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Advancements in Industrial Pharmaceutics: Innovations and Future Directions

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A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Pharmaceutical Technology, Manufacturing and Devices".

Deadline for manuscript submissions: 30 April 2026 | Viewed by 15635

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Special Issue Editors

Dr. Qingliang Yang

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Guest Editor

College of Pharmaceutical Science, Zhejiang University of Technology, Hangzhou 310014, China
Interests: pharmaceutical coating; pharmaceutical particles; engineered particles for drug delivery; 3D printing; mucosal drug delivery systems

Dr. Yan Yang

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Guest Editor

College of Pharmaceutical Science, Zhejiang University of Technology, Hangzhou 310014, China
Interests: pharmaceutical coating; formulation development; 3D-priting; controlled drug delivery; pharmaceutical technology

Special Issue Information

Dear Colleagues,

Industrial pharmaceutics focuses on transforming drug formulations into safe, effective, and commercially viable medications. The key aspects of industrial pharmaceutics include formulation development, namely creating stable and effective drug formulations that ensure proper delivery and bioavailability; manufacturing processes, namely designing and optimizing processes for the mass production of pharmaceuticals, including solid dosage forms, liquid formulations, and biologics; pharmaceutical techniques like granulation, lyophilization, and encapsulation; quality assurance and control, namely implementing rigorous quality control measures to ensure that products meet regulatory standards and are safe, effective, and consistent; and technology integration, namely utilizing advanced technologies, such as automation, data analytics, and digital solutions, to streamline processes, enhance productivity, and improve product quality. By bridging science and industry, industrial pharmaceutics ensures medications are both therapeutically effective and manufacturable at scale. Therefore, the main aim of this Special Issue is to present current research works focusing on industrial pharmaceutics, particularly those recently emerged pharmaceutical techniques. Original research articles and review papers focusing on formulation development, mathematical simulations, and pharmaceutical devices will also be welcome.

Dr. Qingliang Yang
Dr. Yan Yang
Guest Editors

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Keywords

industrial pharmaceutics
formulation development
manufacturing processes
process analysis technology
quality assurance and control
pharmaceutical coating
micronization
granulation
hot-melt extrusion
direct compression
spray drying
packaging
drug release

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Published Papers (8 papers)

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Research

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19 pages, 5536 KB

Open AccessArticle

Improved Dissolution of Poorly Water-Soluble Rutin via Solid Dispersion Prepared Using a Fluid-Bed Coating System

by Hien V. Nguyen, Nga Thi-Thuy Nguyen, Huong Kim-Thien Tran, Thuy Thi-Nhu Huynh, Vi Huyen-Bao Vo, Cuc Thi-Thu Le and Tushar Saha

Pharmaceutics 2025, 17(12), 1559; https://doi.org/10.3390/pharmaceutics17121559 - 3 Dec 2025

Viewed by 981

Abstract

Background/Objectives: Rutin, a bioactive flavonol glycoside known for its antioxidant, anti-inflammatory, and anticancer activities, faces limited clinical application due to its poor aqueous solubility and low oral bioavailability. This study aimed to enhance the dissolution of rutin by preparing solid dispersions (SDs) using a fluid-bed coating system and formulating the resulting SDs into tablet dosage forms. Methods: Rutin was dissolved in methanol and sprayed onto various carriers, including lactose monohydrate, mannitol, microcrystalline cellulose, silicon dioxide, and calcium carbonate. Results: Among the carriers tested, lactose monohydrate produced the highest dissolution enhancement, achieving complete drug release within 15 min versus approximately 60% for free rutin. Further investigation into the effect of the rutin-to-lactose ratio on dissolution enhancement identified 1:10 as the most effective. Characterization by powder X-ray diffraction (PXRD) and differential scanning calorimetry (DSC) confirmed a marked reduction in rutin crystallinity, while scanning electron microscopy (SEM) revealed reduced particle size and successful adsorption onto the carrier. Fourier transformed infrared (FT-IR) analysis suggested hydrogen bonding interactions between rutin and lactose monohydrate, which contributed to improved dissolution. The optimal SD was incorporated into tablets containing 50 mg of rutin via wet granulation, and the inclusion of sodium lauryl sulfate further enhanced dissolution. Stability testing demonstrated that the optimized tablets maintained their dissolution profile after 6 months under accelerated conditions (40 °C and 75% RH). Conclusions: These findings indicate that fluid-bed coating is an effective approach for preparing SDs to improve the dissolution of rutin and may be extended to other natural polyphenolic compounds. Full article

(This article belongs to the Special Issue Advancements in Industrial Pharmaceutics: Innovations and Future Directions)

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17 pages, 1940 KB

Open AccessArticle

Adaptive Closed-Loop Control System for the Optimization of Tablet Manufacturing Processes

by Xiaorong Luo, Zhijian Zhong, Pan Deng, Yicheng Fei, Pengdi Cui, Weifeng Zhu, Zhiqiang Xiao, Ting Wang and Liying Li

Pharmaceutics 2025, 17(12), 1510; https://doi.org/10.3390/pharmaceutics17121510 - 22 Nov 2025

Viewed by 537

Abstract

Background: Tablet manufacturing is challenged by strong dynamic coupling of process parameters, significant material property fluctuations, and delayed quality control, with tablet weight stability being particularly critical in high-speed production. Traditional static optimization methods relying on empirical judgment struggle to manage these dynamics, leading to substantial variations in tablet weight and hardness that severely compromise production efficiency. Methods: This study proposes a data-driven closed-loop control system centered on a novel Iterative Learning Model Predictive Control (IL-MPC) architecture. The core innovation lies in directly integrating iterative learning constraints within the MPC optimization framework. This constraint-embedding mechanism enables systematic utilization of historical batch data while preserving real-time optimization capabilities. The IL-MPC approach achieves enhanced batch-to-batch performance consistency with reduced computational burden, effectively combining the dual advantages of learning and optimization. Results: Simulation experiments and industrial production data validate the practical feasibility of the IL-MPC algorithm. Implementation results demonstrate that the proposed system effectively manages dynamic process variations, significantly improving control precision for both tablet weight and hardness, outperforming conventional control methods. Conclusions: This research breaks through the technical bottleneck of dynamic regulation in tablet manufacturing. The developed IL-MPC framework provides a reproducible closed-loop control paradigm for intelligent pharmaceutical manufacturing, promoting the industry’s transformation toward data-driven models and advancing intelligent drug production. Full article

(This article belongs to the Special Issue Advancements in Industrial Pharmaceutics: Innovations and Future Directions)

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31 pages, 10581 KB

Open AccessArticle

Advancing Personalized Medicine Through FDM 3D Printing: Ketoprofen Tablets with Customizable Drug Release Profiles and In Silico Simulation

by Haya Khader Ahmad Yasin, Moawia M. Al-Tabakha and Siok Yee Chan

Pharmaceutics 2025, 17(11), 1495; https://doi.org/10.3390/pharmaceutics17111495 - 19 Nov 2025

Viewed by 637

Abstract

Background/Objectives: Fused deposition modeling (FDM) three-dimensional (3D) printing represents an emerging manufacturing platform for personalized oral dosage forms. Its success relies on developing robust drug-loaded filaments with consistent mechanical, thermal, and dissolution properties. This work aims to (i) develop and characterize ketoprofen-loaded filaments using hot-melt extrusion (HME) and (ii) utilize them to fabricate both immediate-release (IR) and sustained-release (SR) tablets via FDM 3D printing. Methods: Filaments were prepared using Kollicoat^® IR and hydroxypropyl methylcellulose (HPMC, 2600–5600 cP) as functional polymers. Sorbitol and sodium lauryl sulfate (SLS) were incorporated as plasticizer and surfactant, respectively. Filaments were evaluated for quality attributes, drug content, tensile strength, and physicochemical and surface characteristics using Scanning Electron Microscopy (SEM), Attenuated Total Reflection Fourier-transform infrared (ATR-FTIR), X-ray Diffraction (XRD), Differential Scanning Calorimetry (DSC) and Thermogravimetric Analysis (TGA). Optimized filaments were fed into an FDM 3D printer to fabricate ketoprofen tablets with varied geometries, shell numbers, and infill densities. Tablets were subjected to USP tests (weight variation, friability, hardness, disintegration, assay, content uniformity), dissolution profiling, and release kinetics modeling. Comparative dissolution studies with market Profenid^® and Bi-Profenid^® tablets were conducted. GastroPlus^® simulations were used for in vitro–in silico correlation. Results: Among the tested formulations, Kollicoat^® IR-based filaments with sorbitol and SLS (F6) demonstrated superior printability, characterized by consistent feeding, stable extrusion, and reliable formation of uniform structures for immediate-release applications. In contrast, HPMC-based filaments with sorbitol (F13) offered the most robust performance for SR formulations. Both exhibited uniform diameter, drug loading, and mechanical strength. IR tablets achieved >80% release within 30 min, while SR tablets prolonged release up to 12 h, following Higuchi and Korsmeyer–Peppas kinetics. All quality attributes complied with USP limits. Market products showed comparable dissolution, validating the approach. GastroPlus^® simulations predicted pharmacokinetic profiles consistent with reported data, supporting IVIVC. Conclusions: This integrated workflow establishes a robust strategy for producing IR and SR ketoprofen tablets from a single FDM platform. The results highlight the feasibility of point-of-care, personalized medicine using 3D printing technologies. Full article

(This article belongs to the Special Issue Advancements in Industrial Pharmaceutics: Innovations and Future Directions)

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19 pages, 6908 KB

Open AccessEditor’s ChoiceArticle

Three-Dimensional-Printed Osteochondral Scaffold with Biomimetic Surface Curvature for Osteochondral Regeneration

by Yan Yang, Qu Lin, Zhenhai Hou, Gensheng Yang and Lian Shen

Pharmaceutics 2025, 17(2), 153; https://doi.org/10.3390/pharmaceutics17020153 - 23 Jan 2025

Cited by 2 | Viewed by 1637

Abstract

Objectives: Treatment of osteochondral defects is hindered by several challenges, including the failure of traditional scaffolds with a predefined cylindrical or cuboid shape to comprehensively match the natural osteochondral tissue. Herein, we employed reverse modeling and three-dimensional (3D) printing technologies to prepare subchondral bone and cartilage. Methods: The osteochondral scaffold was prepared by bonding the subchondral bone and cartilage layers, and the curvature distribution and biomechanical behavior were compared with those of the native tissue. Biocompatibility and osteochondral regeneration performance were further evaluated using cell adhesion and proliferation assays, as well as animal osteochondral defect repair tests. Results: We found that increasing the printing temperature or decreasing the layer height improved the dimensional accuracy of printed subchondral bones, whereas increasing the exposure time or decreasing the layer height enhanced the dimensional accuracy of the printed cartilage. Biomimetic scaffolds exhibited curvature distribution and biomechanical behavior more similar to native tissues than traditional cylindrical scaffolds. Incorporating gelatin methacryloyl into poly (ethylene glycol) diacrylate markedly improved the biocompatibility, and correspondingly prepared osteochondral scaffolds had better osteochondral regeneration ability than the traditional scaffolds. Conclusions: Osteochondral scaffolds exhibiting biomimetic morphology and an internal structure could be prepared based on reverse modeling and 3D printing, facilitating personalized osteochondral injury treatment. Full article

(This article belongs to the Special Issue Advancements in Industrial Pharmaceutics: Innovations and Future Directions)

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18 pages, 4357 KB

Open AccessEditor’s ChoiceArticle

Enteric Coated Pellets with Lactoferrin for Oral Delivery: Improved Shelf Life of the Product

by Nika Kržišnik, Blaž Grilc and Robert Roškar

Pharmaceutics 2025, 17(1), 23; https://doi.org/10.3390/pharmaceutics17010023 - 26 Dec 2024

Viewed by 3540

Abstract

Background/Objectives: Lactoferrin (Lf), a multifunctional iron-binding protein, has considerable potential for use as an active ingredient in food supplements due to its numerous positive effects on health. As Lf is prone to degradation, we aimed to develop a formulation that would ensure sufficient stability of Lf in the gastrointestinal tract and during product storage. Methods: A simple, efficient, and well-established technology that has potential for industrial production was used for the double-coating of neutral pellet cores with an Lf layer and a protective enteric coating. Results: The encapsulation efficiency was 85%, which is among the highest compared to other reported Lf formulations. The results of the dissolution tests performed indicated effective protection of Lf from gastric digestion. A comprehensive stability study showed that the stability was similar regardless of the neutral pellet core used, while a significant influence of temperature, moisture, product composition, and packaging on the stability of Lf were observed, and were therefore considered in the development of the final product. The experimentally determined shelf life is extended from 15 to almost 30 months if the product is stored in a refrigerator instead of at room temperature, which ensures the commercial applicability of the product. Conclusion: We successfully transferred a technology commonly used for small molecules to a protein-containing product, effectively protected it from the destructive effects of gastric juice, and achieved an acceptable shelf life. Full article

(This article belongs to the Special Issue Advancements in Industrial Pharmaceutics: Innovations and Future Directions)

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13 pages, 4419 KB

Open AccessArticle

Assembled pH-Responsive Gastric Drug Delivery Systems Based on 3D-Printed Shells

by Haoye Bei, Pingping Zhao, Lian Shen, Qingliang Yang and Yan Yang

Pharmaceutics 2024, 16(6), 717; https://doi.org/10.3390/pharmaceutics16060717 - 27 May 2024

Cited by 3 | Viewed by 3260

Abstract

Gastric acid secretion is closely associated with the development and treatment of chronic gastritis, gastric ulcers, and reflux esophagitis. However, gastric acid secretion is affected by complex physiological and pathological factors, and real-time detection and control are complicated and expensive. A gastric delivery system for antacids and therapeutics in response to low pH in the stomach holds promise for smart and personalized treatment of stomach diseases. In this study, pH-responsive modular units were used to assemble various modular devices for self-regulation of pH and drug delivery to the stomach. The modular unit with a release window of 50 mm² could respond to pH and self-regulate within 10 min, which is related to its downward floatation and internal gas production. The assembled devices could stably float downward in the medium and detach sequentially at specific times. The assembled devices loaded with antacids exhibited smart pH self-regulation under complex physiological and pathological conditions. In addition, the assembled devices loaded with antacids and acid suppressors could multi-pulse or prolong drug release after rapid neutralization of gastric acid. Compared with traditional coating technology, 3D printing can print the shell layer by layer, flexibly adjust the internal and external structure and composition, and assemble it into a multi-level drug release system. Compared with traditional coating, 3D-printed shells have the advantage of the flexible adjustment of internal and external structure and composition, and are easy to assemble into a complex drug delivery system. This provides a universal and flexible strategy for the personalized treatment of diseases with abnormal gastric acid secretion, especially for delivering acid-unstable drugs. Full article

(This article belongs to the Special Issue Advancements in Industrial Pharmaceutics: Innovations and Future Directions)

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22 pages, 11453 KB

Open AccessArticle

Improving Inhalation Performance with Particle Agglomeration via Combining Mechanical Dry Coating and Ultrasonic Vibration

by Qingzhen Zhang, Zheng Wang, Kaiqi Shi, Hang Zhou, Xiaoyang Wei and Philip Hall

Pharmaceutics 2024, 16(1), 68; https://doi.org/10.3390/pharmaceutics16010068 - 31 Dec 2023

Cited by 7 | Viewed by 3222

Abstract

Agglomerate formulations for dry powder inhalation (DPI) formed with fine particles are versatile means for the highly efficient delivery of budesonide. However, uncontrolled agglomeration induces high deposition in the upper airway, causing local side effects due to high mechanical strength, worse deagglomeration, and poor fine-particle delivery. In the present study, fine lactose was mechanically dry-coated prior to particle agglomeration, and the agglomerates were then spheroidized via ultrasonic vibration to improve their aerosol performance. The results showed that the agglomerate produced with the surface-enriched hydrophobic magnesium stearate and ultrasonic vibration demonstrated improved aerosolization properties, benefiting from their lower mechanical strength, less interactive cohesive force, and improved fine powder dispersion behavior. After dispersion utilizing a Turbuhaler^® with a pharmaceutical cascade impactor test, a fine particle fraction (FPF) of 71.1 ± 1.3% and an artificial throat deposition of 19.3 ± 0.4% were achieved, suggesting the potential to improve the therapeutic outcomes of budesonide with less localized infections of the mouth and pharynx. Full article

(This article belongs to the Special Issue Advancements in Industrial Pharmaceutics: Innovations and Future Directions)

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Review

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48 pages, 5616 KB

Open AccessReview

Recent Developments in Pharmaceutical Spray Drying: Modeling, Process Optimization, and Emerging Trends with Machine Learning

by Waasif Wahab, Raya Alshamsi, Bouta Alharsousi, Manar Alnuaimi, Zaina Alhammadi and Belal Al-Zaitone

Pharmaceutics 2025, 17(12), 1605; https://doi.org/10.3390/pharmaceutics17121605 - 13 Dec 2025

Viewed by 685

Abstract

Spray drying techniques are widely used in the pharmaceutical industry to produce fine drug powders with different properties depending on the route of administration. Process parameters play a vital role in the critical quality attributes of the final product. This review highlights the progress and challenges in modeling the spray-drying process, with a focus on pharmaceutical applications. Computational fluid dynamics (CFD) is a well-known method used for the modeling and numerical simulation of spray drying processes. However, owing to their limitations, including high computational costs, experimental validation, and limited accuracy under complex spray drying conditions. Machine learning (ML) models have recently emerged as integral tools for modeling/optimizing the spray drying process. Despite promising accuracy, ML models depend on high-quality data and may fail to predict the influence of new formulation or process parameters on the properties of the dried powder. This review outlines the shortcomings of CFD modeling in the spray drying process. A hybrid model combining ML and CFD models, emerging techniques such as the digital twin approach, transfer learning, and explainable AI (XAI) are also discussed. A hybrid model combining ML and CFD models is also discussed. ML is considered an emerging technique that could assist the spray drying process, and most importantly, the utilization of this method in pharmaceutical spray drying. Full article

(This article belongs to the Special Issue Advancements in Industrial Pharmaceutics: Innovations and Future Directions)

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