Structure and pharmaceutical formulation development of a new long-acting recombinant human insulin analog studied by NMR and MS.

Abstract:

:A monomer structure of a novel human insulin analog A22S-B3K-B31R (SK3R) has been characterized by NMR in water/acetonitrile solution and compared with the structure of human insulin (HIS) established in the same medium. The composition of the oligomer ensemble for neat insulins in water was qualitatively assessed by monitoring, derived from NMR experiment, translational diffusion coefficient Dix10-10m2s-1, whose value is a population averaged of individual coefficients for species in oligomeric ensemble. Nanospray ESI/MS experiment was used to establish the masses of oligomers in pharmaceutical formulation of the SK3R insulin. The pharmacodynamic data were established and compared to insulin glargine characterized by the same profile of action in diabetics. The oligomerization process of insulin during development of pharmaceutical formulation with routinely used excipients has been studied using translation diffusion coefficient Dix10-10m2s-1 established in water solution. These properties were compared with those of human insulin (HIS) which is a standard reference for novel recombinant insulins.

journal_name

J Pharm Biomed Anal

authors

Bednarek E,Sitkowski J,Bocian W,Borowicz P,Płucienniczak G,Stadnik D,Surmacz-Chwedoruk W,Jaworska B,Kozerski L

doi

10.1016/j.jpba.2016.12.005

subject

Has Abstract

pub_date

2017-02-20 00:00:00

pages

126-132

eissn

0731-7085

issn

1873-264X

pii

S0731-7085(16)30623-9

journal_volume

135

pub_type

杂志文章
  • Extraction and determination of 2-pyrazoline derivatives using liquid phase microextraction based on solidification of floating organic drop.

    abstract::A simple, rapid and efficient microextraction method for the extraction and determination of some 2-pyrazoline derivative compounds in aqueous samples was developed. Microliter volumes of 1-undecanol were delivered to the surface of the aqueous sample and the sample was agitated for a desire time. The sample vial was ...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2008.07.029

    authors: Sobhi HR,Yamini Y,Esrafili A,Adib M

    更新日期:2008-12-01 00:00:00

  • Simultaneous LC determination of tiazofurin, its acetyl and benzoyl esters and their active metabolite thiazole-4-carboxamide adenine dinucleotide in biological samples.

    abstract::A rapid and sensitive HPLC-RP method for simultaneous determination of tiazofurin, its 5'-O acetyl and benzoyl esters and their active metabolite thiazole-4-carboxamide adenine dinucleotide was developed and validated. The method allowed determination and quantification of nanomolar quantities of these substances in c...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/s0731-7085(02)00448-x

    authors: Tasic J,Ristic S,Piperski V,Dacevic M,Pejanovic V,Jokanovic M,Mandic L

    更新日期:2002-11-07 00:00:00

  • Characterization of human metabolism and disposition of levo-tetrahydropalmatine: Qualitative and quantitative determination of oxidative and conjugated metabolites.

    abstract::Levo-tetrahydropalmatine (l-THP) is a tetrahydroprotoberberine isoquinoline alkaloid and has been used as an analgesic agent in China for over 50 years. Recent studies revealed that l-THP was effective in the treatment of drug addiction. However, the plasma metabolic profile, mass balance and clearance pathways of l-T...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2016.06.015

    authors: Xiao W,Shen G,Zhuang X,Ran X,Zhu M,Li H

    更新日期:2016-09-05 00:00:00

  • Quality consistency evaluation of Melissa officinalis L. commercial herbs by HPLC fingerprint and quantitation of selected phenolic acids.

    abstract::To evaluate the quality consistency of commercial medicinal herbs, a simple and reliable HPLC method with UV-vis detector was developed, both for fingerprint analysis and quantitation of some pharmacologically active constituents (marker compounds). Melissa officinalis L. (lemon balm) was chosen for this study because...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2013.05.020

    authors: Arceusz A,Wesolowski M

    更新日期:2013-09-01 00:00:00

  • Prussian blue nanoparticles with peroxidase-mimicking properties in a dual immunoassays for glycocholic acid.

    abstract::Prussian Blue nanoparticles (PBNPs) were utilized in a lateral flow immunoassay (LFA) and in an indirect competitive nanozyme-linked immunosorbent assay (icELISA), respectively, for their intense blue color and peroxidase (POx) -like activity. The PBNPs with good POx-like activity was linked to the antibody. Under the...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2020.113317

    authors: He Q,Yang H,Chen Y,Shen D,Cui X,Zhang C,Xiao H,Eremin SA,Fang Y,Zhao S

    更新日期:2020-08-05 00:00:00

  • Fine structural characterization of sulodexide.

    abstract::Sulodexide is a heparinoid which combines the properties of its components heparin and dermatan sulfate and is used not only for the prophylaxis and treatment of thromboembolic diseases but also for the treatment of diabetic nephropathy. Despite many clinical studies have been conducted to investigate its activity and...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2018.04.012

    authors: Veraldi N,Guerrini M,Urso E,Risi G,Bertini S,Bensi D,Bisio A

    更新日期:2018-07-15 00:00:00

  • Identification of the metabolites in normal and AA rat plasma, urine and feces after oral administration of Daphne genkwa flavonoids by LC-Q-TOF-MS spectrometry.

    abstract::Daphne genkwa Sieb. et Zucc., as a traditional oriental herb, has been widely distributed and employed in China. The major bioactive components in D. genkwa are flavonoid compounds, which showed pharmacological activities such as anti-inflammatory, analgesic, anti-tumor and immunomodulatory activities. In this study, ...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2019.112856

    authors: Gan L,Ji J,Wang L,Li QY,Zhang CF,Wang CZ,Yuan CS

    更新日期:2020-01-05 00:00:00

  • Experimental design on liquid chromatographic parameters in the analysis of tetracycline on poly(styrene-divinylbenzene).

    abstract::A previously described isocratic liquid chromatographic (LC) method for the analysis of tetracycline on poly(styrene-divinylbenzene) allows the complete separation and resolution of tetracycline (TC), 4-epitetracycline (ETC), anhydrotetracycline (ATC) and 4-epianhydrotetracycline (EATC). By means of a half-fraction fa...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/0731-7085(93)80110-m

    authors: De Beer JO,Hoogmartens J

    更新日期:1993-11-01 00:00:00

  • Fast simultaneous quantitative analysis of FTY720 and its metabolite FTY720-P in human blood by on-line solid phase extraction coupled with liquid chromatography-tandem mass spectrometry.

    abstract::Fingolimod (Gilenya; FTY720), has been recently approved for the treatment of multiple sclerosis in Europe and in the USA. In the present study, we have developed and validated a rapid and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method to simultaneously quantify FTY720 and FTY720-P in human...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2011.09.021

    authors: Emotte C,Deglave F,Heudi O,Picard F,Kretz O

    更新日期:2012-01-25 00:00:00

  • 2D-LC as an on-line desalting tool allowing peptide identification directly from MS unfriendly HPLC methods.

    abstract::The increasing interest in peptides and proteins in pharmaceutical research and development has led to many challenges for the researchers tasked with characterizing and analyzing these larger molecules. Due to the more complicated impurity profile of peptides and proteins, multiple liquid chromatography techniques ar...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2016.11.012

    authors: Luo H,Zhong W,Yang J,Zhuang P,Meng F,Caldwell J,Mao B,Welch CJ

    更新日期:2017-04-15 00:00:00

  • Development and validation of a high-performance liquid chromatography-mass spectrometry assay for methylxanthines and taurine in dietary supplements.

    abstract::A procedure based on liquid chromatography-mass spectrometry (LC-MS) is described for determination of caffeine, theobromine, theophylline, taurine in different dietary supplements. After addition of tryptophan as internal standard, both solid and liquid specimens were extracted with 4 ml of hexane/isopropanol (9:1). ...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2004.11.013

    authors: Marchei E,Pellegrini M,Pacifici R,Palmi I,Pichini S

    更新日期:2005-03-09 00:00:00

  • High-throughput HPLC assay of acyclovir and its major impurity guanine using a monolithic column and a flow gradient approach.

    abstract::Acyclovir and its major impurity guanine are determined rapidly by the incorporation of a monolithic column (100 mm x 4.6 mm i.d., Merck) to an automated HPLC system. A simple flow gradient protocol was adopted in order to accelerate the separation-detection cycle. Using 0.2% CH(3)COOH (pH 3.1) as the mobile phase and...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2006.11.002

    authors: Tzanavaras PD,Themelis DG

    更新日期:2007-03-12 00:00:00

  • Electrochemical DNA nano-biosensor for the study of spermidine-DNA interaction.

    abstract::An electrochemical DNA nano-biosensor is prepared by immobilization of double stranded DNA (dsDNA) onto a mixed self-assembled monolayer (SAM) composed of azide- and hydroxyl-terminated thiols. The SAMs- and dsDNA-modified gold electrodes were characterized by cyclic voltammetry (CV) and electrochemical impedance spec...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2008.12.035

    authors: Mehdinia A,Kazemi SH,Bathaie SZ,Alizadeh A,Shamsipur M,Mousavi MF

    更新日期:2009-04-05 00:00:00

  • Determination of irbesartan in the presence of hydrochlorothiazide by derivative spectrophotometry.

    abstract::A first-derivative spectrophotometric method for the determination of irbesartan (IRB) alone and in the presence of hydrochlorothiazide (HCT) is described. Measurements are made at the zero-crossing wavelength at 263.0 nm for IRB. The calibration graph was linear over the range 1.0-12.0 mg l(-1) of IRB, detection limi...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/s0731-7085(02)00073-0

    authors: Albero I,Ródenas V,García S,Sánchez-Pedreño C

    更新日期:2002-06-20 00:00:00

  • Difference spectrophotometric assay of 5-hydroxymethylfurfuraldehyde in hydrolysed pharmaceutical syrups-II. Isoniazid reagent.

    abstract::A rapid difference spectrophotometric assay of 5-hydroxymethylfurfuraldehyde (5-HMF) in certain degraded syrups is described. The method involves the measurement of the difference absorbance at 340 nm of the isonicotinoyl hydrazone of 5-HMF, formed at room temperature in an acidic solution of isoniazid, relative to an...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/0731-7085(88)80030-x

    authors: Davidson AG,Dawodu TO

    更新日期:1988-01-01 00:00:00

  • Determination of kava lactones and flavonoid glycoside in Scorzonera austriaca by capillary zone electrophoresis.

    abstract::A capillary zone electrophoretic method has been developed for the quantitative analysis of three active comppounds, 12-hydroxy-desmethoxyyangonin (HD), 12-beta-d-glucopyranoside-desmethoxyyangonin (GD) and luteolin 3'-(6-E-p-coumaroyl-beta-d-glucopyranoside) (LG) in Scorzonera austriaca with UV detection at 254 nm. T...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2006.08.024

    authors: Jiang TF,Wang YH,Lv ZH,Yue ME

    更新日期:2007-02-19 00:00:00

  • FI-chemiluminometric study of thiazides by on-line photochemical reaction.

    abstract::The present manuscript deals with a simple and sensitive flow-injection method for the chemiluminescent determination of thiazides. The method is based on the on-line photodegradation and chemiluminescent determination of the resulting photo-fragments. The on-line photodegradation is performed in basic medium by using...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2004.08.020

    authors: Ciborowski M,Icardo MC,Mateo JV,Martínez Calatayud J

    更新日期:2004-11-19 00:00:00

  • Development and validation of a LC-MS quantification method for the lantibiotic MU1140 in rat plasma.

    abstract::This study reports the first ever development and validation of a quantification method for a lantibiotic in plasma. This method was developed for the quantification of total MU1140 in Sprague Dawley rat plasma. The procedure involved acidification of plasma samples with formic acid followed by precipitation of plasma...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2008.12.022

    authors: Ghobrial OG,Derendorf H,Hillman JD

    更新日期:2009-05-01 00:00:00

  • Metabolites characterization of a novel DPP-4 inhibitor, imigliptin in humans and rats using ultra-high performance liquid chromatography coupled with synapt high-resolution mass spectrometry.

    abstract::Imigliptin has been reported as a novel dipeptidyl-peptidase-IV (DPP-4) inhibitor to treat type 2 Diabetes Mellitus (T2DM), and is currently being tested in clinical trials. In the first human clinical study, imigliptin was well tolerated and proved to be a potent DPP-4 inhibitor. Considering its potential therapeutic...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.jpba.2018.05.029

    authors: Liu Y,Yao X,Song L,Liu H,Zhao Q,Jiang J,Ni G,Shi C,Ma X,Zhou H,Liu D,Hu P

    更新日期:2018-08-05 00:00:00

  • Metabolite characterization of a novel sedative drug, remimazolam in human plasma and urine using ultra high-performance liquid chromatography coupled with synapt high-definition mass spectrometry.

    abstract::Remimazolam is a new chemical entity belonging to the benzodiazepine class of sedative drugs, which shows faster-acting onset and recovery than currently available short-acting sedatives. In the present study, ultra high performance liquid chromatography with synapt high-definition mass spectrometry method combined wi...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.jpba.2017.01.016

    authors: Zhou Y,Hu P,Jiang J

    更新日期:2017-04-15 00:00:00

  • Microwave-assisted extraction followed by salting-out phase separation for hierarchical screening of illegal adulterants in aphrodisiac health products by multi-dimensional fingerprint profiling analysis.

    abstract::A novel method for hierarchical screening of illegal adulterants in Fur seal ginseng pills (FSGP) products was developed by microwave-assisted extraction (MAE) coupled to salting-out assisted liquid-liquid extraction (SALLE) with multi-dimensional fingerprint profiling analysis. Using a homogeneous system formed by di...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2020.113774

    authors: Wang K,Jin P,Pi J,Xie X,Zhang Y,Yue Z,Mai X,Fan H,Zhang W

    更新日期:2021-02-05 00:00:00

  • Effective phospholipids removing microelution-solid phase extraction LC-MS/MS method for simultaneous plasma quantification of aripiprazole and dehydro-aripiprazole: Application to human pharmacokinetic studies.

    abstract::A simple liquid chromatography-tandem mass spectrometry (LC-MS/MS) method has been developed and validated for simultaneous quantification of aripiprazole and its active metabolite, dehydro-aripiprazole, in human plasma. Stable isotopically labeled aripiprazole, aripiprazole-D8, has been used as the internal standard ...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2017.12.049

    authors: Wojnicz A,Belmonte C,Koller D,Ruiz-Nuño A,Román M,Ochoa D,Abad-Santos F

    更新日期:2018-03-20 00:00:00

  • Keratin immobilized on silica as a new stationary phase for chromatographic modelling of skin permeation.

    abstract::Skin permeability of organic compounds depends on their lipophilicity but can also be affected by compounds interactions with specific skin components. A good chromatographic model of percutaneous penetration determined solely by lipophilicity is provided by the immobilized artificial membrane (IAM) columns. To comple...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/s0731-7085(96)02009-2

    authors: Turowski M,Kaliszan R

    更新日期:1997-06-01 00:00:00

  • Simultaneous analysis of methylprednisolone, methylprednisolone succinate, and endogenous corticosterone in rat plasma.

    abstract::A reversed-phase HPLC method is reported for simultaneous quantitation of methylprednisolone (MP), MP succinate (MPS), and endogenous corticosterone (CST) in plasma of rats. Additionally, the 11-keto metabolite of MP (methylprednisone, MPN) is resolved from the other analytes. After addition of internal standard (tria...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/s0731-7085(00)00253-3

    authors: Mehvar R,Dann RO,Hoganson DA

    更新日期:2000-07-01 00:00:00

  • Mechanism of interaction of the non-steroidal antiinflammatory drugs meloxicam and nimesulide with serum albumin.

    abstract::The mechanism of interaction of the non-steroidal antiinflammatory drugs meloxicam and nimesulide with human and bovine serum albumin has been studied using fluorescence spectroscopy. There was only one high affinity site on serum albumin for both the drugs with association constants of the order of 10(5). Negative en...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2005.02.031

    authors: Seedher N,Bhatia S

    更新日期:2005-09-01 00:00:00

  • On-chip assay for determining the inhibitory effects and modes of action of drugs against xanthine oxidase.

    abstract::Xanthine oxidase (XO) is a key enzyme that can catalyze the conversion of xanthine to uric acid, causing various diseases in humans. We have developed a high-throughput chip-based assay that uses a photodiode array (PDA) microchip system to explore the inhibitory effects of drug analogs on XO. Inhibitory activities of...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2009.07.020

    authors: Naoghare PK,Kwon HT,Song JM

    更新日期:2010-01-05 00:00:00

  • Development and validation of a dissolution test method for vitamin A in dietary supplement tablets.

    abstract::A dissolution test method and an analytical procedure by HPLC were developed and validated for evaluation of the dissolution behavior of dietary supplements tablets containing vitamin A in the forms of retinyl acetate or retinyl palmitate. Seven different commercially available products containing retinyl acetate or r...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2010.03.036

    authors: Davydova N,Stippler E,Jin P,Giancaspro G

    更新日期:2010-11-02 00:00:00

  • Biorelevant pK(a) (37 °C) predicted from the 2D structure of the molecule and its pK(a) at 25 °C.

    abstract::Values of the ionization constants at 37 °C, which are scarcely reported, are more meaningful for interpreting mechanisms of cellular transport by ionizable molecules and in mechanistic dissolution studies, which are often performed at the biorelevant temperature. An equation was developed where the pK(a) values of dr...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2011.05.007

    authors: Sun N,Avdeef A

    更新日期:2011-09-10 00:00:00

  • New trends on modified electrodes: applications to drug analysis.

    abstract::It is shown that activity in the area of chemically modified electrodes continues at a high level. This topic is increasing in popularity with a large research field on the incorporation of electroactive groups into a variety of conductive films. These developments are also directed towards catalyzing bioselective and...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/0731-7085(86)80089-9

    authors: Patriarche GJ

    更新日期:1986-01-01 00:00:00

  • Quantification of phenolic acids and their methylates, glucuronides, sulfates and lactones metabolites in human plasma by LC-MS/MS after oral ingestion of soluble coffee.

    abstract::Chlorogenic acids and derivatives like phenolic acids are potentially bioactive phenolics, which are commonly found in many foods. Once absorbed, chlorogenic and phenolic acids are highly metabolized by the intestine and the liver, producing glucuronidated and/or sulphated compounds. These metabolites were analyzed in...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2013.10.009

    authors: Marmet C,Actis-Goretta L,Renouf M,Giuffrida F

    更新日期:2014-01-01 00:00:00