The main objective of this novel study was to develop chlorpheniramine maleate orally disintegrating films (ODF) using hot-melt extrusion technology and evaluate the characteristics of the formulation using in vitro and in vivo methods. Modified starch with glycerol was used as a polymer matrix for melt extrusion. Sweetening and saliva-simulating agents were incorporated to improve palatability and lower the disintegration time of film formulations. A standard screw configuration was applied, and the last zone of the barrel was opened to discharge water vapors, which helped to manufacture non-sticky, clear, and uniform films. The film formulations demonstrated rapid disintegration times (6–11 s) and more than 95% dissolution in 5 min. In addition, the films had characteristic mechanical properties that were helpful in handling and storage. An animal model was employed to determine the taste masking of melt-extruded films. The lead film formulation was subjected to a human panel for evaluation of extent of taste masking and disintegration.
Over the past few decades, nanocrystal formulations have evolved as promising drug delivery systems owing to their ability to enhance the bioavailability and maintain the stability of poorly water-soluble drugs. However, conventional methods of preparing nanocrystal formulations, such as spray drying and freeze drying, have some drawbacks including high cost, time and energy inefficiency, traces of residual solvent, and difficulties in continuous operation. Therefore, new techniques for the production of nanocrystal formulations are necessary. The main objective of this study was to introduce a new technique for the production of nanocrystal solid dispersions (NCSDs) by combining high-pressure homogenization (HPH) and hot-melt extrusion (HME). Efavirenz (EFZ), a Biopharmaceutics Classification System class II drug, which is used for the treatment of human immunodeficiency virus (HIV) type I, was selected as the model drug for this study. A nanosuspension (NS) was first prepared by HPH using sodium lauryl sulfate (SLS) and Kollidon® 30 as a stabilizer system. The NS was then mixed with Soluplus® in the extruder barrel, and the water was removed by evaporation. The decreased particle size and crystalline state of EFZ were confirmed by scanning electron microscopy, zeta particle size analysis, and differential scanning calorimetry. The increased dissolution rate was also determined. EFZ NCSD was found to be highly stable after storage for 6 months. In summary, the conjugation of HPH with HME technology was demonstrated to be a promising novel method for the production of NCSDs.
Pure phase exchange coupled nanocomposites of magnetically hard-soft oxides, (hard) SrFe12-yAlyO19 -(soft) x Wt.% Ni0.5Zn0.5Fe2O4 were prepared via one-pot autocombustion method. The hard-phase magnetic anisotropy was systematically varied via Al3+ doping and magnetic properties of the nanocomposites were assessed as a function of magnetic soft-phase content in the nanocomposite. As synthesized, ferrites were assessed for phase composition, crystallinity, and magnetic properties by using XRD and VSM respectively. Exchange coupling behavior was observed in nanocomposites for all soft phase content in the low field region up to 1200 Oe. Also, exchange coupling was observed to weaken with increase in Al3+ content in the hard phase of the composite. As a result of hard-soft exchange coupling, the saturation magnetization, reduced remanence, and Curie temperature were observed to be higher than those of pure SrFe12O19 hexaferrite. The present study is novel in its approach of tuning magnetic parameters of exchange-spring nanocomposites via systematically controlling magnetic parameters of the hard phase and content of the soft phase.
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