    • pp.67-72
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    • 2018
  • Objectives : Natural extracts have been extensively studied to replace single agent drugs that cause a variety of side effects. However, studies of changes to the formulation of natural extracts has not been nearly proceed. We aimed to investigate whether pharmacological stability of hyeonggaeyeongyotang gagambang (HYT) is altered by formulation changes for foaming tablet. Methods : In this study, we performed freeze - drying of HYT, which is known to have antioxidant and anti - inflammatory properties, and then changed the formulation by foaming. Results : As a result, the foaming reaction appeared normally when HYT foamed tablets were put into water, and almost all of the substances were dissolved in the aqueous solution. In addition, we confirmed using high-performance liquid chromatograph that the geniposide used as an indicator material of HYT was stable in most of the formulations. It was confirmed that the change of HYT formulation did not affect the antioxidant efficacy by the 2,2'-azino-bis-3-ethylbenzothiazoline-6-sulphonic acid assay. Moreover, quantitative real-time PCR confirmed that the inhibitory effect of HYT on IL-$1{\beta}$ mRNA expression induced by lipopolysaccharides treatment in murine macrophage RAW 264.7 cells was similar in the solution of foaming tablet. Conclusions : These results suggest that the materials with various pharmacological effects can be stably maintained even when the formulation is changed by the foaming action of HYT. Our results are expected to provide important basic knowledge on formulation changes using various natural extracts.

A new ALE formulation for sloshing analysis

  • Aquelet, N.;Souli, M.;Gabrys, J.;Olovson, L.
    • Structural Engineering and Mechanics
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    • v.16 no.4
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    • pp.423-440
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    • 2003
  • Arbitrary Lagrangian Eulerian finite element methods gain interest for the capability to control mesh geometry independently from material geometry, the ALE methods are used to create a new undistorted mesh for the fluid domain. In this paper we use the ALE technique to solve fuel slosh problem. Fuel slosh is an important design consideration not only for the fuel tank, but also for the structure supporting the fuel tank. "Fuel slosh" can be generated by many ways: abrupt changes in acceleration (braking), as well as abrupt changes in direction (highway exit-ramp). Repetitive motion can also be involved if a "sloshing resonance" is generated. These sloshing events can in turn affect the overall performance of the parent structure. A finite element analysis method has been developed to analyze this complex event. A new ALE formulation for the fluid mesh has been developed to keep the fluid mesh integrity during the motion of the tank. This paper explains the analysis capabilities on a technical level. Following the explanation, the analysis capabilities are validated against theoretical using potential flow for calculating fuel slosh frequency.

A Mixed Formulation of Lactic Acid Bacteria Inhibits Trinitrobenzene-Sulfonic-Acid-Induced Inflammatory Changes of the Colon Tissue in Mice

  • Cha, Yeon Suk;Seo, Jae-Gu;Chung, Myung-Jun;Cho, Chung Won;Youn, Hyun Joo
    • Journal of Microbiology and Biotechnology
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    • v.24 no.10
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    • pp.1438-1444
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    • 2014
  • Lactic acid bacteria (LAB) are probiotics that provide numerous beneficial effects on the host body, especially on the intestine. Combining several strains of LAB, we prepared a formulation containing four different LAB and studied its anti-inflammatory activity both in vitro and in vivo. The formulation significantly reduced NO production from RAW 264.7 cells treated with bacterial lipopolysaccharide, indicating that the formulation might include anti-inflammatory activity. The formulation also suppressed inflammatory change induced by trinitrobenzene sulfonic acid (TNBS) in mice, where oral or rectal administration of the formulation protected the colon tissue from the damage by TNBS. Expressions of the IL-6 and FasL genes appeared to be down-regulated by the formulation in TNBS-treated colon tissues, suggesting that the suppression of those genes may be involved in the anti-inflammatory activity of the formulation.

Examination of $\alpha$-terpinene on Primary Eye Irritancy and Skin Sensitization

  • Park, Byeoung-Soo;Choi, Won-Sik;Lee, Sung-Eun
    • Molecular & Cellular Toxicology
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    • v.3 no.1
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    • pp.68-75
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    • 2007
  • [ $\alpha$ ]-Terpinene has been known as a repellent against the mosquito Culex pipiens pallens Coquillett based on a human forearm bioassay. $\alpha$-Terpinene showed significantly greater repellency than a commercial formulation, N, N-diethyl-m-methylbenzamide (deet). In this study, skin and eye sensitivity of $\alpha$-terpinene (2%) was examined with bioassays using white New Zealand rabbits. There were somewhat gross and histological changes observed in these treatments. Eye irritancy assays examined gross changes to cornea, iris and conjuctiva, and histological changes to smear of ocular discharge and eye tissue. Treated rabbits were divided into two cohorts, a saline washed cohort (W) or a non-washed cohort (NW). Opacity of cornea and redness, chemosis and discharge of conjuctiva were observed in both cohorts, but disappeared within 4 and 10 days in W and NW, respectively. Main components of ocular discharges were fibrin, epithelial or epitheloid cells, lymphoid cells, erythrocytes and granulocytes. These abnormal cellular components disappeared within 4 days and 10 days in W and NW, respectively. No permanent histological differences were observed between the two cohorts. However, severe irritation was determined as 57.2 of I.I.O.I value on the first day after treatment. These findings indicate a spray-type solution containing 2% $\alpha$-terpinene may serve as an alternative mosquito repellent and further studies need to reduce the eye irritation with formulation changes.

A Case of Skin Eruption Occurred after Switching Formulation of Quetiapine Fumarate (Quetiapine Fumarate의 제형 변경 후 발생한 피부 발진 1예)

  • Kwon, Yong-Seok;Lim, Se-Won
    • Korean Journal of Biological Psychiatry
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    • v.16 no.4
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    • pp.266-270
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    • 2009
  • Adverse drug reactions are very common in clinical practice, and skin is one of the most frequent organs for adverse drug reactions. We report a case of a 71-year-old male patient who developed skin eruptions after switching formulation of quetiapine immediate release(IR) to quetiapine extended release(XR). He had been taking quetiapine IR(400mg/day) for treatment of manic episode which was developed one year ago. The patient showed great improvement of symptoms after taking quetiapine IR for about one year, thus dosage of medication was reduced to 50mg/day on the average. Unfortunately dose reduction has tended to worsen symptoms, so dose of quetiapine was increased again to 200mg/day with formulation changes to XR. Two days after he took new formulation, erythematous papules were occurred over his anterior neck and ventral side of left wrist. As he stopped quetiapine XR, the skin lesions gradually subsided. And he was successfully treated with readministration of quetiapine IR without any skin lesions.

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Finite Element Simulation of Axisymmetric Sheet Hydroforming Processes (축대칭 박판 액압 성형 공정의 유한요소 시뮬레이션)

  • 구본영;김용석;금영탁
    • Transactions of Materials Processing
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    • v.9 no.6
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    • pp.590-597
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    • 2000
  • A finite element formulation lot the simulation of axisymmetric sheet hydroforming is proposed, and an implicit program is coded. In order to describe normal anisotropy of steel sheet, Hill's non-quadratic yield function (Hill, 1979) is employed. Frictional contacts among sheet surface, rigid tool surface, and flexible hydrostatic pressure are considered using mesh normal vectors based on finite element of the sheet. Applied hydraulic pressure is also considered as a function of forming rate and time and treated as an external loading. The complete set of the governing relations comprising equilibrium and interfacial equations is approximately linearized for Newton-Raphson algorithm. In order to verify the validity of the developed finite element formulation, the axisymmetric bulge test is simulated. Simulation results are compared with other FEM results and experimental measurements and showed good agreements. In axisymmetric hydroforming processes of a disk cover, formability changes are observed according to the hydraulic pressure curve changes.

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Scrutiny Made to SUPAC-IR Dealing with Postapproval Changes in Immediate Release Sold Oral Dosage Forms (경구용 속방성 성형제품의 허가 후 변경사항을 다루는 SUPAC-IR에 대한 검토)

  • Sah, Hong-Kee;Park, Sang-Ae;Yun, Mi-Ok;Kang, Shin-Jung
    • Journal of Pharmaceutical Investigation
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    • v.34 no.1
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    • pp.57-71
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    • 2004
  • The objective of this study was to provide a better understanding of SUPAC-IR and its application in handling postapproval changes to immediate release solid oral dosage forms. Originally, SUPAC-IR was aimed at reducing the regulator burdern of the industry when they were making postapproval changes, but still at maintaining the formulation quality and performance of a drug product. The postapproval changes that were covered under SUPAC-IR included variations in the components ad composition of formulation, the site of manufacturing, batch size, manufacturing equipment, and manufacturing process. The guidance defined levels of changes, based on the likelihood of risk ocurrence and potential impact of postapproval changes upon the safety and efficacy of a drug product I suggested what a type of fing report should be submitted to the FDA for each level of change. Chemist, manufacturing, and control tests to be executed were also recommended for each change level The important tests specified in the guidance included batch release, stability, in vitro dissolution, and in vivo bioequivalence tests. However, there have been strong demands on revising the current SUPAC-IR in order to resolve some issues and to improve its usefulness in evaluating postapproval changes to immediate release solid oral dosage forms. In particular, the rigorous requirement of case C dissolution test and the definition of batch size were challenged by both academia and the industry. A revision work was in progress to reflect these inputs and to expand the utility of SUPAC-IR. As a result of these concerted efforts, an updated 2nd version of SPAC-IR would be likely to be issued ver soon to the public.

A Nonlinear Finite Element Formulation for Very Large Deformation based on Updated Material Reference Frame (변화되는 재료의 기준 물성치에 근거한 매우 큰 변화에 대한 비선형 유한요소의 정식화)

  • Yun, Young Muk;Park, Moon Ho
    • Journal of The Korean Society of Civil Engineers
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    • v.12 no.3
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    • pp.25-37
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    • 1992
  • A nonlinear finite element formulation which has the capability of handling very large geometrical changes is presented. The formulation is based on an updated material reference frame and hence true stress-strain test can be directly applied to properly characterize properties of materials which are subjected to very large deformation. For the large deformation, a consistent formulation based on the continuum mechanics approach is derived. The kinematics is referred to an updated material frame. Body equilibrium is also established in an updated geometry and the second Piola-Kirchhoff stress and the updated Lagrangian strain tensor are used in the formulation. Numerical examples for very large deformation of framed structures and plane solids are analyzed for verification purposes. The numerical solutions are obtained by an incremental numerical procedure. The importance of handing material properties properly is also demonstrated.

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