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AAPS PharmSciTech

Ellen Hackl, Joseph Darkwah, Geoff Smith, Irina Ermolina
L-arginine was introduced into protein-based freeze-dried formulations to study the ability of arginine to reduce/prevent from protein aggregation during manufacturing, storage and reconstitution of lyophilized protein-based pharmaceuticals. As L-arginine is known to be very hygroscopic, additional excipients which could provide a moisture buffering capacity need to be introduced into the formulation. In the first part of our study-excipient formulation development-the screening of a number of sugars/polyols has been done in order to select the best combination of excipients that, in a complex with L-arginine, can (i) produce freeze-dried cakes with elegant appearance, adequate mechanical properties and reconstitution times, and (ii) resist/minimise the moisture sorption...
October 18, 2017: AAPS PharmSciTech
Sumit Sharma, Vivek Ranjan Sinha
Present study aims at solubilizing slightly water-soluble peptide into a nanosize emulsion which is filled into a hard gelatin capsule in the form of preconcentrate. Further, liquid-filled capsule was dip-coated with ethyl cellulose and Eudragit S100 for colon targeting. An in vitro release profile was studied for selected formulations, i.e., Formulation A (5 mg ethyl cellulose and 40 mg Eudragit S100), Formulation B (10 mg ethyl cellulose and 30 mg Eudragit S100), and Formulation C (10 mg ethyl cellulose and 20 mg Eudragit S100)...
October 17, 2017: AAPS PharmSciTech
A L Camilletti, F O Ruíz, L M Pascual, I L Barberis
In the majority of Latin-American countries, including Argentina, there is a limited availability of vaginal bioproducts containing probiotics in the market. In addition, the conventional treatments of genital tract infections in women represent a high cost to the public health systems. The future development of this type of bioproducts that employ specific lactobacilli strains would not only have a meaningful impact on women's health but would also represent a significant challenge to the pharmaceutical industry...
October 17, 2017: AAPS PharmSciTech
Yonni E Apeji, Avosuahi R Oyi, Adamu B Isah, Teryila S Allagh, Sameer R Modi, Arvind K Bansal
The development of novel excipients with enhanced functionality has been explored using particle engineering by co-processing. The aim of this study was to improve the functionality of tapioca starch (TS) for direct compression by co-processing with gelatin (GEL) and colloidal silicon dioxide (CSD) in optimized proportions. Design of Experiment (DoE) was employed to optimize the composition of the co-processed excipient using the desirability function and other supporting studies as a basis for selecting the optimized formulation...
October 16, 2017: AAPS PharmSciTech
Liu Tian, Jingjing Liu, Qingwen Jia, Yong Ying, Zhenlei Yang, Guihua Huang
The aim of the study was to design liposomes (Lips) of artemether (ARM), a plant-derived drug for treatment of metastatic tumors, for the intravenous delivery. The ARM-Lips were prepared using ethanol injection method. Based on the optimization of formulation with single-factor experiments, ARM-Lips were spherical with a uniform particle size (187.3 ± 1.83) nm and its EE and DL were (94.49 ± 1.18)% and (10.94 ± 0.10)%, respectively. The in vitro drug release characteristics of ARM-Lips possessed a sustained release characteristic, and their behavior was in accordance with the first-order kinetics equation...
October 16, 2017: AAPS PharmSciTech
Qian Li, Jiaojiao Cao, Zhengguang Li, Xiaoqin Chu
In situ gels containing sinomenine hydrochloride (SMH) for intra-articular (IA) administration to treat rheumatoid arthritis (RA) were designed and investigated in this study. Glycerol monooleate (GMO) was used due to the potential to generate viscous crystalline phase structures upon water absorption. The gels were evaluated using different parameters: syringeability, gelation, viscosity, and drug release. And, polarized light microscopy (PLM), small-angle X-ray scattering investigation (SAXS), and rheological studies were used to analyze their internal structures...
October 12, 2017: AAPS PharmSciTech
Mark Cilia, Sol Ruiz, Peter Richardson, Tomas Salmonson, Anthony Serracino-Inglott, Francesca Wirth, John Joseph Borg
The aim of this study was to identify trends in deficiencies raised during the EU evaluation of the quality part of dossiers for marketing authorisation applications of biosimilar medicinal products. All adopted day 120 list of questions on the quality module of 22 marketing authorisation applications for biosimilars submitted to the European Medicines Agency and concluded by the end of October 2015 was analysed. Frequencies of common deficiencies identified were calculated and summarised descriptions included...
October 12, 2017: AAPS PharmSciTech
Amber Doty, Jon Schroeder, Kou Vang, Mark Sommerville, Mervin Taylor, Brad Flynn, David Lechuga-Ballesteros, Peter Mack
To ensure consistency of clinical outcomes, orally inhaled therapies must exhibit consistent delivered dose and aerosol properties at the time of manufacturing, throughout storage, and during various patient-use conditions. Achieving consistency across these scenarios has presented a significant challenge, especially for combination products that contain more than one drug. This study characterized the delivered dose and aerosol properties of glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI; Bevespi Aerosphere™)...
October 10, 2017: AAPS PharmSciTech
Carin Ru Shan Siow, Paul Wan Sia Heng, Lai Wah Chan
The compaction of multiple-unit pellet system (MUPS) is a challenging process due to the ease of coat damage under high compression pressure, thereby altering drug release rates. To overcome this, cushioning excipients are added to the tablet formulation. Excipients can be processed into pellets/granules and freeze-dried to increase their porosity and cushioning performance. However, successful formation of pellets/granules has specific requirements that limit formulation flexibility. In this study, a novel top-down approach that harnessed bulk freeze-drying milling was explored to avoid the challenges of pelletization/granulation...
October 10, 2017: AAPS PharmSciTech
Xinlong Wang, Yuheng Liang, Siyang Fei, Haibing He, Yu Zhang, Tian Yin, Xing Tang
Gemcitabine-loaded core-shell nanoparticles (CSNPs), comprised of a cross-linked HSA-core and PLGA-shell, were prepared through a modified double emulsification method, and the processing parameters were systematically investigated. The optimized CSNPs had a particle size of 241 ± 36.2 nm and an encapsulation efficiency of 41.52%. The core-shell structure was characterized by optical microscope (OM), scanning electron microscopy (SEM), and transmission electron microscopy (TEM). The amorphous nature of the encapsulated drug was confirmed by differential scanning calorimetry (DSC) and X-ray diffraction (XRD)...
October 10, 2017: AAPS PharmSciTech
Huy Dao, Prit Lakhani, Anitha Police, Venkataraman Kallakunta, Sankar Srinivas Ajjarapu, Kai-Wei Wu, Pranav Ponkshe, Michael A Repka, S Narasimha Murthy
This review gives a brief overview about microbial contamination in pharmaceutical products. We discuss the distribution and potential sources of microorganisms in different areas, ranging from manufacturing sites, pharmacy stores, hospitals, to the post-market phase. We also discuss the factors that affect microbial contamination in popular dosage forms (e.g., tablets, sterile products, cosmetics). When these products are contaminated, the microorganisms can cause changes. The effects range from mild changes (e...
October 10, 2017: AAPS PharmSciTech
Shallu Kutlehria, Gautam Behl, Ketan Patel, Ravi Doddapaneni, Imran Vhora, Nusrat Chowdhury, Arvind Bagde, Mandip Singh
Triple-negative breast cancer (TNBC) is the leading cancer in women. Chemotherapeutic agents used for TNBC are mainly associated with dose-dependent toxicities and development of resistance. Hence, novel strategies to overcome resistance and to offer dose reduction are warranted. In this study, we designed a novel dual-functioning agent, conjugate of cholecalciferol with PEG2000 (PEGCCF) which can self-assemble into micelles to encapsulate doxorubicin (DOX) and act as a chemosensitizer to improve the therapeutic potential of DOX...
October 10, 2017: AAPS PharmSciTech
Lizhen Cheng, Siqi Gao, Defang Ouyang, Haiying Wang, Yongfei Wang, Weisan Pan, Xinggang Yang
The objective of this study was to develop an authentic ionic-driven osmotic pump system and investigate the release mechanism, simultaneously exploring the in vitro and in vivo correlation of the ionic-driven osmotic pump tablet. A comparison of the ionic-driven and conventional theophylline osmotic pump, the influence of pH and the amount of sodium chloride on drug release, the relationship between the ionic osmotic pressure and the drug release, and the pharmacokinetics experiment in beagle dogs were investigated...
October 10, 2017: AAPS PharmSciTech
Tao Liu, Guili Yao, Xue Zhang, Ximin Zuo, Lihong Wang, Haipeng Yin, Jan P Möschwitzer
Three different methods, i.e., high-pressure homogenization, wet bead milling, and a combination approach of freeze-drying and high-pressure homogenization, were used to produce meloxicam nanosuspensions, respectively. Wet bead milling led to the nanosuspensions with smallest particle size (88 nm) after 4 h and optimal dissolution performances. Freeze-dried meloxicam powder could highly improve the size reduction efficiency compared to the unmodified drug and particle size of the freeze-dried sample could be reduced to 342 nm after only one homogenization cycle at 1000 bar...
October 10, 2017: AAPS PharmSciTech
Giovana Maria Fioramonti Calixto, Francesca Damiani Victorelli, Lívia Nordi Dovigo, Marlus Chorilli
The buccal mucosa is accessible, shows rapid repair, has an excellent blood supply, and shows the absence of the first-pass effect, which makes it a very attractive drug delivery route. However, this route has limitations, mainly due to the continuous secretion of saliva (0.5 to 2 L/day), which may lead to dilution, possible ingestion, and unintentional removal of the active drug. Nanotechnology-based drug delivery systems, such as liquid crystalline systems (LCSs), can increase drug permeation through the mucosa and thereby improve drug delivery...
October 10, 2017: AAPS PharmSciTech
Haipeng Wang, Huiyun Wang, Wenlong Yang, Mengjie Yu, Shuilin Sun, Baogang Xie
Minimal information is available on the oral bioavailability and liver-targeting properties of sorafenib solid lipid nanoparticles (SRF-SLNs) in rats. In this study, SRF-SLNs were prepared via the combined methods of high-speed shearing and ultrasonic treatment. SRF-SLN formulations were also optimized. Particle size, zeta potential, entrapment efficiency (EE), and drug loading (DL) were used as indices for the evaluation of the as-prepared SRF-SLNs. SRF concentration was determined by the high-performance liquid chromatography method...
October 5, 2017: AAPS PharmSciTech
Vamshi Krishna Tippavajhala, Thiago de Oliveira Mendes, Airton Abrahão Martin
This research work mainly deals with the application of confocal Raman spectroscopic technique to study in vivo human skin penetration of sunscreen products, as there are a lot of controversies associated with their skin penetration. Healthy human volunteers were tested for penetration of two commercial sunscreen products into their volar forearm skin for a period of 2 h. Measurements were taken before and after application of these sunscreen products. All the confocal Raman spectra were pre-processed and then subjected to multivariate two-dimensional principal component analysis and classical least squares analysis to determine the skin penetration of these sunscreens in comparison to the "sunscreen product spectrum" which was considered as the control...
October 5, 2017: AAPS PharmSciTech
Panagiotis Barmpalexis, Agni Grypioti, Georgios K Eleftheriadis, Dimitris G Fatouros
In the present study, liquisolid formulations were developed for improving dissolution profile of aprepitant (APT) in a solid dosage form. Experimental studies were complemented with artificial neural networks and genetic programming. Specifically, the type and concentration of liquid vehicle was evaluated through saturation-solubility studies, while the effect of the amount of viscosity increasing agent (HPMC), the type of wetting (Soluplus® vs. PVP) and solubilizing (Poloxamer®407 vs. Kolliphor®ELP) agents, and the ratio of solid coating (microcrystalline cellulose) to carrier (colloidal silicon dioxide) were evaluated based on in vitro drug release studies...
October 4, 2017: AAPS PharmSciTech
Patcharawalai Jaisamut, Kamonthip Wiwattanawongsa, Potchanapond Graidist, Yaowaporn Sangsen, Ruedeekorn Wiwattanapatapee
A supersaturatable self-microemulsifying drug delivery system (S-SMEDDS) with a reduced amount of surfactant and incorporation of a polymer precipitation inhibitor, Eudragit® E PO was developed. The optimized S-SMEDDS formulation (SS-15) consisted of 55% surfactants, 40% oils, and 5% Eudragit® E PO (curcumin at 44.4 mg/g of the formulation). The precipitation profiles from the supersaturation assay revealed that the curcumin S-SMEDDS performed as a better inhibitor of curcumin precipitation in simulated gastric fluid over a 240-min study than the normal curcumin SMEDDS and an aqueous curcumin suspension...
October 3, 2017: AAPS PharmSciTech
M Naiserová, K Kubová, J Vysloužil, S Pavloková, D Vetchý, M Urbanová, J Brus, J Vysloužil, P Kulich
Burst drug release is often considered a negative phenomenon resulting in unexpected toxicity or tissue irritation. Optimal release of a highly soluble active pharmaceutical ingredient (API) from hypromellose (HPMC) matrices is technologically impossible; therefore, a combination of polymers is required for burst effect reduction. Promising variant could be seen in combination of HPMC and insoluble Eudragits(®) as water dispersions. These can be applied only on API/insoluble filler mixture as over-wetting prevention...
October 2, 2017: AAPS PharmSciTech
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