Impact of glass corrosion on drug substance stability.

Abstract:

:The delamination of glass contact surfaces because of hydrolytic instability has been well documented. However, the lack of glass surface integrity can also lead to other undesirable outcomes prior to visible glass delamination. This work shows how the early stages of delamination, namely, glass corrosion, can influence the chemical stability of active pharmaceutical ingredient (API) solutions contained within a glass container, even prior to the observation of visible delamination. Multiple containers, all constructed of glass classified as USP Type I, were evaluated for hydrolytic stability and how they influence the chemical stability of the API in question. The glass composition of these analytical consumables, the vendor source, and presumably manufacturing process were examined. The implications of glass container durability on product development decisions, the influence on analytical results, and the practice of like-for-like glass container interchangeability are considered.

journal_name

J Pharm Sci

authors

Watkins MA,Iacocca RG,Shelbourn TL,Dong X,Stobba-Wiley C

doi

10.1002/jps.24069

subject

Has Abstract

pub_date

2014-08-01 00:00:00

pages

2456-63

issue

8

eissn

0022-3549

issn

1520-6017

pii

S0022-3549(15)30484-6

journal_volume

103

pub_type

杂志文章
  • Feasibility of atomic force microscopy for determining crystal growth rates of nifedipine at the surface of amorphous solids with and without polymers.

    abstract::Amorphous nifedipine (NFD), which has a smooth surface immediately after preparation, was shown to have structures resembling clusters of curling and branching fibers approximately 1 μm wide by atomic force microscopy (AFM) after storage at 25°C. The size of the cluster-like structures increased with storage over time...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/jps.22603

    authors: Miyazaki T,Aso Y,Kawanishi T

    更新日期:2011-10-01 00:00:00

  • Development of aqueous parenteral formulations for carbamazepine through the use of modified cyclodextrins.

    abstract::The poor aqueous solubility of carbamazepine was dramatically increased via complexation with various chemically modified beta-cyclodextrins and gamma-cyclodextrins. A preparation of carbamazepine and 2-hydroxypropyl-beta-cyclodextrin was found to be stable to steam sterilization and to storage under a variety of cond...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/jps.2600800420

    authors: Brewster ME,Anderson WR,Estes KS,Bodor N

    更新日期:1991-04-01 00:00:00

  • Kinetics and mechanism of hydroxy group acetylations catalyzed by N-methylimidazole.

    abstract::The kinetics of acetylation of alcohols by acetyl chloride and acetic anhydride, with N-methylimidazole as the catalyst, were studied in acetonitrile solution at 25 degrees; some measurements were also made with 4-dimethylaminopyridine as the catalyst. The acetic anhydride-N-methylimidazole system proceeds entirely by...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/jps.2600710503

    authors: Pandit NK,Connors KA

    更新日期:1982-05-01 00:00:00

  • Molecular Dynamics of Amorphous Sulfamethazine With Structurally Related Sulfonamide Impurities Evaluated Using Thermal Analysis.

    abstract::In this study, the effects of structurally related organic impurities on the molecular dynamics of amorphous sulfamethazine were evaluated using thermal analysis. Sulfanilamide (SNA), sulfamerazine (SMR), and sulfadimethoxine were used as virtual impurities of sulfamethazine. The amorphous state was prepared in situ i...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1016/j.xphs.2016.12.008

    authors: Hamada Y,Ono M,Ohara M,Yonemochi E

    更新日期:2017-04-01 00:00:00

  • Determination of drug plasma protein binding by solid phase microextraction.

    abstract::The plasma protein binding of drugs has been shown to have significant effects on the quantitative relationship between clinical pharmacokinetics and pharmacodynamics. In many clinical situations, measurement of the total drug concentration does not provide the needed information concerning the unbound fraction of dru...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/jps.20558

    authors: Musteata FM,Pawliszyn J,Qian MG,Wu JT,Miwa GT

    更新日期:2006-08-01 00:00:00

  • Characterization of the physical stability of a lyophilized IgG1 mAb after accelerated shipping-like stress.

    abstract::Upon exposure to shaking stress, an IgG1 mAb formulation in both the liquid and lyophilized state formed subvisible particles. Because freeze-drying was expected to minimize protein physical instability under these conditions, the extent and nature of aggregate formation in the lyophilized preparation were examined us...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/jps.24242

    authors: Telikepalli S,Kumru OS,Kim JH,Joshi SB,O'Berry KB,Blake-Haskins AW,Perkins MD,Middaugh CR,Volkin DB

    更新日期:2015-02-01 00:00:00

  • Antitumor agents. XXXIV: Mechanism of action of bruceoside A and brusatol on nucleic acid metabolism of P-388 lymphocytic leukemia cells.

    abstract::The quassinoids bruceantin, brucein D, brucein E, bruceoside A, and brusatol significantly inhibited P-388 lymphocytic leukemic cell RNA and protein synthesis in tissue culture. However, DNA synthesis inhibition seemed to correlate more directly with the anti-neoplastic activity of these compounds in the in vivo P-338...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/jps.2600680726

    authors: Hall IH,Lee KH,Eigebaly SA,Imakura Y,Sumida Y,Wu RY

    更新日期:1979-07-01 00:00:00

  • Low-Molecular-Weight Heparin-Coated and Montelukast-Filled Inhalable Particles: A Dual-Drug Delivery System for Combination Therapy in Asthma.

    abstract::Montelukast, a cysteinyl leukotriene type 1 receptor antagonist, exhibits secondary anti-inflammatory properties when used at higher concentrations. Low-molecular-weight heparin (LMWH) evokes pronounced anti-inflammatory effects by interrupting leukocyte adhesion and migration. We hypothesized that inhalable particles...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1016/j.xphs.2016.12.025

    authors: Patel B,Rashid J,Gupta N,Ahsan F

    更新日期:2017-04-01 00:00:00

  • Polynitro aromatic compounds in analytical chemistry I: reaction with ouabain and digitoxin.

    abstract::By the use of NMR spectroscopy, the highly colored reaction products formed by ouabain or digitoxin in with 1,3,5-trinitrobenzene or 2,4,6-trinitroanisole in the presence of alkali (as used for the determination of these glycosides) are shown to be Meisenheimer complexes. The complexes are produced by attachment of a ...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/jps.2600660544

    authors: Burns LB,Stedman RJ,Tuckerman MM

    更新日期:1977-05-01 00:00:00

  • Evaluation of New Chemical Entities as Substrates of Liver Transporters in the Pharmaceutical Industry: Response to Regulatory Requirements and Future Steps.

    abstract::This article discusses the evaluation of drug candidates as hepatic transporter substrates. Recently, research on the applications of hepatic transporters in the pharmaceutical industry has improved to meet the requirements of the regulatory guidelines for the evaluation of drug interactions. To identify the risk of t...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章,评审

    doi:10.1016/j.xphs.2017.05.009

    authors: Okudaira N

    更新日期:2017-09-01 00:00:00

  • Prediction of granule packing and flow behavior based on particle size and shape analysis.

    abstract::Packing behavior and flowability of particulate material have long been acknowledged as important parameters for the processing of pharmaceutical materials. When properly understood, these properties can provide insight into weight uniformity, tableting performance and process design. The aim of this study was to meas...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/jps.21884

    authors: Sandler N,Wilson D

    更新日期:2010-02-01 00:00:00

  • Isomerization of ceftibuten in aqueous solution.

    abstract::The isomerization reactions of ceftibuten and ceftibuten-related compounds in aqueous solution were investigated to estimate the substitution effect on the isomerization reaction and identify the three proximal dissociation constants of ceftibuten kinetically from the pH-rate profiles. The isomerization reaction of ce...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1021/js980048z

    authors: Hashimoto N,Hirano K

    更新日期:1998-09-01 00:00:00

  • Impact of formulation and methods of pulmonary delivery on absorption of parathyroid hormone (1-34) from rat lungs.

    abstract::The aim of this work was to optimize the absorption of parathyroid hormone 1-34 (PTH) from the lungs by determining factors favoring its transport from the air spaces into the bloodstream. We simultaneously conducted pharmacokinetic and regional lung deposition studies in vivo in the rat following intratracheal admini...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/jps.20053

    authors: Codrons V,Vanderbist F,Ucakar B,Préat V,Vanbever R

    更新日期:2004-05-01 00:00:00

  • The biological characteristics and pharmacodynamics of a mycophenolate mofetil nanosuspension ophthalmic delivery system in rabbits.

    abstract::The purpose of this study was to investigate corneal mucoadhesion, pharmacokinetics in lacrimal fluid and aqueous humor, the immune suppression induced by corneal transplantation of mycophenolate mofetil (MMF) nanosuspensions (NS), and the use of a chitosan-modified MMF nanosuspension (C-NS) as an ophthalmic delivery ...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/jps.22356

    authors: Wu XG,Xin M,Yang LN,Shi WY

    更新日期:2011-04-01 00:00:00

  • Structural functions of the sweet pharmacophore.

    abstract::The relative sweetness, onset times, and durations of response of D-glucose, D-xylose, D-quinovose, D-galactose, L-arabinose, and D-fucose were determined at four temperatures. The results can be interpreted by simple concepts of intramolecular hydrogen bonding which indicate that the so-called gamma-function of the t...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/jps.2600700313

    authors: Birch GG,Dziedzic SZ,Shallenberger RS,Lindley MG

    更新日期:1981-03-01 00:00:00

  • A new potential prodrug to improve the duration of L-dopa: L-3-(3-hydroxy-4-pivaloyloxyphenyl)alanine.

    abstract::L-3-(3-Hydroxy-4-pivaloyloxyphenyl)alanine (1, NB-355) is a novel L-dopa prodrug. After oral administration with carbidopa in rats, 1 demonstrated 2.3 times longer duration (MRT) and 1.4 times larger bioavailability (AUC) on plasma L-dopa concentrations than those of L-dopa itself. Similar results were obtained in dog...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/jps.2600780703

    authors: Ihara M,Tsuchiya Y,Sawasaki Y,Hisaka A,Takehana H,Tomimoto K,Yano M

    更新日期:1989-07-01 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

  • Rapid GLC determination of fusaric acid in biological fluids.

    abstract::A simple, sensitive GLC assay was developed for fusaric acid, the active metabolite of bupicomide, to follow the disposition of this investigational antihypertensive agent in patients undergoing therapy. Fusaric acid is efficiently extracted from biological samples, derivatized by on-column methylation, and chromatogr...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/jps.2600650430

    authors: Fung KK,Koda RT,Maronde RF,Cohen JL

    更新日期:1976-04-01 00:00:00

  • "Predicting" Polymorphs of Pharmaceuticals Using Hydrogen Bond Propensities: Probenecid and Its Two Single-Crystal-to-Single-Crystal Phase Transitions.

    abstract::The recently developed hydrogen-bonding propensity tool in the Cambridge Structural Database software package (Mercury) was tested to predict polymorphs. The compounds for the study were chosen from a list of approximately 300 pharmaceutically important compounds, for which multiple crystal forms had not been previous...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/jps.24449

    authors: Nauha E,Bernstein J

    更新日期:2015-06-01 00:00:00

  • Effects of Product Handling Parameters on Particle Levels in a Commercial Factor VIII Product: Impacts and Mitigation.

    abstract::To reduce the risk of immunogenicity that may be caused by therapeutic protein products, it is important to properly characterize subvisible particles and to develop strategies to reduce the levels of particles delivered to patients. In the present study, by using state-of-the-art methods to quantify particle levels, ...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1016/j.xphs.2018.08.022

    authors: Ueda T,Nakamura K,Abe Y,Carpenter JF

    更新日期:2019-01-01 00:00:00

  • Biopharmaceutic Profiling of Salts to Improve Absorption of Poorly Soluble Basic Drugs.

    abstract::AZD1175 and AZD2207 are 2 highly lipophilic compounds with a significant risk of not achieving therapeutic plasma concentrations due to solubility-limited absorption. The compounds have the same molecular weight and minimal structural differences. The aim of the present work was to investigate whether salts could be a...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.xphs.2016.07.016

    authors: Tannergren C,Karlsson E,Sigfridsson K,Lindfors L,Ku A,Polentarutti B,Carlert S

    更新日期:2016-11-01 00:00:00

  • Application of salivary concentration data to pharmacokinetic studies with antipyrine.

    abstract::The concentrations of antipyrine in plasma and saliva were equivalent in normal volunteers and in patients with acute viral hepatitis following oral doses of antipyrine. Estimates of clearance, volume of distribution, and half-life made from either plasma or saliva samples were not statistically different in these sub...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/jps.2600660140

    authors: Meffin PJ,Williams RL,Blaschke TF,Rowland M

    更新日期:1977-01-01 00:00:00

  • Tocainide conjugation in humans: novel biotransformation pathway for a primary amine.

    abstract::The metabolism of tocainide, an experimental antiarrhythmic drug, was studied in humans. Urinary excretion of unchanged drug was 28-55% in 24 hr after oral dosing. Urine hydrolysis with hydrochloric acid or beta-glucuronidase increased tocainide recovery to 55-79%. Saccharo-1,4-lactone inhibited the beta-glucuronidase...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/jps.2600690113

    authors: Elvin AT,Keenaghan JB,Byrnes EW,Tenthorey PA,McMaster PD,Takman BH,Lalka D,Manion CV,Baer DT,Wolshin EM,Meyer MB,Ronfeld RA

    更新日期:1980-01-01 00:00:00

  • Introduction of solvent-accessible surface area in the calculation of the hydrophobicity parameter log P from an atomistic approach.

    abstract::A conventional atomistic approach of estimating molecular hydrophobicity (log P) was improved by taking into account the proximity effect of substituent groups as well as the importance of solute-solvent interaction in the partition phenomena. The new method reassigns atomic parameters when the molecule is fully expos...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1021/js960237m

    authors: Masuda T,Jikihara T,Nakamura K,Kimura A,Takagi T,Fujiwara H

    更新日期:1997-01-01 00:00:00

  • Application of Bayesian estimation for the prediction of an appropriate dosage regimen of amikacin.

    abstract::A Bayesian approach was developed to determine an amikacin dosage regimen to achieve the desired plasma concentrations for each patient. Statistical characteristics of pharmacokinetic parameters were first evaluated in a group of patients (reference population), which when combined with three individual plasma concent...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/jps.2600780911

    authors: Garraffo R,Iliadis A,Cano JP,Dellamonica P,Lapalus P

    更新日期:1989-09-01 00:00:00

  • Development of a Novel Lung Slice Methodology for Profiling of Inhaled Compounds.

    abstract::The challenge of defining the concentration of unbound drug at the lung target site after inhalation limits the possibility to optimize target exposure by compound design. In this study, a novel rat lung slice methodology has been developed and applied to study drug uptake in lung tissue, and the mechanisms by which t...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/jps.24575

    authors: Bäckström E,Lundqvist A,Boger E,Svanberg P,Ewing P,Hammarlund-Udenaes M,Fridén M

    更新日期:2016-02-01 00:00:00

  • Formulation of Granules for Site-Specific Delivery of an Antimicrobial Essential Oil to the Animal Intestinal Tract.

    abstract::Owing to proliferation of antibiotic-resistant bacteria, the use of antibiotics for livestock growth promotion is banned in many countries and alternatives to in-feed antibiotics are needed. Cinnamon essential oil exhibits strong in vitro antibacterial activity; however, direct addition of essential oils to animal fee...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1016/j.xphs.2015.10.001

    authors: Ma YH,Wang Q,Gong J,Wu XY

    更新日期:2016-03-01 00:00:00

  • Binder-Jet 3D Printing of Indomethacin-laden Pharmaceutical Dosage Forms.

    abstract::Emerging 3D printing technologies offer an exciting opportunity to create customized 3D objects additively from a digital design file. 3D printing may be further leveraged for personalized medicine, clinical trial, and controlled release applications. A wide variety of 3D printing methods exists, and many studies focu...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1016/j.xphs.2020.06.027

    authors: Chang SY,Li SW,Kowsari K,Shetty A,Sorrells L,Sen K,Nagapudi K,Chaudhuri B,Ma AWK

    更新日期:2020-10-01 00:00:00

  • Frog intestinal sac: a new in vitro method for the assessment of intestinal permeability.

    abstract::The aim of this study was to evaluate a new experimental protocol utilizing isolated frog intestinal sacs for the assessment of intestinal drug permeability in humans. Segments of approximately 5.0 cm in length were used for these experiments. The intestinal sacs were filled with a solution of the appropriate drug in ...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/jps.20180

    authors: Trapani G,Franco M,Trapani A,Lopedota A,Latrofa A,Gallucci E,Micelli S,Liso G

    更新日期:2004-12-01 00:00:00

  • Pharmacokinetics of polychlorinated biphenyl components in swine and sheep after a single oral dose.

    abstract::Single-dose oral administration of a commercial polychlorinated biphenyl product containing 54% chlorine provided data with which to plot the time course of total polychlorinated biphenyl and individual components in the blood of swine and sheep. Pharmacokinetic parameters describing absorption from the gut and elimin...

    journal_title:Journal of pharmaceutical sciences

    pub_type: 杂志文章

    doi:10.1002/jps.2600640807

    authors: Borchard RE,Welborn ME,Wiekhorst WB,Wilson DW,Hansen LG

    更新日期:1975-08-01 00:00:00