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https://www.readbyqxmd.com/read/28213278/identifying-overarching-excipient-properties-towards-an-in-depth-understanding-of-process-and-product-performance-for-continuous-twin-screw-wet-granulation
#1
N Willecke, A Szepes, M Wunderlich, J P Remon, C Vervaet, T De Beer
The overall objective of this work is to understand how excipient characteristics influence the process and product performance for a continuous twin-screw wet granulation process. The knowledge gained through this study is intended to be used for a Quality by Design (QbD)-based formulation design approach and formulation optimization. A total of 9 preferred fillers and 9 preferred binders were selected for this study. The selected fillers and binders were extensively characterized regarding their physico-chemical and solid state properties using 21 material characterization techniques...
February 14, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28212319/a-validated-stability-indicating-hplc-method-for-simultaneous-determination-of-amoxicillin-and-enrofloxacin-combination-in-an-injectable-suspension
#2
Nidal Batrawi, Shorouq Wahdan, Fuad Al-Rimawi
The combination of amoxicillin and enrofloxacin is a well-known mixture of veterinary drugs; it is used for the treatment of Gram-positive and Gram-negative bacteria. In the scientific literature, there is no high-performance liquid chromatography (HPLC)-UV method for the simultaneous determination of this combination. The objective of this work is to develop and validate an HPLC method for the determination of this combination. In this regard, a new, simple and efficient reversed-phase HPLC method for simultaneous qualitative and quantitative determination of amoxicillin and enrofloxacin, in an injectable preparation with a mixture of inactive excipients, has been developed and validated...
February 16, 2017: Scientia Pharmaceutica
https://www.readbyqxmd.com/read/28212300/amorphous-amorphous-phase-separation-in-api-polymer-formulations
#3
Christian Luebbert, Fabian Huxoll, Gabriele Sadowski
The long-term stability of pharmaceutical formulations of poorly-soluble drugs in polymers determines their bioavailability and therapeutic applicability. However, these formulations do not only often tend to crystallize during storage, but also tend to undergo unwanted amorphous-amorphous phase separations (APS). Whereas the crystallization behavior of APIs in polymers has been measured and modeled during the last years, the APS phenomenon is still poorly understood. In this study, the crystallization behavior, APS, and glass-transition temperatures formulations of ibuprofen and felodipine in polymeric PLGA excipients exhibiting different ratios of lactic acid and glycolic acid monomers in the PLGA chain were investigated by means of hot-stage microscopy and DSC...
February 15, 2017: Molecules: a Journal of Synthetic Chemistry and Natural Product Chemistry
https://www.readbyqxmd.com/read/28205401/computer-aided-drug-design-to-explore-cyclodextrin-therapeutics-and-biomedical-applications
#4
Azizeh Abdolmaleki, Fatemeh Ghasemi, Jahan B Ghasemi
Cyclodextrin (CD) is a subset of the macrocyclic structural class, which is an important class of small organic agents that are useful functional excipients. They have wide range application possibilities in different fields of sciences such as material preparation, medicine, analytical chemistry, and separation processes. They are used widely in pharmaceutical formulations and drug delivery for increasing the water solubility of low soluble drugs and drug candidates. Due to the ring structure, they behave differently than smaller molecules and may be capable of hitting new classes of targets...
February 2017: Chemical Biology & Drug Design
https://www.readbyqxmd.com/read/28198632/engineering-oral-and-parenteral-amorphous-amphotericin-b-formulations-against-experimental-trypanosoma-cruzi-infections
#5
Miriam Rolón, Dolores R Serrano, Aikaterini Lalatsa, Esther de Pablo, Juan Jose Torrado, Maria Paloma Ballesteros, Anne Marie Healy, Celeste Vega, Cathia Coronel, Francisco Bolas-Fernández, Maria Auxiliadora Dea-Ayuela
Chagas disease (CD) is a parasitic zoonosis endemic in most mainland countries of Central and South America affecting nearly 10 million people, with 100 million people at high risk of contracting the disease. Treatment is only effective if received at the early stages of the disease. Only two drugs (benznidazole and nifurtimox) have so far been marketed and both share various limitations such as variable efficacy, many side effects and long duration of treatment, thus reducing compliance. The in vitro and in vivo efficacy of poly-aggregated amphotericin B (AmB), encapsulated poly-aggregated AmB in albumin microspheres (AmB-AME) and dimeric AmB - sodium deoxycholate micelles (AmB-NaDC) was evaluated...
February 15, 2017: Molecular Pharmaceutics
https://www.readbyqxmd.com/read/28196344/identification-characterization-and-in-silico-admet-prediction-of-roflumilast-degradation-products
#6
Mariana S Pinheiro, Gil M Viana, Bárbara de A Abrahim Vieira, Alessandra Mendonça Teles de Souza, Carlos Rangel Rodrigues, Rita de Cássia E E Marins, Lúcio M Cabral, Valéria P de Sousa
The present study reports the degradation behavior of roflumilast (RFL), a new drug developed for the treatment of chronic obstructive pulmonary disease. The degradation of RFL was tested under various stress conditions as per the guidelines of the International Conference on Harmonization. The degradation products (DPs) of RFL were identified, characterized and in silico predictions were made of their pharmacokinetic properties, absorption, distribution, metabolism, excretion and toxicity (ADMET). RFL was subjected to various stress conditions including photodegradation, alkaline and acidic hydrolysis, oxidative and metallic degradation...
February 6, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28194635/using-the-slug-mucosal-irritation-assay-to-investigate-the-tolerability-of-tablet-excipients-on-human-skin-in-the-context-of-the-use-of-a-nipple-shield-delivery-system
#7
Richard Kendall, Joke Lenoir, Stephen Gerrard, Rebekah L Scheuerle, Nigel K H Slater, Catherine Tuleu
PURPOSE: Neonates are particularly challenging to treat. A novel patented drug delivery device containing a rapidly disintegrating tablet held within a modified nipple shield (NSDS) was designed to deliver medication to infants during breastfeeding. However concerns exist around dermatological nipple tolerability with no pharmaceutical safety assessment guidance to study local tissue tolerance of the nipple and the areola. This is the first Slug Mucosal Irritation (SMI) study to evaluate irritancy potential of GRAS excipients commonly used to manufacture rapidly disintegrating immediate release solid oral dosage form METHODS: Zinc sulphate selected as the antidiarrheal model drug that reduces infant mortality, was blended with functional excipients at traditional levels [microcrystalline cellulose, sodium starch glycolate, croscarmellose sodium, magnesium stearate]...
February 13, 2017: Pharmaceutical Research
https://www.readbyqxmd.com/read/28188353/direct-and-model-free-detection-of-carbohydrate-excipients-in-traditional-chinese-medicine-formula-granules-by-atr-ftir-microspectroscopic-imaging
#8
Jianbo Chen, Suqin Sun, Qun Zhou
A formula granule is a traditional Chinese medicine preparation made from the decoction of a single herbal medicinal. Because of the flexibility for combination and the convenience for utilization, formula granules are becoming popular in clinical applications. However, the efficacy and safety of commercial formula granules often suffer from the improper addition of carbohydrate excipients. Therefore, the detection of carbohydrate excipients is indispensable for the quality control of formula granules. FTIR spectroscopy has been used for the detection of carbohydrate excipients in formula granules...
February 10, 2017: Analytical and Bioanalytical Chemistry
https://www.readbyqxmd.com/read/28186947/survey-of-community-pharmacists-perception-of-electronic-cigarettes-in-london
#9
Ana C N Marques Gomes, Shereen Nabhani-Gebara, Reem Kayyali, Federico Buonocore, Gianpiero Calabrese
OBJECTIVES: To seek community pharmacists' perception on use, safety and possible effectiveness of e-cigarettes as quit smoking tools, and their future regulation. SETTING: A survey of a sample of 154 community pharmacies across London, UK. CONTEXT: E-cigarettes have exclusively established themselves in the market through consumers-led demand. To date, e-cigarettes still remain unregulated and can be easily purchased in shops, over the internet, but more controversially also in pharmacies in the UK...
November 10, 2016: BMJ Open
https://www.readbyqxmd.com/read/28185962/design-and-evaluation-of-antibiotic-releasing-self-assembled-scaffolds-at-room-temperature-using-biodegradable-polymer-particles
#10
Prasad Admane, Jatin Gupta, Ancy Ij, Robin Kumar, Amulya K Panda
Biodegradable polymer based drug eluting implants offer many advantages such as predictable drug release kinetics, safety, and acceptable drug loading under ambient conditions. Herein, we describe fabrication and evaluation of antibiotic loaded scaffolds for localized delivery and tissue engineering applications. PDLLA particles entrapping gentamycin were formulated using solvent evaporation method and used for scaffold fabrication. Optimization of formulation parameters such as pH of the internal aqueous phase and combination of excipients like glycerol, polyvinyl alcohol (PVA) resulted in high entrapment efficiencies up to 96% of gentamicin in particles with drug load of 16-18μg/mg of polymer particles...
February 6, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28185958/characterisation-of-aggregates-of-cyclodextrin-drug-complexes-using-taylor-dispersion-analysis
#11
Hadar Zaman, Andrew G Bright, Kevin Adams, David M Goodall, Robert T Forbes
There is a need to understand the nature of aggregation of cyclodextrins (CDs) with guest molecules in increasingly complex formulation systems. To this end an innovative application of Taylor dispersion analysis (TDA) and comparison with dynamic light scattering (DLS) have been carried out to probe the nature of ICT01-2588 (ICT-2588), a novel tumor-targeted vascular disrupting agent, in solvents including a potential buffered formulation containing 10% hydroxypropyl-β-cyclodextrin. The two hydrodynamic sizing techniques give measurement responses are that fundamentally different for aggregated solutions containing the target molecule, and the benefits of using TDA in conjunction with DLS are that systems are characterised through measurement of both mass- and z-average hydrodynamic radii...
February 6, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28185930/fabrication-of-letrozole-formulation-using-chitosan-nanoparticles-through-ionic-gelation-method
#12
Thandapani Gomathi, P N Sudha, J Annie Kamala Florence, Jayachandran Venkatesan, Sukumaran Anil
In this study, the anticancer drug letrozole (LTZ) was formulated using chitosan nanoparticles (CS-NPs) with the crosslinking agent sodium tripolyphosphate (TPP). The nano-formulation was optimized by varying the concentration of drug. The prepared particles were characterized using FTIR, TGA, XRD, SEM, TEM and DLS. From the FTIR results, the appearance of a new peak for CH, CC and CN confirms the formation of LTZ loaded chitosan nanoparticles. TEM images shows that the average particle size was in the range of 60-80nm and 20-40mm air dried and freeze dried samples respectively...
February 7, 2017: International Journal of Biological Macromolecules
https://www.readbyqxmd.com/read/28181622/a-framework-for-multi-scale-simulation-of-crystal-growth-in-the-presence-of-polymers
#13
Taraknath Mandal, Wenjun Huang, Jodi M Mecca, Ashley Getchell, William W Porter, Ronald G Larson
We present a multi-scale simulation method for modeling crystal growth in the presence of polymer excipients. The method includes a coarse-grained (CG) model for small molecules of known crystal structure whose force field is obtained using structural properties from atomistic simulations. This CG model is capable of stabilizing the molecular crystal structure and capturing the crystal growth from the melt for a wide range of small organic molecules, as demonstrated by application of our method to the molecules isoniazid, urea, sulfamethoxazole, prilocaine, oxcarbazepine, and phenytoin...
February 9, 2017: Soft Matter
https://www.readbyqxmd.com/read/28179133/dissolution-and-dissolution-permeation-experiments-for-predicting-systemic-exposure-following-oral-administration-of-the-bcs-class-ii-drug-clarithromycin
#14
Forner Kristin, Holm René, Morakul Boontida, Junyaprasert Varaporn Buraphacheep, Ackermann Maximilian, Mazur Johanna, Langguth Peter
In order to save time and resources in early drug development, in vitro methods that correctly predict the formulation effect on oral drug absorption are necessary. The aim of this study was to 1) evaluate various BCS class II drug formulations with in vitro methods and in vivo in order to 2) determine which in vitro method best correlates with the in vivo results. Clarithromycin served as model compound in formulations with different particle sizes and content of excipients. The performed in vitro experiments were dissolution and dissolution/permeation experiments across two types of membrane, Caco-2 cells and excised rat intestinal sheets...
February 4, 2017: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28176838/n-n-dimethylacetamide-a-drug-excipient-that-acts-as-bromodomain-ligand-for-osteoporosis-treatment
#15
Chafik Ghayor, Bebeka Gjoksi, Jing Dong, Barbara Siegenthaler, Amedeo Caflisch, Franz E Weber
N,N-Dimethylacetamide (DMA) is a water-miscible solvent, FDA approved as excipient and therefore widely used as drug-delivery vehicle. As such, DMA should be devoid of any bioactivity. Here we report that DMA is epigenetically active since it binds bromodomains and inhibits osteoclastogenesis and inflammation. Moreover, DMA enhances bone regeneration in vivo. Therefore, our in vivo and in vitro data reveal DMA's potential as an anti-osteoporotic agent via the inhibition of osteoclast mediated bone resorption and enhanced bone regeneration...
February 8, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28171787/high-throughput-nir-chemometric-methods-for-chemical-and-pharmaceutical-characterization-of-sustained-release-tablets
#16
Alina Porfire, Cristina Filip, Ioan Tomuta
The aim of this study was the development and validation of methods based on near-infrared spectroscopy (NIRS) and chemometry, useful for characterization of sustained release (SR) tablets with indapamide, in terms of tablet composition (API and two excipients), in vitro drug release mechanism (k and n Peppas) and crushing strength. A calibration set consisting of 25 different tablets formulations containing API, HPMC and lactose at five different content levels in the range 100±20% relative to a targeted tablet composition, were manufactured by direct compression in order to develop the methods for prediction of tablet composition, and in vitro drug release mechanism...
January 19, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28165821/successful-delivery-of-docetaxel-to-rat-brain-using-experimentally-developed-nanoliposome-a-treatment-strategy-for-brain-tumor
#17
Tapan Kumar Shaw, Dipika Mandal, Goutam Dey, Murari Mohan Pal, Paramita Paul, Samrat Chakraborty, Kazi Asraf Ali, Biswajit Mukherjee, Amal Kumar Bandyopadhyay, Mahitosh Mandal
Docetaxel (DTX) is found to be very effective against glioma cell in vitro. However, in vivo passage of DTX through BBB is extremely difficult due to the physicochemical and pharmacological characteristics of the drug. No existing formulation is successful in this aspect. Hence, in this study, effort was made to send DTX through blood-brain barrier (BBB) to brain to treat diseases such as solid tumor of brain (glioma) by developing DTX-loaded nanoliposomes. Primarily drug-excipients interaction was evaluated by FTIR spectroscopy...
November 2017: Drug Delivery
https://www.readbyqxmd.com/read/28165180/faster-acting-insulin-aspart-provides-faster-onset-and-greater-early-exposure-vs-insulin-aspart-in-children-and-adolescents-with-type-1-diabetes-mellitus
#18
Maryam Fath, Thomas Danne, Torben Biester, Lars Erichsen, Olga Kordonouri, Hanne Haahr
BACKGROUND: Faster-acting insulin aspart (faster aspart) is insulin aspart (IAsp) in a new formulation with additional excipients (L-arginine and niacinamide). In adults, faster aspart provides faster onset and greater early exposure and action vs IAsp. AIM: This randomized, double-blind, 2-period crossover trial investigated the pharmacological properties of faster aspart vs IAsp in 12 children (6-11 years), 13 adolescents (12-17 years), and 15 adults (18-64 years) with type 1 diabetes mellitus...
February 6, 2017: Pediatric Diabetes
https://www.readbyqxmd.com/read/28163226/humidity-induced-phase-transformation-of-poloxamer-188-and-its-effect-on-physical-stability-of-amorphous-solid-dispersion-of-amg-579-a-ped10a-inhibitor
#19
Qiong Wu, Michael T Kennedy, Karthik Nagapudi, Y-H Kiang
Poloxamer 188, a commonly used emulsifying and solubilizing agent, was found to be the cause of crystallization of an investigational drug, AMG 579, from its amorphous solid dispersion at accelerated storage conditions. Investigation of this physical stability issue included thorough characterization of poloxamer 188 at non-ambient conditions. At 40°C, poloxamer 188 becomes deliquescent above relative humidity of 75%. Upon returning to ambient conditions, the deliquescent poloxamer 188 loses water and re-solidifies...
February 2, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28163222/salt-disproportionation-a-material-science-perspective
#20
REVIEW
Naveen K Thakral, Ron C Kelly
While screening the counter-ions for salt selection for an active pharmaceutical substance, there is often an uncertainty about disproportionation of the salt and hence physical stability of the final product formulation to provide adequate shelf life. Several examples of disproportionation reactions are reviewed to explain the concepts of pHmax, microenvironmental pH, and buffering capacity of excipients and APIs to gain mechanistic understanding of disproportionation reaction. Miscellaneous factors responsible for disproportionation are examined...
February 2, 2017: International Journal of Pharmaceutics
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