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Y Xu, X Wen, X Feng, Z Liang, X Ye, H Nie, X Liao, J Li, Y Zeng, S Tang, J He
The objective of this work was to manufacture an enteric formulation of florfenicol (FF) using hot-melt extrusion (HME) technology and to evaluate its in vitro dissolution and in vivo pharmacokinetics. For the HME process, hypromellose acetate succinate LG (HPMCAS-LG) was the enteric polymer mixed with FF, and the two components were extruded with a standard screw configuration at a speed of 50 rpm. Differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), powder X-ray diffraction (PXRD), and Fourier transform infrared spectroscopy (FT-IR) were performed to characterize the HME extrudate...
March 2, 2018: Journal of Veterinary Pharmacology and Therapeutics
Luis Antonio D Silva, Susana L Almeida, Ellen C P Alonso, Priscila B R Rocha, Felipe T Martins, Luís A P Freitas, Stephania F Taveira, Marcilio S S Cunha-Filho, Ricardo N Marreto
Hot-melt extrusion (HME) has gained increasing attention in the pharmaceutical industry; however, its potential in the preparation of solid self-emulsifying drug delivery systems (S-SMEDDS) is still unexplored. This study sought to prepare enteric S-SMEDDS by HME and evaluate the effects of the process and formulation variables on S-SMEDDS properties via Box-Behnken design. Liquid SMEDDS were developed, and carvedilol was used as a class II model drug. Mean size, polydispersity index (PdI) and zeta potential of the resulting microemulsions were determined...
February 16, 2018: International Journal of Pharmaceutics
Luisa Duque, Martin Körber, Roland Bodmeier
The objectives of this study were to prepare lipid-based implants by hot melt extrusion (HME) for the prolonged release of ovalbumin (OVA), and to relate protein release to crystallinity and polymorphic changes of the lipid matrix. Two lipids, glycerol tristearate and hydrogenated palm oil, with different composition and degree of crystallinity were studied. Solid OVA was dispersed within the lipid matrixes and it preserved its stability during extrusion. This was partially attributed to a protective effect of the lipidic matrix...
February 13, 2018: European Journal of Pharmaceutical Sciences
Jaywant Pawar, Dilipkumar Suryawanshi, Kailas Moravkar, Rahul Aware, Vasant Shetty, Mohammed Maniruzzaman, Purnima Amin
The current study investigates the dissolution rate performance of amorphous solid solutions of a poorly water-soluble drug, efavirenz (EFV), in amorphous Soluplus® (SOL) and Kollidon® VA 64 (KVA64) polymeric systems. For the purpose of the study, various formulations with varying drug loadings of 30, 50, and 70% w/w were developed via hot-melt extrusion processing and adopting a Box-Behnken design of experiment (DoE) approach. The polymers were selected based on the Hansen solubility parameter calculation and the prediction of the possible drug-polymer miscibility...
February 9, 2018: Drug Delivery and Translational Research
Lorena F B Malaquias, Lívia C L Sá-Barreto, Daniel O Freire, Izabel C R Silva, Kapish Karan, Thomas Durig, Eliana M Lima, Ricardo N Marreto, Guilherme M Gelfuso, Tais Gratieri, Marcilio Cunha-Filho
This study aimed to mask fluconazole (FLU) taste and improve its rheological properties by an efficient process of cyclodextrin complexation. For this, hot-melt extrusion (HME) was used to obtain extrudates composed of FLU, hydroxypropylcellulose, and one of two different cyclodextrins (β-cyclodextrin or hydroxypropyl-β-cyclodextrin) maintaining the drug:cyclodextrin molar ratio at 1:0.3 or 1:0.2, respectively. Samples were characterized by physicochemical tests, palatability using e-tongue and antifungal assays...
April 1, 2018: Carbohydrate Polymers
Guiyu Lou, Ke Yang, Litao Qin, Yuwei Zhang, Hongdan Wang, Qiaofang Hou, Miao He, Shixiu Liao
OBJECTIVE To detect potential mutations of the EXT1 and EXT2 genes in a pedigree affected with hereditary multiple exostosis (HME). METHODS For a four-generation family with 7 affected individuals from 17 family members,genomic DNA was extracted from peripheral venous blood samples. All exons of the EXT1 and EXT2 genes were screened for potential mutation by PCR and Sanger sequencing. RESULTS A novel heterozygous frameshift mutation c.1202delT (p.I401Tfs*2)was found in exon 4 of the EXT1 gene in the proband and the other 6 affected individuals...
February 10, 2018: Zhonghua Yi Xue Yi Chuan Xue za Zhi, Zhonghua Yixue Yichuanxue Zazhi, Chinese Journal of Medical Genetics
Ron Farrell, Glen Oomen, Pauric Carey
There is a shift in critical care to adopt volatile anaesthetics as sedatives for certain patients using mechanical ventilation. Accompanying this shift is a growing body of literature describing the advantages or disadvantages of using isoflurane or sevoflurane for long term sedation. This practise requires a cost effective, efficient and safe means to deliver these drugs that can simultaneously operate with modern critical care ventilators and ventilation protocols while protecting the care environment and care workers from excessive exposure to the drugs...
January 31, 2018: Journal of Clinical Monitoring and Computing
Hagen Bomberg, Max Veddeler, Thomas Volk, Heinrich V Groesdonk, Andreas Meiser
Inhalation sedation is increasingly performed in intensive care units. For this purpose, two anaesthetic reflectors, AnaConDa™ and Mirus™ are commercially available. However, their internal volume (100 ml) and possible carbon dioxide reflection raised concerns. Therefore, we compared carbon dioxide elimination of both with a heat moisture exchanger (HME, 35 ml) in a test lung model. A constant flow of carbon dioxide was insufflated into the test lung, ventilated with 500 ml, 10 breaths per minute. HME, MIRUS and AnaConDa were connected successively...
January 27, 2018: Journal of Clinical Monitoring and Computing
Nicolaos Scoutaris, Steven A Ross, Dennis Douroumis
PURPOSE: Three- dimensional (3D) printing has received significant attention as a manufacturing process for pharmaceutical dosage forms. In this study, we used Fusion Deposition Modelling (FDM) in order to print "candy - like" formulations by imitating Starmix® sweets to prepare paediatric medicines with enhanced palatability. METHODS: Hot melt extrusion processing (HME) was coupled with FDM to prepare extruded filaments of indomethacin (IND), hypromellose acetate succinate (HPMCAS) and polyethylene glycol (PEG) formulations and subsequently feed them in the 3D printer...
January 16, 2018: Pharmaceutical Research
Elise Marsan, Stéphanie Baulac
Over the last decade, there has been increasing evidence that hyperactivation of the mechanistic target of rapamycin (mTOR) pathway is a hallmark of focal cortical dysplasia (FCD), as well as other cortical malformations such as hemimegalencephaly (HME) or in tuberous sclerosis complex (TSC). The mTOR pathway governs protein and lipid synthesis, cell growth and proliferation as well as metabolism and autophagy. The molecular genetic aetiology of mTOR hyperactivation has only been recently clarified. This article will review the current and still evolving genetic advances in the elucidation of the molecular basis of FCD...
January 23, 2018: Neuropathology and Applied Neurobiology
Luisa Duque, Martin Körber, Roland Bodmeier
The objectives of this study were to assess the feasibility of hot melt extrusion (HME) for the preparation of PLGA-based ovalbumin-loaded implants as well as to characterize and improve protein release from the implants. Ovalbumin (OVA) was stable during extrusion, which was attributed to a protective effect of the biodegradable matrix. OVA release was characterized by a low burst, a slow release up to day 21, which plateaued thereafter resulting in incomplete release for all evaluated protein loadings. Release incompleteness was accompanied by the formation of an insoluble residual mass...
January 16, 2018: International Journal of Pharmaceutics
Gati Krushna Panigrahi, Neeraj Verma, Nivedita Singh, Somya Asthana, Shailendra K Gupta, Anurag Tripathi, Mukul Das
Consumption of Cassia occidentalis (CO) seeds has been associated with the hepatomyoencephalopathy (HME) in children. Recently, we have characterized the toxic anthraquinones (AQs) such as Emodin, Rhein, Aloe-emodin, Chrysophanol and Physcion in CO seeds and detected these moieties in the bio fluids of CO poisoning cases. As AQs were detected in the serum of HME patients, their interaction with key biomolecules including protein, DNA and glutathione (GSH) is imperative. In this regard, we have previously reported the interaction of these AQs with serum albumin protein and their subsequent biological effects...
2018: Toxicology Reports
Kaushalendra Chaturvedi, Bhavin Y Gajera, Ting Xu, Harsh Shah, Rutesh H Dave
The objective of the present study was to investigate the influence of processing methods on the physical and mechanical properties of formulations containing Ibuprofen and HPC-SSL. The powder blends, containing Ibuprofen and HPC-SSL in ratio of 9:0.5, were processed using melt granulation (MG) by hot melt extrusion (HME) and wet granulation (WG) by high shear mixer. Formulated granules and powder blends were compressed into round flat faced tablets using Riva Piccola tablet press. Differential scanning calorimetry (DSC) and X-ray powder diffraction (XRPD) studies proved that granulation process did not significantly alter the crystallinity of Ibuprofen, however particle density and flow properties were significantly improved...
January 9, 2018: Pharmaceutical Development and Technology
Klaus Wening, Sebastian Schwier, Hans-J Stahlberg, Eric Galia
OBJECTIVE: Hot-melt extrusion (HME) technology has been used for manufacturing extended-release abuse-deterrent formulations (ADFs) of opioid-type analgesics with improved tamper-resistant properties. Our objective was to describe application of this technology to immediate-release (IR) ADFs. DESIGN: For development of a sample IR ADF (hydrocodone 10 mg/acetaminophen 325 mg) based on HME, feasibility studies were performed using different excipients. The formulation selected for further development was evaluated via in vitro test battery...
November 2017: Journal of Opioid Management
B J de Kleijn, C J van As-Brooks, J Wedman, B F A M van der Laan
Objective: The aim of this study was to evaluate the clinical feasibility of the ProTrach DualCare (Atos Medical, Hörby, Sweden), a device combining a hands-free speaking valve and a Heat and Moisture Exchanger (HME) for tracheotomized patients. Study Design: A non-randomized, prospective single center feasibility study. Methods: Sixteen adult tracheotomized patients were included. Participants were asked to test the DualCare for two weeks while continuing their normal activities...
December 2017: Laryngoscope Investigative Otolaryngology
Lizhen Cheng, Ting Li, Ling Dong, Xiaoyu Wang, Qiye Huo, Haoyu Wang, Zhujun Jang, Xinyu Shan, Weisan Pan, Xinggang Yang
In this study, a bi-layer osmotic pump tablet (OPT) of Flurbiprofen (FP) solid dispersions (SDs) was developed to increase the solubility of the poorly soluble drug and control drug release at a constant rate. Based on the thermodynamic properties investigation of the drug, the carrier and the calculation of the solubility parameters, the FP-SD was prepared by hot melt extrusion (HME) technique with the carrier of PVPVA64. Then central composite design-response surface methodology (CCD-RSM) was used to evaluate the influence of factors on the responses...
December 29, 2017: Journal of Pharmaceutical Sciences
Alissa M D'Gama, Mollie B Woodworth, Amer A Hossain, Sara Bizzotto, Nicole E Hatem, Christopher M LaCoursiere, Imad Najm, Zhong Ying, Edward Yang, A James Barkovich, David J Kwiatkowski, Harry V Vinters, Joseph R Madsen, Gary W Mathern, Ingmar Blümcke, Annapurna Poduri, Christopher A Walsh
Focal cortical dysplasia (FCD) and hemimegalencephaly (HME) are epileptogenic neurodevelopmental malformations caused by mutations in mTOR pathway genes. Deep sequencing of these genes in FCD/HME brain tissue identified an etiology in 27 of 66 cases (41%). Radiographically indistinguishable lesions are caused by somatic activating mutations in AKT3, MTOR, and PIK3CA and germline loss-of-function mutations in DEPDC5, NPRL2, and TSC1/2, including TSC2 mutations in isolated HME demonstrating a "two-hit" model...
December 26, 2017: Cell Reports
Maurizio Pacifici
Heparan sulfate (HS) is an essential component of cell surface and matrix proteoglycans (HS-PGs) that include syndecans and perlecan. Because of their unique structural features, the HS chains are able to specifically interact with signaling proteins -including bone morphogenetic proteins (BMPs)- via their HS-binding domain, regulating protein availability, distribution and action on target cells. Hereditary Multiple Exostoses (HME) is a rare pediatric disorder linked to germline heterozygous loss-of-function mutations in EXT1 or EXT2 that encode Golgi-resident glycosyltransferases responsible for HS synthesis, resulting in a systemic HS deficiency...
December 22, 2017: Matrix Biology: Journal of the International Society for Matrix Biology
Sooyong Park, Seok-Hwa Yoon, Ann Misun Youn, Seung Hyun Song, Ja Gyung Hwang
Background: Intraoperative hypothermia is common in patients undergoing general anesthesia during arthroscopic hip surgery. In the present study, we assessed the effect of heating and humidifying the airway with a heated wire humidification circuit (HHC) to attenuate the decrease of core temperature and prevent hypothermia in patients undergoing arthroscopic hip surgery under general anesthesia. Methods: Fifty-six patients scheduled for arthroscopic hip surgery were randomly assigned to either a control group using a breathing circuit connected with a heat and moisture exchanger (HME) (n = 28) or an HHC group using a heated wire humidification circuit (n = 28)...
December 2017: Korean Journal of Anesthesiology
Esther S Bochmann, Kristina E Steffens, Andreas Gryczke, Karl G Wagner
Simulation of HME processes is a valuable tool for increased process understanding and ease of scale-up. However, the experimental determination of all required input parameters is tedious, namely the melt rheology of the amorphous solid dispersion (ASD) in question. Hence, a procedure to simplify the application of hot-melt extrusion (HME) simulation for forming amorphous solid dispersions (ASD) is presented. The commercial 1D simulation software Ludovic® was used to conduct (i) simulations using a full experimental data set of all input variables including melt rheology and (ii) simulations using model-based melt viscosity data based on the ASDs glass transition and the physical properties of polymeric matrix only...
March 2018: European Journal of Pharmaceutics and Biopharmaceutics
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