Betulinic Acid-Loaded Oleogel as a Novel Pharmaceutical Formulation for Potential Cutaneous Applications: Development, Characterization, and Biosafety Profile
Skin disorders constitute a persistent health problem, covering both acute and chronic conditions that manifest in patients of all ages. Betulinic acid (BA) is a triterpene previously studied as an efficient treatment of skin ailments due to its innate pharmacological properties. Nonetheless, due to...
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2025-06-01
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| author | Andreea Smeu Daliana Minda Casiana Boru Lavinia Vlaia Vicențiu Vlaia Cristina Adriana Dehelean Sergio Liga George Puenea Daniela Lucia Muntean |
| author_facet | Andreea Smeu Daliana Minda Casiana Boru Lavinia Vlaia Vicențiu Vlaia Cristina Adriana Dehelean Sergio Liga George Puenea Daniela Lucia Muntean |
| author_sort | Andreea Smeu |
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| description | Skin disorders constitute a persistent health problem, covering both acute and chronic conditions that manifest in patients of all ages. Betulinic acid (BA) is a triterpene previously studied as an efficient treatment of skin ailments due to its innate pharmacological properties. Nonetheless, due to its lipophilic nature and low bioavailability, topical delivery systems are necessary for its proper administration. Oleogels are efficient carriers for the incorporation of hydrophobic biomolecules; however, their use for the delivery of BA remains scarce. Therefore, this study was designed to develop, characterize, and evaluate a BA-containing oleogel (BA-O) regarding its cutaneous safety profile as a potential pharmaceutical formulation targeting dermatologic issues. The findings illustrated the efficient formulation of BA as oleogel, the product presenting the specific conditions of topical semi-solid formulations in terms of physico-chemical characteristics and high biocompatibility in vitro and in ovo, as BA-O lacked a cytotoxic effect in HaCaT and JB6 Cl 41-5a skin cells (cell viability percentages being > 70%) and was categorized as non-irritant in EpiDerm™ tissues (viability > 80%) and on the chorioallantoic membrane (Irritation Score = 0.186). These results present the preclinical biosafety profile of BA-O with prospective potential for cutaneous applications that should be investigated in future studies. |
| format | Article |
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| institution | OA Journals |
| issn | 2075-1729 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | MDPI AG |
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| series | Life |
| spelling | doaj-art-0482e877f1d44cf489113dc2ec6df1af2025-08-20T02:20:58ZengMDPI AGLife2075-17292025-06-0115695410.3390/life15060954Betulinic Acid-Loaded Oleogel as a Novel Pharmaceutical Formulation for Potential Cutaneous Applications: Development, Characterization, and Biosafety ProfileAndreea Smeu0Daliana Minda1Casiana Boru2Lavinia Vlaia3Vicențiu Vlaia4Cristina Adriana Dehelean5Sergio Liga6George Puenea7Daniela Lucia Muntean8Research Centre for Pharmaco-Toxicological Evaluation, Faculty of Pharmacy, “Victor Babes” University of Medicine and Pharmacy, 2nd Eftimie Murgu Square, 300041 Timisoara, RomaniaDepartment of Pharmacognosy, Faculty of Pharmacy, “Victor Babeș” University of Medicine and Pharmacy, Eftimie Murgu Square, No. 2, 300041 Timisoara, RomaniaDepartment of Medicine, Vasile Goldis Western University of Arad, Street Liviu Rebreanu, No. 86, 310048 Arad, RomaniaDepartment of Pharmaceutical Technology, Faculty of Pharmacy, “Victor Babeş” University of Medicine and Pharmacy, Eftimie Murgu Square 1, 300041 Timişoara, RomaniaDepartment of Organic Chemistry, Faculty of Pharmacy, “Victor Babes” University of Medicine and Pharmacy, 2nd Eftimie Murgu Square, 300041 Timisoara, RomaniaResearch Centre for Pharmaco-Toxicological Evaluation, Faculty of Pharmacy, “Victor Babes” University of Medicine and Pharmacy, 2nd Eftimie Murgu Square, 300041 Timisoara, RomaniaDepartment of Applied Chemistry and Engineering of Organic and Natural Compounds, Faculty of Chemical Engineering, Biotechnologies and Environmental Protection, Politehnica University Timisoara, Vasile Pârvan No. 6, 300223 Timisoara, RomaniaDepartment of Rehabilitation, Physical Medicine and Rheumatology, “Victor Babes” University of Medicine and Pharmacy, 300041 Timisoara, RomaniaFaculty of Pharmacy, “George Emil Palade” University of Medicine, Pharmacy, Science and Technology of Târgu Mureș, 540142 Târgu Mureș, RomaniaSkin disorders constitute a persistent health problem, covering both acute and chronic conditions that manifest in patients of all ages. Betulinic acid (BA) is a triterpene previously studied as an efficient treatment of skin ailments due to its innate pharmacological properties. Nonetheless, due to its lipophilic nature and low bioavailability, topical delivery systems are necessary for its proper administration. Oleogels are efficient carriers for the incorporation of hydrophobic biomolecules; however, their use for the delivery of BA remains scarce. Therefore, this study was designed to develop, characterize, and evaluate a BA-containing oleogel (BA-O) regarding its cutaneous safety profile as a potential pharmaceutical formulation targeting dermatologic issues. The findings illustrated the efficient formulation of BA as oleogel, the product presenting the specific conditions of topical semi-solid formulations in terms of physico-chemical characteristics and high biocompatibility in vitro and in ovo, as BA-O lacked a cytotoxic effect in HaCaT and JB6 Cl 41-5a skin cells (cell viability percentages being > 70%) and was categorized as non-irritant in EpiDerm™ tissues (viability > 80%) and on the chorioallantoic membrane (Irritation Score = 0.186). These results present the preclinical biosafety profile of BA-O with prospective potential for cutaneous applications that should be investigated in future studies.https://www.mdpi.com/2075-1729/15/6/954oleogelbetulinic acidnovel formulationtextural analysisFTIRbiosafety |
| spellingShingle | Andreea Smeu Daliana Minda Casiana Boru Lavinia Vlaia Vicențiu Vlaia Cristina Adriana Dehelean Sergio Liga George Puenea Daniela Lucia Muntean Betulinic Acid-Loaded Oleogel as a Novel Pharmaceutical Formulation for Potential Cutaneous Applications: Development, Characterization, and Biosafety Profile Life oleogel betulinic acid novel formulation textural analysis FTIR biosafety |
| title | Betulinic Acid-Loaded Oleogel as a Novel Pharmaceutical Formulation for Potential Cutaneous Applications: Development, Characterization, and Biosafety Profile |
| title_full | Betulinic Acid-Loaded Oleogel as a Novel Pharmaceutical Formulation for Potential Cutaneous Applications: Development, Characterization, and Biosafety Profile |
| title_fullStr | Betulinic Acid-Loaded Oleogel as a Novel Pharmaceutical Formulation for Potential Cutaneous Applications: Development, Characterization, and Biosafety Profile |
| title_full_unstemmed | Betulinic Acid-Loaded Oleogel as a Novel Pharmaceutical Formulation for Potential Cutaneous Applications: Development, Characterization, and Biosafety Profile |
| title_short | Betulinic Acid-Loaded Oleogel as a Novel Pharmaceutical Formulation for Potential Cutaneous Applications: Development, Characterization, and Biosafety Profile |
| title_sort | betulinic acid loaded oleogel as a novel pharmaceutical formulation for potential cutaneous applications development characterization and biosafety profile |
| topic | oleogel betulinic acid novel formulation textural analysis FTIR biosafety |
| url | https://www.mdpi.com/2075-1729/15/6/954 |
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