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Pharmaceutical Development and Technology

Zhiying Yu, Lin Huang, Ruiting Wen, Yuzhen Li, Qiang Zhang
Recombinant human growth hormone (rhGH) therapy must be administered as a daily injection due to its short half-life. To achieve sustained release of rhGH, the preparation of rhGH-loaded PLGA microspheres was investigated, and the influence of various factors on encapsulation efficiency was tested, including rhGH concentration, the ratio of internal phase to organic phase, stirring speed, PVA concentration, surrounding pH value, and the type of emulsifier and organic solvent. A pharmacokinetic study was performed by subcutaneous administration to explore the sustained release effect...
November 13, 2018: Pharmaceutical Development and Technology
Michael Leane, Kendal Pitt, Gavin K Reynolds, Neil Dawson, Iris Ziegler, Aniko Szepes, Abina M Crean, Rafaela Dall Agnol, The Manufacturing Classification System McS Working Group
Following the first Manufacturing Classification System (MCS) paper, the team conducted surveys to establish which active pharmaceutical ingredient (API) properties were important when selecting or modifying materials to enable an efficient and robust pharmaceutical manufacturing process. The most commonly identified factors were (1) API particle size: small particle sizes are known to increase risk of processing issues; (2) Drug loading in the formulation: high drug loadings allow less opportunity to mitigate poor API properties through the use of excipients...
November 13, 2018: Pharmaceutical Development and Technology
Pinak Khatri, Dipen Desai, Tamara Minko
The objective of the research was to demonstrate the plasticization properties of divalproex sodium, due to its component-valproic acid, on ethyl cellulose, which could prove beneficial for film fabrications or hot melt extrusion based formulations. Films containing 10-50% w/w (DVS/EC) as dry weight were prepared using solvent evaporation method and characterized using texture analyzer, hybrid rheometer, differential scanning calorimetry, thermogravimetry, X-ray diffractometry, polarized microscopy, FTIR, and Raman spectroscopy...
November 6, 2018: Pharmaceutical Development and Technology
Rania Hamed
The objective of this study was to investigate the effect of the physiological parameters (pH, buffer capacity, and ionic strength) of the gastrointestinal (GI) fluid on the dissolution behavior of the class II weakly acidic (BCS class IIa) drug valsartan. A series of in vitro dissolution studies was carried out on Diovan® immediate release tablets using media that cover the physiological range of pH (1.2 - 7.8), buffer capacity (0 - 0.047 M/ΔpH) , and ionic strength (0 - 0.4 mol/L) of the GI fluid during fasted and fed states using the conventional USP II apparatus...
October 15, 2018: Pharmaceutical Development and Technology
Hamed Nosrati, Marziyeh Salehiabar, Zahra Bagheri, Hamid Rashidzadeh, Soodabeh Davaran, Hossein Danafar
This study is a report about the synthesis iron oxide magnetic nanoparticles (IONPs) which modified with positive and negative charged amino acids (AAs). L-arginine (Arg) and L-aspartic acid (Asp) which have of guanidinium and carboxylic acid groups, respectively, were selected for this study. After loading Chrysin in amino acids modified iron oxide magnetic nanoparticles (F@AAs@Chrysin NPs), it was characterized by XRD, TGA, FTIR, VSM and TEM techniques. Finally, MTT assays on HFF-2 and HEK-293 cell lines were performed for determination of biocompatibility of AA coated IONPs...
October 15, 2018: Pharmaceutical Development and Technology
Aymeric Ousset, Céline Bassand, Pierre-François Chavez, Joke Meeus, Florent Robin, Martin Alexander Schubert, Pascal Somville, Kalliopi Dodou
The present study details the development of a small-scale spray-drying approach for the routine screening of amorphous solid dispersions (ASDs). This strategy aims to overcome the limitations of standard screening methodologies like solvent casting and quench cooling to predict drug-polymer miscibility of spray-dried solid dispersions (SDSDs) and therefore to guarantee appropriate carrier and drug-loading (DL) selection. A DoE approach was conducted to optimize process conditions of ProCept 4M8-TriX spray-drying to maximize the yield from a 100 mg batch of Itraconazole/HPMCAS-LF and Itraconazole/Soluplus 40:60 (w/w)...
October 10, 2018: Pharmaceutical Development and Technology
Mike Tobyn, Ana Patricia Ferreira, Jane Lightfoot, Elaine B Martin, Manish Ghimire, Charles Vesey, Andrea Kasuboski-Freeman, Ali Rajabi-Siahboomi
A key part of the Risk Assessment of excipients is to understand how raw material variability could (or does) contribute to differences in performance of the drug product. Here we demonstrate an approach which achieves the necessary understanding for a complex, functional, excipient. Multivariate analysis (MVA) of the certificates of analysis of an ethylcellulose aqueous dispersion (Surelease) formulation revealed low overall variability of the properties of the systems. Review of the scores plot to highlight batches manufactured using the same ethylcellulose raw material in the formulation, indicated that these batches tend to be more closely related than other randomly selected batches...
October 10, 2018: Pharmaceutical Development and Technology
Inderjeet Singh, Rajesh Sreedharan Nair, Suyin Gan, Victor Cheong, Andrew Morris
The drawbacks associated with chemical skin permeation enhancers such as skin irritation and toxicity necessitated the research to focus on potential permeation enhancers with a perceived lower toxicity. Crude palm oil (CPO) is obtained by direct compression of the mesocarp of the fruit of the oil palm belonging to the genus Elaeis. In this research, CPO and tocotrienol-rich fraction (TRF) of palm oil were evaluated for the first time as skin permeation enhancers using full-thickness human skin. The in vitro permeation experiments were conducted using excised human skin mounted in static upright 'Franz-type' diffusion cells...
October 3, 2018: Pharmaceutical Development and Technology
Siriwan Srisang, Norased Nasongkla
In this study, chlorhexidine-loaded poly(ε-caprolactone) nanospheres (CHX-NS) were prepared and successfully coated on the urinary catheters. Properties of CHX-NS were evaluated including drug loading content and the nanosphere size. Effects of different lyoprotectants for long-term storage of CHX-NS were also investigated. In vitro release study and antibacterial activity were also conducted using 20 cycles coated-urinary catheters. Results showed that the high-pressure emulsification-solvent evaporation technique provided the drug loading content at 1...
September 28, 2018: Pharmaceutical Development and Technology
Randa Hanie Awadeen, Mariza F Boughdady, Mahasen Mohamed Meshali
Glimepiride (Gmp) a third generation of sulphonylurea is a weakly acidic hypoglycemic drug that belongs to Biopharmaceutical Classification System (BCS) class II. It suffers from poor solubility as well as erratic and variable therapeutic effect. The authors investigated the feasibility of utilizing two nontoxic and biodegradable biopolymers (casein (CA) and chitosan (CT)) as a new in-situ gelling tablet matrix to circumvent this limitation. Both polymers in different ratios were combined with constant dose of the drug and compressed by direct compression to produce constant weights of different tablet matrices...
September 27, 2018: Pharmaceutical Development and Technology
Behnaz Daneshmand, Homa Faghihi, Maryam Amini Pouya, Shabnam Aghababaie, Majid Darabi, Alireza Vatanara
PURPOSE: Spray-freeze drying (SFD) is a recently applied method to develop pharmaceutical powders. This study aimed to analyze the competence of Trehalose, Mannitol, Lactose, and Sorbitol instability and aerosolization of Immunoglobulin G (IgG) via SFD. METHODS: Induced soluble aggregates were quantified at 0 and 3 months, and 45 °C using size-exclusion chromatography. Conformation and thermogravimetric assessments were done by Fourier transform infrared spectroscopy and differential scanning calorimetry...
September 27, 2018: Pharmaceutical Development and Technology
Nicola Cuccato, Luca Nardo, Solveig Kristensen, Hanne Hjorth Tønnesen, Marianne Lilletvedt Tovsen
The efficacy of surfactant mixtures of Pluronic® F127 and Tween 80 at overall concentration in the micromolar range and molar ratio 1:1, 1:10, and 10:1 in inhibiting aggregation of the photosensitizer meso-tetraphenyl chlorin disulphonate (TPCS2a ) was investigated in aqueous media at pH 2.9 by means of steady-state absorption and fluorescence emission spectroscopy as well as time-resolved fluorescence analysis. Corresponding experiments were performed at pH 7.4 in the absence of surfactants to determine the spectroscopic properties of a monomeric sample...
September 26, 2018: Pharmaceutical Development and Technology
Janet Sui Ling Tan, Clive J Roberts, Nashiru Billa
This study describes the properties of an amphotericin B-containing mucoadhesive nanostructured lipid carrier (NLC), with the intent to maximize uptake within the gastrointestinal tract. We have reported previously that lipid nanoparticles can significantly improve the oral bioavailability of amphotericin B (AmpB). On the other hand, the aggregation state of AmpB within the NLC has been ascribed to some of the side effects resulting from IV administration. In the undissolved state, AmpB (UAmpB) exhibited the safer monomeric conformation in contrast to AmpB in the dissolved state (DAmpB), which was aggregated...
September 26, 2018: Pharmaceutical Development and Technology
Tim Feuerbach, Sara Callau-Mendoza, Markus Thommes
The manufacturing of custom implants and patient-tailored drug dosage forms with fused deposition modeling (FDM) three-dimensional (3D) printing is currently considered to be very promising. Most FDM printers are designed as an open filament system, for which filaments with a defined size are required. In addition to this processing requirement, the filament material must be of medical or pharmaceutical quality, in order to be suitable in these applications. In this work, filaments with nominal diameters of 1...
September 25, 2018: Pharmaceutical Development and Technology
Thilini Rasika Thrimawithana, Sebastian D'Amore, Youseph Dib, Nazanin Fadavi Firooz, Wafaa Fakhouri, Athraa Saeed, Ayman Allaham
Oral liquid formulations are compounded by pharmacists to meet the needs of patients when a suitable commercially available product is not available. To minimise the errors associated with measuring multiple excipients and to enhance the shelf-life of the medicines, commercially available suspending bases are commonly used. This review aims to compare the stability and shelf life of commercially available extemporaneous formulation to traditional formulation methods. Five (5) databases were searched (Pubmed, SCOPUS, Science direct, Embase and EBSCOhost)...
September 21, 2018: Pharmaceutical Development and Technology
Takayuki Furuishi, Kohei Sekino, Mihoko Gunji, Kaori Fukuzawa, Hiromasa Nagase, Tomohiro Endo, Haruhisa Ueda, Etsuo Yonemochi
Clozapine (CLZ) is an atypical antipsychotic medication used in the treatment of schizophrenia and is poorly soluble in water (0.05 mM). In this study, we have investigated the effect of β-cyclodextrin (CD) and its derivatives on the solubility of CLZ. The solubility of the CLZ was measured to generate a phase solubility diagram, and the interaction between CLZ and sulfobutyl ether-β-cyclodextrin (SBE-β-CD) in aqueous solution was observed by 1 H- and 2D rotating-frame Overhauser enhancement spectroscopy (ROESY)-NMR methods...
September 11, 2018: Pharmaceutical Development and Technology
Rahul V Haware, Bhavani Prasad Vinjamuri, Monika Gavireddi, Vivek S Dave, Deepak Gupta, Mahavir C Chougule, William C Stagner
Low-order high-energy nifedipine (NIF) solid dispersions (SDs) were generated by melt solvent amorphization with PEG 1450 and HPMCAS-HF to increase NIF solubility while achieving acceptable physical stability. HPMCAS-HF was used as a crystallization inhibitor. Individual formulation components, their physical mixtures (PMs), and SDs were characterized by DSC, PXRD, and FTIR. NIF solubility and percent crystallinity (PC) were determined at initial time and after 5 days stored at 25°C and 60% RH. FTIR indicated that hydrogen bonding was involved with the amorphization process...
September 3, 2018: Pharmaceutical Development and Technology
Thunyaporn Jullaphant, Titpawan Nakpeng, Teerapol Srichana
OBJECTIVES: The aim of this study was to evaluate potential development of montelukast sodium (MTS) as a nasal spray. MATERIALS AND METHODS: The formulations were prepared using hydroxypropyl cellulose (HPC) and carbomer 940 (C940). The prepared formulations were evaluated for clarity, pH, hydrodynamic size, zeta potential, viscosity, contact angle, surface tension, droplet size distribution, muco-adhesiveness, drug release and stability. The suitable formulations were also assessed for their effects on nasal epithelial cells...
August 20, 2018: Pharmaceutical Development and Technology
V Merino-Bohórquez, M Delgado-Valverde, M García-Palomo, M C Dávila-Pousa, C Cañete, M Villaronga, B Rodriguez-Marrodán, R López-Rojas, M Cameán
Pediatric patients present changing physiological features. Because of the lack of land suitable for commercial management, pediatric specialties very often need to prepare extemporaneous formulations to improve the dosage and administration of drugs for children. Oral liquid formulations are the most suitable for pediatric patients. Clonidine is widely used in the pediatric population for opioid withdrawal, hypertensive crisis, attention deficit disorders and hyperactivity syndrome, and as an analgesic in neuropathic cancer pain...
August 20, 2018: Pharmaceutical Development and Technology
Paul W S Heng
No abstract text is available yet for this article.
November 2018: Pharmaceutical Development and Technology
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