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Drug Development and Industrial Pharmacy

Tibor Casian, Sonia Iurian, Catalina Bogdan, Lucia Rus, Mirela Moldovan, Ioan Tomuta
OBJECTIVE: This study proposed the development of oral lyophilisates with respect to pediatric medicine development guidelines, by applying risk management strategies and DoE as an integrated QbD approach. METHODS: Product critical quality attributes were overviewed by generating Ishikawa diagrams for risk assessment purposes, considering process, formulation and methodology related parameters. Failure Mode Effect Analysis was applied to highlight critical formulation and process parameters with an increased probability of occurrence and with a high impact on the product performance...
August 16, 2017: Drug Development and Industrial Pharmacy
Martha-Estrella García-Pérez, Zoe Lemus-Rodríguez, Mario Hung-Arbelo, Marlen Vistel-Vigo
PURPOSE: Petiveria alliacea L. (Phytolaccaceae) is a perennial shrub used by its immunomodulatory, anticancerogenic and anti-inflammatory properties. This study determined the influence of polyvinylpyrrolidone (PVP), colloidal silicon dioxide (CSD) and microcrystalline cellulose (MC) on the technological characteristic of a high-dose P.alliacea tablet prepared by the wet granulation method. METHODOLOGY: The botanical and pharmacognostic analysis of the plant material was firstly performed, followed by a 2(3) factorial design considering three factors at two levels: a) the binder (PVP) incorporated in formulation at 10 and 15% (w/w); b) the compacting agent (CSD) added at 10 and 15% (w/w) and; c) the diluent (MC) included at 7...
August 1, 2017: Drug Development and Industrial Pharmacy
Tang Li, Li Chen, Yihui Deng, Xinrong Liu, Xiaoyun Zhao, Yiwen Cui, Jia Shi, Rui Feng, Yanzhi Song
As an anti-tumor drug, gemcitabine (Gem) is commonly used for the treatment of non-small cell lung cancer and pancreatic cancer. However, there are several clinical drawbacks to using Gem, including its extremely short plasma half-life and side effects. To prolong its half-life and reduce its side effects, we synthesized a derivative of Gem using cholesterol (Chol). This derivative, called gemcitabine-cholesterol (Gem-Chol) was entrapped into liposomes by a thin-film dispersion method. The particle size of the Gem-Chol liposomes was 112...
August 1, 2017: Drug Development and Industrial Pharmacy
Seitaro Kamiya, Kenichiro Nakashima
Nanoparticle suspensions are thermodynamically unstable and subject to aggregation. Freeze-drying on addition of saccharides is a useful method for preventing aggregation. In the present study, tetrasaccharides (stachyose) was employed as an additive. In addition, we hypothesize the interactive mechanism between stachyose and the nanoparticles during freeze-drying for the first time. The mean particle size of the rehydrated freeze-dried stachyose -containing nanoparticles (104.7 nm) was similar to the initial particle size before freeze-drying (76...
July 31, 2017: Drug Development and Industrial Pharmacy
Amira Mohamed Mohsen, Marwa Hasanein Asfour, Abeer A A Salama
The main objective of the present work was to formulate, characterize and evaluate silymarin (SM) loaded bilosomes, compared to conventional liposomes, aiming at increasing the hepatoprotective activity of the drug. SM loaded bilosomes were prepared by thin film hydration technique employing Soybean Phosphatidyl Choline (SPC) and different bile salts. After being subjected to different methods of characterization, SM loaded bilosomes were investigated for their hepatoprotective activity, in CCl4 hepatointoxicated rat model...
July 31, 2017: Drug Development and Industrial Pharmacy
Jingying Liu, Philip C Christophersen, Mingshi Yang, Hanne M Nielsen, Huiling Mu
OBJECTIVE: The present study aimed at elucidating the influence of polymorphic stability of lipid excipients on the physicochemical characterizations of different solid lipid microparticles (SLM), with the focus on the alteration of protein distribution in SLM. METHODS: Labeled lysozyme was incorporated into SLM prepared with different excipients, i.e. trimyristin (TG14), distearate (GDS) and glyceryl monostearate (GMS), by water-oil-water (w/o/w) or solid-oil-water (s/o/w) method...
July 29, 2017: Drug Development and Industrial Pharmacy
Yinghui Wei, Xiaoting Luo, Jiani Guan, Jianping Ma, Yicong Zhong, Jingwen Luo, Fanzhu Li
The aim of this work is to develop biodegradable nanoparticles for improved kidney bioavailability of rhein (RH). RH-loaded nanoparticles were prepared using an emulsification solvent evaporation method and fully characterized by several techniques. Kidney pharmacokinetics was assessed by implanting a microdialysis probe in rat's kidney cortex. Blood samples were simultaneously collected (via femoral artery) for assessing plasma pharmacokinetics. Optimized nanoparticles were small, with a mean particle size of 132...
July 26, 2017: Drug Development and Industrial Pharmacy
H Danafar, K Rostamizadeh, S Davaran, M Hamidi
Co-delivery strategy has been proposed to minimize the amount of each drug and to achieve the synergistic effect for cancer therapies. A conjugate of the antitumor drug, doxorubicin, with diblock methoxy poly (ethylene glycol)-poly caprolactone (mPEG-PCL) copolymer was synthesized by the reaction of mPEG-PCL copolymer with doxorubicin in the presence of p-nitrophenylchloroformate. The conjugated copolymer was characterized in vitro by (1)H NMR, FTIR, DSC and GPC techniques. Then, the doxorubicin conjugated mPEG-PCL(DOX-mPEG-PCL) was self-assembled into micelles in the presence of curcumin in aqueous solution...
July 24, 2017: Drug Development and Industrial Pharmacy
Neha Shah, Rahul Aware, Vasant Shetty, Tejal Mehta
The present work aims at studying process parameters affecting coating of minitablets (3 mm in diameter) through Wurster coating process. Minitablets of Naproxen with high drug loading were manufactured using 3 mm multi-tip punches. The release profile of core pellets (published) and minitablets was compared with that of marketed formulation. The core formulation of minitablets was found to show similarity in dissolution profile with marketed formulation and hence was further carried forward for functional coating over it...
July 24, 2017: Drug Development and Industrial Pharmacy
Marek Ochowiak, Magdalena Matuszak, Sylwia Włodarczak
OBJECTIVE: The paper contains results of the experimental studies on atomization process of inhaled drugs and aqueous solutions of glycerol with aqueous solutions of glycerol-polyacrylamide (Rokrysol WF1) in pneumatic nebulizers. In experiments the different concentration of aqueous solutions of glycerol-polyacrylamide have been tested. In addition, the effect of nebulizer design on atomization process has been determined. The one of the main elements of medical pneumatic nebulizer is nebulizer cup...
July 24, 2017: Drug Development and Industrial Pharmacy
Elham Zakerzadeh, Roya Salehi, Mehrdad Mahkam
Due to multidrug resistance of cancer tissues and immune-suppression of cancerous patients during chemotherapy in one hand and the use of tetrazole derivatives in medicine because of its anticancer, antifungal and antiviral properties, on the other, we were encouraged to design novel smart antibacterial nanocomposites-based polymer of tetrazole as dual anticancer drug delivery systems. The structures of nanocomposites characterized by FTIR, (1)H NMR, FESEM-EDX and TGA analyses and antibacterial activity of smart carriers were evaluated by determination of minimum inhibitory concentration (MIC) values against some bacteria and fungi...
July 20, 2017: Drug Development and Industrial Pharmacy
Bao Ngoc Tran, Hanh Thuy Nguyen, Jong Oh Kim, Chul Soon Yong, Chien Ngoc Nguyen
OBJECTIVES: Paclitaxel (PTX) has been indicated for treatment of a variety of solid tumors, while artesunate (ART) has been reported to have the potential for use in combination chemotherapy. In this study, the combination of ART and PTX was prepared in nanoparticle to induce the synergic effect and improve therapeutic efficiency in treatment of breast cancer Methods: Dual anti-cancer agents (PTX and ART) were loaded into Poly-D,L-lactic-co-glycolic acid (PLGA) nanoparticle (NP) by solvent evaporation technique from oil in water emulsion, stabilized with Tween 80...
July 20, 2017: Drug Development and Industrial Pharmacy
Kazem Nejati-Koshki, Younes Pilehvar-Soltanahmadi, Effat Alizadeh, Abbas Ebrahimi-Kalan, Yousef Mortazavi, Nosratollah Zarghami
Adipose tissue-derived stem cells (ASCs) are promising candidate in stem cell therapies, and maintaining their stemness potential is vital to achieve effective treatment. Natural based scaffolds have been recently attracted increasing attention in nanomedicine and drug delivery. In the present study, a polymeric nanofibrous scaffold was developed based on the polycaprolactone/Collagen (PCL/Coll) containing Emu oil as a bioactive material to induce the proliferation of ASCs, while simultaneously preserve the stemness property of those cells...
July 18, 2017: Drug Development and Industrial Pharmacy
Flavia Laffleur, Muhammad Ijaz, Claudia Menzel
This study aimed to screen the stability, disintegration, and swelling behavior of chemically modified anionic polymers. Investigated polymers were well-known and widely used staples of the pharmaceutical and medical field, namely, alginate (AL), carboxymethyl cellulose (CMC), polycarbophil (PC), and hyaluronic acid (HA). On the basis of amide bond formation between the carboxylic acid moieties of anionic polymers and the primary amino group of the modification ligand cysteine (CYS), the modified polymers were obtained...
July 18, 2017: Drug Development and Industrial Pharmacy
Anastasia Foppoli, Alessandra Maroni, Matteo Cerea, Lucia Zema, Andrea Gazzaniga
Dry coating techniques enable manufacturing of coated solid dosage forms with no, or very limited, use of solvents. As a result, major drawbacks associated with both organic solvents and aqueous coating systems can be overcome, such as toxicological, environmental and safety-related issues on one hand as well as costly drying phases and impaired product stability on the other. The considerable advantages related to solventless coating has been prompting a strong research interest in this field of pharmaceutics...
July 14, 2017: Drug Development and Industrial Pharmacy
Sumio Chono, Kohei Togami, Shirou Itagaki
OBJECTIVE: We have previously shown that aerosolized liposomes with dipalmitoyl phosphatidylcholine (DPPC) enhance the pulmonary absorption of encapsulated insulin. In this study, we aimed to compare insulin encapsulated into the liposomes versus co-administration of empty liposomes and unencapsulated free insulin, where the DPCC liposomes would serve as absorption enhancer. SIGNIFICANCE: The present study provides the useful information for development of noninvasive treatment of diabetes...
July 10, 2017: Drug Development and Industrial Pharmacy
Amir Hossein Mohammad Zadeh, Abdolhosein Rouholamini Najafabadi, Alireza Vatanara, Homa Faghihi, Kambiz Gilani
The influence of PEG (poly ethylene glycol) at different molecular weights and ratios was studied on the stability of freeze- dried IgG (immune globulin G). PEGs (600 to 4000 Dalton) at concentrations of 0.5 and 5% W/V were applied in the presence of 40 and 60% W/W of trehalose to prepare freeze- dried IgG formulations. Size- exclusion chromatography, Infra- red spectroscopy, Differential scanning calorimetery and Gel electrophoresis were performed to characterize lyophilized samples. Pure IgG demonstrated the highest aggregation of 5...
July 10, 2017: Drug Development and Industrial Pharmacy
Yasaman Soltani, Navid Goodarzi, Reza Mahjub
OBJECTIVE: The aim of this study was the preparation of a self nano-emulsifying drug delivery system (SNEDDS) for oral delivery of heparin. SIGNIFICANCE: Preparation of hydrophobic complexes between heparin as the hydrophilic macromolecule and cationic polymer of β-cyclodextrin (CPβCD) was considered for preparation of orally administered SNEDDS in which the drug incorporated in internal oil phase of O/W nano-droplets. METHOD: Hydrophobic complexes of heparin-CPβCD were prepared by electrostatic interaction...
July 7, 2017: Drug Development and Industrial Pharmacy
Qandeel Khalid, Mahmood Ahmad, Muhammad Usman Minhas
OBJECTIVE: This study was aimed to enhance aqueous solubility of dexibuprofen through designing β-cyclodextrin (βCD) hydrogel nanoparticles and to evaluate toxicological potential through acute toxicity studies in rats. SIGNIFICANCE: Dexibuprofen is a non-steroidal analgesic and anti-inflammatory drug that is one of safest over the counter medications. However, its clinical effectiveness is hampered due to poor aqueous solubility. METHODS: βCD hydrogel nanoparticles were prepared and characterized by percent yield, drug loading, solubilization efficiency, FTIR, XRD, DSC, FESEM and in-vitro dissolution studies...
July 6, 2017: Drug Development and Industrial Pharmacy
Ronak Savla, Jeff Browne, Vincent Plassat, Kishor M Wasan, Ellen K Wasan
Lipid-based drug delivery systems (LBDDS) are one of the most studied bioavailability enhancement technologies and are utilized in a number of U.S. Food and Drug Administration (FDA) approved drugs. While researchers have used several general rules of thumb to predict which compounds are likely to benefit from LBDDS, formulation of lipid systems is primarily an empiric endeavor. One of the challenges is that these rules of thumb focus in different areas and are used independently of each other. The Developability Classification System attempts to link physicochemical characteristics with possible formulation strategies...
July 6, 2017: Drug Development and Industrial Pharmacy
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