{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T05:43:54Z","timestamp":1793252634416,"version":"4.5.0"},"reference-count":127,"publisher":"MDPI AG","issue":"12","license":[{"start":{"date-parts":[[2025,11,29]],"date-time":"2025-11-29T00:00:00Z","timestamp":1764374400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Ministry of Innovation and Technology of Hungary","award":["TKP2021-EGA-24"],"award-info":[{"award-number":["TKP2021-EGA-24"]}]},{"DOI":"10.13039\/501100012550","name":"National Research, Development and Innovation Fund","doi-asserted-by":"crossref","award":["TKP2021-EGA"],"award-info":[{"award-number":["TKP2021-EGA"]}],"id":[{"id":"10.13039\/501100012550","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceutics"],"abstract":"<jats:p>Background\/Objectives: \u03b2-galactosidase (lactase) is a transformative enzyme used in many different fields. Its significance spans from biotechnology to food and pharmaceutical industries. \u03b2-galactosidase catalyzes the hydrolysis of lactose into glucose and galactose. In medicine, \u03b2-galactosidase has gained attention and has many applications, mainly in enzyme replacement therapy. \u03b2-galactosidase is the main active ingredient of medications for lactose intolerance. Industrially \u03b2-galactosidase is typically produced by the Aspergillus oryzae filamentous fungus. Therapeutic interventions involving \u03b2-galactosidase aim to mitigate symptoms and improve the patients\u2019 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 \u03b2-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 \u03b2-galactosidase in various applications. The aim of this manuscript is to summarize current knowledge about \u03b2-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 \u03b2-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: \u03b2-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 \u03b2-galactosidase as an active ingredient and outline opportunities for advancing its application in oral drug delivery systems.<\/jats:p>","DOI":"10.3390\/pharmaceutics17121538","type":"journal-article","created":{"date-parts":[[2025,12,1]],"date-time":"2025-12-01T13:03:02Z","timestamp":1764594182000},"page":"1538","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Advances in \u03b2-Galactosidase Research: A Systematic Review from Molecular Mechanisms to Enzyme Delivery Systems"],"prefix":"10.3390","volume":"17","author":[{"given":"M\u00e1rton","family":"Kir\u00e1ly","sequence":"first","affiliation":[{"name":"Department of Pharmaceutics, Semmelweis University, H\u0151gyes E. Street 7-9, 1092 Budapest, Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7658-280X","authenticated-orcid":false,"given":"\u00c1d\u00e1m Tibor","family":"Barna","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutics, Semmelweis University, H\u0151gyes E. Street 7-9, 1092 Budapest, Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8164-3993","authenticated-orcid":false,"given":"Nikolett","family":"K\u00e1llai-Szab\u00f3","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutics, Semmelweis University, H\u0151gyes E. Street 7-9, 1092 Budapest, Hungary"},{"name":"Center for Pharmacology and Drug Research & Development, Semmelweis University, 1085 Budapest, Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Borb\u00e1la Dalmadin\u00e9","family":"Kiss","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutics, Semmelweis University, H\u0151gyes E. Street 7-9, 1092 Budapest, Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5434-201X","authenticated-orcid":false,"given":"Istv\u00e1n","family":"Antal","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutics, Semmelweis University, H\u0151gyes E. Street 7-9, 1092 Budapest, Hungary"},{"name":"Center for Pharmacology and Drug Research & Development, Semmelweis University, 1085 Budapest, Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Krisztina","family":"Lud\u00e1nyi","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutics, Semmelweis University, H\u0151gyes E. Street 7-9, 1092 Budapest, Hungary"},{"name":"Center for Pharmacology and Drug Research & Development, Semmelweis University, 1085 Budapest, Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,11,29]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"117","DOI":"10.1016\/j.drudis.2021.09.004","article-title":"The past, present, and future of enzyme-based therapies","volume":"27","author":"Hennigan","year":"2022","journal-title":"Drug Discov. 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