Enhancing Process Control and Quality in Amorphous Solid Dispersions Using In-Line UV–Vis Monitoring of L* as a Real-Time Response

Pharmaceutics, Journal Year: 2025, Volume and Issue: 17(2), P. 151 - 151

Published: Jan. 23, 2025

Background: This study demonstrates the application of sequential design experiments (DoE) approach within quality by (QbD) framework to optimize extrusion processes through screening, optimization, and robustness testing. Methods: An in-line UV–Vis process analytical technology (PAT) system was successfully employed monitor critical attributes (CQAs) piroxicam amorphous solid dispersion (ASD) products, specifically lightness (L*). Results: L* measurement proved highly effective for ensuring uniformity ASDs, offering real-time insights into their physical appearance stability. Small variations in acted as early indicators processing issues, such phase separation or bubble formation, enabling timely intervention. straightforward rapid technique supports monitoring control, allowing automated adjustments maintain product consistency quality. By adopting this strategy, manufacturers can minimize variability, reduce waste, ensure adherence target profiles (QTPPs). Conclusions: Overall, highlights value spectroscopy a PAT tool hot melt extrusion, enhancing CQA assessment advancing efficiency reliability ASD manufacturing.

Language: Английский

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Continuous manufacturing and process analytical technology: focusing on dosage forms with improved solubility and controlled release

Journal of Pharmaceutical Investigation, Journal Year: 2025, Volume and Issue: unknown

Published: March 7, 2025

Language: Английский

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Reinforced Polymer Composite Filaments in Fused Deposition Modeling of 3D Printing Technology: A Review

Advanced Engineering Materials, Journal Year: 2025, Volume and Issue: unknown

Published: March 3, 2025

Fused deposition modeling (FDM) is one of the most commonly used 3D printing techniques. FDM uses thermoplastics to manufacture final product. This review article provides a comprehensive overview use composite materials in printing. It explores various filament manufacturing methods, highlighting extrusion The main advantages using are discussed, then recycled filaments, their benefits, and difficulties possibilities related applications covered. Next, filaments aerospace, automotive, medical, electronics, prosthetics/orthotics explored. Finally, discusses current challenges suggests future directions for research.

Language: Английский

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Aqueous Solution Spray Drying Preparations of Binary Amorphous Solid Dispersions

Crystals, Journal Year: 2025, Volume and Issue: 15(4), P. 323 - 323

Published: March 28, 2025

Spray drying of poorly water-soluble drugs in organic solvents is a mature process the preparation amorphous solids dispersions (ASDs). The use under increasing environmental protection and safety pressure restricts application advanced polymers as proteins which are usually insoluble unstable solvents. Aqueous solution spray technology candidate method for preparing ASDs without Increasing temperature adding volatile additives can improve solubility water introducing additional components energy needed. In this work, ammonia assisted aqueous was successfully used to prepare various indomethacin (25%) with synthetic polyvinylpyrrolidone β-lactoglobulin, lactalbumin hydrolysate, bovine serum albumin, high yields, special micro golfs morphology, precise compositions longtime stabilities, compared high-temperature method. hydrolysate albumin show better dissolution profiles than other ASDs. easily extended sulfamerazine celecoxib, providing possibility avoid preparations via drying.

Language: Английский

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Scaling Up Pharmaceutical Cocrystals

Published: March 29, 2025

Language: Английский

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Preparation Techniques of Pharmaceutical Cocrystals

Published: March 29, 2025

Language: Английский

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Calorimetric Monitoring of the Sub-Tg Crystal Growth in Molecular Glasses: The Case of Amorphous Nifedipine

Molecules, Journal Year: 2025, Volume and Issue: 30(8), P. 1679 - 1679

Published: April 9, 2025

Non-isothermal differential scanning calorimetry (DSC) and Raman microscopy were used to study the crystallization behavior of 20–50 μm amorphous nifedipine (NIF) powder. In particular, was focused on diffusionless glass-crystal (GC) growth mode occurring below glass transition temperature (Tg). The exothermic signal associated with GC indeed directly reproducibly recorded at heating rates q+ ≤ 0.5 °C·min−1. During growth, αp polymorphic phase exclusively formed, as confirmed via microscopy. addition freshly prepared NIF samples, powders annealed for 7 h 20 °C also monitored—approx. 50–60% crystallinity achieved. For powders, confocal verified a proportional absence crystalline sample surface (indicating its dominant formation along internal micro-cracks, which is characteristic growth). All DSC data modeled in terms solid-state kinetic equation paired autocatalytic model; complexity described reaction mechanism based overlap 3–4 independent processes. trends decreasing identified, confirming temperature-dependent behavior, calculate theoretical prediction conformable experimentally performed annealing °C. model slightly underestimated true extent predicting be 35–40% after (such accuracy still extremely good comparison standard approaches nowadays). Further research field analysis should thus focus methodological ways increasing considerably extrapolated predictions.

Language: Английский

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Preparation of IBU-NTM Cocrystals via HME and Their Exploitation in FDM-3D Printing for Advanced Pharmaceutical Applications

Journal of Drug Delivery Science and Technology, Journal Year: 2025, Volume and Issue: unknown, P. 106917 - 106917

Published: April 1, 2025

Language: Английский

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Advances in Oral Solid Drug Delivery Systems: Quality by Design Approach in Development of Controlled Release Tablets

BioChem, Journal Year: 2025, Volume and Issue: 5(2), P. 9 - 9

Published: April 25, 2025

Oral solid drug delivery continues to be the gold standard in pharmaceutical formulations, owing its cost-effectiveness, ease of administration, and high patient compliance. Tablets, most widely used dosage form, are favored for their precise dosing, simplicity, economic advantages. Among these, controlled release (CR) tablets stand out ability maintain consistent levels, enhance therapeutic efficacy, reduce dosing frequency, thereby improving adherence treatment outcomes. A well-designed CR system ensures a sustained targeted supply, optimizing performance while minimizing side effects. This review delves into latest advancements with particular focus on hydrophilic matrix systems, which regulate through mechanisms such as swelling, diffusion, erosion. These systems rely variety polymers drug-retarding agents achieve tailored profiles. Recent breakthroughs crystal engineering polymer science have further enhanced solubility bioavailability, addressing critical challenges associated poorly soluble drugs. In terms manufacturing, direct compression has emerged efficient method producing tablets, streamlining production ensuring release. The integration Quality by Design framework been instrumental product systematically linking formulation process variables patient-centric quality attributes. advent cutting-edge technologies artificial intelligence 3D printing is revolutionizing field formulations. AI enables predictive modeling data-driven optimization profiles, facilitates development personalized medicines highly customizable kinetics. innovations paving way more patient-specific therapies. However, regulatory hurdles, patent constraints, need robust vivo validation remain significant barriers widespread adoption these advanced technologies. succinct underscores synergistic traditional emerging strategies tablets. It highlights potential co-crystal particularly those produced via compression, improve adherence, deliver superior By bridging gap between established practices innovative approaches, this poised address unmet clinical needs advance future oral delivery.

Language: Английский

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Development of Mathematical Function Control-Based 3D Printed Tablets and Effect on Drug Release

Pharmaceutical Research, Journal Year: 2024, Volume and Issue: 41(11), P. 2235 - 2246

Published: Oct. 21, 2024

Abstract Purpose The application of 3D printing technology in drug delivery is often limited by the challenges achieving precise control over release profiles. goal this study was to apply surface equations construct printed tablet models, adjust functional parameters obtain multiple models and correlate model with vitro behavior. Methods This reports development 3D-printed tablets using geometries controlled mathematical functions modulate release. Utilizing fused deposition modeling (FDM) coupled hot-melt extrusion (HME) technology, personalized systems were produced thermoplastic polymers. Different shapes (T1-T5) varying depth parabolic ( b = 4, 2, 0, -2, -4 mm) assess impact curvature on dissolution. Results T5 formulation, greatest curvature, demonstrated fastest release, complete within 4 h. In contrast, T1 T2 exhibited a slower approximately 6 correlation between area rate confirmed, supporting predictions Noyes-Whitney equation. Differential Scanning Calorimetry (DSC) Electron Microscope (SEM) analyses verified uniform dispersion acetaminophen consistency internal structures, respectively. Conclusions geometry effectively tailored profiles, enhancing patient compliance treatment efficacy. novel approach offers significant advancements medicine providing highly reproducible adaptable platform for optimizing delivery. Graphical

Language: Английский

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