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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
Tim Feuerbach, Sara Callau-Mendoza, Markus Thommes
The manufacturing of custom implants and patient-tailored drug dosage forms with Fused Deposition Modeling (FDM) 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 1.75 mm and diameter tolerances of ± 0...
August 28, 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...
August 23, 2018: Pharmaceutical Development and Technology
Janet Tan Sui Ling, Nashiru Billa, Clive J Roberts
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...
August 22, 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
Sana Al-Jawadi, Pier Capasso, Manisha Sharma
The scope of Implantable Drug Delivery systems (IDDSs) comprehends a variety of sterile therapeutic implements placed inside the body to exert a certain therapeutic action for extended duration. They are classified under different categories from pharmaceutical science and regulatory perspectives. The novelty and variety of IDDSs prevents the application of a uniform regulation for all IDDS products; therefore, sponsors face regulatory challenges to register and market their products. This review investigates pharmaceutical science literature and the United States Food and Drug Administration (US FDA) regulatory guidance to find how any IDDS is classified, regulated and introduce in the market...
August 7, 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...
August 7, 2018: Pharmaceutical Development and Technology
XingJun Wang, Ying Huang, Thomas M Michelitsch
Reliable monitoring of solution crystallization processes is important to provide further insight into process dynamics and to improve process control in the regimen of Process Analytical Technology (PAT), e.g. as the case studied here: detection of crystallization of the anhydrous and monohydrate forms of Citric Acid (CA). To set up the relationship between acoustic emission (AE) and crystallization form, two experiments (monohydrate and anhydrous citric acid) were carried out to specify the features and origins of the different acoustic signals emitted during batch cooling solution crystallization processes...
August 3, 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 develope pharmaceutical powders. This study aimed to analyze the competence of Trehalose, Mannitol, Lactose and Sorbitol in stability 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 (SEC-HPLC). Conformation and thermogravimetric assessment were done by Fourier transform infra red (FTIR-spectroscopy) and differential scanning calorimetry (DSC)...
August 2, 2018: Pharmaceutical Development and Technology
Kriti Soni, Kanchan Kohli
This study aims to develop sulforaphane loaded gold nanoparticles (SFN-GNPs) as a potential nanomedicine against the solid tumors. Citrate mediated electrolysis optimized by 4-factors 3-levels Box-Behnken experimental design was used to get nanoparticles of size < 200nm. The formulation was characterized and evaluated for cytotoxicity B16-F10, MCF-7, SW-620 and Caco-2 cell line. Single dose oral pharmacokinetics, gamma scintigraphy-based bio-distribution and tumor regression studies were conducted to evaluate the in vivo performance...
July 31, 2018: Pharmaceutical Development and Technology
Pedro Durão, Clémence Fauteux-Lefebvre, Jean-Maxime Guay, Jean-Sébastien Simard, Nicolas Abatzoglou, Ryan Gosselin
The application of Process Analytical Technologies in pharmaceutical manufacturing has been the subject of many studies. Active pharmaceutical ingredient monitoring in real time throughout the manufacturing process is commonly the target of many such implementations. The tools in place must be sensitive to, and selective of, the parameter(s) to be monitored, i.e. in the case of component quantification, they must respond to the component in question and be robust against all others. In this study, four different ingredients (riboflavin, ferrous fumarate, ginseng, and ascorbic acid) in a multi-component blend were monitored by three different tools (near infrared spectroscopy, laser-induced fluorescence and red-green-blue camera) using a full factorial design...
July 31, 2018: Pharmaceutical Development and Technology
Trusha J Purohit, Sara M Hanning, Zimei Wu
Drug delivery via the rectum is a useful alternative route of administration to the oral route for patients who cannot swallow. Traditional rectal dosage forms have been historically used for localized treatments including delivery of laxatives, treatment of hemorrhoids and for delivery of antipyretics. However, the recent trend is showing an increase in the development of novel rectal delivery systems to deliver drug directly into the systemic circulation by taking advantage of porto-systemic shunting. The present review is based on research studies carried out between years 1969-2017...
July 24, 2018: Pharmaceutical Development and Technology
Ivan M Savic, Emilija Jocic, Vesna D Nikolic, Mirjana M Popsavin, Srdjan J Rakic, Ivana M Savic-Gajic
PURPOSE: The aim of paper was to develop the simple procedures for preparation of inclusion complexes of ellagic acid with cyclodextrins and to investigate their antioxidant and antimicrobial activity. METHODS: The structural characterization was carried out using FTIR, XRD and NMR methods. The phase solubility technique was used to investigate the interactions between "host" and "guest" molecules and to estimate the molar ratio between them...
July 23, 2018: Pharmaceutical Development and Technology
Alicia Potuck, Robert Leming, Stephanie Lam
This article describes a method to quantitatively track the solvation of HPC in a non-aqueous solvent system during topical gel manufacture. Where visual observation and microscopy could not establish a trend, straight-forward rheological profiling demonstrated a correlation between increased solvation of hydroxypropyl cellulose polymer (viscosity modifier) and decreased tan δ, indicating the formation of a viscoelastic gel network over time during processing. This correlation serves as a valuable tool for process optimization and HPC solvation tracking in non-aqueous topical gel formulations...
July 23, 2018: Pharmaceutical Development and Technology
Tim Feuerbach, Stefanie Kock, Markus Thommes
Fused deposition modeling (FDM) is a promising 3D printing technique for the fabrication of personalized drug dosage forms and patient-specific implants. However, there are no market products produced by FDM available at this time. One of the reasons is the lack of a consistent and harmonized approval procedure. In this study, three FDM printers have been characterised with respect to printing parameters relevant for pharmaceutical and medical applications, namely the positioning, hot-end temperature, material residence time, printing velocity and volumetric material flow...
July 23, 2018: Pharmaceutical Development and Technology
Mahboubeh Rezazadeh, Maryam Parandeh, Vajihe Akbari, Zahra Ebrahimi, Azade Taheri
Rosuvastatin (RSV) has been shown to have significant impact on the simulation of bone regeneration after local injection. The current study aimed to develop a localized controlled delivery system from RSV by incorporating RSV-loaded chitosan/chondroitin sulfate (CTS/CS) nanoparticles into thermosensitive Pluronic F127/hyaluronic acid (PF127/HA) hydrogel. RSV-loaded CTS/CS nanoparticles were prepared by ionic gelation, and the impact of various formulation variables was assessed using the Box-Behnken design...
July 23, 2018: Pharmaceutical Development and Technology
Rajesh Katara, Sameer Sachdeva, Dipak K Majumdar
The aim of the present study was to develop and evaluate positively charged nanoparticles of aceclofenac for ocular delivery. The nanoparticles were prepared by the nanoprecipitation method using Eudragit RS 100. The optimized nanoparticles were found to have narrow particle size range (238.9 ± 8 nm) with nearly spherical shape, positive zeta potential (40.3 ± 3.8). Higher entrapment efficiency of aceclofenac (94.53 ± 1.0%) with prolonged in vitro drug release profiles was also observed. Powder X-ray diffraction and differential scanning calorimetry studies indicated decrease in crystallinity of drug within the nanoparticulate polymeric matrix...
July 13, 2018: Pharmaceutical Development and Technology
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