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https://www.readbyqxmd.com/read/28924630/role-of-in-vitro-release-methods-in-liposomal-formulation-development-challenges-and-regulatory-perspective
#1
Deepak Solomon, Nilesh Gupta, Nihal S Mulla, Snehal Shukla, Yadir A Guerrero, Vivek Gupta
In the past few years, measurement of drug release from pharmaceutical dosage forms has been a focus of extensive research because the release profile obtained in vitro can give an indication of the drug's performance in vivo. Currently, there are no compendial in vitro release methods designed for liposomes owing to a range of experimental challenges, which has created a major hurdle for both development and regulatory acceptance of liposome-based drug products. In this paper, we review the current techniques that are most often used to assess in vitro drug release from liposomal products; these include the membrane diffusion techniques (dialysis, reverse dialysis, fractional dialysis, and microdialysis), the sample-and-separate approach, the in situ method, the continuous flow, and the modified United States Pharmacopeia methods (USP I and USP IV)...
September 18, 2017: AAPS Journal
https://www.readbyqxmd.com/read/28919911/comprehensibility-of-selected-usp-pictograms-by-illiterate-and-literate-farsi-speakers-the-first-experience-in-iran-part-i
#2
Amir H Zargarzadeh, Sahar Ahamdi
BACKGROUND: Good understanding of medication instructions is paramount to a good pharmaceutical care. The aim of our study was to examine the understandability of the selected three most applicable pictograms by participants and their recall after educational mini sessions. MATERIALS AND METHODS: First, nine experienced pharmacists selected the three most potentially applicable pictograms. Pictograms A to C were determined, respectively, "A-take medication with food," "B-medication may cause drowsiness," and "C-take medication before sleep...
2017: Journal of Research in Medical Sciences: the Official Journal of Isfahan University of Medical Sciences
https://www.readbyqxmd.com/read/28913839/long-term-stability-of-a-compounded-suspension-of-torsemide-5-mg-ml-for-oral-administration
#3
D Adin, P R Johnson, C H Kim, T Nguyenba, S Rosen
BACKGROUND: Torsemide use for congestive heart failure (CHF) has been reported, but prescription frequency is unknown. Commercially available tablet sizes in North America limit dosing precision, indicating a need to evaluate its strength and stability in suspension. OBJECTIVES: To determine the frequency of torsemide prescriptions and to determine a beyond use date (BUD) of a compounded suspension of torsemide for oral administration stored under 2 temperature conditions for 90 days...
September 15, 2017: Journal of Veterinary Internal Medicine
https://www.readbyqxmd.com/read/28911658/identification-of-an-exposure-risk-to-heavy-metals-from-pharmaceutical-grade-rubber-stoppers
#4
Xianghui Li, Pingping Qian
Exposure to low concentrations of heavy metals and metalloids represents a well-documented risk to animal and human health. However, current standards (European Pharmacopeia [EP], United States Pharmacopoeia [USP], International Organization for Standardization [ISO], YBB concerned with rubber closures) only require testing for Zn in pharmaceutical-grade rubber stoppers and then using only pure water as a solvent. We extracted and quantified heavy metals and trace elements from pharmaceutical-grade rubber stoppers under conditions that might occur during the preparation of drugs...
July 2017: Journal of Food and Drug Analysis
https://www.readbyqxmd.com/read/28888419/clinical-skills-and-professionalism-assessing-orthopaedic-residents-with-unannounced-standardized-patients
#5
David P Taormina, Joseph D Zuckerman, Raj Karia, Sondra Zabar, Kenneth A Egol, Donna P Phillips
OBJECTIVE: We developed a series of orthopedic unannounced standardized patient (USP) encounters for the purpose of objective assessment of residents during clinic encounters. DESIGN: Consecutive case-series. SETTING: NYU-Langone Multi-center Academic University Hospital System. PARTICIPANTS: NYU-Langone/Hospital for Joint Diseases Orthopedic Surgery residents; 48 consecutive residents assessed. METHODS: Four orthopedic cases were developed...
September 6, 2017: Journal of Surgical Education
https://www.readbyqxmd.com/read/28885603/functional-characterization-of-selected-universal-stress-protein-from-salvia-miltiorrhiza-smusp-in-escherichia-coli
#6
Xiao-Fan Wang, Jiao Su, Na Yang, Hui Zhang, Xiao-Yan Cao, Jie-Fang Kang
The multigene universal stress protein (USP) family is evolutionarily conserved. Members play indispensable roles in plant tolerance to abiotic stresses. Although relatively well-characterized in model plants, such as Arabidopsis thaliana and Oryzasativa, this family has not been investigated in Salvia miltiorrhiza, an important herbal plant for which yields can be limited by various abiotic stresses. Here, we identified 32 USP family members in the S. miltiorrhiza genome, and used phylogenetic analysis to sort these SmUSPs into four groups...
September 8, 2017: Genes
https://www.readbyqxmd.com/read/28881612/the-b-box-module-of-cyld-is-responsible-for-its-intermolecular-interaction-and-cytoplasmic-localization
#7
Songbo Xie, Miao Chen, Siqi Gao, Tao Zhong, Peng Zhou, Dengwen Li, Jun Zhou, Jinmin Gao, Min Liu
The tumor suppressor protein cylindromatosis (CYLD), as a microtubule-associated deubiquitinase, plays a pivotal role in a wide range of cellular activities, including innate immunity, cell division, and ciliogenesis. Structural characterization reveals a small zinc-binding B-box inserted within the ubiquitin specific protease (USP) domain of CYLD; however, the exact role for this module remains yet to be elucidated. Here we identify a critical role for the B-box in facilitating the intermolecular interaction and subcellular localization of CYLD...
August 1, 2017: Oncotarget
https://www.readbyqxmd.com/read/28851456/formulation-of-an-aloe-based-product-according-to-iranian-traditional-medicine-and-development-of-its-analysis-method
#8
Elham Moein, Homa Hajimehdipoor, Tayebeh Toliyat, Rasool Choopani, Maryam Hamzeloo-Moghadam
BACKGROUND: Currently, people are more interested to traditional medicine. The traditional formulations should be converted to modern drug delivery systems to be more acceptable for the patients. In the present investigation, a poly herbal medicine "Ayarij-e-Faiqra" (AF) based on Iranian traditional medicine (ITM) has been formulated and its quality control parameters have been developed. METHODS: The main ingredients of AF including barks of Cinnamomum zeylanicum Blume and Cinnamomum cassia J...
August 29, 2017: Daru: Journal of Faculty of Pharmacy, Tehran University of Medical Sciences
https://www.readbyqxmd.com/read/28845100/determination-of-the-enantiomeric-purity-of-epinephrine-by-hplc-with-circular-dichroism-detection
#9
Douglas Kirkpatrick, Jingyue Yang, Michael Trehy
Several hundred drug substances approved by the U.S. Food and Drug Administration are chiral molecules. For the enantiomeric purity assessment, current practice is to develop separation techniques using chiral columns or mobile phase modifiers to separate enantiomers before detection. An alternative approach is to use currently accepted HPLC assay methods and use chiral-specific detectors to confirm whether the correct enantiomer is present. In this paper, adding a circular dichroism (CD) detector to an achiral HPLC method from the US Pharmacopeia (USP) is shown to be amenable for the determination of the enantiomeric purity of epinephrine, a substance used to treat anaphylaxis...
2017: Journal of Liquid Chromatography & related Technologies
https://www.readbyqxmd.com/read/28834824/comparison-of-central-corneal-thickness-measurements-using-ultrasonic-pachymetry-anterior-segment-oct-and-noncontact-specular-microscopy
#10
Riccardo Scotto, Alessandro Bagnis, Marina Papadia, Carlo Alberto Cutolo, Domenico Risso, Carlo Enrico Traverso
PURPOSE: To evaluate and compare central corneal thickness (CCT) values measured with anterior segment optical coherence tomography (AS-OCT), noncontact specular microscopy (NCSM), and ultrasound pachymetry (USP). MATERIALS AND METHODS: CCT was measured in 182 healthy eyes without ocular abnormalities other than refractive errors. Three consecutive measurements of CCT by the same examiner were obtained during the same session. The testing sequence of AS-OCT and NCSM was randomly selected...
August 30, 2017: Journal of Glaucoma
https://www.readbyqxmd.com/read/28834434/biorelevant-dissolution-models-for-a-weak-base-to-facilitate-formulation-development-and-overcome-reduced-bioavailability-caused-by-hypochlordyria-or-achlorhydria
#11
Dawen Kou, Sudharsan Dwaraknath, Yannick Fischer, Daniel Nguyen, Myeonghui Kim, Hiuwing Yiu, Preeti Patel, Tania Ng, Chen Mao, Matthew Durk, Leslie Chinn, Helen Winter, Larry Wigman, Peter Yehl
In this study, two dissolution models were developed to achieve in vitro-in vivo relationship for immediate release formulations of Compound-A, a poorly soluble weak base with pH-dependent solubility and low bioavailability in hypochlorhydric and achlorhydric patients. The dissolution models were designed to approximate the hypo-/achlorhydric and normal fasted stomach conditions after ingesting a glass of water with the drug. The dissolution data from the two models were predictive of the relative in vivo bioavailability of various formulations under the same gastric condition, hypo-/achlorhydric or normal...
August 23, 2017: Molecular Pharmaceutics
https://www.readbyqxmd.com/read/28825546/a-validated-capillary-electrophoretic-method-for-the-determination-of-olopatadine-and-its-application-to-a-pharmaceutical-preparation-of-eye-drops
#12
Tufan Güray, Tugba Turan, Muzaffer Tunçel, Ulku Dilek Uysal
A validated rapid and sensitive capillary zone electrophoretic method for the determination of olopatadine hydrochloride (OLO) is described. Optimum conditions were found: 20 mmol/L sodium tetraborate buffer, acetonitrile 15% (v/v), 10 mmol/L NaCl at pH 9.5, with 25 kV of applied potential, injection time of 10 s at 5 × 103 N/m2, at a wavelength of 205 nm, and fixed temperature of 30°C. The calibration curve was linear in the range of 1.13 × 10-5 mol/L (4.22 μg/mL) to 5.65 × 10-5 mol/L (21.12 μg/mL), with R = 0...
January 1, 2017: Journal of AOAC International
https://www.readbyqxmd.com/read/28808837/a-multiparticulate-delivery-system-for-potential-colonic-targeting-using-bovine-serum-albumin-as-a-model-protein
#13
Bowen Jiang, Hua Yu, Yongrong Zhang, Hanping Feng, Stephen W Hoag
PURPOSE: There are many important diseases whose treatment could be improved by delivering a therapeutic protein to the colon, for example, Clostridium difficile infection, ulcerative colitis and Crohn's Disease. The goal of this project was to investigate the feasibility of colonic delivery of proteins using multiparticulate beads. METHODS: In this work, bovine serum albumin (BSA) was adopted as a model protein. BSA was spray layered onto beads, followed by coating of an enteric polymer EUDRAGIT® FS 30 D to develop a colonic delivery system...
August 14, 2017: Pharmaceutical Research
https://www.readbyqxmd.com/read/28795201/downstream-processing-technologies-capturing-and-final-purification-opportunities-for-innovation-change-and-improvement-a-review-of-downstream-processing-developments-in-protein-purification
#14
Nripen Singh, Sibylle Herzer
Increased pressure on upstream processes to maximize productivity has been crowned with great success, although at the cost of shifting the bottleneck to purification. As drivers were economical, focus is on now on debottlenecking downstream processes as the main drivers of high manufacturing cost. Devising a holistically efficient and economical process remains a key challenge. Traditional and emerging protein purification strategies with particular emphasis on methodologies implemented for the production of recombinant proteins of biopharmaceutical importance are reviewed...
August 10, 2017: Advances in Biochemical Engineering/biotechnology
https://www.readbyqxmd.com/read/28793042/a-prospective-randomized-study-of-the-inflammatory-responses-to-multiport-and-singleport-laparoscopic-hysterectomies
#15
Renata Assef Tormena, Sérgio Conti Ribeiro, José Maria Soares, Gustavo Arantes Rosa Maciel, Edmund Chada Baracat
Purpose: To evaluate the inflammatory responses induced by laparoscopic hysterectomies with multiport and singleport approaches. Methods: This was a pilot prospective randomized study that included 42 women candidates for hysterectomy at School of Medicine, Hospital das Clínicas, USP. The patients were randomized to two groups: MP-TLH (total laparoscopic hysterectomy with 3 abdominal incisions), and SP-TLH (total laparoscopic hysterectomy with a single umbilical incision)...
July 2017: Acta Cirúrgica Brasileira
https://www.readbyqxmd.com/read/28791382/potential-role-of-zeb1-as-a-dna-repair-regulator-in-colorectal-cancer-cells-revealed-by-cancer-associated-promoter-profiling
#16
Miao Wang, Su-Fei He, Lei-Lei Liu, Xiao-Xia Sun, Fan Yang, Qian Ge, Wei-Kang Wong, Jing-Yan Meng
Besides being a key contributor to epithelial‑to‑mesenchymal transition (EMT) activation and stemness maintenance, zinc finger E-box binding homeobox 1 (ZEB1) is also a crucial inducer of chemoresistance and radioresistance. Unlike the clear mechanism that mediates its effect on EMT and dedifferentiation, the mechanism of how ZEB1 promotes chemo- and radio-resistance remains to be elucidated. It has been previously reported that ZEB1 promotes DNA double-strand break clearance by enhancing the deubiquitylating activity of ubiquitin-specific peptidase (USP)7 on checkpoint kinase 1, which is an important step during DNA repair...
August 8, 2017: Oncology Reports
https://www.readbyqxmd.com/read/28790255/-safe-handling-of-cancer-chemotherapy-drugs-in-pharmacy-preparations-transport-and-safe-deposit
#17
Hisanaga Nomura
Recently, 1 out of 2 people are diagnosed as cancer, the number of patients who are given chemotherapy increases year by year. As a result, amount of anticancer drugs used also increases. Anticancer drug preparation work is one of pharmacist work. In many hospital, pharmacists prepare anticancer drugs at pharmacy. However, it is enough to take steps to exposure measures at all facilities. According to the United States Pharmacopeial(USP)and the handling standards of hazardous and drugs, there are 3 levels, the first level(safety cabinet), the second level(anticancer agent preparation room in pharmacy) and supplemental engineering control(CSTD)...
July 2017: Gan to Kagaku Ryoho. Cancer & Chemotherapy
https://www.readbyqxmd.com/read/28790253/-the-necessity-and-the-current-status-of-safe-handling-of-anticancer-drugs
#18
Kiyoko Kanda
Number of people who handle anticancer drugs in their profession is increasing. Anticancer drugs, which are hazardous drugs(HD), exert cytocidal effects on cancer cells, but many have also been shown to have mutagenicity, teratogenicity and carcinogenicity; therefore, safe handling of anticancer drugs is necessary. In July 2015, the first Japanese guidelines for exposure control measures, namely, the "Joint Guidelines for Safe Handling of Cancer Chemotherapy Drugs", were published jointly by 3 societies. Our guideline is the creation of the Japanese Society of Cancer Nursing(JSCN), Japanese Society of Medical Oncology(JSMO)and Japanese Society of Pharmaceutical Oncology(JASPO)and has a historical significance...
July 2017: Gan to Kagaku Ryoho. Cancer & Chemotherapy
https://www.readbyqxmd.com/read/28767808/preliminary-results-of-severe-venous-insufficiency-treatment-with-thermal-ablation-of-the-great-saphenous-vein-by-endovascular-technique-with-laser-diode-980nm-developed-in-brazil-associated-with-sclerotherapy-with-polidocanol
#19
Matheus Bertanha, Marcone Lima Sobreira, Paula Angelelli Bueno Camargo, Rafael Elias Farres Pimenta, Jamil Victor Oliveira Mariúba, Regina Moura, Vanderlei Salvador Bagnato, Winston Bonetti Yoshida
The endovenous laser ablation (EVLA) of the insufficient saphenous vein has similar results to open conventional surgery, but less morbidity. The echo-guided polidocanol foam sclerotherapy technique has been used for the same purpose. The combined techniques may play a role for more severe diseases, such as those with varicose ulcers. An EVLA device (called VELAS) has been developed in the Optics and Photonics Research Center of USP-São Carlos in agreement with FMB-UNESP. In this study, we present the preliminary results of the VELAS device (MMO 980nm diode) in patients with chronic venous ulcer, associated with echo-guided polidocanol foam sclerotherapy for the treatment of varicosities...
May 2017: Revista do Colégio Brasileiro de Cirurgiões
https://www.readbyqxmd.com/read/28765232/usp-to-establish-new-general-chapter-on-compounding
#20
(no author information available yet)
No abstract text is available yet for this article.
August 2017: Journal of Nuclear Medicine: Official Publication, Society of Nuclear Medicine
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