Search Results (4)

Background/Objectives: Improving the production rates of modern tablet presses places ever greater demands on the performance of excipients. Although co-processing has emerged as a promising solution, there is still a lack of directly compressible excipients for modified-release formulations. The aim of the present study was to address this issue by investigating the potential of novel co-processed excipients for the manufacture of modified-release tablets containing ibuprofen. Methods: The excipients were prepared by melt granulation of lactose monohydrate with glyceryl palmitostearate as a binder. The influence of glyceryl palmitostearate particle size, ibuprofen content, compression pressure, and compression speed on the compaction behavior of the tablet blends was analyzed. Results: Novel co-processed excipients ensured good flowability and acceptable mechanical properties of the tablets containing up to 70% ibuprofen. Furthermore, lipid-based co-processed excipients proved to be very promising for directly compressible formulations with high-dose, highly adhesive active pharmaceutical ingredients such as ibuprofen, as they do not require additional lubricants. The influence of compression speed on the tensile strength of the tablets prepared was not pronounced, indicating the robustness of these directly compressible excipients. The investigated lipid-based excipients enabled a prolonged release of ibuprofen over 10 h. Conclusions: The novel lipid-based co-processed excipients have shown great potential for directly compressible formulations with modified release of high-dose, challenging active pharmaceutical ingredients. Full article

The aim of this work was to study the purification of silicon kerf loss waste (KLW) by a combination of single-acid leaching followed by inductive melting at high temperatures with an addition of fluidized bed reactor (FBR) silicon granules. The KLW indicated an average particle size (D50) of approximately 1.6 µm, and a BET surface area of 30.4 m²/g. Acid leaching by 1 M HCl indicated significant removal of impurities such as Ni (77%), Fe (91%) and P (75%). The combined two-stage treatment resulted in significant removal of the major impurities: Al (78%), Ni (79%), Ca (85%), P (92%) and Fe (99%). The general material loss during melting decreased with an increasing amount of FBR silicon granules which aided in the melting process and indicated better melting. It was observed that the melting behavior of the samples improved as the temperature increased, with complete melting being observed throughout the crucibles at the highest temperature (1800 °C) used, even without any additives. At lower temperatures (1600 °C–1700 °C) and lower FBR-Si (<30 wt.%) additions, the melting was incomplete, with patches of molten silicon and a lot of surface oxidation as confirmed by both visual observation and electron microscopy. In addition, it was indicated that more reactive and volatile elements (Ga, Mg and P) compared to silicon are partially removed in the melting process (51–87%), while the less reactive elements end up in the final silicon melt. It was concluded that if optimized, the combined treatment of single-acid leaching and inductive melting with the addition of granular FBR silicon has great potential for the recycling of KLW to solar cells and similar applications. Moreover, the application of higher melting temperatures is accompanied by a higher silicon yield of the process, and the involved mechanisms are presented. Full article

Several studies have demonstrated the feasibility of in situ co-crystallization in different pharmaceutical processes such as spray drying, hot melt extrusion, and fluidized bed granulation (FBG) to produce co-crystal-in-excipient formulations. However, no previous studies have examined such a one step in situ co-crystallization process for co-crystal formulations where the coformer is a polymer. In the current study, we explored the use of FBG to produce co-crystal granules of dapsone (DAP) and different molecular weight polyethylene glycols (PEGs). Solvent evaporation (SE) was proven to generate DAP-PEGs co-crystals at a particular weight ratio of 55:45 w/w between DAP and PEG, which was subsequently used in FBG, using microcrystalline cellulose and hydroxypropyl methyl cellulose as filler excipient and binder, respectively. FBG could generate co-crystals with higher purity than SE. Granules containing DAP-PEG 400 co-crystal could be prepared without any additional binder. DAP-PEG co-crystal granules produced by FBG demonstrated superior pharmaceutical properties, including flow properties and tableting properties, compared to DAP and DAP-PEG co-crystals prepared by SE. Overall, in situ co-crystallization via FBG can effectively produce API-polymer co-crystals and enhance the pharmaceutical properties. Full article

The understanding of granule growth mechanisms and the effects of formulation and operating conditions over product quality and process performance in fluidized bed co-melt granulation is nowadays of great interest. In this sense, this work systematically studies the combined effects of binder content (W_PEG) and fluidization air flowrate (F_A) and temperature (T_A) on granules’ quality and process-related variables (product mass (M_P), elutriated fines (M_f), mass stuck on walls (M_W)) by using a Box–Behnken-type design of experiments (DoE), as it is a statistical tool suggested by the Quality by Design (QbD) initiative. It was found that the granules’ size and powder flowability are significantly affected by W_PEG (higher W_PEG, higher granule size and better flowability). Interestingly, T_A is the process variable that significantly affects M_P, enhancing process performance at high temperature values. Regarding F_A, it significantly affects d₁₀, promoting the formation of small particles due to breakage at high flowrates and the presence of non-elutriated powder at low flowrates. As a consequence, intermediate F_A is the optimum for obtaining higher M_P. Regarding regime map studies, most runs experienced a rapid growth regime, which is in accordance with the granules’ high pore saturation. This result agrees with the observed high increment in particle size and the morphology of the final granules, allowing researchers to validate and extend existing previous maps. Full article