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Pharmaceutical Development and Technology

Vinícius Raphael de Almeida Borges, Marina R Tavares, Julianna Henriques da Silva, Lidia Tajber, Fabio Boylan, Ana Ferreira Ribeiro, Luiz Eurico Nasciutti, Lucio Mendes Cabral, Valeria Pereira de Sousa
Copaiba oleoresin (CPO) obtained from Copaifera landgroffii, is described as active to a large number of diseases and more recently in the endometriosis treatment. In this work poly(lactic-co-glycolic acid) (PLGA) nanoparticles containing CPO were obtained using the design of experiments (DOE) as a tool to optimize the production process. The nanoparticles optimized by means of DOE presented an activity in relation to the cellular viability of endometrial cells. The DOE showed that higher amounts of CPO combined with higher surfactant concentrations resulted in better encapsulation efficiency and size distribution along with good stability after freeze drying...
February 1, 2017: Pharmaceutical Development and Technology
Somchai Sawatdee, Apichart Atipairin, Attawadee Sae Yoon, Teerapol Srichana, Narumon Changsan
Dry foam formulation technology is alternative approach to enhance dissolution of the drug. Sildenafil citrate was suspended in sodium dodecyl sulfate solution and adding a mixture of maltodextrin and mannitol as diluent to form a paste. Sildenafil citrate paste was passed through a nozzle spray bottle to obtain smooth foam. The homogeneous foam was dried in a vacuum oven and sieved to obtain dry foam granules. The granules were mixed with croscarmellose sodium, magnesium stearate and compressed into tablet...
January 30, 2017: Pharmaceutical Development and Technology
A Bonaccorso, T Musumeci, C Carbone, L Vicari, M Rosaria Lauro, G Puglisi
The efficient design of nanocarriers is a major challenge and must be correlated to the route of administration. Intranasal route is studied for local, systemic or cerebral treatments. In order to develop nanocarriers with suitable properties for intranasal delivery, to achieve brain, and to market the product, it is extremely important the simplification of the formulation in terms of raw materials. Surfactants and cryoprotectants are often added to improve structuration and/or storage of polymeric nanoparticles...
January 27, 2017: Pharmaceutical Development and Technology
Peng Cheng, Darren Svirskis, Sung Je Lee, Indrawati Oey, Hae-Soo Kwak, Guanyu Chen, Craig Bunt, Jingyuan Wen
Beta-carotene is a potent antioxidant for maintaining human health. However, its oral absorption is low due to poor aqueous solubility of less than 1 µg/ml. A microemulsion delivery system was designed to solubilize beta-carotene towards enhancing its oral bioavailability. From seven pseudo-ternary diagrams constructed, three systems were selected with large microemulsion areas suitable for oral administration and dilution in the predominately aqueous gastrointestinal fluids. Conductivity and rheology characterization were conducted along four dilution lines within the selected systems...
January 27, 2017: Pharmaceutical Development and Technology
P Barmpalexis, P Syllignaki, K Kachrimanis
Water diffusion through the matrix of three superdisintegrants, namely sodium starch glycolate (SSG), croscarmellose sodium (cCMC-Na) and crospovidone (cPVP), was studied at the sub-molecular level using Attenuated Total Reflectance (ATR)-FTIR spectroscopy and molecular dynamics simulations, and the results were correlated to water uptake studies conducted at the particulate level using Parallel Exponential Kinetics (PEK) modeling in dynamic moisture sorption studies and optical microscopy. ATR-FTIR studies indicated that water diffuses inside cPVP by a single fast acting process, while in SSG and cCMC-Na, a slow and a fast process acting simultaneously, were identified...
January 26, 2017: Pharmaceutical Development and Technology
Venkata R Naidu, Rucha S Deshpande, Moinuddin R Syed, Pravin S Wakte
A direct imaging system (Eyecon™) was used as a Process Analytical Technology (PAT) tool to monitor fluid bed coating process. Eyecon™ generated real-time onscreen images, particle size and shape information of two identically manufactured lab-scale batches. Eyecon™ has accuracy of measuring the particle size increase of ± 1 μm on particles in the size range of 50-3000 μm. Eyecon™ captured data every 2 seconds during the entire process. The moving average of D90 particle size values recorded by Eyecon™ were calculated for every 30 minutes to calculate the radial coating thickness of coated particles...
January 25, 2017: Pharmaceutical Development and Technology
Guolian Ren, Mengjuan Jiang, Weiling Guo, Bingjun Sun, He Lian, Yongjun Wang, Zhonggui He
A redox-responsive docetaxel (DTX) prodrug consisting of a disulfide linkage between DTX and vitamin E (DTX-SS-VE) was synthesized in our laboratory and was successfully formulated into liposomes. The aim of this study was to optimize the formulation and investigate the cellular uptake of DTX prodrug-loaded liposomes (DPLs). The content of DTX-SS-VE was determined by ultra high performance liquid chromatography (UPLC). The formulation and process were optimized using entrapment efficiency (EE), drug-loading (DL), particle size and polydispersity index (PDI) as the evaluation indices...
January 25, 2017: Pharmaceutical Development and Technology
Darjan Košir, Tadej Ojsteršek, Saša Baumgartner, Franc Vrečer
The drug release profile from hydrophilic matrix tablets can be crucially affected by the variability of physicochemical properties of the controlled release agent. This study investigates and seeks to understand the functionality-related characteristics (FRCs) of hydroxypropyl methylcellulose (HPMC) type 2208, K4M grade, that influence the release rate of the model drug carvedilol from hydrophilic matrix tablets during the entire dissolution profile. The following FRCs were examined: particle size distribution, degree of substitution, and viscosity...
December 23, 2016: Pharmaceutical Development and Technology
Mouhamad Reslan, Veysel Kayser
Protein aggregation is a significant problem affecting the integrity of proteins, and is a major hindrance to the development of biopharmaceutical products. Deuterium oxide (D2O), widely used in protein characterization studies, has been shown to promote protein aggregation when used as a substitute for water in most buffered protein solutions; however, a few studies have reported minor improvements in melting point temperatures for some proteins. Our study aims to investigate the effect of D2O on protein stability, using bovine serum albumin (BSA) as a model...
December 21, 2016: Pharmaceutical Development and Technology
Sakine Tuncay Tanrıverdi, Catalina Natalia Cheaburu-Yilmaz, Sonia Carbone, Özgen Özer
Melatonin-loaded hyaluronic acid (HA) and poly(vinyl alcohol) (PVA) gels were prepared by using freeze-thaw technique and an emulsion method followed by freeze-thaw technique to produce a new synergistic system for topical application. Freeze-thaw hydrogels and emulgels were characterized by means of Fourier transform infrared spectroscopy, rheology and swelling tests. The porous structure of the hydrogels was shown by scanning electron microscopy observations and thermal properties were tested by differential scanning calorimetry measurements...
December 20, 2016: Pharmaceutical Development and Technology
Tai Xia, Qin He, Kairong Shi, Yang Wang, Qianwen Yu, Li Zhang, Qianyu Zhang, Huile Gao, Lifang Ma, Ji Liu
The dense collagen network in tumors restricts the penetration of drugs into tumors. Free losartan could inhibit collagen, but it would cause hypotension at the dosage of 10 mg/kg/d. In this study, losartan was encapsulated in liposomes (LST-Lip) and the collagen inhibition ability of LST-Lip was investigated. Our results showed the blood pressure was not affected by LST-Lip at the dosage of 2.5 mg/kg every other day. The amount of Evans Blue in tumor in LST-Lip group was 1.98 times of that in control group...
December 15, 2016: Pharmaceutical Development and Technology
Preetanshu Pandey, Christopher Levins, Steve Pafiakis, Brian Zacour, Dilbir S Bindra, Jade Trinh, David Buckley, Shruti Gour, Shasad Sharif, Howard Stamato
The objective of this study was to improve the disintegration and dissolution characteristics of a highly water-soluble tablet matrix by altering the manufacturing process. A high disintegration time along with high dependence of the disintegration time on tablet hardness was observed for a high drug loading (70% w/w) API when formulated using a high-shear wet granulation (HSWG) process. Keeping the formulation composition mostly constant, a fluid-bed granulation (FBG) process was explored as an alternate granulation method using a 2((4-1)) fractional factorial design with two center points...
December 15, 2016: Pharmaceutical Development and Technology
Ramsharan Singh, Jin Chen, Teresa Miller, Michael Bergren, Rangan Mallik
PURPOSE: The objective of this study was to compare the stability of recently approved Captisol-stabilized propylene glycol-free melphalan injection (Evomela™) against currently marketed propylene glycol-based melphalan injection. The products were compared as reconstituted solutions in vials as well as admixture solutions prepared from normal saline in infusion bags. METHODS: Evomela and propylene glycol-based melphalan injection were reconstituted in normal saline and organic custom diluent, respectively, according to their package insert instructions...
December 14, 2016: Pharmaceutical Development and Technology
Min-Ho Park, Hye-Suk Jun, Jong-Woon Jeon, Jin-Kyu Park, Bong-Joo Lee, Guk-Hyun Suh, Jeong-Sook Park, Cheong-Weon Cho
Bee venom-loaded poly(lactic-co-glycolic acid) (PLGA) particles were prepared by double emulsion-solvent evaporation, and characterized for a sustained-release system. Factors such as the type of organic solvent, the amount of bee venom and PLGA, the type of PLGA, the type of polyvinyl alcohol, and the emulsification method were considered. Physicochemical properties, including the encapsulation efficiency, drug loading, particle size, zeta-potential and surface morphology were examined by Fourier transform infrared (FT-IR) spectroscopy, differential scanning calorimetry (DSC), and X-ray diffraction (XRD)...
December 14, 2016: Pharmaceutical Development and Technology
Maryam Maghsoodi, Ali Nokhodchi
AIM: The aim of the present research is to investigate the feasibility of agglomeration of crystals by the quasi emulsion solvent diffusion method without using a stabilizer. METHOD: Two solvent systems comprising a solvent and an antisolvent (water) were used to prepare celecoxib agglomerates. To this end, seven solvents including propanol, methyl acetate, methyl ethyl ketone, butanol, ethyl acetate, isopropyl acetate and pentanol were examined. The agglomerates were evaluated by micromeritic properties (e...
December 12, 2016: Pharmaceutical Development and Technology
Paweł Ramos, Barbara Pilawa
Free radicals in thermally treated chloramphenicol were examined by electron paramagnetic resonance (EPR) spectroscopy. The parameters and shape of EPR spectra were analysed and free radical concentrations were obtained in the tested drug samples. Chloramphenicol was thermally sterilized at pharmacopeia conditions: 100 °C (120 min). Sterilization was also carried out at different conditions, 110 °C (60 min) and 120 °C (30 min), for comparison with pharmacopeia settings. Microbiological analysis was performed on the samples to confirm sterility...
December 12, 2016: Pharmaceutical Development and Technology
Yu Xia, Chun-Yang Shi, Jian-Guo Fang, Wen-Qing Wang
Microcrystalline cellulose (MCC) is widely regarded as the excellent choice to manufacture pellets via wet extrusion-spheronisation (ES) process due to its excellent water uptake capability, water holding capacity, desirable rheological properties, cohesiveness and plasticity etc. Nevertheless, in spite of all these advantages, limitations associated with the application of MCC also have been reported. The most prevailing limitation is prolonged or incomplete drug release profile due to the lack of disintegration as pellet contracts significantly during the drying process, especially when in combination with poorly soluble drug at a high level...
December 9, 2016: Pharmaceutical Development and Technology
Azar Kajbafvala, Alireza Salabat, Anayatollah Salimi
The aim of this study was to develop a new microemulsion formulation for topical application of poorly soluble drug named quercetin. In order to design suitable microemulsion system, the pseudo-ternary phase diagrams of microemulsion systems were constructed at different surfactant/co-surfactant ratios using tween 80 as surfactant, transcutol(®) P as a co-surfactant and oleic acid as an oil phase. Some physicochemical properties such as droplet size, density, refractive index, electrical conductivity, pH, surface tension, and viscosity of the microemulsion systems were measured at 298...
December 9, 2016: Pharmaceutical Development and Technology
Muhammad Tayyab Ansari, Muhammad Sohail Arshad, Altaf Hussain, Zeeshan Ahmad
The purpose of this study was to investigate changes in the water solubility of artemether; a poorly soluble drug used for the treatment of malaria. Different solid dispersions (SDs) of artemether were prepared using artemether and polyethylene glycol 6000 at ratio 12:88 (Group 1), self-emulsified solid dispersions (SESDs) containing artemether, polyethylene glycol 6000, cremophor-A-25, olive oil, hydroxypropylmethylcellulose and transcutol in the ratio 12:75:5:4:2:2, respectively (Group 2). SESDs were also prepared by substituting cremophor-A-25 in Group 2 with poloxamer 188 (noted as Group 3)...
December 8, 2016: Pharmaceutical Development and Technology
Ahmad Ainurofiq, Syaiful Choiri
The purpose of this research was to develop an inclusion complex of meloxicam (MEL)/β-cyclodextrin (β-CD) incorporated into an orally disintegrating tablet (ODT), using statistical analysis to optimize the ODT formulation based on a quality by design (QbD) approach. MEL/β-CD complexation was performed by kneading, co-precipitation and spray drying methods under different molar ratios. Fourier transform infrared spectroscopy, X-ray diffraction and thermal analysis were utilized to evaluate the complexes. A central composite design (α = 2) was applied to optimize and assess the influence of Primojel, Primellose and crushing strength (CS) as independent variables on tablet friability, disintegration behavior, wicking properties and drug release...
December 8, 2016: Pharmaceutical Development and Technology
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