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Journal of Pharmaceutical Sciences

Joe Nguyen, Hayley Lewis, Ashley Queja, Anh Ngoc Diep, Guillaume Hochart, Mahmoud Ameri
Adhesive Dermally-Applied Microarray (ADAM) is a new drug delivery system that uses microprojections (340 μm long) for intracutaneous drug self-administration. We formulated zolmitriptan, a well-accepted and commonly used migraine medication, for administration using ADAM. In vivo studies were conducted in female prepubescent Yorkshire pigs using ADAM 1.9 mg zolmitriptan, applied to the inner thigh and left in place for 1 hour. Pharmacokinetic studies showed that the ADAM 1.9 mg zolmitriptan delivered with high efficiency (85%) and high absolute bioavailability (77%)...
May 14, 2018: Journal of Pharmaceutical Sciences
Chester E Markwalter, Robert K Prud'homme
Flash NanoPrecipitation (FNP) is a scalable approach to generate polymeric nanoparticles using rapid micromixing in specially-designed geometries such as a confined impinging jets (CIJ) mixer or a Multi-Inlet Vortex Mixer (MIVM). A major limitation of formulation screening using the MIVM is that a single run requires tens of milligrams of the therapeutic. To overcome this, we have developed a scaled-down version of the MIVM, requiring as little as 0.2 mg of therapeutic, for formulation screening. The redesigned mixer can then be attached to pumps for scale-up of the identified formulation...
May 14, 2018: Journal of Pharmaceutical Sciences
Yangjie Wei, Prashant Kumar, Newton Wahome, Nicholas J Mantis, C Russell Middaugh
Lumazine synthase (LS) is a family of enzyme involved in the penultimate step in the biosynthesis of riboflavin. Its enzymatic mechanism has been well defined and many LS structures have been solved using x-ray crystallography or cryo-electron microscopy. LS is composed of homo-oligomers, which vary in size and subunit number, including pentamers, decamers, and icosahedral sixty-mers, depending on its species of origin. Research on LS has expanded beyond the initial focus on its enzymatic function to properties related to its oligomeric structure and exceptional conformational stability...
May 12, 2018: Journal of Pharmaceutical Sciences
Nizar Al-Zoubi, Faten Odah, Wasfy Obeidat, Ahmad Al-Jaberi, Ioannis Partheniadis, Ioannis Nikolakakis
Solid dispersions of spironolactone with Soluplus® and PVP were prepared by spray drying according to a mixture experimental design and evaluated for moisture content, particle size, drug solubility, crystallinity (PXRD and DSC) and physicochemical interactions (FTIR, Raman). In vitro dissolution was evaluated for the spray dried product itself and after compression into tablets and prediction models were derived using multiple linear regression analysis. The spray dried products consisted of amorphous drug, indicated by the absence of crystalline PXRD peaks...
May 9, 2018: Journal of Pharmaceutical Sciences
Sayantan Chattoraj, Patrick Daugherity, Todd McDermott, Angela Olsofsky, Wyatt J Roth, Mike Tobyn
Sticking and picking during tablet manufacture has received increasing interest recently, as it causes tablet defects, downtime in manufacturing and yield losses. The capricious nature of the problem means that it can appear at any stage of the development cycle, even when it has been deemed as low risk by models, tests and previous experience. In many cases, the problem manifests when transferring the process from one manufacturing site to another. Site transfers are more common than in previous times due to the multinational nature of drug product manufacture and the need for redundancy in manufacturing networks...
May 8, 2018: Journal of Pharmaceutical Sciences
Apurva S More, Ronald T Toth, Solomon Z Okbazghi, C Russell Middaugh, Sangeeta B Joshi, Thomas J Tolbert, David B Volkin, David D Weis
We have utilized hydrogen exchange-mass spectrometry (HX-MS) to characterize local backbone flexibility of four well-defined IgG1-Fc glycoforms expressed and purified from Pichia pastoris, two of which were prepared using subsequent in vitro enzymatic treatments. Progressively decreasing the size of the N-linked N297 oligosaccharide from high mannose (Man8-Man12), to Man5, to GlcNAc, to non-glycosylated N297Q resulted in progressive increases in backbone flexibility. Comparison of these results with recently published physicochemical stability and Fcγ receptor binding data with the same set of glycoproteins provide improved insights into correlations between glycan structure and these pharmaceutical properties...
May 8, 2018: Journal of Pharmaceutical Sciences
Daqian Gao, Xinqin Zhou, ZhenHua Gao, Xincui Shi, Zongliang Wang, Yu Wang, Peibiao Zhang
In this study, we prepared a series of silver sulfadiazine (AgSD) loaded polyvinyl alcohol (PVA) hydrogels via electron beam (e-beam) irradiation. Our objective was to explore the influence of e-beam irradiation on the chemical structure and crystallinity of AgSD and the antibacterial properties of AgSD/PVA hydrogels. Prior to irradiation, we mixed AgSD in PVA solution in two forms, either suspended in water (WS) or dissolved in ammonia solution (AS). We noted that nano silver was released from AgSD/PVA-AS hydrogels immersed in deionized water, while it would not happen in AgSD/PVA-WS hydrogels...
May 8, 2018: Journal of Pharmaceutical Sciences
Jiali Chen, Yuqi Chen, Wencong Huang, Hanning Wang, Yang Du, Subin Xiong
The objectives of this study were to explore sodium dodecyl sulfate (SDS) and Soluplus on the crystallization inhibition and dissolution of felodipine (FLDP) extrudates by bottom-up and top-down approaches. FLDP extrudates with Soluplus and/or SDS were prepared by hot melt extrusion (HME), and characterized by PLM, DSC and FT-IR. Results indicated that Soluplus inhibited FLDP crystallization and the whole amorphous solid dispersions (ASDs) were binary FLDP-Soluplus (1:3) and ternary FLDP-Soluplus-SDS(1:2:0...
May 5, 2018: Journal of Pharmaceutical Sciences
Erik Van Kampen, Craig Vandervelden, Amir Fakhari, Jian Qian, Cory Berkland, Stevin H Gehrke
A hollow cylinder intravitreal implant was developed to achieve sustained release of protein to the retina for the treatment of retinal diseases. Hollow cylinders were fabricated by molding and crosslinking hyaluronic acid (HA), the major component of the vitreous humor. Hollow cylinders were filled with a concentrated protein solution and the properties of the cylinder walls were tested. Crosslinked HA hydrogels with swelling degrees as low as 2.7 were achieved as a means to extend the release of protein. Hollow cylinders were capable of releasing an antigen-binding fragment (Fab) for over 4 months at a maximum release rate of 4 micrograms a day...
May 3, 2018: Journal of Pharmaceutical Sciences
Kamilia Kemel, Sana Tfaili, Ali Tfayli, Arlette Baillet-Guffroy, Vincent Faivre, Cécile Laugel
The present work deals with original bi-compartmental lipid Janus nanoparticles (JNP) which are characterized by the presence of an oily compartment associated with an aqueous compartment delimited by a phospholipid-based bilayer. The size of JNP varies between 150 and 300 nm. As JNP are promising candidates for cutaneous application, the purpose of this study was to implement reliable infrared descriptors over time of JNP, in order to follow the physical stability of JNP in open air and over time. Therefore, a comparative study with the nanoemulsion (NE) and the physical mixture (PM) formulations was conducted by attenuated total reflection by Fourier transform infrared spectroscopy (ATR-FTIR)...
April 30, 2018: Journal of Pharmaceutical Sciences
Ashwinkumar Bhirde, Meng-Jung Chiang, Ramesh Venna, Serge Beaucage, Kurt Brorson
Stability of therapeutic proteins (TPs) is a critical quality attribute that impacts both safety and efficacy of the drug. Size stability is routinely performed during and after biomanufacturing. Dynamic light scattering is a commonly used technique to characterize hydrodynamic (HD) size of the TPs. Herein we have developed a novel method to evaluate in-use and thermal stress stability of TPs using algorithm-driven high throughput dynamic light scattering (HTS-DLS). Five marketed TPs were tested under the guidance of customized algorithms...
April 28, 2018: Journal of Pharmaceutical Sciences
Matteo Puccetti, Stefano Giovagnoli, Teresa Zelante, Luigina Romani, Maurizio Ricci
Considering the recent evidences on the therapeutic potential of post-biotics, this study was focused on two mains goals: i) to develop an enteric microparticle (MP) formulation for intestinal localized delivery of Indole-3-aldehyde (3-IAld) (a microbial-derived metabolite produced by the host's lactobacilli during the catabolic pathway of tryptophan); ii) to provide support to the employment of spray-drying as innovative one-step manufacturing technique for enteric products. For this purpose, special attention was taken in the knowledge of the influence of equipment setup and feedstock properties on MP enteric behaviour...
April 28, 2018: Journal of Pharmaceutical Sciences
Yichao Yu, Hardik Chandasana, Taran Sangari, Christoph Seubert, Hartmut Derendorf
Concentrations in the interstitial tissue space are of clinical interest for many antibiotics and can be directly measured by microdialysis. Quantitative microdialysis strongly depends on reliable recovery estimates obtained from a suitable calibrator. Cefazolin is frequently used as a prophylactic antibiotic to prevent surgical site infections. This study aimed to develop a reliable and rapid calibration technique for cefazolin microdialysis using cefuroxime as a calibrator, which is applied simultaneously in the opposite direction via retrodialysis...
April 28, 2018: Journal of Pharmaceutical Sciences
Marieke E Klijn, Jürgen Hubbuch
Protein phase diagrams are a tool to investigate cause and consequence of solution conditions on protein phase behavior. The effects are scored according to aggregation morphologies such as crystals or amorphous precipitates. Solution conditions affect morphological features, such as crystal size, as well as kinetic features, such as crystal growth time. Common used data visualization techniques include individual line graphs or symbols-based phase diagrams. These techniques have limitations in terms of handling large datasets, comprehensiveness or completeness...
April 27, 2018: Journal of Pharmaceutical Sciences
H Frederick Frasch, Larry Lee, Ana M Barbero
The current study has two aims. First the method of spectral reflectance was used to measure evaporation rates of thin (∼25-300 μm) films of neat liquid volatile organic chemicals exposed to a well-regulated wind speed u. Gas phase evaporation mass transfer coefficient (kevap ) measurements of 10 chemicals, 9 of which were measured at similar u, are predicted (slope of log-log data = 1.01; intercept = 0.08; R2 = 0.996) by a previously proposed mass transfer correlation. For one chemical, isoamyl alcohol, the dependence of kevap on u0...
April 27, 2018: Journal of Pharmaceutical Sciences
Wei Qi, Scott Orgel, Alain Francon, Theodore W Randolph, John F Carpenter
Stable formulations of inactivated polio vaccine (IPV) could reduce cold chain requirements and increase distribution of the vaccine to developing countries. Recently significant improvement in thermal stability of IPV vaccines has been achieved by including urea in lyophilized formulations. In the current study, we investigated the effects of urea on recovery of potency of IPV after lyophilization and storage at 37 o C and the correlation of potency recovery with key biophysical properties of IPV. By dynamic light scattering and transmission light microscopy we found that loss of potency appeared to be due to agglomeration of virus particles during lyophilization and that moderate concentrations (e...
April 27, 2018: Journal of Pharmaceutical Sciences
Claudia Kunz, Henning Gieseler
The goal of the present study was to assess the applicability of dynamic vapor sorption (DVS) analysis of freeze dried products. Water vapor sorption profiles of intact and ground cakes were recorded to determine the relevance of powder handling. Grinding prior to measurements appeared to be related with a more rapid uptake of water vapor and crystallization. Crystallization may be prevented when analyzing intact cakes. More hygroscopic materials appeared to require a longer time to achieve a constant mass...
April 23, 2018: Journal of Pharmaceutical Sciences
Tania F Bahamondez-Canas, Silvia Ferrati, Daniel F Moraga-Espinoza, Hugh D C Smyth
Pseudomonas aeruginosa is an opportunistic bacteria responsible for recurrent lung infections. Previously, we demonstrated that certain materials improved the activity of tobramycin (Tob) against P. aeruginosa biofilms in vitro. We aimed to develop prototype dry powder formulations comprising Tob and a mixture of excipients and test its aerodynamic properties and antimicrobial activity. First, we evaluated different combinations of excipients with Tob in solution against P. aeruginosa biofilms. We selected the compositions with the highest activity, to prepare dry powders by spray drying...
April 23, 2018: Journal of Pharmaceutical Sciences
Akash Patil, Prit Lakhani, Pranjal Taskar, Kai-Wei Wu, Corinne Sweeney, Bharathi Avula, Yan-Hong Wang, Ikhlas A Khan, Soumyajit Majumdar
Current study aimed at formulating and optimizing natamycin (NT) loaded PEGylated NLCs (NT-PEG-NLCs) using Box-Behnken Design and investigating their potential in ocular applications. Response surface methodology (RSM) computations and plots for optimization were performed using Design Expert® software, to obtain optimum values for response variables based on the criteria of desirability. Optimized NT-PEG-NLCs had predicted values for the dependent variables not significantly different from the experimental values...
April 23, 2018: Journal of Pharmaceutical Sciences
Mohammad Chaheen, Noelia M Sanchez-Ballester, Bernard Bataille, Ahmad Yassine, Emmanuel Belamie, Tahmer Sharkawi
Due to the increasing interest in multifunctional excipients for tableting, coprocessing of individual excipients is regularly used to produce excipients of improved multifunctionality superior to that of individual excipients or their physical mix. The use of chitin as an excipient in tablet formulation is limited due to certain drawbacks such as poor flowability and low true density. The objective of this work is to improve these properties through coprocessing of chitin with calcium carbonate (CaCO3 ) by precipitating CaCO3 on chitin particles using different methods...
April 23, 2018: Journal of Pharmaceutical Sciences
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