Frequency: Quarterly E- ISSN: 2250-0340 P- ISSN: 2249-3638 IBI Factor: 4.09, Global Impact Factor 0.76 Abstracted/ Indexed in: Ulrich's International Periodical Directory, Google Scholar, SCIRUS, Genamics Journal Seek, PSOAR, getCITED, InfoBase Index, EBSCO Information Services
Quarterly published in print and online "Inventi Impact: Pharmaceutical Process Development" publishes high quality unpublished as well as high impact pre-published research and reviews catering to the needs of researchers and professionals. It focuses on multidimensional aspects of pharmaceutical process development, particularly ingredients and equipment selection, scale-up and pilot plant studies, factoring environment, automaton and robotic procedures, in-process characterization, bioprocesses etc.
Visual impairment and blindness affects 285 million people worldwide, resulting in a\nhigh public health burden. This study reports, for the first time, the use of three-dimensional (3D)\nprinting to create orally disintegrating printlets (ODPs) suited for patients with visual impairment.\nPrintlets were designed with Braille and Moon patterns on their surface, enabling patients to identify\nmedications when taken out of their original packaging. Printlets with different shapes were fabricated\nto offer additional information, such as the medication indication or its dosing regimen. Despite the\npresence of the patterns, the printlets retained their original mechanical properties and dissolution\ncharacteristics, wherein all the printlets disintegrated within...................
Three-dimensional printing (3DP) has demonstrated great potential for multi-material\nfabrication because of its capability for printing bespoke and spatially separated material\nconformations. Such a concept could revolutionise the pharmaceutical industry, enabling the\nproduction of personalised, multi-layered drug products on demand. Here, we developed a novel\nstereolithographic (SLA) 3D printing method that, for the first time, can be used to fabricate multi-layer\nconstructs (polypills) with variable drug content and/or shape. Using this technique, six drugs,\nincluding paracetamol, caffeine, naproxen, chloramphenicol, prednisolone and aspirin, were printed\nwith different geometries and material compositions. Drug distribution was visualised using Raman\nmicroscopy, which showed that whilst separate layers were successfully printed, several of the drugs\ndiffused across the layers depending on their amorphous or crystalline phase. The printed constructs\ndemonstrated excellent physical properties and the different material inclusions enabled distinct drug\nrelease profiles of the six actives within dissolution tests. For the first time, this paper demonstrates the\nfeasibility of SLA printing as an innovative platform for multi-drug therapy production, facilitating a\nnew era of personalised polypills....
Currently, there is a shortage of pediatric medicines on the market, and 3D printing technology can more flexibly produce personalized medicines to meet individual needs. The study developed a child-friendly composite gel ink (carrageenan-gelatin), created 3D models by computeraided design technology, then produced personalized medicines using 3D printing to improve the safety and accuracy of medication for pediatric patients. An in-depth understanding of the printability of different formulations was obtained by analyzing the rheological and textural properties of different gel inks and observing the microstructure of different gel inks, which guided the formulation optimization. Through formulation optimization, the printability and thermal stability of gel ink were improved, and F6 formulation (carrageenan: 0.65%; gelatin: 12%) was selected as the 3D printing inks. Additionally, a personalized dose linear model was established with the F6 formulation for the production of 3D printed personalized tablets. Moreover, the dissolution tests showed that the 3D printed tablets were able to dissolve more than 85% within 30 min and had similar dissolution profiles to the commercially available tablets. This study demonstrates that 3D printing is an effective manufacturing technique that allows for flexible, rapid, and automated production of personalized formulations....
Native collagen doughs were processed using a syringe-based extrusion 3D printer to obtain collagen scaffolds. Before processing, the rheological properties of the doughs were analyzed to determine the optimal 3D printing conditions. Samples showed a high shear-thinning behavior, reported beneficial in the 3D printing process. In addition, tetrahydrocurcumin (THC) was incorporated into the dough formulation and its effect on collagen structure, as well as the resulting scaffold’s suitability for wound healing applications, were assessed. The denaturation peak observed by differential scanning calorimetry (DSC), along with the images of the scaffolds’ surfaces assessed using scanning electron microscopy (SEM), showed that the fibrillar structure of collagen was maintained. These outcomes were correlated with X-ray diffraction (XRD) results, which showed an increase of the lateral packaging of collagen chains was observed in the samples with a THC content up to 4%, while a higher content of THC considerably decreased the structural order of collagen. Furthermore, physical interactions between collagen and THC molecules were observed using Fourier transform infrared (FTIR) spectroscopy. Additionally, all samples showed swelling and a controlled release of THC. These results along with the mucoadhesive properties of collagen suggested the potential of these THC–collagen scaffolds as sustained THC delivery systems....
Maintaining chemical and physical stability of the product during freeze-drying is\nimportant but challenging. In addition, freeze-drying is typically associated with long process\ntimes. Therefore, mechanistic models have been developed to maximize drying efficiency without\naltering the chemical or physical stability of the product. Dried product mass transfer resistance (Rp)\nis a critical input for these mechanistic models. Currently available techniques to determine Rp only\nprovide an estimation of the mean Rp and do not allow measuring and determining essential local (i.e.,\nintra-vial) Rp differences. In this study, we present an analytical method, based on four-dimensional\nmicro-computed tomography (4D-microCT), which enables the possibility to determine intra-vial Rp\ndifferences. Subsequently, these obtained Rp values are used in a mechanistic model to predict the\ndrying time distribution of a spin-frozen vial. Finally, this predicted primary drying time distribution\nis experimentally verified via thermal imaging during drying. It was further found during this\nstudy that 4DmicroCT uniquely allows measuring and determining other essential freeze-drying process\nparameters such as the moving direction(s) of the sublimation front and frozen product layer thickness,\nwhich allows gaining accurate process knowledge. To conclude, the study reveals that the variation\nin the end of primary drying time of a single vial could be predicted accurately using 4D-microCT as\nsimilar results were found during the verification using thermal imaging....
Assessment of lethal dose-50 is often done by veterinarians in animal houses at biological units. The more reliable method we use for this is Reed and Muench. The calculations involved in the assessment are complex, confusing, time consuming and less easily reproducible. The aim of this research was to design a spreadsheet program based on the steps involved in Reed and Muench for assessment lethal dose 50. This way the laborious steps involved in the method can be easily calculated in a simple, clear, faster, reproducible, accurate and user-friendly manner....
In this study, a hybrid multi-scale model has been developed for a continuous\r\nfluid bed wet granulation process by dynamically coupling computational fluid dynamics\r\n(CFD) with a discrete element model (DEM) and population balance model (PBM). In this\r\nprocess, the granules are formed by spraying the liquid binder on the fluidized powder bed.\r\nThe fluid flow field has been solved implementing CFD principles and the behavior of the\r\nsolid particles has been modeled using DEM techniques whereas the change in particle size\r\nhas been quantified with the help of PBM. The liquid binder droplets have been modeled\r\nimplicitly in DEM. A detailed understanding of the process aids in the development of better\r\ndesign, optimization and control strategies. The model predicts the evolution of important\r\nprocess variables (i.e., average particle diameter, particle size distribution (PSD) and particle\r\nliquid content) over time, which have qualitative similarity with experimentally observed\r\ntrends. The advantage of incorporating the multi-scale approach is that the model can be\r\nused to study the distributions of collision frequencies, particle velocity and particle liquid\r\ncontent in different sections of the fluid bed granulator (FBG), in a more mechanistic manner....
The supramolecular structure in peptides’ prolonged-released gel formulations is the most critical parameter for the determination of the pharmaceutical profile of the drug. Here, we report our investigation on lanreotide Autogel as a case study. For the first time, we describe the use of the pulsed field gradient (PFG) diffusion-ordered spectroscopy (DOSY) magic-angle spinning NMR to characterize the supramolecular self-assembly and molecular mobility of different samples of lanreotide Autogel formulations prepared according to different formulation protocols. The diffusion coefficient was used to calculate the hydrodynamic radii of supramolecular assemblies and build relative molecular models. DOSY data were integrated with NMR imaging (MRI) measurements and atomic force microscopy (AFM) imaging....
To produce the pharmaceutical dosage forms via hot-melt granulation, a pharmaceutical grade polymer must be selected that can be processed at a relatively low temperature due to the thermal sensitivity of most drugs. Melt granulation is a process by which pharmaceutical powders gets converted to granules form by the use of a binder which can be a molten liquid, a solid or a solid that melts during the process. For accomplishing this process, the apparatus of choice comprises of high-shear mixers, Rapid mixer and granulator etc. where the product temperature is raised above the melting point of the binder either by a heating jacket. More recently, this work also describes a hot melt granulation technique to improve the dissolution characteristics of a poorly water-soluble drug and sustained release property. Melt granulation technique is a process by which pharmaceutical powders are efficiently agglomerated by a meltable binder. The advantage of this technique compared to conventional granulation is that no water or organic solvents are needed. Because there is no drying step, the process is less time consuming and uses less energy than wet granulation....
Liquisolid system has attracted considerable interest as an efficient means of improving the dissolution rate and hence increases the bioavailability of a range of hydrophobic drugs. By this new formulation technique, a liquid drug may be converted into a dry-looking, non-adherent, free flowing and easily compressible powder by simply blending with selected powder excipients referred to as carrier and coating materials...
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