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Drug Development and Industrial Pharmacy

Jesse Xu, Hui Xin Ong, Daniela Traini, Michael Byrom, Jonathan Williamson, Paul M Young
Airway stents are commonly used in the management of patients suffering from central airway obstruction (CAO). CAO may occur directly from airway strictures, obstructing airway cancers, airway fistulas or tracheobronchomalacia, resulting from weakening and dynamic collapse of the airway wall. Current airway stents are constructed from biocompatible medical-grade silicone or from a nickel-titanium (nitinol) alloy with fixed geometry. The stents are inserted via the mouth during a bronchoscopic procedure. Existing stents have many shortcomings including the development of obstructing granulation tissue in the weeks and months following placement, mucous build up within the stent, and cough...
September 12, 2018: Drug Development and Industrial Pharmacy
Sahar Youssef Al-Okbi, Doha Abdou Mohamed, Thanaa El-Sayed Hamed, Sameh Hosam Abd El-Alim, Ahmed Alaa Kassem, Dina Mahmoud Mostafa
Chronic renal failure (CRF) is among the major health problems that could lead to increased morbidity and mortality among population. 'Nutraceuticals' is an emerging field for natural agents from plant foods that could reduce the progression of such disease. Many newly developed drugs are having bioavailability problems owing to their water insolubility. Liquisolid technique is one of the promising technological approaches to increase solubility and hence, drug absorption. The aim of the present research is to prepare and evaluate the renoprotective effect of the walnut extracts liquisolid formulations in CRF rat model...
September 11, 2018: Drug Development and Industrial Pharmacy
Nina Dragicevic, Danina Krajisnik, Jela Milic, Alfred Fahr, Howard Maibach
OBJECTIVE: The aim of this study was to develop, characterize and evaluate stability of a gel containing coenzyme Q10 (Q10 )-loaded liposomes, and enhance the stability of Q10 in the nanocarrier-containing gel compared to the conventional gel. METHODS: Q10 -loaded liposome dispersions prepared from unsaturated or saturated lecithin, were characterized for particle size, polydispersity index (PDI), zeta-potential, pH value, oxidation index, Q10 -content and morphology, and incorporated into carbomer gel...
September 11, 2018: Drug Development and Industrial Pharmacy
Rahul B Chavan, Anurag Lodagekar, Nalini R Shastri
Precipitation inhibitory potential of polymers screened from precipitation study may be altered once it is formulated in amorphous solid dispersions (ASDs). OBJECTIVE: Present study was embarked with an objective to determine whether the polymers retain the same inhibitory potential after formulating them into ASDs. METHODS: Screening of polymers was based on a new dimensionless parameter 'Supersaturation Holding Capacity (SHC)' calculated from the precipitation study...
September 11, 2018: Drug Development and Industrial Pharmacy
Nabeel Shahid, Muhammad Irfan Siddique, Zunera Razzaq, Haliza Katas, Muhammad Khurram Waqas, Kashif-Ur- Rahman
OBJECTIVE: This study was designed to optimize and develop matrix type transdermal drug delivery system (TDDS) containing tizanidine hydrochloride (TZH) using different polymers by solvent evaporation method. SIGNIFICANCE: A strong need exists for the development of transdermal patch having improved bioavailability at the site of action with fewer side effects at off-target organs. METHODS: The patches were physically characterized by texture analysis (color, flexibility, smoothness, transparency, and homogeneity), in vitro dissolution test and FTIR analysis...
September 11, 2018: Drug Development and Industrial Pharmacy
Wenhao Xu, Murong Wen, Jingbo Yu, Qihong Zhang, Nikolay E Polyakov, Alexandr V Dushkin, Weike Su
In this study, complexes of kaempferol (KF) with polysaccharide arabinogalactan (AG) and disodium glycyrrhizinate (Na2 GA) were prepared through mechanochemical technique to improve the solubility and bioavailability of KF. The physicochemical properties and the interactions of KF with AG/Na2 GA were investigated through dissolution, SEM, XRD, and DSC studies. The reduction of particle sizes and destruction of crystal forms revealed the formation of solid dispersion which may have assisted the dissolution of the drug...
September 11, 2018: Drug Development and Industrial Pharmacy
Jie Liao, Xiaoting Ren, Bowen Yang, Hou Li, Yuexin Zhang, Zongning Yin
Lumbrokinase (LK) has strong fibrinolytic and thrombolytic activities, but it has a short half-life, can be easily inactivated, and may cause hemorrhage as a side effect. This study develops a potential thrombolytic therapy by fabricating N,N,N-Trimethyl Chitosan (TMC) nanoparticles modified with the cyclic Arg-Gly-Asp-Phe-Lys peptide (c-RGD) and loaded with LK (i.e., c-RGD-LK-NPs). The binding of c-RGD to platelet membrane GPIIb/IIIa receptors is expected to enable targeted delivery of the c-RGD-conjugated TMC to the thrombus...
September 10, 2018: Drug Development and Industrial Pharmacy
Jingwen Luo, Jiang Sun, Xiaoting Luo, Yinghui Wei, Hangsheng Zheng, Chaofeng Mu, Wenjie Yao
OBJECTIVE: This paper aims to design low molecular weight chitosan(LMWC) based conjugates of Rhein(RH) by means of an amino acid linker (Alanine) for improved solubility and enhanced bioavailability. SIGNIFICANCE: Rhein is a potential candidate for the therapy of kidney disease. However, the poor solubility, inadequate bioavailability and lack of proper formulation restrict its clinical applicability. Low molecular weight chitosan-drug conjugates offer the potential to improve the water-solubility of RH, increase its oral absorption, and thereby, enhance its bioavailability...
September 10, 2018: Drug Development and Industrial Pharmacy
Hong Yu, Li Ming Lim, Bingxue Dong, Kunn Hadinoto
OBJECTIVES: To carry out a proof-of-concept study on the development of dual-drug amorphous nanoparticle complex (nanoplex in short) as a potential formulation platform for fixed-dose combination (FDC) of poorly-soluble drugs. SIGNIFICANCE: FDC has been proven effective in improving patient compliance for treatment that requires complex multidrug regimen. Currently, there is growing interest to develop FDC of poorly-soluble drugs due to the increased number of drugs exhibiting poor solubility thus low bioavailability...
September 10, 2018: Drug Development and Industrial Pharmacy
Mehtap Saydam, Sevgi Takka
The main objective of this study was the development of pH-independent controlled release valsartan matrix tablet in Quality by design (QbD) framework. The quality target product profile (QTPP), critical quality attributes (CQAs) and critical material attributes (CMAs) were defined by science and risk-based methodologies. Potential risk factors were identified with Fishbone diagram. Following, CMAs were further investigated with a semi-quantitative risk assessment method, which has been revised with mitigated risks after development and optimization studies...
September 10, 2018: Drug Development and Industrial Pharmacy
Vivek Viswanathan, Rajesh Pharande, Anilkumar Bannalikar, Pushpa Gupta, Umesh Gupta, Alka Mukne
OBJECTIVE: The current study involves the development of liposomal dry powder for inhalation (LDPI) containing licorice extract (LE) for use in tuberculosis. SIGNIFICANCE: The current epidemiology of tuberculosis along with the increasing emergence of resistant forms of tuberculosis necessitates the need for developing alternative efficacious medicines for treatment. Licorice is a medicinal herb with reported activity against Mycobacterium tuberculosis. METHODS: Liposomes with LE were prepared by thin film hydration technique and freeze dried to obtain LDPI...
September 7, 2018: Drug Development and Industrial Pharmacy
Nusaiba K Al-Nemrawi, Juliana Marques, Carlos J Tavares, Rami J Oweis, Mohamed G Al-Fandi
The aim of this work is to prepare ultraviolet (UV) triggered controlled release of compounds from microcapsule systems (MCs). Polyurethane (PU) and poly(methyl methacrylate) (PMMA) microcapsules were studied with/without chemical functionalization using photocatalytic TiO2 nanoparticles (NPs) on their surface. Once TiO2 nanoparticles are illuminated with UV light (λ = 370 nm), they initiate the rupture of the polymeric bonds of the microcapsule and subsequently initiate the encapsulated compound release, methotrexate (MTX) or rhodamine (Rh), in the present work...
September 7, 2018: Drug Development and Industrial Pharmacy
Mahima Mathur, Kusum Devi Vemula
Different nanoparticles, namely solid lipid nanoparticles, nanocrystals and nanosponges loaded with atorvastatin were successfully fabricated with desirable technological properties which reckoned promising methods of their preparation. Further, suitable characterization and evaluation parameters for in-vitro and in-vivo studies were conducted which led to increase in drug's bioavailability, provided better in-vivo efficacy and reduced toxicity in treating hyperlipidemia systemically. Particle sizes were found to be less than 300 nm with minimal polydispersity indices and maximized entrapment efficiency which are pre-requisites for their absorption in intestines...
September 7, 2018: Drug Development and Industrial Pharmacy
Peter Grdešič, Tamás Sovány, Ilija German Ilić
CONTEXT: Knowledge of the effects of high-shear granulation process parameters and scale-up on the properties of the produced granules is essential for formulators who face challenges regarding poor flow and compaction during development of modified release tablets based on high-molecular weight hypromellose (hydroxypropylmethylcellulose (HPMC)) polymers. Almost none of the existing studies deal with realistic industrial formulation. OBJECTIVE: The aim was to investigate the effects of scale-up and critical process parameters (CPPs) of high-shear granulation on the quality attributes of the granules, particularly in terms of the flow and compaction, using a realistic industrial formulation based on HPMC K100M polymer...
September 7, 2018: Drug Development and Industrial Pharmacy
Julie Babyar
Substandard, falsified, and counterfeit medications are a concern for the industry and for the public's health. Data collection and research on these illegitimate drugs must continue to be a priority and common recommendations must be implemented immediately. The health of the public continues to be at risk, and as such global consensus and collaboration must be swift. Process improvements and policy decisions can support expert recommendations while technology and research continue to drive home change. Addressing counterfeit and substandard drugs is cost effective, feasible, and the right thing to do...
September 5, 2018: Drug Development and Industrial Pharmacy
Yunyun Di, Ellen K Wasan, Jacqueline Cawthray, Kishor M Wasan
PURPOSE: CPX-351 is a liposomal formulation of cytarabine and daunorubicin encapsulated at a 5:1 molar ratio, for the treatment of acute myeloid leukemia. The Scavenger Receptor class B type I (SR-BI) plays an important role in mediating the uptake of high-density lipoproteins. The purpose of this study is to assess the role of the cell surface lipoprotein receptor SR-BI in the uptake of CPX-351 liposomes (Jazz Pharmaceuticals) into K562 leukemia cells. METHODS: K562 cells were pre-treated with 10 nM siRNA for 48 h and then treated with varying amount of CPX-351 for 24, 48 and 72 h...
September 5, 2018: Drug Development and Industrial Pharmacy
Deeb Abu Fara, Iyad Rashid, Khouloud Alkhamis, Mahmoud Al-Omari, B Z Chowdhry, Adnan Badwan
Roller compaction was used to prepare a direct-compressed lactose excipient using crystalline α-lactose monohydrate. The effect of various roller compaction process parameters (compaction pressure, compaction repetition, and speed ratio) on the characteristics of compacted α-lactose monohydrate was investigated. Results were compared with data obtained using industrial spray-dried lactose and lactose samples with different degrees of crystallinity. XRPD analysis revealed that roller compaction reduced the crystallinity of α-lactose monohydrate, and the resulting material is similar to spray-dried lactose in behavior as a direct compression excipient...
September 5, 2018: Drug Development and Industrial Pharmacy
Mahsa Tarantash, Hamed Nosrati, Hamidreza Kheiri Manjili, Ali Baradar Khoshfetrat
In this study, magnetic nanoparticles (MNPs) coated with L-aspartic acid (F-Asp NPs) were synthesized through a co-precipitation method and conjugated with paclitaxel (PTX) (F-Asp-PTX NPs) by esterification reaction between the carboxylic acid end groups on MNPs surface and the hydroxyl groups of the PTX and studied its cytotoxic effect in vitro. The successful conjugating of PTX onto the nanoparticles (NPs) was confirmed by X-ray diffraction (XRD), thermogravimetric analysis (TGA), differential scanning calorimetry (DSC), fourier transform infrared spectroscopy (FTIR), vibrating sample magnetometer (VSM) and transmission electron microscopy (TEM) techniques...
September 5, 2018: Drug Development and Industrial Pharmacy
Heather J Boyce, Ahmed Ibrahim, Stephen W Hoag
OBJECTIVE: The monitoring and evaluation of sintering-induced tablet strength of a polyethylene oxide (PEO) based placebo tables was accomplished using infrared spectroscopy (NIRS). SIGNIFICANCE: Evaluation of high molecular weight PEO-based tablet matrices for abuse deterrent formulation applications is an analytical challenge. NIRS is one tool that can provide physical and chemical evaluation of this polymer and tablet system. In addition, the use of NIRS as a process analytical tool (PAT) to monitor oven sintering of pharmaceutical tablets has not been recorded in the literature...
September 5, 2018: Drug Development and Industrial Pharmacy
Heba F Salem, Rasha M Kharshoum, Ossama M Sayed, Lekaa F Abdel Hakim
BACKGROUND: The present study describes glycerosomes (vesicles composed of phospholipids, glycerol and water) as a novel drug delivery system for topical application of celecoxib (CLX) and cupferron (CUP) compound. AIM: The goal of this research was to design topical soft innovative vesicles loaded with CLX or CUP for enhancing the efficacy and avoiding systemic toxicity of CLX and CUP. METHODS: CLX and CUP loaded glycerosomes were prepared by hydrating phospholipid-cholesterol films with glycerol aqueous solutions (20-40%, v/v)...
September 5, 2018: Drug Development and Industrial Pharmacy
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