Background/Objectives: β-galactosidase (lactase) is a transformative enzyme used in many different fields. Its significance spans from biotechnology to food and pharmaceutical industries. β-galactosidase catalyzes the hydrolysis of lactose into glucose and galactose. In medicine, β-galactosidase has gained attention and has many applications, mainly in enzyme replacement therapy. β-galactosidase is the main active ingredient of medications for lactose intolerance. Industrially β-galactosidase is typically produced by the Aspergillus oryzae filamentous fungus. Therapeutic interventions involving β-galactosidase aim to mitigate symptoms and improve the patients’ quality of life. In the food industry, it plays a crucial role in the production of lactose-free products, improving accessibility to dairy products. However, despite its versatility and wide use, challenges connected to β-galactosidase still exist, such as the need for cost-effective and more efficient methods for administering the enzyme. Additionally, there are several ongoing studies that seek to enhance stability and optimize the performance of β-galactosidase in various applications. The aim of this manuscript is to summarize current knowledge about β-galactosidase as an active ingredient and to present some preparations that are commercially available or mentioned in the literature. Methods: A systematic search was conducted in PubMed, Scopus, Embase and Web of Science to identify relevant articles on formulations related to β-galactosidase, focusing on original research articles published between 1895 and 2025 that exclusively examine the use of oral drug delivery. Results: After a rigorous search across multiple databases, 45 relevant studies out of 1633 initial results were selected for analysis. Conclusions: β-galactosidase remains a highly versatile enzyme with broad industrial and medical relevance. While current formulations offer significant benefits, further innovation is needed to improve delivery efficiency, stability, and cost-effectiveness. The findings of this review contribute to a deeper understanding of β-galactosidase as an active ingredient and outline opportunities for advancing its application in oral drug delivery systems.

In this study, an artificial intelligence-based machine vision system was developed for in-line particle size analysis during the pellet layering process. Drug-layered pellets were produced by coating microcrystalline cellulose cores with an ibuprofen-containing layering liquid until the target drug content was achieved. Drug content increases with pellet size; therefore, particle size monitoring can ensure product safety and quality. The direct imaging system, consisting of a rigid endoscope, a light source, and a high-speed camera, provides real-time information about pellet size and layer uniformity, enabling timely intervention in the case of out-of-spec products. A convolutional neural network-based instance segmentation algorithm was employed to detect particles in focus, ensuring that pellet size could be accurately determined despite the dense flow of the particles. After training the model, the performance of the developed system was assessed by analysing the particle size distribution of pellet cores with variable sizes within the 250–850 μm size range. The endoscopic system was tested in-line at a larger scale during the drug layering of inert pellet cores. The particle size data acquired in real time with the endoscopic imaging system corresponded with the reference methods, demonstrating the feasibility of the proposed machine vision-based method as a process analytical technology tool for in-line process monitoring.

Vaginal candidiasis poses significant health concerns that affect approximately 75% of women globally and often leads to discomfort and a decrease in quality of life. Traditional treatments, despite their effectiveness, may cause discomfort and adverse effects, such as vaginal discharge, bleeding, and dryness, promoting the exploration of alternative formulations. In this study, we aimed to develop a novel therapeutic approach for the treatment of vaginal candidiasis utilizing oleic acid containing emulgels made from thermoresponsive poloxamer-based hydrogels. These emulgels were designed to provide a sustained release of clotrimazole, an antifungal agent. Incorporating oleic acid enhanced the drug’s solubility and contributed to vaginal health. The formulations were characterized by their rheological properties, in vitro release, mucoadhesion, and spreadability. We conducted rheological measurements on the hydrogels that served as the base for the emulgels, as well as on the emulgels themselves. The emulgels exhibited continuous rheological behavior with changing temperatures, making them suitable for storage at room temperature. With an increasing HPMC content, we achieved enhanced mucoadhesion, which is beneficial for formulations used in body cavities. Moreover, in vitro release studies revealed sustained drug release profiles, which can be adjusted by varying the ratios of poloxamers and HPMC. These findings suggest that the developed emulgels offer a promising therapeutic option for vaginal candidiasis, addressing both the symptoms and the treatment of discomfort.

Background/Objectives: The growing demand for personalised, patient-centric drug delivery systems has driven innovation in pharmaceutical manufacturing, particularly in multi-unit particulate systems (MUPS). Methods: In this study, inert cores with tailor-made geometry for multi-particulate formulations were fabricated with high-resolution stereolithography (SLA) 3D printing. By a printable photopolymer resin, dimensionally accurate and mechanically robust starter cores were produced. The additively manufactured inert subunits were drug-layered with ibuprofen sodium using a fluidised bed process. Then, a controlled-release film coating of Eudragit RS 30D was applied with varying coating thicknesses. The initial 3D-printed subunits, together with the drug-layered and finally film-coated microparticles, were characterised by image analysis, Raman microspectroscopic measurements, and official methods of the European Pharmacopoeia. Results: The combined approach of 3D printing and traditional pharmaceutical processing proved highly effective. The 3D-printed cores demonstrated both flexibility in design and consistency in performance. Conclusions: These findings highlight the feasibility of using 3D printing to produce patient-specific, functional cores in multi-particulate systems that can be easily modified according to the patient’s needs. The fabricated minitablets can be used as alternatives to widely used inert cores. Integrating additive manufacturing with conventional coating techniques offers promising new avenues for developing next-generation, personalised drug delivery solutions.

Background/Objectives: Gastro-resistant multiparticulate systems are designed to protect drugs in acidic environments and to ensure intestinal release. In practice, the method of administration may need to be modified: pellet-containing capsules opened or tablets halved for patients with swallowing difficulties, yet the type of liquid used for administration is often not specified. This study examined the stability of gastro-resistant coated pellets after exposure to various aqueous media prior to ingestion. Methods: To evaluate administration instructions, 103 Summaries of Product Characteristics of gastro-resistant products were reviewed. Pellets were produced using a bottom-spray fluidized bed process and coated with Eudragit L 30 D-55. Dissolution testing in pH 1.2 medium was performed after pre-soaking the pellets for 5, 15, and 30 min in beverages with various pH and conductivity. Drug release was measured by UV-VIS method, and morphological changes were assessed by image analysis. Marketed gastro-resistant products were also examined visually. Results: SmPC review revealed that the beverage for intake was frequently unspecified. Among the tested beverages differences in pH and conductivity were observed. Alkaline medicinal mineral waters induced increased and time-dependent premature drug release compared to tap and filtered water. Image analysis indicated a reduction in surface area after exposure to alkaline media. Conclusions: Contact with non-specified aqueous media before swallowing may weaken the protective function of gastro-resistant films. More explicit recommendations on suitable administration manipulation and media may improve therapeutic consistency.