abstract：:Mechanical shock may cause cavitation in vials containing liquid formulations of therapeutic proteins and generate protein aggregates and other particulates. To test whether common formulation components such as protein molecules, air bubbles, or polysorbate 20 (PS20) micelles might nucleate cavitation, a high-speed v...

journal_title：Journal of pharmaceutical sciences

authors： Wu H,Chisholm CF,Puryear M,Movafaghi S,Smith SD,Pokhilchuk Y,Lengsfeld CS,Randolph TW

更新日期：2020-03-01 00:00:00

abstract：:Cephalosporins are among the most frequently used broad-spectrum antimicrobial agents. Ceftazidime is a semisynthetic β-lactam antibiotic for parenteral administration widely used in the clinical practice, which has been categorized as a third-generation cephalosporin antibiotic. This drug crystallizes as a pentahydra...

journal_title：Journal of pharmaceutical sciences

authors： Alves de Santana MS,Santiago de Oliveira Y,de Castro Fonseca J,Ferreira WC,Neto VS,Ayala AP

更新日期：2020-03-01 00:00:00

abstract：:In this work, a novel risk-based methodology for lot release is proposed. Its objective is to assess the risk that a lot declared to have passed truly meets product specifications. The methodology consists of 3 parts: adaptive sample size determination, estimation of the probability that the product was within specifi...

journal_title：Journal of pharmaceutical sciences

authors： Mockus L,Reklaitis G,Morris K,LeBlond D

更新日期：2020-02-01 00:00:00

abstract：:The crystallization tendency of 2 crystalline polymorphs of indomethacin (Iα, Iγ) in the undercooled melt has been investigated using molecular dynamics simulations. The main thermodynamical and dynamical physical parameters involved in the nucleation and growth processes have been determined. A careful attention has ...

journal_title：Journal of pharmaceutical sciences

authors： Gerges J,Affouard F

更新日期：2020-02-01 00:00:00

abstract：:Herein, curcumin amorphous solid dispersions (Cur ASDs) were prepared using binary polymers (Eudragit EPO with polyvinylpyrrolidone K30 [EuD-PVP], Eudragit EPO with hydroxypropyl methylcellulose E50 [EuD-HPMC]) as excipient, and surface tracking of Cur ASDs was mainly addressed. Infrared spectroscopy, in situ Raman im...

journal_title：Journal of pharmaceutical sciences

authors： Fan N,Lu T,Li J

更新日期：2020-02-01 00:00:00

abstract：:Specifically tailored amino acid-based formulations were previously shown to have a high potential to avoid stress-mediated degradation of complex molecules such as monoclonal antibodies and viral vectors. By using adenovirus 5 (Ad5) as a model, we studied whether such formulations may also efficiently protect viral v...

journal_title：Journal of pharmaceutical sciences

authors： Reinauer EB,Grosso SS,Henz SR,Rabas JA,Rodenstein C,Altrichter J,Scholz M,Kemter KF

更新日期：2020-01-01 00:00:00

abstract：:Pancreatic islet transplantation is a promising advanced therapy that has been used to treat patients suffering from diabetes type 1. Traditionally, pancreatic islets are infused via the portal vein, which is subsequently intended to engraft in the liver. Severe immunosuppressive treatments are necessary, however, to ...

journal_title：Journal of pharmaceutical sciences

authors： Scheiner KC,Coulter F,Maas-Bakker RF,Ghersi G,Nguyen TT,Steendam R,Duffy GP,Hennink WE,O'Cearbhaill ED,Kok RJ

更新日期：2020-01-01 00:00:00

abstract：:Inducing immune responses protecting from HIV infection or at least controlling replication poses a huge challenge to modern vaccinology. An increasingly discussed strategy to elicit a potent and broad neutralizing antibody response is the immobilization of HIV's trimeric envelope (Env) surface receptor on a nanoparti...

journal_title：Journal of pharmaceutical sciences

authors： Thalhauser S,Peterhoff D,Wagner R,Breunig M

更新日期：2020-01-01 00:00:00

abstract：:Alzheimer's disease (AD) is historically difficult to treat, in part because of the inaccessible nature of brain pathology. Amyloid beta and tau proteins drive pathology by forming toxic oligomers that eventually deposit as insoluble amyloid plaques and neurofibrillary tangles. Recent clinical studies suggest that eff...

journal_title：Journal of pharmaceutical sciences

authors： Vander Zanden CM,Chi EY

更新日期：2020-01-01 00:00:00

abstract：:In the present work, the effect of controlled nucleation on the stability of human growth hormone (hGH) during freeze-drying has been investigated. More specifically, the vacuum-induced surface freezing technique has been compared to conventional freezing, both with and without an annealing step. Size exclusion chroma...

journal_title：Journal of pharmaceutical sciences

authors： Oddone I,Arsiccio A,Duru C,Malik K,Ferguson J,Pisano R,Matejtschuk P

更新日期：2020-01-01 00:00:00

abstract：:Protein aggregates are a potential risk factor for immunogenicity. The measurement, characterization, and control of protein aggregates in drug products are indispensable for the development of biopharmaceuticals, including therapeutic mAbs. In this study, Fcγ receptor (FcγR)-expressing reporter cell lines were used t...

journal_title：Journal of pharmaceutical sciences

authors： Tada M,Aoyama M,Ishii-Watabe A

更新日期：2020-01-01 00:00:00

abstract：:Successful development of stable solid protein formulations usually requires the addition of one or several excipients to achieve optimal stability. In these products, there is a potential risk of an inhomogeneous distribution of the various ingredients, specifically the ratio of protein and stabilizer may vary. Such ...

journal_title：Journal of pharmaceutical sciences

authors： Nguyen KTT,Frijlink HW,Hinrichs WLJ

更新日期：2020-01-01 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

abstract：:Dynamic imaging analysis instruments are used for sizing particles of different types that might appear in a biopharmaceutical. These instruments are calibrated using polystyrene latex microspheres in water, which is a significantly different system than the typical particles imaged in a formulation. We show how the i...

journal_title：Journal of pharmaceutical sciences

authors： Cavicchi RE,Ripple DC,Bioprocess Measurements Group.

更新日期：2020-01-01 00:00:00

abstract：:Aggregation of therapeutic monoclonal antibodies has a potential risk of immunogenicity, requiring minimization of aggregate formation. We have developed a fitting formula for antibody aggregation at 40°C based on physicochemical parameters, including colloidal and conformational stabilities. An IgG1 monoclonal antibo...

journal_title：Journal of pharmaceutical sciences

authors： Oyama H,Koga H,Tadokoro T,Maenaka K,Shiota A,Yokoyama M,Noda M,Torisu T,Uchiyama S

更新日期：2020-01-01 00:00:00

abstract：:Sucrose is a common cryoprotectant and lyoprotectant to stabilize labile biopharmaceuticals during freeze-drying and storage. Sucrose-based formulations require low primary drying temperatures to avoid collapse and monoclonal antibody (mAb) containing products need to be stored refrigerated. The objective of this stud...

journal_title：Journal of pharmaceutical sciences

authors： Haeuser C,Goldbach P,Huwyler J,Friess W,Allmendinger A

更新日期：2020-01-01 00:00:00

abstract：:This review addresses a major question of importance to pharmaceutical scientists: how can novel drug delivery systems play a role in maximizing the UV protection of sunscreens? Because more and more people are being diagnosed with skin cancer each year than all other cancers combined, adequate sun protective measures...

journal_title：Journal of pharmaceutical sciences

authors： Damiani E,Puglia C

更新日期：2019-12-01 00:00:00

abstract：:Transcutaneous immunization is the administration of a vaccine on the skin to generate efficient systemic and mucosal immune responses against an antigen. In the present study, reconstituted hepatitis B surface antigen vesicles (HBsAg-REVs) integrated with monophosphoryl lipid A were prepared by the delipidation-recon...

journal_title：Journal of pharmaceutical sciences

authors： Kaurav M,Kumar R,Jain A,Pandey RS

更新日期：2019-11-01 00:00:00

abstract：:Anionic surfactants compromise skin's barrier function by damaging stratum corneum lipids and proteins. The objective of this study was to examine anionic surfactant-induced changes in the skin's polar and transcellular pathways and the resulting impact on surfactant penetration into the skin. Three anionic surfactant...

journal_title：Journal of pharmaceutical sciences

authors： Morris SAV,Ananthapadmanabhan KP,Kasting GB

更新日期：2019-11-01 00:00:00

abstract：:This work aimed at establishing a framework to screen and understand the product variability deeming from factors that affect the quality features of cream formulations. As per Quality by Design - based approach, cream quality target profile and critical quality attributes were identified, and a risk assessment analys...

journal_title：Journal of pharmaceutical sciences

authors： Simões A,Veiga F,Vitorino C

更新日期：2019-10-01 00:00:00

abstract：:The aims of this study were to evaluate the pharmacokinetics of doripenem (Finibax®, Doribax®, S-4661), a parenteral carbapenem antibiotic, in pediatric patients based on concentrations of doripenem in plasma after administration of 20 mg/kg 2 or 3 times daily and to evaluate the dosing regimens by using Monte-Carlo p...

journal_title：Journal of pharmaceutical sciences

authors： Matsuo Y,Ishibashi T,Matsumoto S,Katsube T,Wajima T

更新日期：2019-09-01 00:00:00

abstract：:Azo compounds are commonly used to study radical-mediated degradation of pharmaceutical compounds. The favorable chemical and physical properties of 2,2'-azobis(2-methylpropanenitrile) (AIBN) have made it one of the most widely used compound for these type of studies. This article describes the characterization of a s...

journal_title：Journal of pharmaceutical sciences

authors： Wells-Knecht KJ,Dunn D

更新日期：2019-09-01 00:00:00

abstract：:The cyclopropyl amine moiety in GSK2879552 (1) degrades hydrolytically in high pH conditions. This degradation pathway was observed during long-term stability studies and impacted the shelf life of the drug product. This article describes the work to identify the degradation impurities, elucidate the degradation mecha...

journal_title：Journal of pharmaceutical sciences

authors： Campbell JM,Lee M,Clawson J,Kennedy-Gabb S,Bethune S,Janiga A,Kindon L,Leach KP

更新日期：2019-09-01 00:00:00

abstract：:Phenytoin has been decreasingly used because of the high interindividual variability in drug concentration and the narrow therapeutic window. Despite such drawbacks, phenytoin is still essential as a second-line therapy for status epilepticus when patients are resistant to benzodiazepines. This study aimed to develop ...

journal_title：Journal of pharmaceutical sciences

authors： Guk J,Lee SG,Chae D,Kim JH,Park K

更新日期：2019-08-01 00:00:00

abstract：:This article shows how milling can be used to explore the phase diagram of pharmaceuticals. This process has been applied to sulindac. A short milling has been found to trigger a polymorphic transformation between form II and form I upon heating which is not seen in the nonmilled material. This possibility was clearly...

journal_title：Journal of pharmaceutical sciences

authors： Latreche M,Willart JF,Guerain M,Hédoux A,Danède F

更新日期：2019-08-01 00:00:00

abstract：:In this study, black phosphorus nanosheets (BPNSs) were incorporated into a hydrogel formed from dibenzaldehyde-functionalized polymer (DF-PEG) and polyaspartylhydrazide (PAHy) polymer to create an injectable and pH-sensitive DF-PEG-PAHy/BPNSs hydrogel, which can be used as a smart depot for synergistic chemo-photothe...

journal_title：Journal of pharmaceutical sciences

authors： Wu RS,Lin J,Xing YM,Dai ZL,Wang LW,Zhang XP

更新日期：2019-08-01 00:00:00

abstract：:Systemic administration of drugs is ineffective in the treatment of central nervous system disorders because of the blood-brain barrier. Nasal administration has been suggested as an alternative administration route as drugs absorbed in the olfactory epithelium bypass the blood-brain barrier and reach the brain within...

journal_title：Journal of pharmaceutical sciences

authors： Wu IY,Nikolaisen TE,Škalko-Basnet N,di Cagno MP

更新日期：2019-08-01 00:00:00

abstract：:Particulate matter present in drug products intended for parenteral administration to patients is typically monitored and controlled in the finished drug product to minimize potential risks to patients. In contrast to particulates found in drug products, the current study evaluated particulates representative of mater...

journal_title：Journal of pharmaceutical sciences

authors： Pollo M,Mehta A,Torres K,Thorne D,Zimmermann D,Kolhe P

更新日期：2019-07-01 00:00:00

abstract：:The solubility of butamben has been measured gravimetrically in pure methanol, 1-propanol, 2-propanol, 1-butanol, and toluene over the temperature range 268-298 K. Polymorph transition and melting temperatures, associated enthalpy changes, and the heat capacity of the solid forms and the supercooled melt have been mea...

journal_title：Journal of pharmaceutical sciences

authors： Svärd M,Zeng L,Valavi M,Krishna GR,Rasmuson ÅC

更新日期：2019-07-01 00:00:00

abstract：:One of the most important challenges for pharmaceutical and cosmetic industries is solubilization and preservation of their active ingredients. Therefore, most of these formulations contain irritant chemical additives to improve their shelf-life and the solubility of hydrophobic ingredients. An interesting alternative...

journal_title：Journal of pharmaceutical sciences

authors： Rodríguez-López L,Rincón-Fontán M,Vecino X,Cruz JM,Moldes AB

更新日期：2019-07-01 00:00:00

abstract：:Live attenuated influenza vaccine (LAIV) is considered one of the most effective vaccines and can be manufactured quickly and inexpensively to counter seasonal or pandemic influenza. Lyophilization is widely used in vaccine production. However, it requires a longer production cycle and large-scale equipment, thus posi...

journal_title：Journal of pharmaceutical sciences

authors： Sun Y,Shen Z,Zhang C,Yi Y,Zhu K,Xu F,Kong W

更新日期：2019-07-01 00:00:00

abstract：:A number of biopharmaceuticals are available as lyophilized formulations along with a prefilled syringe (PFS) containing water for injection (WFI). Submicron- and micron-size droplets of lubricating silicone oil (SO) applied to the inner surface of the PFS barrel might migrate into the WFI, to which protein pharmaceut...

journal_title：Journal of pharmaceutical sciences

authors： Krayukhina E,Yokoyama M,Hayashihara KK,Maruno T,Noda M,Watanabe H,Uchihashi T,Uchiyama S

更新日期：2019-07-01 00:00:00

abstract：:Product temperature (Tb) and drying time constitute critical material attributes and process parameters in the lyophilization process and especially during the primary drying stage. In the study, we performed a temperature measurement by the sublimation rate (TMbySR) to monitor the Tb value and determine the end point...

journal_title：Journal of pharmaceutical sciences

authors： Kawasaki H,Shimanouchi T,Sawada H,Hosomi H,Hamabe Y,Kimura Y

更新日期：2019-07-01 00:00:00

abstract：:In adult patients, nilotinib is indicated for chronic myeloid leukemia at an approved oral dose of 300 or 400 mg BID. Physiologically based pharmacokinetic (PBPK) model was developed to describe and supplement limited PK data in the pediatric population ranging from 2 to less than 6 years of age and ultimately inform ...

journal_title：Journal of pharmaceutical sciences

authors： Heimbach T,Lin W,Hourcade-Potelleret F,Tian X,Combes FP,Horvath N,He H

更新日期：2019-06-01 00:00:00

abstract：:Antibody therapeutics with poor solubility in the subcutaneous matrix may carry unintended risks when administered to patients. The objective of this work was to estimate the risk of antibodies that precipitate in vitro at neutral pH by determining the impact of poor solubility on distribution of the drug from the inj...

journal_title：Journal of pharmaceutical sciences

authors： Kinderman F,Yerby B,Jawa V,Joubert MK,Joh NH,Malella J,Herskovitz J,Xie J,Ferbas J,McBride HJ

更新日期：2019-06-01 00:00:00

abstract：:Spray freeze-drying is an evolving technology that combines the benefits of spray-drying and conventional lyophilization techniques to produce drug substance and drug product as free-flowing powders. The high surface-to-volume ratio associated to the submillimeter spray-frozen particles contributes to shorter drying a...

journal_title：Journal of pharmaceutical sciences

authors： Sebastião IB,Bhatnagar B,Tchessalov S,Ohtake S,Plitzko M,Luy B,Alexeenko A

更新日期：2019-06-01 00:00:00

abstract：:It was reported that wax matrix (WM) particles composed of low-melting-point microcrystalline wax showed unique release behaviors; the particles released only a small amount of the entrapped drug (non-diffusion-controlled release) at 37°C, whereas it showed comparatively fast drug release in a diffusion-controlled man...

journal_title：Journal of pharmaceutical sciences

authors： Matsumoto K,Kimura SI,Noguchi S,Itai S,Kondo H,Iwao Y

更新日期：2019-06-01 00:00:00

abstract：:Tryptophan (Trp) oxidation in proteins leads to a number of events, including changes in color, higher order structure (HOS), and biological activity. We describe here a number of new findings through a comprehensive characterization of 6 monoclonal antibodies (mAbs) following selective oxidation of Trp residues by 2,...

journal_title：Journal of pharmaceutical sciences

authors： Barnett GV,Balakrishnan G,Chennamsetty N,Hoffman L,Bongers J,Tao L,Huang Y,Slaney T,Das TK,Leone A,Kar SR

更新日期：2019-06-01 00:00:00

abstract：:In the transition of the pharmaceutical industry from batchwise to continuous drug product manufacturing, the drying process has proven challenging to control and understand. In a semicontinuous fluid bed dryer, part of the ConsiGma™ wet granulation line, the aforementioned production methods converge. Previous resear...

journal_title：Journal of pharmaceutical sciences

authors： Ghijs M,Schäfer E,Kumar A,Cappuyns P,Van Assche I,De Leersnyder F,Vanhoorne V,De Beer T,Nopens I

更新日期：2019-06-01 00:00:00

abstract：:Characterizing and quantifying subvisible particles in protein drug products is critical to ensuring product quality. A variety of analytical methods are used to detect and make meaningful measurements of subvisible particles. Resonant mass measurement (RMM) is a novel technology that characterizes the subvisible part...

journal_title：Journal of pharmaceutical sciences

authors： Krueger AB,Hadley J,Cheney PP,Markova N,Carpenter JF,Fradkin AH

更新日期：2019-05-01 00:00:00