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Drug Development and Industrial Pharmacy

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https://www.readbyqxmd.com/read/28166428/design-of-experiments-doe-in-pharmaceutical-development
#1
Stavros N Politis, Paolo Colombo, Gaia Colombo, Dimitrios M Rekkas
At the beginning of the 20(th) century, Sir Ronald Fisher introduced the concept of applying statistical analysis during the planning stages of research rather than at the end of experimentation. When statistical thinking is applied from the design phase, it enables to build quality into the product, by adopting Deming's profound knowledge approach, comprising system thinking, variation understanding, theory of knowledge and psychology. The pharmaceutical industry was late in adopting these paradigms, compared to other sectors...
February 6, 2017: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/28165803/tanshinol-sustained-release-pellets-with-absorption-enhancer-optimization-characterization-pharmacokinetics-and-pharmacodynamics
#2
Panpan Yu, Shuangshuang Zhang, Wenli Zhang, Jikun Yang, Jing Lu, Jianping Liu
The objective of this study was to develop tanshinol sustained-release pellets (TS-SRPs) for the treatment of angina. Considering the poor intestinal absorption of TS, sodium caprate (SC) was used as an absorption enhancer for bioavailability improvement. Single-pass intestinal perfusion in rats demonstrated that the permeability of TS was remarkably enhanced, when the weight ratio of TS to SC was 1:3. Then, the cores were prepared with TS, SC and MCC at a weight ratio of 1:3:16 via extrusion-spheronization, followed by coating with Eudragit® RS30D/RL30D dispersion (9:1, w/w)...
February 6, 2017: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/28161991/stabilizing-ability-of-surfactant-on-physicochemical-properties-of-drug-nanoparticles-generated-from-solid-dispersions
#3
Thanu Thongnopkoon, Satit Puttipipatkhachorn
This study was aimed to examine the nanoparticle formation from redispersion of binary and ternary solid dispersions. Binary systems composed of various ratios of glibenclamide (GBM) and polyvinylpyrrolidone K30 (PVP-K30), whereas a constant amount at 2.5%w/w of a surfactant, sodium lauryl sulfate (SLS) or Gelucire44/14 (GLC), was added to create ternary systems. GBM nanoparticles were collected after the systems were dispersed in water for 15 minutes. The obtained nanoparticles were characterized for size distribution, crystallinity, thermal behavior, molecular structure, and dissolution properties...
February 6, 2017: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/28161984/formulation-of-piperine-solid-lipid-nanoparticles-sln-for-treatment-of-rheumatoid-arthritis
#4
M R Bhalekar, A R Madgulkar, Puja S Desale, Gyce Marium
The purpose of this work was to formulate piperine solid lipid nanoparticle (SLN) dispersion to exploit its efficacy orally and topically. Piperine-SLN were prepared by melt emulsification method and formula was optimized by the application of 3(2) factorial design. The nanoparticulate dispersion was evaluated for particle size, entrapment efficiency (EE) and zeta potential(ZP). Optimized batch (128.80 nm average size, 78.71% EE and -23.34 Mv Zeta Potential) was characterized for differential scanning calorimetry (DSC), X-ray diffraction(XRD) which revealed amorphous nature of piperine in SLN...
February 6, 2017: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/28157445/creatinine-based-non-phospholipid-vesicular-carrier-for-improved-oral-bioavailability-of-azithromycin
#5
Shafi Ullah, Muhammad Raza Shah, Mohammad Shoaib, Muhammad Imran, Syed Wadood Ali Shah, Imdad Ali, Farid Ahmed
CONTEXT: Novel, safe, efficient and cost effective nano-carriers from renewable resources have got greater interest for enhancing solubility and bioavailability of hydrophobic dugs. OBJECTIVES: This study reports the synthesis of a novel biocompatible non-phospholipid human metabolite "Creatinine" based niosomal delivery system for Azithromycin improved oral bioavailability. METHODS: Synthesized surfactant was characterized through spectroscopic and spectrometric techniques and then evaluated for niosomal vesicles formation potential using Azithromycin as model drug...
February 3, 2017: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/28142290/nanoparticulate-strategies-for-the-treatment-of-polyglutamine-diseases-by-halting-the-protein-aggregation-process-%C3%A2
#6
Oscar Escalona-Rayo, Paulina Fuentes-Vázquez, Gerardo Leyva-Gómez, Bulmaro Cisneros, Rafael Villalobos, Jonathan J Magaña, David Quintanar-Guerrero
Polyglutamine (polyQ) diseases are a class of neurodegenerative disorders that cause cellular dysfunction and, eventually, neuronal death in specific regions of the brain. Neurodegeneration is linked to the misfolding and aggregation of expanded polyQ-containing proteins, and their inhibition is one of major therapeutic strategies used commonly. However, successful treatment has been limited to date because of the intrinsic properties of therapeutic agents (poor water solubility, low bioavailability, poor pharmacokinetic properties), and difficulty in crossing physiological barriers, including the blood-brain barrier (BBB)...
January 31, 2017: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/28076697/development-and-characterization-of-a-mucoadhesive-sublingual-formulation-for-pain-control-extemporaneous-oxycodone-films-in-personalized-therapy
#7
Brunella Parodi, Eleonora Russo, Sara Baldassari, Guendalina Zuccari, Sara Pastorino, Mengying Yan, Karthik Neduri, Gabriele Caviglioli
OBJECTIVE: The aim of this work was the development of mucoadhesive sublingual films, prepared using a casting method, for the administration of oxycodone. MATERIALS AND METHODS: A solvent casting method was employed to prepare the mucoadhesive films. A calibrated pipette was used to deposit single aliquots of different polymeric solutions on a polystyrene plate lid. Among the various tested polymers, hydroxypropylcellulose at low and medium molecular weight (HPC) and pectin at two different degrees of esterification (PC) were chosen for preparing solutions with good casting properties, capable of producing films suitable for mucosal application...
January 31, 2017: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/27977311/flurbiprofen-loaded-niosomes-in-gel-system-improves-the-ocular-bioavailability-of-flurbiprofen-in-the-aqueous-humor
#8
Marwa M El-Sayed, Amal K Hussein, Hatem A Sarhan, Heba F Mansour
The present work aimed to prolong the contact time of flurbiprofen (FBP) in the ocular tissue to improve the drug anti-inflammatory activity. Different niosome systems were fabricated adopting thin-film hydration technique and using the nonionic surfactant Span 60. The morphology of the prepared niosomes was characterized by scanning electron microscopy (SEM). Physical characterization by differential scanning calorimetry, X-ray powder diffraction and Fourier transform infrared spectroscopy were conducted for the optimized formula (F5) that was selected on the basis of percent entrapment efficiency, vesicular size and total lipid content...
January 31, 2017: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/28128647/preparation-and-evaluation-of-metoprolol-tartrate-sustained-release-pellets-using-hot-melt-extrusion-combined-with-hot-melt-coating
#9
Yan Yang, Lian Shen, Juan Li, Weiguang Shan
The objective of this study was to prepare and evaluate metoprolol tartrate sustained-release pellets. Cores were prepared by hot melt extrusion and coated pellets were prepared by hot melt coating. Cores were found to exist in a single-phase state and drug in amorphous form. Plasticizers had a significant effect on torque and drug content, while release modifiers and coating level significantly affected the drug release behavior. The mechanisms of drug release from cores and coated pellets were Fickian diffusion and diffusion-erosion, respectively...
January 27, 2017: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/28122460/co-milled-api-lactose-systems-for-inhalation-therapy-impact-of-magnesium-stearate-on-physico-chemical-stability-and-aerosolization-performance
#10
Michael Lau, Paul M Young, Daniela Traini
CONTEXT: Particle micronization for inhalation can impart surface disorder (amorphism) of crystalline structures. This can lead to stability issues upon storage at elevated humidity from recrystallization of the amorphous state, which can subsequently affect the aerosol performance of the dry powder formulation. OBJECTIVE: The aim of this study was to investigate the impact of an additive, magnesium stearate (MGST), on the stability and aerosol performance of co-milled active pharmaceutical ingredient (API) with lactose...
January 26, 2017: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/28122459/increased-dissolution-rates-of-tranilast-solid-dispersions-extruded-with-inorganic-excipients
#11
M Maniruzzaman, S A Ross, M T Islam, N Scoutaris, A Nair, Dennis Douroumis
The purpose of this study was to evaluate the performance of Neusilin® (NEU) a synthetic magnesium aluminometasilicate as inorganic drug carrier co-processed with the hydrophilic surfactants Labrasol and Labrafil to develop Tranilast (TLT) based solid dispersions using continuous melt extrusion (HME) processing. Twin - screw extrusion was optimized to develop various TLT/excipient/surfactant formulations followed by continuous capsule filling in the absence of any downstream equipment. Physicochemical characterisation showed the existence of TLT in partially crystalline state in the porous network of inorganic NEU for all extruded formulations...
January 26, 2017: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/28121206/a-reconstituted-thermosensitive-hydrogel-system-based-on-paclitaxel-loaded-amphiphilic-copolymer-nanoparticles-and-antitumor-efficacy
#12
Yanqin Liang, Chengxia Dong, Jianhua Zhang, Liandong Deng, Anjie Dong
Combination delivery systems composed of injectable hydrogels and drug-incorporated nanoparticles are urgently in regional cancer chemotherapy to facilitate efficient delivery of chemotherapeutic agents, enhance antitumor efficiency and decrease side effects. Here, we developed a novel thermosensitive amphiphilic triblock copolymer consisting of methoxy poly(ethylene glycol), poly(octadecanedioic anhydride) and D,L-lactic acid oligomer (PEOALA), built a combination system of thermosensitive injectable hydrogel PTX/PEOALA(Gel) based on paclitaxel (PTX)-loaded PEOALA nanoparticles (NPs)...
January 25, 2017: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/28121196/nanoethosomes-for-transdermal-delivery-of-tropisetron-hcl-multi-factorial-predictive-modeling-characterization-and-ex-vivo-skin-permeation
#13
Hanaa A Abdel Messih, Rania A H Ishak, Ahmed S Geneidi, Samar Mansour
OBJECTIVE: The aim of the present work is to exclusively optimize and model the effect of phospholipid type either egg phosphatidylcholine (EPC) or soybean phosphatidylcholine (SPC), together with other formulation variables, on the development of nano-ethosomal systems for transdermal delivery of a water-soluble antiemetic drug. Tropisetron HCl (TRO) is available as hard gelatin capsules and IV injections. The transdermal delivery of TRO is considered as a novel alternative route supposing to improve BAV as well as patient convenience...
January 25, 2017: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/28121194/in-vitro-characterization-studies-of-self-microemulsified-bosentan-systems
#14
Harini Chowdary Vadlamudi, Prasanna Raju Yalavarthi, M V Basaveswara Rao, Arun Rasheed, Tejeswari N
CONTEXT: Bosentan is a poorly soluble drug and pose challenges in design delivery systems. OBJECTIVE: To enhance the solubility, dissolution and shelf-life of bosentan by formulating it as S-SMEDDS capsules. MATERIALS AND METHODS: Solubility of bosentan was tested in various liquid vehicles such as oils (rice bran and sunflower), surfactants (span 20 and tween 80) and co-surfactants (PEG 400 and propylene glycol) and microemulsions were developed...
January 25, 2017: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/28121189/amorphous-nanoparticle-complex-of-perphenazine-and-dextran-sulfate-as-a-new-solubility-enhancement-strategy-of-antipsychotic-perphenazine
#15
Bingxue Dong, Kunn Hadinoto
OBJECTIVE: To develop a new solubility enhancement strategy of antipsychotic drug - perphenazine (PPZ) - in the form of its amorphous nanoparticle complex (or nanoplex) with polyelectrolyte dextran sulfate (DXT). SIGNIFICANCE: Poor bioavailability of PPZ necessitated the development of fast-dissolving PPZ formulations regardless of delivery routes. Existing fast-dissolving formulations, however, exhibited low PPZ payload. The high-payload PPZ-DXT nanoplex represents an attractive fast-dissolving formulation, as dissolution rate is known to be proportional to payload...
January 25, 2017: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/28105857/feasibility-of-obtaining-in-situ-nanocapsules-through-modified-self-microemulsifying-drug-delivery-systems-a-new-manufacturing-approach-for-oral-route-administration
#16
Viridiana Gisela Llera-Rojas, L Alicia Del Real, Néstor Mendoza-Muñoz, Luz María Melgoza-Contreras, David Quintanar-Guerrero
Nanocapsules (NCs) are submicron-sized core shell systems which present important advantages such as improvement of drug efficacy and bioavailability, prevention of drug degradation, and provision of controlled-release delivery. The available methods for NC production require expensive recovery and purification steps which compromised the morphology of nanocapsules. Industrial applications of NCs have been avoided due to the aforementioned issues. In this study, we developed a new method based on a modified self automicroemulsifying drug delivery system (SMEDDS) for in situ NCs production within the gastrointestinal tract...
January 20, 2017: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/28102715/capsaicin-pretreatment-enhanced-the-bioavailability-of-fexofenadine-in-rats-by-p-glycoprotein-modulation-in-vitro-in-situ-and-in-vivo-evaluation
#17
Satish Kumar Bedada, Ramgopal Appani, Praveen Kumar Boga
BACKGROUND AND OBJECTIVE: Capsaicin is the main pungent principle present in chilli peppers has been found to possess P-glycoprotein (P-gp) inhibition activity in vitro, which may have the potential to modulate bioavailability of P-gp substrates. Therefore, purpose of the present study was to evaluate the effect of capsaicin on intestinal absorption and bioavailability of fexofenadine, a P-gp substrate in rats. METHODS: The mechanistic evaluation was determined by non-everted sac and intestinal perfusion studies to explore the intestinal absorption of fexofenadine...
January 19, 2017: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/28044468/investigations-on-pharmacokinetics-and-biodistribution-of-polymeric-and-solid-lipid-nanoparticulate-systems-of-atypical-antipsychotic-drug-effect-of-material-used-and-surface-modification
#18
Emil Joseph, Ranendra N Saha
The present study focuses on the effect of material used for the preparation of nanoparticulate (NP) systems and surface modification on the pharmacokinetics and biodistribution of atypical antipsychotic, olanzapine (OLN). NP carriers of OLN were prepared from two different materials such as polymer (polycaprolactone) and solid lipid (Glyceryl monostearate). These systems were further surface modified with surfactant, Polysorbate 80 and studied for pharmacokinetics-biodistribution in Wistar rats using in-house developed bioanalytical methods...
January 18, 2017: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/28032521/the-influence-of-direct-compression-powder-blend-transfer-method-from-the-container-to-the-tablet-press-on-product-critical-quality-attributes-a-case-study
#19
Michał Teżyk, Emilia Jakubowska, Kasylda Milczewska, Bartłomiej Milanowski, Adam Voelkel, Janina Lulek
OBJECTIVE: The aim of this article is to compare the gravitational powder blend loading method to the tablet press and manual loading in terms of their influence on tablets' critical quality attributes (CQA). SIGNIFICANCE: The results of the study can be of practical relevance to the pharmaceutical industry in the area of direct compression of low-dose formulations, which could be prone to content uniformity (CU) issues. METHODS: In the preliminary study, particle size distribution (PSD) and surface energy of raw materials were determined using laser diffraction method and inverse gas chromatography, respectively...
January 17, 2017: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/28005437/self-nanoemulsifying-granules-snegs-of-meloxicam-preparation-characterization-molecular-modeling-and-evaluation-of-in-vivo-anti-inflammatory-activity
#20
Vidhi J Parekh, Namita D Desai, Mushtaque S Shaikh, Ujwala A Shinde
Meloxicam, a BCS class II drug belonging to the class of NSAIDs is indicated in conditions of rheumatoid arthritis, ankylosing spondylitis and osteoarthritis in which rapid onset of drug action is desired to reduce inflammation and pain. The objective of the study was to thus develop Self Nanoemulsifying Granules (SNEGs) of Meloxicam (MLX) for enhancement of solubility; and subsequently dissolution rate, thus aiming for a faster onset of action. Preliminary studies along with molecular modeling studies were carried out for selection of appropriate lipids, surfactants and cosurfactants for the development of MLX-loaded Self Nanoemulsifying preconcentrate (SNEP)...
January 17, 2017: Drug Development and Industrial Pharmacy
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