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Pharmaceutical Development and Technology

Jaleh Varshosaz, Vahab Ziaei, Mohsen Minaiyan, Ali Jahanian, Leila Seyed Tabatabaei
The purpose of the present study was to enhance the bioavailability and anti-osteoporotic effects of raloxifene HCl (RH) by increasing its solubility and inhibition of the p-glycoprotein-pump using surfactant micelles of Igepal CO-890. The micelles were prepared by the direct method and their critical micellar concentration, drug dissolution rate, saturated solubility, drug loading and surface morphology were defined. The cytotoxicity of Igepal CO-890 and its ability to inhibit the p-glycoprotein pump were studied on Caco-2 cells...
January 16, 2018: Pharmaceutical Development and Technology
Huolong Liu, Shaun C Galbraith, Seo-Young Park, Bumjoon Cha, Zhuangrong Huang, Robert Frederick Meyer, Matthew H Flamm, Thomas O'Connor, Sau Lee, Seongkyu Yoon
In this study, a novel three-compartmental population balance model for a continuous twin screw wet granulation process is developed, combining the techniques of population balance modeling and regression process modeling. The developed model links screw configuration, screw speed and blend throughput with granule properties to predict the granule size distribution and volume-average granule diameter. The granulator screw barrel was divided into three compartments along barrel length: wetting compartment, mixing compartment and steady growth compartment...
January 16, 2018: Pharmaceutical Development and Technology
Chengliang Zhang, Yanan Liu, Wei Li, Ping Gao, Dong Xiang, Xiuhua Ren, Dong Liu
A bilayered mucoadhesive buccal film containing a combination of ornidazole (OD) and dexamethasone sodium phosphate (DEX) was prepared using solvent casting to treat oral ulcers. Films were systematically evaluated in vitro to obtain the optimum formulation. The therapeutic effects of these films were investigated in the rabbit oral ulcer model and the in vivo release of OD and DEX in the human oral cavity was also evaluated. The backing layer contained ethyl cellulose and an optimal mucoadhesive layer containing both OD and DEX was produced...
January 15, 2018: Pharmaceutical Development and Technology
Mana Okasaka, Koji Kubota, Emi Yamasaki, Jianzhong Yang, Sadaki Takata
Anionic surfactants are often used for cleaning and pharmaceutical purposes because of their strong surfactancy and foaming property. However, they are rarely ingested orally, the skin is a part of human body most affected by surfactants. Barrier function of the skin is very strong, but the anionic surfactants can serious damage it. Recently, amino acid-based surfactants have attracted attentions as safer options owing to their biocompatibility. Cytotoxicity examinations revealed the amino acid-based surfactants are superior to sulfate-based surfactants...
January 11, 2018: Pharmaceutical Development and Technology
B Siska, E Snejdrova, I Machac, P Dolecek, J Martiska
Rheological behaviour of pharmaceutical semisolid preparations significantly affects manufacturing process, administration, stability, homogeneity of incorporated drug, accuracy of dosing, adhesion in the place of application, drug release, and resulting therapeutic effect of the product. We performed test of consistency by penetrometry, rotational, oscillation and creep tests, and squeeze and tack tests of model samples to introduce methods suitable for characterization and comparison of semisolids in practice...
January 9, 2018: Pharmaceutical Development and Technology
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
Hamed Nosrati, Reza Adinehvand, Manjili Hamidreza Kheiri, Kobra Rostamizadeh, Hossein Danafar
In this study, we designed a polymersome system for the controlled release of methotrexate (MTX) as an anticancer drug with the objective of improving the loading efficiency of the drug in polymersomes as well as achievement of an efficient control on the release rate of drug from nanocarriers. We synthesized mono methoxy poly (ethylene glycol)-poly (e-caprolactone) (mPEG-PCL) di block copolymers. The structure of the copolymers was characterized by H-NMR, FT-IR and DSC techniques. MTX was encapsulated within nanoparticles through multiple emulsion method...
January 8, 2018: Pharmaceutical Development and Technology
Jinjiang Li, Sneha Rudraraju, Songyan Zheng, Archana Jaiswal
Protein therapeutics are exposed to various surfaces during product development, where their adsorption possibly causes unfolding, denaturation, and aggregation. In this paper, we aim to characterize four types of typical surfaces used in the development of biologics: polycarbonate, polyethersulfone, borosilicate glass, and cellulose. Contact angles of these surfaces were measured using three probing liquids: water, formamide, and diidomethane, from which acid/base (AB) and Lifshitz-van der Waals (LW) interaction components were derived...
January 5, 2018: Pharmaceutical Development and Technology
Shaun C Galbraith, Huolong Liu, Bumjoon Cha, Seo-Young Park, Zhuangrong Huang, Seongkyu Yoon
Continuous manufacturing techniques are increasingly being adopted in the pharmaceutical industry and powder blending is a key operation for solid-dosage tablets. A modeling methodology involving axial and radial tanks-in-series flowsheet models is developed to describe the residence time distribution (RTD) and blend uniformity of a commercial powder blending system. Process data for a six-component formulation processed in a continuous direct compression line (GEA Pharma Systems) is used to test the methodology...
January 5, 2018: Pharmaceutical Development and Technology
Fakhar Ud Din, Gul Majid Khan
The purpose of this study was to develop and characterize levosulpiride loaded liquid suppository with improved bioavailability. The content of levosulpiride-loaded liquid suppositories were optimized in a series of experiments using various weight ratios of P188, P407, Tween 80 and drug. The suppositories were liquid at room temperature, however, when rectally administered, they became gel at body temperature. Their rheological properties and release characteristics were determined in vitro while pharmacokinetic study was performed after its rectal administration in rats and compared with drug suspension...
December 18, 2017: Pharmaceutical Development and Technology
Claudia Hildebrandt, Srikanth R Gopireddy, Alexander K Fritsch, Thomas Profitlich, Regina Scherließ, Nora A Urbanetz
The focus of this study is to establish a characterization method determining the powder flowability in context of tableting. At first, flowability of different materials is measured using the ring shear tester, and its prediction from particle size is established. Next, the model die filling system is presented which is a modified version of previous studies. Using this system flowability of different materials is measured at varying die speeds. A new curve fit to assess die fill ratio vs die speed is suggested improving predictability, and a novel flowability metric, "Die Fill Index" (DFI), is derived...
December 11, 2017: Pharmaceutical Development and Technology
Osama Abd El-Aazeem Soliman, Elham Abdel Monem Mohamed, Nabil Abdullah Ali Khatera
Fungal keratitis may cause vision loss if it is not treated. Methods other than ocular delivery exhibited several limitations. No previous studies investigated and compared ocular bioavailability of fluconazole (FLZ) from niosomal gels and microemulsions. Niosomal gels of FLZ (0.3% w/w) based on Span® 60 and cholesterol (CH) using 1% w/w carbopol® 934 (CP) were evaluated. FLZ microemulsions (0.3% w/v) containing isopropyl myristate (IPM, as oil phase) and a 3:1 mixture of Tween® 80 (as surfactant) and polyethylene glycol 400 (PEG 400, as cosurfactant) were characterized...
December 6, 2017: Pharmaceutical Development and Technology
Nizar Al-Zoubi, Ahmad Al-Rusasi, Al-Sayed Sallam
The aim of this study was to investigate under in vitro conditions the influence of ethanol on acid resistance of four commercially-available enteric polymers (Acryl-EZE®, AQOAT®, Hypromellose phthalate and Sureteric®). For this purpose, custom-prepared paracetamol tablets were coated with the enteric polymers and tested for release using the buffer-addition method. Ten different hydro-ethanolic media were used in the acid stage corresponding to five levels of ethanol (0, 5, 10, 20 and 40% v/v) in two acidic solutions representing low and high gastric pH (0...
December 4, 2017: Pharmaceutical Development and Technology
Fabian Klar, Nora Anne Urbanetz
Dry coating utilizing a fluidized bed was evaluated in order to produce films with sustained drug release using amino methacrylate copolymers as film former. In contrast to other dry coating procedures using amino methacrylate copolymers, the described method enables an appropriate polymer adhesion by the selection of a plasticizer additive mixture in combination with the use of a three-way nozzle for simultaneous application. Well spreading fatty acid esters were found to increase the coating efficiency from 73% to approximately 86%, when they were used in conjunction with the plasticizer...
December 1, 2017: Pharmaceutical Development and Technology
Mônica Villa Nova, Bianca A Ratti, Leandro S Herculano, Paulo R S Bittencourt, Cláudio R Novello, Roberto Barbosa Bazotte, Sueli de Oliveira Silva Lautenschlager, Marcos Luciano Bruschi
Catabolic conditions like acquired immunodeficiency syndrome, cancer and burn can cause immunosuppression. Amino acids such as alanine and glutamine are essential for the activity of the immune system. Propolis is immunostimulant and the waste of propolis extraction has been reused with technological and therapeutic purposes. Therefore, this study describes the association of propolis byproduct extract with pectin to prepare spray-dried microparticles containing the dipeptide L-alanyl-L-glutamine as stimulant systems of neutrophils...
November 27, 2017: 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
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