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Pharmaceutical Development and Technology

Wipada Samprasit, Prasert Akkaramongkolporn, Ruchadaporn Kaomongkolgit, Praneet Opanasopit
This work deals with fast-dissolving drug delivery systems of meloxicam (MX) derived from electrospun polyvinylpyrrolidone (PVP)/2-hydroxypropyl-β-cyclodextrin (HPβCD) nanofiber mats. Electrospinning of solutions with different solvent systems (dimethylformamide (DMF) and ethyl alcohol (EtOH)) was performed. Prepared films were evaluated for morphology, physical and mechanical properties. MX content, dissolving time, MX release, and cytotoxicity of films were investigated. In vivo studies were also performed in healthy human volunteers...
November 6, 2017: Pharmaceutical Development and Technology
Chi-Wah Yeung, Hubert Rein
Hot-melt extruded sugar-starch pellets are an alternative for commercial sugar spheres, but their coating properties remain to be studied. Both the European Pharmcopoeia 8.6 and the United States Pharmacopoeia 40 specify the composition of sugar-starch pellets without giving requirements for the manufacturing process. Due to various fabrication techniques, the physicochemical properties of pellets may differ. Therefore, the adhesion energies of three coating dispersions (sustained, enteric and immediate release) on different types of pellets were investigated...
November 6, 2017: Pharmaceutical Development and Technology
Diego Fontana de Andrade, Branko Vukosavljevic, Edilson Valmir Benvenutti, Adriana Raffin Pohlmann, Sílvia Stanisçuaski Guterres, Maike Windbergs, Ruy Carlos Ruver Beck
This study proposes a new approach to produce easily redispersible spray-dried lipid-core nanocapsules (LNC) intended for oral administration, evaluating the influence of the particle number density of the fed sample. The proposed approach to develop redispersible spray-dried LNC formulations intended for oral route is innovative, evidencing the needing of an optimization of the initial particle number density in the liquid suspension of nanocapsules. A mixture of maltodextrin and L-leucine (90:10 w/w) was used as drying adjuvant...
November 2, 2017: Pharmaceutical Development and Technology
Seo Young Dai, Su-Eon Jin, Daehyun Kim, Don Haeng Lee, Su-Geun Yang
Megestrol acetate (MGA) is used as a progestagen to treat advanced cancers in the breast or uterus and anorexia-cachexia syndrome in cancer patients. Due to its low solubility (BCS class II), MGA bioavailability needs to be enhanced for efficacy and safety. We developed MGA-encapsulated Eudragit(®) L100 (EUD) nanoparticles (MGA-EUD (1:1) and MGA-EUD (2:1)) using an ultrasonic nebulization method. MGA-EUD (1:1) and MGA-EUD (2:1) consisted of MGA and EUD at the mass ratios of 1:1 and 2:1. Their physicochemical properties, i...
November 2, 2017: Pharmaceutical Development and Technology
Ketsia Yekpe, Nicolas Abatzoglou, Bernard Bataille, Ryan Gosselin, Tahmer Sharkawi, Jean-Sébastien Simard, Antoine Cournoyer
This study applied the concept of Quality by Design (QbD) to tablet dissolution. Its goal was to propose a quality control strategy to model dissolution testing of solid oral dose products according to International Conference on Harmonization guidelines. The methodology involved the following three steps: (1) a risk analysis to identify the material- and process-related parameters impacting the critical quality attributes of dissolution testing, (2) an experimental design to evaluate the influence of design factors (attributes and parameters selected by risk analysis) on dissolution testing, and (3) an investigation of the relationship between design factors and dissolution profiles...
November 2, 2017: Pharmaceutical Development and Technology
Emrah Yildir, Erica Sjöholm, Maren Preis, Poonam Trivedi, Jani Trygg, Pedro Fardim, Niklas Sandler
Mucoadhesive formulations have a wide scope of application for both systemic and local treatment of various diseases. In the case of recurrent aphthous stomatitis, to ensure effective therapy, the concentration of corticosteroids and/or anesthetics at the mouth ulcer side should be maintained with minimal systemic absorption. Therefore, the aim of the study was to investigate cellulose-based formulations, in achieving suitable hardness, mucoadhesiveness and sustained release of the active ingredients directed towards the mucosa for an extended period of time (approx...
October 25, 2017: Pharmaceutical Development and Technology
Arnaud Potier, Julien Voyat, Alain Nicolas
Clonidine hydrochloride is administered to opioid-addicted mothers' neonates to reduce neonatal abstinence syndrome. It is prescribed off-label to neonates at 0.5-1 µg/kg/6 h, alone or in combination. The commercially injectable form of clonidine-Catapressan(®) 0.15 mg/mL-is being orally given after an appropriate dilution in water. However, this practice is not suitable for a perfectly safe and accurate administration. The objectives were to design a 10 µg/mL oral solution of clonidine hydrochloride in Inorpha(®) and to study the stability of this solution by a validated stability-indicating liquid chromatography (LC) method...
October 24, 2017: Pharmaceutical Development and Technology
Alan D Gift, Jacob A Hettenbaugh, Rachel A Quandahl, Madison Mapes
The effects of polymers on the anhydrate-to-hydrate transformation of carbamazepine (CBZ) was investigated. The three types of polymers studied were polyvinylpyrrolidone (PVP), polyvinyl alcohol (PVA) and substituted celluloses which included hydroxypropyl methylcellulose (HPMC) and methylcellulose (MC). Anhydrous CBZ was added to dilute aqueous polymer solutions and Raman spectroscopy measurements were collected to monitor the kinetics of the solution-mediated transformation to CBZ dihydrate. Polymers exhibiting the greatest inhibition were able to reduce the growth phase of the solvent mediated transformation and change the habit of the hydrate crystal indicating polymer adsorption to the hydrate crystal surface as the mechanism of inhibition...
October 19, 2017: Pharmaceutical Development and Technology
Sandra Cvijić, Ivana Aleksić, Svetlana Ibrić, Jelena Parojčić
Consumption of alcoholic beverages with sustained-release oral dosage forms may pose a risk to patients due to potential alcohol-induced dose dumping (ADD). Regulatory guidances recommend in vitro dissolution testing to identify the risk of ADD, but the question remains whether currently proposed test conditions can be considered biopredictive. The purpose of this study was to evaluate different dissolution setups to assess ADD, and the potential of combined in vitro-in silico approach to predict drug absorption after concomitant alcohol intake for hydrophilic and lipophilic sustained-release tablets containing ibuprofen or diclofenac sodium...
October 18, 2017: Pharmaceutical Development and Technology
Sander van den Ban, Kendal G Pitt, Marshall Whiteman
A scientific understanding of interaction of product, film coat, film coating process, and equipment is important to enable design and operation of industrial scale pharmaceutical film coating processes that are robust and provide the level of control required to consistently deliver quality film coated product. Thermodynamic film coating conditions provided in the tablet film coating process impact film coat formation and subsequent product quality. A thermodynamic film coating model was used to evaluate film coating process performance over a wide range of film coating equipment from pilot to industrial scale (2...
October 13, 2017: Pharmaceutical Development and Technology
Ruixue Bai, Xueqing Deng, Qiong Wu, Xiaomian Cao, Tiantian Ye, Shujun Wang
Main challenges of the clinical use of 7-ethyl-10-hydroxycamptothecin (SN-38) are its facile transition between the active lactone form (SN-38A) and the inactive carboxylate form (SN-38I) under physiological conditions and its low solubility. The purpose of this study was to develop a thermo-sensitive hydrogel system with acidic SN-38 liposomes (SN-38-Lip-Gel) for local chemotherapy to solve these problems and to evaluate its antitumor activity and tissue distribution in tumor-bearing mice. A study of structural conversion between SN-38I and SN-38A under various pH conditions indicated that acidic solution could inhibit the conversion...
October 11, 2017: Pharmaceutical Development and Technology
Lari K Dkhar, Jim Bartley, David White, Ali Seyfoddin
This review article highlights the importance and advantages of the drug delivery systems applied via the nasal route after endoscopic sinus surgery (ESS) for patients suffering from chronic rhinosinusitis. After ESS, patients often require ongoing topical and systemic medication. To reduce the incidence of immediate and delayed post-surgical complications, a variety of temporary postoperative nasal interventions are currently used. However, newly developed intranasal drug delivery devices can enhance tissue recovery after endoscopic sinus surgery by releasing therapeutic drugs locally, while providing structural support to reduce tissue adhesion and scaring...
October 10, 2017: Pharmaceutical Development and Technology
Slavomira Doktorovova, Eliana B Souto, Amélia M Silva
Curcumin, a phenolic compound from turmeric rhizome (Curcuma longa), has many interesting pharmacological effects, but shows very low aqueous solubility. Consequently, several drug delivery systems based on polymeric and lipid raw materials have been proposed to increase its bioavailability. Solid lipid nanoparticles (SLN), consisting of solid lipid matrix and a surfactant layer can load poorly water-soluble drugs, such as curcumin, deliver them at defined rates and enhance their intracellular uptake. In the present work, we demonstrate that, despite the drug's affinity to lipids frequently used in SLN production, the curcumin amount loaded in most SLN formulations may be too low to exhibit anticancer properties...
October 10, 2017: Pharmaceutical Development and Technology
Muhammad U Ghori, Liam M Grover, Kofi Asare-Addo, Alan M Smith, Barbara R Conway
Swelling, erosion, deformation and consolidation properties can affect the performance of cellulose ethers, the most commonly used matrix former in hydrophilic sustained tablet formulations. The present study was designed to comparatively evaluate the swelling, erosion, compression, compaction and relaxation properties of the cellulose ethers in a comprehensive study using standardised conditions. The interrelationship between various compressional models and the inherent deformation and consolidation properties of the polymers on the derived swelling and erosion parameters are consolidated...
October 6, 2017: Pharmaceutical Development and Technology
Ghada Zidan, Ilva D Rupenthal, Carol Greene, Ali Seyfoddin
Corneal blindness can occur due to improper healing of the corneal tissues after induced injury or abrasion which can be accidental, pathogenic, or after corneal surgery. Abnormal regulation of the healing mechanisms can lead to corneal opacity. Reducing inflammation and promoting epithelial wound healing are crucial for scar-free corneal recovery without eyesight complications. Current approaches for corneal wound healing involve amniotic membrane (AM) bandages, bandage contact lenses (BCL), and collagen shields in conjunction with frequent administration of therapeutic eye drops...
September 21, 2017: Pharmaceutical Development and Technology
Ali Ramazani, Mojtaba Keramati, Hojat Malvandi, Hossein Danafar, Hamidreza Kheiri Manjili
PURPOSE: Artemisinin (ART) has anti-inflammatory, antimicrobial, antioxidant, anti-amyloid, and anti-malarial effects, but its application is limited due to its low water solubility and poor oral bioavailability. In this study, the bioavailability, water solubility, and anti-plasmodial property of ART were improved by PCL-PEG-PCL tri-block copolymers. METHODS: The structure of the copolymers was characterized by (1)H NMR, FT-IR, DSC, and GPC techniques. ART was encapsulated within micelles by a single-step nano-precipitation method, leading to the formation of ART-loaded PCL-PEG-PCL micelles...
September 11, 2017: Pharmaceutical Development and Technology
Sachin S Thakur, Jared Solloway, Anneloes Stikkelman, Ali Seyfoddin, Ilva D Rupenthal
This study reports on the impact of cyclodextrin addition on the phase behavior of microemulsion systems. Three distinct oil-in-water microemulsions were formulated and subjected to increasing concentrations of various cyclodextrins. The prepared formulations underwent visual, textural and microscopic characterization followed by the evaluation of their in vitro drug release and ex vivo tissue retention behavior. Combining microemulsions with cyclodextrins resulted in either phase separation or transition into a liquid crystalline state depending on the concentration and type of cyclodextrin utilized...
September 3, 2017: Pharmaceutical Development and Technology
Dominique Jasmin Lunter
Mesoporous silica particles have recently been used in the preparation of solid oral as well as dermal pharmaceutical formulations. In this work, the use of mesoporous silica of different particle size, pore size and pore volume as carrier for curcumin in hydrogels for dermal use was investigated. Oil absorption capacity of the silica, in vitro release of curcumin from formulations and chemical stability of curcumin during three months storage were evaluated. It was found that the silica particles did not alter in vitro release of curcumin compared to an emulsion...
August 31, 2017: Pharmaceutical Development and Technology
S Arunkumar, H N Shivakumar, S Narasimha Murthy
OBJECTIVE: The aim of the study was to enhance the transdermal delivery of diclofenac potassium (DP) from hydrogels by constant voltage iontophoresis (CVI). The other objective was to establish the safety and efficacy of CVI in rats. MATERIALS AND METHODS: Hydrogels of DP were developed using hydroxyethyl cellulose as matrix material and geraniol, l-menthol and thymol as iontophoretic efficiency enhancers (IEE). In vitro permeation of hydrogels under CVI (1.5 V) was performed in Franz diffusion cells across porcine skin...
August 31, 2017: Pharmaceutical Development and Technology
Paige Solomon, Jenny Nelson
In this study, we investigated the elemental impurities present in the plastic material of ophthalmic eye drop bottles using inductively coupled plasma-mass spectrometry (ICP-MS). Metallic contaminations, especially localized within the small cavity of the eye, can significantly perturb the ocular metallome. The concern is two-fold: first certain elements, for example heavy metals, can be toxic to humans at even trace levels, and second, these contaminations can have adverse reactions with other medicines or enzymatic processes in the eye...
August 24, 2017: Pharmaceutical Development and Technology
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