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

abstract：:This article describes a procedure to facilitate scale-up for the primary drying phase of lyophilization using a combination of empirical testing and numerical modeling. Freeze dry microscopy is used to determine the temperature at which lyophile collapse occurs. A laboratory scale freeze-dryer equipped with manometri...

journal_title：Journal of pharmaceutical sciences

authors： Kramer T,Kremer DM,Pikal MJ,Petre WJ,Shalaev EY,Gatlin LA

更新日期：2009-01-01 00:00:00

abstract：:The major objective of this study was to investigate and characterize the solution properties of cromolyn sodium (in D(2)O or D(2)O/H(2)O phosphate buffer at pH 7.5) using nuclear magnetic resonance (NMR) spectroscopy. The self-association of cromolyn molecules was examined primarily via one-dimensional (1)H and (13)C...

journal_title：Journal of pharmaceutical sciences

authors： Ding X,Stringfellow TC,Robinson JR

更新日期：2004-05-01 00:00:00

abstract：:Unlike most organic compounds, both digoxin and digitoxin melted over a wide temperature range, with the widest range being 88 and 33 degrees for both compounds, respectively. Furthermore, the melting ranges varied markedly among several untriturated powders obtained from commercial sources and after recrystallization...

journal_title：Journal of pharmaceutical sciences

authors： Chiou WL,Kyle LE

更新日期：1979-10-01 00:00:00

abstract：:Nonsteroidal anti-inflammatory drugs (NSAIDs) are among the most frequently used drugs in the world, primarily for symptoms associated with osteoarthritis and other chronic musculoskeletal conditions. However, adverse effects caused by oral administration, such as local or systemic disturbance in the gastrointestinal ...

journal_title：Journal of pharmaceutical sciences

authors： Cheng Y,Man N,Xu T,Fu R,Wang X,Wang X,Wen L

更新日期：2007-03-01 00:00:00

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

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

abstract：:Previous studies have shown that protein storage stability in freeze-dried l-arginine-based systems improved in the presence of chloride ions. However, chloride ions reduced the glass transition temperature of the freeze concentrate (Tg') and made freeze drying more challenging. In this study, l-arginine was freeze dr...

journal_title：Journal of pharmaceutical sciences

authors： Stärtzel P,Gieseler H,Gieseler M,Abdul-Fattah AM,Adler M,Mahler HC,Goldbach P

更新日期：2016-10-01 00:00:00

abstract：:A rapid, sensitive, and accurate reversed-phase HPLC method has been developed for the analysis and quantification of pharmaceutical formulations containing tyrothricin (1), an antibiotic used in antiseptic buccal compressed tablets for local application. The assay has been carried out under isocratic conditions, usin...

journal_title：Journal of pharmaceutical sciences

authors： Caraballo I,Fernandez-Arevalo M,Holgado MA,Vela MT,Rabasco AM

更新日期：1994-08-01 00:00:00

abstract：:Two new methods for the simultaneous determination of chloroquine and its two main metabolites (monodesethylchloroquine and bisdesethylchloroquine) in biological samples, radioimmunoassay (RIA) and enzyme-linked immunosorbent assay (ELISA), are described. Antiserum is produced in rabbits immunized with N-(2-carboxyeth...

journal_title：Journal of pharmaceutical sciences

authors： Escande C,Chevalier P,Verdier F,Bourdon R

更新日期：1990-01-01 00:00:00

abstract：:We extend and modify the Noyes-Whitney equation and the Hixon-Crowell cube root law to include surface roughness effects on the dissolution rate of drugs. The problem is treated theoretically in terms of the fractal reaction dimension, DR, of the effective surface which undergoes dissolution. Effects of changes in DR ...

journal_title：Journal of pharmaceutical sciences

authors： Farin D,Avnir D

更新日期：1992-01-01 00:00:00

abstract：:The long serum half-lives of mAbs are conferred by pH-dependent binding of IgG-Fc to the neonatal Fc receptor (FcRn). The Fc region of human IgG1 has three conserved methionine residues, Met252, Met358, and Met428. Recent studies showed oxidation of these Met residues impairs FcRn binding and consequently affects phar...

journal_title：Journal of pharmaceutical sciences

authors： Gao X,Ji JA,Veeravalli K,Wang YJ,Zhang T,Mcgreevy W,Zheng K,Kelley RF,Laird MW,Liu J,Cromwell M

更新日期：2015-02-01 00:00:00

abstract：:A stability-indicating high-performance liquid chromatographic assay has been used to investigate the stability of solutions of melphalan under conditions that pertain to setting up in vitro chemosensitivity assays. Melphalan (1 and 20 micrograms/mL) was found to be 30% more stable in 150 mM NaCl solution (normal sali...

journal_title：Journal of pharmaceutical sciences

authors： Bosanquet AG

更新日期：1985-03-01 00:00:00

abstract：:The interaction of L-tryptophan with alpha-cyclodextrin was investigated in a 0.1 M phosphate buffer at pH 7.4 with a LKB 2277 microcalorimeter, using flow mixed mode at 25 degrees C. The thermodynamic parameters for inclusion complex formation obtained are as follows; DeltaG(0) = - 7.03 kJ/mol (K = 17.0), DeltaH(0) =...

journal_title：Journal of pharmaceutical sciences

authors： Nishijo J,Tsuchitani M

更新日期：2001-02-01 00:00:00

abstract：:Nicotine is absorbed from the lungs into the systemic circulation during cigarette smoking. However, there is little information concerning the transport mechanism of nicotine in alveolar epithelial cells. In this study, we characterized the uptake of nicotine in rat primary cultured type II (TII) and transdifferentia...

journal_title：Journal of pharmaceutical sciences

authors： Takano M,Nagahiro M,Yumoto R

更新日期：2016-02-01 00:00:00

abstract：:The results of this study show that pentamidine isethionate (PI) can exist in at least four crystalline forms-three anhydrates designated as forms A, B, and C, and a trihydrate. Form C is the high-temperature modification, produced by heating forms A, B, and the trihydrate above 130 degrees C and cannot be produced un...

journal_title：Journal of pharmaceutical sciences

authors： Chongprasert S,Griesser UJ,Bottorff AT,Williams NA,Byrn SR,Nail SL

更新日期：1998-09-01 00:00:00

abstract：:Nonionic surfactants (caprylocaproyl macrogol-8 glycerides, octoxynol-12, polysorbate-20, and polyethylene glycol-40 hydrogenated castor oil) (47.03%, w/w), costabilizer (poloxamer 407) (12%-20%, w/w), oil (isopropyl myristate) (5.22%, w/w), water (q.s. ad 100%, w/w), and ibuprofen (5%, w/w) were used to develop oil-i...

journal_title：Journal of pharmaceutical sciences

authors： Djekic L,Martinovic M,Stepanović-Petrović R,Tomić M,Micov A,Primorac M

更新日期：2015-08-01 00:00:00

abstract：:Polymeric nanoparticles (NPs) are interesting drug carriers for dermal application and drug targeting to certain skin structures. NP interactions with diseased skin and the associated benefits and risks have been hardly explored. Today, we study the behavior of polymeric NPs for selective drug delivery to inflamed ski...

journal_title：Journal of pharmaceutical sciences

authors： Abdel-Mottaleb MM,Moulari B,Beduneau A,Pellequer Y,Lamprecht A

更新日期：2012-11-01 00:00:00

abstract：:The aminoxyl (nitroxyl) labeled (2-chloroethyl)nitrosocarbamoyl (CNC) derivatives of amino acids, i.e., N-[[N'-(2-chloroethyl)-N'-nitrosoamino]carbonyl]-A-(1-oxy-2,2,6,6- tetramethylpiperidin-4-yl)amides, A = glycyl (10a), A = L-alanyl (10b), A = L-valyl (10c), A = L-phenylalanyl (10d), were synthesized and evaluated ...

journal_title：Journal of pharmaceutical sciences

authors： Sosnovsky G,Baysal M,Erciyas E

更新日期：1994-07-01 00:00:00

abstract：:3-Fluoro-, 3-chloro-, and 3-bromocyclophosphamide were prepared from the reaction of trifluoromethylhypofluorite, sodium hypochlorite, and bromine with the anticancer drug cyclophosphamide. Treatment of cis- and trans-4-phenylcyclophosphamide and 5,6-benzocyclophosphamide with sodium hypochlorite afforded cis- and tra...

journal_title：Journal of pharmaceutical sciences

authors： Zon G,Ludeman SM,Ozkan G,Chandrasegaran S,Hammer CF,Dickerson R,Mizuta K,Egan W

更新日期：1983-06-01 00:00:00

abstract：:The goal was to evaluate the effects of acidity, expressed as the Hammett acidity function, on chemical reactivity in freeze-dried materials (lyophiles). Dextran-sucrose-citrate and polyvinyl pyrrolidone (PVP)-sucrose-citrate aqueous solutions, adjusted to pH values of 2.6, 2.8, and 3.0 were freeze dried, and characte...

journal_title：Journal of pharmaceutical sciences

authors： Chatterjee K,Shalaev EY,Suryanarayanan R,Govindarajan R

更新日期：2008-01-01 00:00:00

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

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

更新日期：2004-08-01 00:00:00

abstract：:Quantitative prediction of unbound drug fraction (fu) is essential for scaling pharmacokinetics through physiologically based approaches. However, few attempts have been made to evaluate the projection of fu values under pathological conditions. The primary objective of this study was to predict fu values (n = 105) of...

journal_title：Journal of pharmaceutical sciences

authors： Li GF,Yu G,Li Y,Zheng Y,Zheng QS,Derendorf H

更新日期：2018-07-01 00:00:00

abstract：:Solubilization of nonpolar drugs constitutes one of the most important tasks in parenteral formulations design. This study investigates and assesses the solubility enhancement of Fluasterone by various techniques including cosolvency, micellization, and complexation. Of the solubilizing agents used, the modified beta-...

journal_title：Journal of pharmaceutical sciences

authors： Zhao L,Li P,Yalkowsky SH

更新日期：1999-10-01 00:00:00

abstract：:A semi-automated protein binding assay using equilibrium dialysis (ED) and a novel mixed-matrix methodology has been developed. This method decreases mass spectrometer run time and reduces the likelihood of experimental artifacts. In this cassette-based approach, a single matrix is prepared following dialysis by mixin...

journal_title：Journal of pharmaceutical sciences

authors： Plise EG,Tran D,Salphati L

更新日期：2010-12-01 00:00:00

abstract：:This study describes a fast spectrophotometic titration method for apparent ionization constant (pKa) determination. In this method, a Universal pH indicator is utilized instead of the conventional pH electrode. An autoburette is set to add HCl at a constant rate to a vigorously stirred 1 cm UV cuvette which contains ...

journal_title：Journal of pharmaceutical sciences

authors： Kong X,Zhou T,Liu Z,Hider RC

更新日期：2007-10-01 00:00:00

abstract：:The ability to successfully formulate and manufacture therapeutic protein dosage forms requires a thorough understanding of their physico-chemical properties. Proteins are inherently dynamic molecules of marginal stability. These properties present unique challenges to the pharmaceutical scientist attempting to develo...

journal_title：Journal of pharmaceutical sciences

authors： Kamerzell TJ,Middaugh CR

更新日期：2008-09-01 00:00:00

abstract：:A multidisciplinary team approach to identify pharmaceutical impurities is presented in this article. It includes a representative example of the methodology. The first step is to analyze the sample by LC-MS. If the structure of the unknown impurity cannot be conclusively determined by LC-MS, LC-NMR is employed. If th...

journal_title：Journal of pharmaceutical sciences

authors： Alsante KM,Boutros P,Couturier MA,Friedmann RC,Harwood JW,Horan GJ,Jensen AJ,Liu Q,Lohr LL,Morris R,Raggon JW,Reid GL,Santafianos DP,Sharp TR,Tucker JL,Wilcox GE

更新日期：2004-09-01 00:00:00

abstract：:We have previously reported the development of novel nanocapsules made of polyarginine (PArg) specifically designed for the delivery of small anticancer drugs into cells. Our goal, in this work, has been to investigate the potential of these nanocarriers for oral delivery of peptide anticancer drugs. To reach this obj...

journal_title：Journal of pharmaceutical sciences

authors： Lollo G,Gonzalez-Paredes A,Garcia-Fuentes M,Calvo P,Torres D,Alonso MJ

更新日期：2017-02-01 00:00:00

abstract：:A pharmacokinetic model that permits prediction of aqueous humor pilocarpine levels following topical application to rabbit eyes was developed. The model is able to account for changes in both instilled solution volume and drug concentration. The model, although simplified, relies mainly on experimentally verifiable a...

journal_title：Journal of pharmaceutical sciences

authors： Himmelstein KJ,Guvenir I,Patton TF

更新日期：1978-05-01 00:00:00

abstract：:The synthesis of diazoketone analogs of amino acids and associated problems were investigated with N-phthaloyl-DL-alanine serving as a model. The carboxyl was activated by conversion to the acid chloride or, under mild conditions, to the mixed anhydride obtained with ethyl chloroformate or dicyclohexylcarbodiimide; th...

journal_title：Journal of pharmaceutical sciences

authors： Paul B,Korytnyk W

更新日期：1978-05-01 00:00:00

abstract：:Stent implantation following angioplasty is the standard treatment of coronary artery disease necessitating interventional procedures. The use of stents as a platform for local drug delivery is a popular strategy to achieve local pharmacological treatment to the diseased artery. Drug eluting stents (DES) are now large...

journal_title：Journal of pharmaceutical sciences

authors： Sharkawi T,Cornhill F,Lafont A,Sabaria P,Vert M

更新日期：2007-11-01 00:00:00