Current Issue : April - June Volume : 2020 Issue Number : 2 Articles : 6 Articles
In this study, the rapid expansion of the supercritical solutions (RESS) process was used\nto produce microparticles of a commonly used anti-inflammatory drug, ethenzamide. The effects\nof process parameters in RESS including the extraction temperature, pre-expansion temperature,\nand post-expansion temperature were investigated using the Boxâ??Behnken design. According to\nthe results of the analysis of variance (ANOVA), the effect of pre-expansion temperature is the most\nsignificant parameter on the mean size of RESS-produced ethenzamide. A higher pre-expansion\ntemperature benefits the production of smaller crystals............................
We have previously reported that heated powder mixtures of ibuprofen (IBU) and high\nsurface area nanocellulose exhibit an enhanced dissolution and solubility of the drug due to IBU\namorphization. The goal of the present work was to further elaborate the concept and conduct\nside-by-side in vitro drug release comparisons with commercial formulations, including film-coated\ntablets, soft gel liquid capsules, and IBU-lysine conjugate tablets, in biorelevant media. Directly\ncompressed tablets were produced from heated mixtures of 20% w/w IBU and high surface area\nCladophora cellulose (CLAD), with 5% w/w sodium croscarmelose (AcDiSol) as superdisintegrant.\nThe side-by side studies in simulated gastric fluid, fasted-state simulated intestinal fluid, and fed-state\nsimulated intestinal fluid corroborate that the IBU-CLAD tablets show more rapid and less variable\nrelease in various media compared to three commercial IBU formulations. On the sidelines of the\nmain work, a possibility of the presence of a new meta-crystalline form of IBU in mixture with\nnanocellulose is discussed....
Present study investigated most efficient technique for the development of atorvastatin calcium liposomes. Aorvastatin calcium is a HMG-Co reductase inhibitor widely used in the treatment or prevention of hypercholesterolemia, mixed hyperlipidemia, coronary heart disease or stroke. Our work is mainly focused on in-vitro studies of liposomal formulation encapsulated with atorvastatin calcium which may have high drug entrapment, effective vesicle size. Drug loaded liposomes were prepared by thin film hydration techniques using soya lecithin, cholesterol and surfactant in various molar ratios. Liposome was evaluated for vesicle size, entrapment efficiency, zeta potential and drug release parameters. Optimized batches of atorvastatin Ca liposomal formulations prepared by thin film hydration technique have shown drug release as 90.43% respectively....
Nanocrystal formation for the dissolution enhancement of glimepiride was attempted\nby wet media milling. Different stabilizers were tested and the obtained nanosuspensions were\nsolidified by spray drying in presence of mannitol, and characterized regarding their redispersibility\nby dynamic light scattering, physicochemical properties by differential scanning calorimetry (DSC),\nFT-IR spectroscopy, powder X-ray diffraction (PXRD), and scanning electron microcopy (SEM), as\nwell as dissolution rate. Lattice energy frameworks combined with topology analysis were used in\norder to gain insight into the mechanisms of particle fracture. It was found that nanosuspensions with\nnarrow size distribution can be obtained in presence of poloxamer 188, HPC-SL and Pharmacoat® 603\nstabilizers, with poloxamer giving poor redispersibility due to melting and sticking of nanocrystals\nduring spray drying. DSC and FT-IR studies showed that glimepiride does not undergo polymorphic\ntransformations during processing, and that the milling process induces changes in the hydrogen\nbonding patterns of glimepiride crystals. Lattice energy framework and topology analysis revealed\nthe existence of a possible slip plane on the (101) surface, which was experimentally verified by PXRD\nanalysis. Dissolution testing proved the superior performance of nanocrystals, and emphasized the\nimportant influence of the stabilizer on the dissolution rate of the nanocrystals....
In this study, we established a robust feed-forward control model for the tableting process\nby partial least squares regression using the near-infrared (NIR) spectra and physical attributes of\nthe granules to be compressed. The NIR spectra of granules are rich in information about chemical\nattributes, such as the compositions of any ingredients and moisture content. Polymorphism and\npseudo-polymorphism can also be quantitatively evaluated by NIR spectra. We used the particle\nsize distribution, flowability, and loose and tapped density as the physical attributes of the granules.\nThe tableting process was controlled by the lower punch fill depth and the minimum distance between\nthe upper and lower punches at compression, which were specifically related to the tablet weight\nand thickness, respectively. The feed-forward control of the process would be expected to provide\nsome advantages for automated and semi-automated continuous pharmaceutical manufacturing.\nAs a result, our model, using a combination of NIR spectra and the physical attributes of granules\nto control the distance between punches, resulted in respectable agreement between the predicted\nprocess parameters and actual settings to produce tablets of the desired thickness....
Continuous manufacturing (CM) is a promising strategy to achieve various benefits in\nthe context of quality, flexibility, safety and cost in pharmaceutical production. One of the main\ntechnical challenges of CM is that the process needs to handle transient conditions such as the start-up\nphase before state of control operation is reached, which can potentially cause out-of-specification\n(OOS) material. In this context, the presented paper aims to demonstrate that suitable process control\nstrategies during start-up of a continuous granulation and drying operation can limit or even avoid\nOOS material production and hence can ensure that the provided benefits of CM are not compromised\nby poor production yields. In detail, heat-up of the drying chamber prior the start of production\ncan lead to thermal energy being stored inside of the stainless-steel housing, acting as an energy\nbuffer that is known to cause over-dried granules in the first few minutes of the drying process.\nTo compensate this issue, an automatic ramping procedure of dryer rotation speed (and hence drying\ntime) was introduced into the plantâ??s process control system, which counteracts the excessive drying\ncapacity during start-up. As a result, dry granules exiting the dryer complied with the targeted\nintermediate critical quality attribute loss-on-drying (LOD) from the very beginning of production....
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