Validation of washing procedures for maintaining a microbiologically clean gel filtration column.

Abstract:

:Chromatographic gel filtration matrixes used in various separation techniques are subject to microbial contamination. The need for a microbe-free column is critical when preparing materials that require a low or zero microbial count. This report proposes two alternative washing systems: 0.02 N HCl containing 0.81% NaCl, and 0.1 M tromethamine--hydrochloride buffer (pH 7.0) containing 0.81% NaCl and 0.02% thimerosal. These washing systems were validated using a 100 x 2.6-cm column packed with a modified dextran gel slurry previously inoculated with known counts of USP test organisms. After each wash, the column separation characteristics were verified further with appropriate test proteins.

journal_name

J Pharm Sci

authors

Wen LF,Bohannon T,Crabb A,Mamaril F

doi

10.1002/jps.2600690205

subject

Has Abstract

pub_date

1980-02-01 00:00:00

pages

140-4

issue

2

eissn

0022-3549

issn

1520-6017

pii

S0022-3549(15)43076-X

journal_volume

69

pub_type

杂志文章
  • Permeability of tritiated water through human cervical and vaginal tissue.

    abstract::The increased incidence of human immunodeficiency virus infection in women has identified an urgent need to develop a female-controlled method to prevent acquisition of human immunodeficiency virus and other sexually transmitted diseases. Women would apply the product intravaginally before intercourse. Development of ...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/jps.20107

    authors: Sassi AB,McCullough KD,Cost MR,Hillier SL,Rohan LC

    更新日期:2004-08-01 00:00:00

  • Identification of Endogenous Biomarkers to Predict the Propensity of Drug Candidates to Cause Hepatic or Renal Transporter-Mediated Drug-Drug Interactions.

    abstract::Drug transporters expressed in liver and kidney play a critical role in the elimination of a wide range of drugs and xenobiotics and inhibition of these transporters may therefore cause clinically significant drug-drug interactions (DDIs). Currently, in vitro transporter inhibition data are used to assess the risk tha...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章,评审

    doi:10.1016/j.xphs.2017.04.007

    authors: Chu X,Chan GH,Evers R

    更新日期:2017-09-01 00:00:00

  • Self-setting hydroxyapatite cement: a novel skeletal drug-delivery system for antibiotics.

    abstract::A novel approach using a self-setting hydroxyapatite (HAP) cement as a skeletal drug-delivery system has been proposed to solve the problem of delivering drugs to skeletal tissue at sufficiently high local concentrations for desirable therapeutic effects. HAP cements loaded with antibiotics can be formed in situ and c...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/jps.2600810611

    authors: Yu D,Wong J,Matsuda Y,Fox JL,Higuchi WI,Otsuka M

    更新日期:1992-06-01 00:00:00

  • Characterization and evaluation of triamcinolone, raloxifene, and their dual-loaded microspheres as prospective local treatment system in rheumatic rat joints.

    abstract::In this study, injectable microspheres were developed for the local treatment of joint degeneration in rheumatoid arthritis (RA). Microspheres loaded with triamcinolone (TA), a corticosteroid drug, and/or raloxifene (Ral), a cartilage regenerative drug, were prepared with a biodegradable and biocompatible polymer, pol...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/jps.24058

    authors: Ocal Y,Kurum B,Karahan S,Tezcaner A,Ozen S,Keskin D

    更新日期:2014-08-01 00:00:00

  • Mechanism of phosphate adsorption to a three-dimensional structure of boehmite in the presence of bovine serum albumin.

    abstract::A new microcrystalline boehmite (tentatively named PT-A) was synthesized as an efficient phosphate adsorbent to replace aluminum hydroxide gel. The characteristic structure of PT-A was examined by nitrogen adsorption/desorption, X-ray diffraction, deviation microscopy, and scanning electron microscopy to establish a p...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/jps.2600820714

    authors: Ookubo A,Nishida M,Ooi K,Ishida K,Hashimura Y,Ikawa A,Yoshimura Y,Kawada J

    更新日期:1993-07-01 00:00:00

  • Michaelis-Menten metabolite formation kinetics: equations relating area under the curve and metabolite recovery to the administered dose.

    abstract::A computational approach which concomitantly determines the capacity-limited rate constants of parent drug elimination and metabolite formation is presented. The approach applies both the presently derived total excretory recovery versus dose relationships of the metabolite and the AUC versus dose relationships of the...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/jps.2600791012

    authors: Chow AT,Jusko WJ

    更新日期:1990-10-01 00:00:00

  • A triple-transgenic immunotolerant mouse model.

    abstract::Avoiding unwanted immunogenicity is of key importance in the development of therapeutic drug proteins. Animal models are of less predictive value because most of the drug proteins are recognized as foreign proteins. However, different methods have been developed to obtain immunotolerant animal models. So far, the immu...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/jps.23447

    authors: Brenden N,Madeyski-Bengtson K,Martinsson K,Svärd R,Albery-Larsdotter S,Granath B,Lundgren H,Lövgren A

    更新日期:2013-03-01 00:00:00

  • Liquid membrane phenomenon in diuretics.

    abstract::Surface activity and critical micelle concentrations are reported for two diuretic drugs, furosemide and triamterene. The drugs generate a liquid membrane on a supporting membrane. Transport of chloride, sodium, and potassium ions through the liquid membranes generated by the drugs was studied. The data suggest that t...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/jps.2600731123

    authors: Bhise SB,Bhattacharjee D,Srivastava RC

    更新日期:1984-11-01 00:00:00

  • Solvent influences on metastable polymorph lifetimes: real-time interconversions using energy dispersive X-ray diffractometry.

    abstract::Solvent influences on the crystallization of polymorph and hydrate forms of the nootropic drug piracetam (2-oxo-pyrrolidineacetamide) were investigated from water, methanol, 2-propanol, isobutanol, and nitromethane. Crystal growth profiles of piracetam polymorphs were constructed using time-resolved diffraction snapsh...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/jps.20924

    authors: DeMatos LL,Williams AC,Booth SW,Petts CR,Taylor DJ,Blagden N

    更新日期:2007-05-01 00:00:00

  • Explanation of the crystallization rate of amorphous nifedipine and phenobarbital from their molecular mobility as measured by (13)C nuclear magnetic resonance relaxation time and the relaxation time obtained from the heating rate dependence of the glass

    abstract::To gain further insight into the effect of molecular mobility on the crystallization rate of amorphous drugs, the mean relaxation times of amorphous nifedipine and phenobarbital were calculated based on the Adam-Gibbs-Vogel (AGV) equation, using the parameters D, T(0), and T(f), derived from the heating rate dependenc...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/jps.1033

    authors: Aso Y,Yoshioka S,Kojima S

    更新日期:2001-06-01 00:00:00

  • Enhanced transdermal delivery of sex hormones in swine with a novel topical aerosol.

    abstract::This study investigated the enhanced transdermal delivery of testosterone (Tes) and estradiol (E2) in swine in vivo with novel metered-dose topical aerosols containing the penetration enhancer padimate O (PadO) and predicted the dose deliverable in humans from the calculated drug flux across the skin. Weanling swine w...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1021/js980026c

    authors: Morgan TM,Parr RA,Reed BL,Finnin BC

    更新日期:1998-10-01 00:00:00

  • An Extrusion Spheronization Approach to Enable a High Drug Load Formulation of a Poorly Soluble Drug with a Low Melting Surfactant.

    abstract::Vitamin E tocopherol polyethylene glycol succinate (TPGS) is a non-ionic surface active agent, known to enhance the bioavailability of lipophilic compounds via wettability, solubility, and in some cases permeability enhancement. MK-0536 is an anti-retroviral drug with poor wettability and solubility and a high dose. B...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/jps.24585

    authors: Tatavarti A,Kesisoglou F

    更新日期:2015-11-01 00:00:00

  • Degradation kinetics of (+/-)-4'-ethyl-2-methyl-3-(1-pyrrolidinyl)propiophenone hydrochloride (HY-770) and structure-stability relationship among its analogues in aqueous solution.

    abstract::The kinetics and pathways for degradation of (+/-)-4'-ethyl-2-methyl-3-(1-pyrrolidinyl)propiophenone hydrochloride (HY-770; 1), a newly developed muscle-relaxing agent, and its analogues were studied in aqueous solution at 50 degrees C, ionic strength 0.5 M, and pH 8.0-12.0. Compound 1 and its four analogues followed ...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/jps.2600780115

    authors: Nagata O,Terasaki T,Yada E,Sato H,Tamai I,Tsuji A

    更新日期:1989-01-01 00:00:00

  • Protein Nanoparticles Promote Microparticle Formation in Intravenous Immunoglobulin Solutions During Freeze-Thawing and Agitation Stresses.

    abstract::In this study, we investigated the potential roles of nanoparticles (<100 nm) and submicron (100-1000 nm) particles in the formation of microparticles (>1000 nm) in protein formulations under some pharmaceutically relevant stress conditions. Exposure of intravenous immunoglobulin solutions to the interface-associated ...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1016/j.xphs.2018.03.016

    authors: Pardeshi NN,Zhou C,Randolph TW,Carpenter JF

    更新日期:2018-07-01 00:00:00

  • Potency of synthetic luteinizing hormone releasing hormone preparations in rat anterior pituitary cell cultures.

    abstract::Selected synthetic luteinizing hormone releasing hormone preparations were assayed, and their potencies were determined relative to one sample utilizing primary cultures of enzymatically dispersed rat anterior pituitary cells. Preliminary cell culture experiments indicated that luteinizing hormone releasing hormone ha...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/jps.2600660319

    authors: Dermody WC,Pastushok CA,Sakowski R,Vaitkus JW,Reel JR

    更新日期:1977-03-01 00:00:00

  • Prediction of onset of crystallization from experimental relaxation times. II. Comparison between predicted and experimental onset times.

    abstract:UNLABELLED:Given a good correlation between onsets of crystallization and mobility above T(g), one might be able to predict crystallization onsets at a temperature of interest far below T(g) from this correlation and measurement of mobility at a temperature below T(g). Such predictions require that: (a) correlation bet...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/jps.21162

    authors: Bhugra C,Shmeis R,Krill SL,Pikal MJ

    更新日期:2008-01-01 00:00:00

  • Respirable form of crystals of cromoglycic acid.

    abstract::Respirable crystals of cromoglycic acid (CA) were prepared by precipitation of CA with hydrochloric acid from aqueous solutions of cromolyn sodium and subsequent recrystallization from hot water or mixtures of dimethyl sulphoxide and water. The properties of the materials were established by melting point measurements...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/jps.2600780221

    authors: Chan HK,Gonda I

    更新日期:1989-02-01 00:00:00

  • Solubility profiles and thermodynamics of parabens in aliphatic alcohols.

    abstract::The solubility of a series of compounds was determined in a wide polarity spectrum of normal aliphatic alcohols over a limited temperature range. The solutes chosen were the methyl through n-butyl p-hydroxybenzoates, several of these being useful preservatives. Solubility profiles were determined for these compounds, ...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/jps.2600660110

    authors: Alexander KS,Mauger JW,Petersen H Jr,Paruta AN

    更新日期:1977-01-01 00:00:00

  • Enhanced econazole penetration into human nail by 2-n-nonyl-1,3-dioxolane.

    abstract::This study determines the enhancing effects of 2-n-nonyl-1,3-dioxolane on the penetration of econazole, an antifungal drug, into the deeper layers of the human nail where fungal infection resides. Aliquots (10 microL) of Econail lacquer formulation containing 0.45 mg of [(14)C]-econazole with 18% 2-n-nonyl-1,3-dioxola...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/jps.10291

    authors: Hui X,Chan TC,Barbadillo S,Lee C,Maibach HI,Wester RC

    更新日期:2003-01-01 00:00:00

  • Synthesis and characterization of surface-hydrophobic ion-exchange microspheres and the effect of coating on drug release rate.

    abstract::Biodegradable, dextran-based ion-exchange microspheres (IE-MS) have been used for localized delivery of anticancer drugs and chemosensitizers. Because of their hydrophilic nature, the IE-MS release their payload quickly. The purpose of this work was to develop an IE-MS system that could provide a broad range of releas...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/(SICI)1520-6017(200006)89:6<807::AID-JPS13

    authors: Liu Z,Wu XY,Ballinger JR,Bendayan R

    更新日期:2000-06-01 00:00:00

  • Interactions of nonsteroidal antiinflammatory drugs with phospholipids: comparison between octanol/buffer partition coefficients and chromatographic indexes on immobilized artificial membranes.

    abstract::A set of seventeen nonsteroidal antiinflammatory drugs (NSAIDs), consisting of structurally unrelated carboxylic acids and piroxicam, was examined by high-performance liquid chromatography (HPLC) on an immobilized artificial membrane (IAM) column that is a solid-phase model of fluid membranes. The chromatographic capa...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1021/js960233h

    authors: Barbato F,La Rotonda MI,Quaglia F

    更新日期:1997-02-01 00:00:00

  • Quantitative microradiographic study of simultaneous demineralization/remineralization of dental enamel in weak acid buffers.

    abstract::The remineralization behavior of weak acid-treated bovine tooth enamel has been investigated using a recently developed quantitative microradiographic method. Acetate buffer solutions at pH 4.5 containing calcium, phosphate, and 10 ppm fluoride were used in this study. When the solution ion activity product ( KFAP = a...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/jps.2600730516

    authors: Bergstrom DH,Fox JL,Higuchi WI

    更新日期:1984-05-01 00:00:00

  • Plasma protein binding of zomepirac sodium.

    abstract::The plasma protein binding of zomepirac, a new nonnarcotic analgesic, was studied using equilibrium dialysis. Experiments were performed using human plasma and plasma from mice, rats, and rhesus monkeys, all species of pharmacological or toxicological interest. At concentrations approximating those achieved in vivo, t...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/jps.2600700733

    authors: O'Neill PJ

    更新日期:1981-07-01 00:00:00

  • Progesterone retention by rat uterus I. Pharmacokinetics after uterine intraluminal instillation.

    abstract::Tritium-labeled progesterone was administered to mature female rats in the proestrous stage by three different routes, gastric intubation, subcutaneous injection, and uterine intraluminal instillation, to study the kinetics involved in the uptake and retention of radioactivity by the uterus and various other tissues. ...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/jps.2600661223

    authors: Fang SM,Lin CS,Lyon V

    更新日期:1977-12-01 00:00:00

  • Synthesis and preliminary pharmacology of an internal standard for assay of neostigmine.

    abstract::The synthesis of the diethyl analog of neostigmine, its preliminary pharmacology, and its use as an internal standard for the GLC assay of neostigmine are described. Both the diethyl analog and neostigmine undergo thermal demethylation in the injection port. The column selected produced satisfactory resolution and sho...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/jps.2600700423

    authors: Ward HE Jr,Freeman JJ,Sowell JW,Kosh JW

    更新日期:1981-04-01 00:00:00

  • Effect of time errors on infinity values obtained using Prony's method.

    abstract::The estimates of infinity values obtained using Prony's method are shown to be subject to significant error arising from small errors in the assigned sample times. The error of the estimate may be reduced by increasing the time interval between samples. ...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:

    authors: Newburger J,Stavchansky S,Pearlman RS

    更新日期:1980-10-01 00:00:00

  • Trileucine improves aerosol performance and stability of spray-dried powders for inhalation.

    abstract::For particles to be useful medicinal aerosols, not only their aerodynamic diameter has to be on the order of a few micrometers but also they have to be chemically and physically stable. Manufacture of respirable particles is a technical challenge because as particles are reduced in size by conventional milling techniq...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/jps.21078

    authors: Lechuga-Ballesteros D,Charan C,Stults CL,Stevenson CL,Miller DP,Vehring R,Tep V,Kuo MC

    更新日期:2008-01-01 00:00:00

  • Evaluation of Transdermal Drug Permeation as Modulated by Lipoderm and Pluronic Lecithin Organogel.

    abstract::The transdermal delivery of 2 fluorescent probes with similar molecular weight but different lipophilicity, into and through the skin from 2 commercially available transdermal bases, pluronic lecithin organogel, and Lipoderm® has been evaluated. First, in vitro penetration of fluorescein sodium and fluorescein (free a...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1016/j.xphs.2017.09.008

    authors: Zhang Q,Song Y,Page SW,Garg S

    更新日期:2018-02-01 00:00:00

  • The Use of Binary Polymeric Networks in Stabilizing Polyethylene Oxide Solid Dispersions.

    abstract::The objective of this study was to determine if a high Tg polymer (Eudragit(®) S100) could be used to stabilize amorphous domains of polyethylene oxide (PEO) and hence improve the stability of binary polymer systems containing celecoxib (CX). We propose a novel method of stabilizing the amorphous PEO solid dispersion ...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1016/j.xphs.2016.06.004

    authors: Jones DS,Tian Y,Li S,Yu T,Abu-Diak OA,Andrews GP

    更新日期:2016-10-01 00:00:00

  • Porous resins as a cavitation enhancer for low-frequency sonophoresis.

    abstract::The application of low-frequency ultrasound enhances drug transport through the skin, a phenomenon referred to as low-frequency sonophoresis. This enhancement is mediated through cavitation, the formation and collapse of gaseous bubbles. We hypothesized that the efficacy of low-frequency sonophoresis can be significan...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/jps.10080

    authors: Terahara T,Mitragotri S,Langer R

    更新日期:2002-03-01 00:00:00