Contribution of Intravenous Administration Components to Subvisible and Submicron Particles Present in Administered Drug Product.

abstract：:(-)-1-Cyclopropylmethyl-4-(3-trifluoromethylthio-5H-dibenzo [a,d]cyclohepten-5-ylidene)piperidine (MK-160) was extracted from human plasma and urine with petroleum ether and quantitated by GLC using a nitrogen-sensitive detector. A homologue of the drug served as the internal standard. The method is specific for the d...

journal_title：Journal of pharmaceutical sciences

authors： Hucker HB,Hutt JE

更新日期：1983-07-01 00:00:00

abstract：:A novel method is described for the preparation of sterile and pyrogen-free submicron liposomes of narrow size distribution. The method is based on the formation of a homogeneous dispersion of lipids in water-soluble carrier materials. To obtain the lipid-containing solid dispersion, liposome-forming lipids and water-...

journal_title：Journal of pharmaceutical sciences

authors： Li C,Deng Y

更新日期：2004-06-01 00:00:00

abstract：:Stability testing of morphine sulfate formulated with nonpareil sugar seeds (consisting of sucrose and starch) and fumaric acid revealed the formation of the three impurities 5-(hydroxymethyl)-2-furfural, 10-hydroxymorphine and 10-oxomorphine. 5-(Hydroxymethyl)-2-furfural was isolated via semipreparative HPLC utilizin...

journal_title：Journal of pharmaceutical sciences

authors： Kelly SS,Glynn PM,Madden SJ,Grayson DH

更新日期：2003-03-01 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：:Surface adsorption of two monoclonal antibodies (mAb1 and mAb2), with widely different hydrophobicity and self-association behavior in solution, was examined by quartz crystal microbalance with dissipation monitoring to understand how adsorption and protein self-interactions near the surface are impacted by their intr...

journal_title：Journal of pharmaceutical sciences

authors： Oom A,Poggi M,Wikström J,Sukumar M

更新日期：2012-02-01 00:00:00

abstract：:The aim of this study was to synthetize cocrystals of nateglinide, an antidiabetic agent of biopharmaceutics classification system Class IIa, as a strategy to improve both the solubility and the dissolution rate of the drug. Benzamide was selected by a screening procedure as a suitable coformer, and binary mixtures wi...

journal_title：Journal of pharmaceutical sciences

authors： Bruni G,Maggi L,Mustarelli P,Sakaj M,Friuli V,Ferrara C,Berbenni V,Girella A,Milanese C,Marini A

更新日期：2019-04-01 00:00:00

abstract：:Peptidomimetic drugs have favorable bioavailability owing to H(+)/peptide transporter 1 (PEPT1) located in the intestine. Sartans are commonly used and likely coadministered with peptidomimetic drugs in the clinic; however, in vivo interactions between sartans and peptidomimetic drugs have not been systemically unders...

journal_title：Journal of pharmaceutical sciences

authors： Huo X,Liu Q,Wang C,Meng Q,Sun H,Peng J,Ma X,Sun P,Liu K

更新日期：2014-02-01 00:00:00

abstract：:Two novel series of benzimidazole derivatives bearing structural modifications of certain drugs were prepared for evaluation for potential anticancer activity. The first series was a group of alkylating agents, and the second series was a variety of 4-substituted-1-thioacetyl-3-thiosemicarbazides. The tests of some re...

journal_title：Journal of pharmaceutical sciences

authors： Ibrahim ES,Omar AM,Khalil MA

更新日期：1980-11-01 00:00:00

abstract：:Hexamidine isethionate in various pharmaceutical formulations was analyzed quantitatively by high-performance liquid chromatography. The method is rapid, accurate, and precise. Excellent results were obtained from four commercial bases. ...

journal_title：Journal of pharmaceutical sciences

authors： Taylor P,Braddock PD,Ross S

更新日期：1983-12-01 00:00:00

abstract：:The aim of this work is to determine if a stability testing protocol based on the correlations between crystallization onset and relaxation time above the glass transition temperature (T(g)) can be used to predict the crystallization onsets in amorphous pharmaceutical systems well below their T(g). This procedure assu...

journal_title：Journal of pharmaceutical sciences

authors： Caron V,Bhugra C,Pikal MJ

更新日期：2010-09-01 00:00:00

abstract：:2 closely related prostaglandins (PGs), A2 and B2, were separated by ion-exchange liquid chromatography. PGA2 and PGB2 are an isomeric pair of PGs which show little resolution on thin-layer chromatography; the pair can be resolved as gas-liquid chromatography, but use of this method requires protection of the C9-carb...

journal_title：Journal of pharmaceutical sciences

authors： Morozowich W

更新日期：1974-05-01 00:00:00

abstract：:The concept of cosolvent exclusion was developed by a group of Timasheff's laboratory in 1970-1990 and is currently used widely to explain the effects of a variety of cosolvents on the stability and solubility of macromolecules. Not surprisingly, these concepts have had substantial influence in the fields of formulati...

journal_title：Journal of pharmaceutical sciences

authors： Arakawa T,Gagnon P

更新日期：2018-09-01 00:00:00

abstract：:There is a recognized need for new approaches to understand unit operations with pharmaceutical relevance. A method for analyzing complex interactions in experimental data is introduced. Higher-order interactions do exist between process parameters, which complicate the interpretation of experimental results. In this ...

journal_title：Journal of pharmaceutical sciences

authors： Naelapää K,Allesø M,Kristensen HG,Bro R,Rantanen J,Bertelsen P

更新日期：2009-05-01 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：:Results of studies carried out in rats for model compounds, D-(-) mandelic acid, benzoylformic acid, and some of their para-alkylated homologs, showed that their biological half-lives determined from the elimination phase of urinary excretion data were longer than those determined from the elimination phase of blood l...

journal_title：Journal of pharmaceutical sciences

authors： Amin YM,Nagwekar JB

更新日期：1976-09-01 00:00:00

abstract：:The objective of the present study was to investigate the iontophoretic transport behavior across multiple membranes of different barrier properties. Spectra/Por(R) (SP) and Ionac membranes were the synthetic membranes and sclera was the biomembrane in this model study. The barrier properties of SP membranes were dete...

journal_title：Journal of pharmaceutical sciences

authors： Molokhia SA,Zhang Y,Higuchi WI,Li SK

更新日期：2008-01-01 00:00:00

abstract：:The majority of gene therapy clinical trials use plasmid DNA that is susceptible to shear-induced degradation. Many processing steps in the extraction, purification, and preparation of plasmid-based therapeutics can impart significant shear stress that can fracture the phosphodiester backbone of polynucleotides, and r...

journal_title：Journal of pharmaceutical sciences

authors： Lengsfeld CS,Anchordoquy TJ

更新日期：2002-07-01 00:00:00

abstract：:After having been used in treating HIV infection for a decade, zidovudine (AZT) continues to be an essential component of antiretroviral regimens. Because antiviral responses and toxicity of AZT seem to be related to cells in specific target tissues, being able to understand and predict the distribution of AZT into di...

journal_title：Journal of pharmaceutical sciences

authors： Chow HH

更新日期：1997-11-01 00:00:00

abstract：:To elucidate drug lipophilicity effects on the bioavailability (BA) of drugs from skin after administration by dissolving microneedles, nine compounds with different lipophilicity indexes (log p value) were formulated into two-layered dissolving microneedles and administered percutaneously to rat skin: desmopressin (D...

journal_title：Journal of pharmaceutical sciences

authors： Ito Y,Yoshimura M,Tanaka T,Takada K

更新日期：2012-03-01 00:00:00

abstract：:Treatment of systemic diseases by means of the inhalation route is hampered by uncertainties of the drug dose applied by inhalation. In this study, the hypothesis was tested that by standardization of the breathing maneuver used for inhalation, the interindividual variability of the dose deposited intrathoracically ca...

journal_title：Journal of pharmaceutical sciences

authors： Brand P,Friemel I,Meyer T,Schulz H,Heyder J,Häubetainger K

更新日期：2000-06-01 00:00:00

abstract：:Sustained-release formulations such as hydroxypropyl methylcellulose (HPMC)-based hydrophilic matrix tablets of poorly water-soluble drugs often result in incomplete release because of the poor solubility and dissolution rate of the drug in the hydrophilic matrix. Sulfobutylether-beta-cyclodextrins ((SBE)(7M)-beta-CDs...

journal_title：Journal of pharmaceutical sciences

authors： Rao VM,Haslam JL,Stella VJ

更新日期：2001-07-01 00:00:00

abstract：:The objective of this study was to investigate product performance of freeze dried l-arginine/sucrose-based formulations under variation of excipient weight ratios, l-arginine counter ions and formulation pH as a matrix to stabilize a therapeutic monoclonal antibody (MAb) during freeze drying and shelf life. Protein a...

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：2015-07-01 00:00:00

abstract：:The purpose of this study was to elucidate the effect of heat treatment on the miscibility of multiple concentrated solutes that mimic biopharmaceutical formulations in frozen solutions. The first heating thermal analysis of frozen solutions containing either a low-molecular-weight saccharide (e.g., sucrose, trehalose...

journal_title：Journal of pharmaceutical sciences

authors： Izutsu K,Yomota C,Kawanishi T

更新日期：2011-12-01 00:00:00

abstract：:Two high-performance liquid chromatographic (HPLC) assay procedures were developed for the determination of salicylamide and its metabolites in serum, urine, and saliva. One method involves reverse-phase ion-pair chromatography and UV detection, and is used to determine salicylamide, salicylamide glucuronide, and sali...

journal_title：Journal of pharmaceutical sciences

authors： Morris ME,Levy G

更新日期：1983-06-01 00:00:00

abstract：:The affinity chromatographic technique was used to study the interaction of bovine serum albumin and salicylic acid at 3.3 +/- 1.1 degrees. Beaded agarose gel, on which the albumin was immobilized by covalent linkage, was packed in a column as an affinity adsorbent. Frontal analysis was performed on this column to eva...

journal_title：Journal of pharmaceutical sciences

authors： Nakano NI,Oshio T,Fujimoto Y,Amiya T

更新日期：1978-07-01 00:00:00

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

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

更新日期：1981-04-01 00:00:00

abstract：:Melphalan (30 microgram/ml) is completely hydrolyzed in water at 37 degrees after 8 hr. At lower temperatures, hydrolysis proceeds at slower rates. The presence of bovine serum albumin retards hydrolysis of melphalan (30 microgram/ml) in water. The melphalan hydrolysis rate is directely releated to the bovine serum al...

journal_title：Journal of pharmaceutical sciences

authors： Chang SY,Alberts DS,Farquhar D,Melnick LR,Walson PD,Salmon SE

更新日期：1978-05-01 00:00:00

abstract：:Resveratrol trimethyl ether (trans-3,5,4'-trimethoxystilbene, RTE) is a naturally occurring and pharmacologically active resveratrol derivative. To evaluate its suitability as a drug candidate, a pharmacokinetic study was carried out in Sprague-Dawley rats with the emphasis to identify the impact of aqueous solubility...

journal_title：Journal of pharmaceutical sciences

authors： Lin HS,Ho PC

更新日期：2011-10-01 00:00:00

abstract：:The health effects of green tea are associated with catechins: (-)-epigallocatechin-3-O-gallate (EGCG), (-)-epigallocatechin, (-)-epicatechin-3-O-gallate, and (-)-epicatechin. An understanding of compound absorption, distribution, metabolism, excretion, and toxicity characteristics is essential for explaining its biol...

journal_title：Journal of pharmaceutical sciences

authors： Matić S,Jadrijević-Mladar Takač M,Barbarić M,Lučić B,Gall Trošelj K,Stepanić V

更新日期：2018-11-01 00:00:00

abstract：:Although many biotech products are successfully stored in the frozen state, there are cases of degradation of biologicals during freeze storage. These examples are discussed in the Perspective to emphasize the fact that stability of frozen biologicals should not be taken for granted. Frozen-state degradation (predomin...

journal_title：Journal of pharmaceutical sciences

authors： Authelin JR,Rodrigues MA,Tchessalov S,Singh SK,McCoy T,Wang S,Shalaev E

更新日期：2020-01-01 00:00:00