Current Issue : January - March Volume : 2015 Issue Number : 1 Articles : 6 Articles
The present study aimed at the formulation of matrix tablets for colon-specific drug delivery (CSDD) system of indomethacin\n(IDM) by applying liquisolid (LS) technique. A CSDD system based on time-dependent polymethacrylates and enzyme degradable\npolysaccharides was established. Eudragit RL 100 (E-RL 100) was employed as time-dependent polymer, whereas bacterial\ndegradable polysaccharides were presented as LS systems loaded with the drug. Indomethacin-loaded LS systems were prepared\nusing different polysaccharides, namely, guar gum (GG), pectin (PEC), and chitosan (CH), as carriers separately or in mixtures of\ndifferent ratios of 1 : 3, 1 : 1, and 3 : 1. Liquisolid systems that displayed promising results concerning drug release rate in both pH 1.2\nand pH 6.8 were compressed into tablets after the addition of the calculated amount of E-RL 100 and lubrication with magnesium\nstearate and talc in the ratio of 1 : 9. It was found that E-RL 100 improved the flowability and compressibility of all LS formulations.\nThe release data revealed that all formulations succeeded to sustain drug release over a period of 24 hours. Stability study indicated\nthat PEC-based LS system as well as itsmatrix tablets was stable over the period of storage (one year) and could provide a minimum\nshelf life of two years...
Nanomaterials, with their size range (1-100 nm) that corresponds\nto basic biological materials such as DNA, vastly increased surface\narea (1000 m2/g) and unique mechanical, electronic, photonic\nand magnetic properties are projected to have a wide range of\napplications from drug and gene delivery to biomedical imaging\nand more recently to personalized medicine. The major advantages\nof using nanomaterials as a carrier for anticancer agents are the\npossibility of targeted delivery to the tumor, tumor imaging, their\nability to hold thousands of molecules of a drug and also their ability\nto overcome solubility, stability and resistance issues. Currently,\nthere are several nanotechnology-enabled diagnostic and therapeutic\nagents undergoing clinical trials and a few are already approved by the\nFDA. Targeted delivery of anticancer agents is achieved by exploiting\na unique characteristic of the tumor cells called ââ?¬Å?the Enhanced\nPermeation and Retention Effect (EPR effect). In addition to this\npassive targeting based mainly on size, the nanoparticle surface may\nbe modified with a variety of ligands that would interact with specific\nreceptors over-expressed on the surface of the tumor cells, thus\nimparting specificity for active targeting. Site-specific release of a drug\ncontained in a nanoparticulate system by the application of external\nstimuli such as hyperthermia to a thermosensitive device is another\ninnovative strategy for targeted delivery. This review provides an\nupdate on the FDA approved cancer nanomedicines such as Abraxane,\nDoxil, daunoxome, Oncaspar, DepoCyt and those in nanoplatforms\nthat have reached an advanced stage of clinical development utilizing\nliposomes, lipid nanoparticles, lipoplexes, albumin nanospheres,\nthermosensitive devices, micelles and gold nanoparticles....
In this work, the response surface methodology was employed to optimize the microencapsulation of Agave tequilana Weber var.\nazul juice with whey protein isolated using a spray drying technique. A Box-Behnken design was used to establish optimum spray\ndrying conditions for Agave tequilana juice.The process was optimized to obtain maximum powder yield with the best solubility\ntime, hygroscopicity, bulk density, water activity, and reducing sugars. The independent parameters for the spray drying process\nwere outlet temperature of 70ââ?¬â??80?C, atomizer speed of 20000ââ?¬â??30000 rpm, and airflow of 0.20ââ?¬â??0.23m3 s?1. The best spray drying\ncondition was at outlet temperature of 80?C, atomizer speed of 20000 rpm, and air flow rate of 0.23m3 s?1 to obtain maximum\npowder yield (14.65%bm), minimum solubility time (352.8 s), maximum bulk density (560 kgm?3), minimum hygroscopicity (1.9Ã?â??\n10?7 kgwater s?1), and minimum ?? (0.39). The Agave tequilana powder may be considered as an interesting source of dietary fiber\nused as food additive in food and nutraceutical industries....
The purpose of this research was to prepare and evaluate the pantoprazole sodium enteric coated tablets using eudragit L30D55 as aqueous enteric polymer by dip coating technique and to optimize the critical process variables involved. Core tablets were prepared by wet granulation technique; prepared tablets were evaluated for physicochemical parameters and the results obtained are within acceptable limits. Results of preliminary trials indicate that inlet air temperature, dipping time and pan speed influences the efficiency of the coating process, critical coating parameters like inlet air temperature, dipping time and pan speed were optimized. Enteric coated tablets were evaluated for all physicochemical parameters and in-vitro drug release studies. The optimized batch showed better results when the dip time of 2 sec, inlet air temperature at 60 to 70°C and pan speed of 10 to 25 rpm were maintained....
In recent years, the concept of quality by design in (global) pharmaceutical development has received much attention. The purpose is to ensure that the compound under investigation will possess good drug characteristics such as identity, strength, purity, quality, safety, efficacy and stability before and post approval. A pharmaceutical development process consists of non-clinical (e.g., assay/process validation and stability testing), pre-clinical (e.g., animal and bioavailability/bioequivalence studies), and clinical (e.g., phases 1-3 clinical trials) development. In this article, various statistical designs that are commonly considered for achieving desired good drug characteristics as described in the United States Pharmacopeia and National Formulary (USP/NF) at various stages of non-clinical, pre-clinical, and clinical development are reviewed. In addition, the possible use of innovative adaptive clinical trial designs that may lead to (i) the identification of any signals, trends/patterns, and optimal clinical benefits of a test treatment under investigation, and (ii) increase the probability of success of the development process with limited resources available are discussed....
The following work aimed at validating the cleaning procedure of a vial filling machine. The machine was used for the dosing sterile powders of many products. It was necessary that it would clean efficiently between batches of the same product and between batches of different products. Ceftazidime pentahydrate was the product of choice as the worst case product for validating the cleaning procedure. A method was adopted for cleaning the machine using purified hot water. Visual examination and swab sampling were performed to ensure the absence of the active ingredient residues and micro-organisms. Rinse samples were also analyzed to ensure the validity of the cleaning procedure. Ceftazidime pentahydrate was analyzed using a reliable HPLC method of assay. Nonspecific methods for detecting residues in the final rinse as total organic carbon (TOC), conductivity and pH determination were employed. Results of sample analysis proved the validity of the cleaning procedure employed as no residues were detected and analysis results were all within the acceptance limits determined through calculations....
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