Development, Optimization, and Stability Study of a Yataprasen Film-Forming Spray for Musculoskeletal Pain Management

Yataprasen (YTPS) remedy ethanolic spray, one of the National Thai Traditional Medicine Formulary, is extensively employed in Thai traditional healthcare to manage musculoskeletal pain and inflammation. Despite its widespread use, the quality and stability of the YTPS formulation, critical to its ef...

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Main Authors: Jaenjira Angsusing, Weerasak Samee, Sarin Tadtong, Supachoke Mangmool, Siriporn Okonogi, Nopparut Toolmal, Chuda Chittasupho
Format: Article
Language:English
Published: MDPI AG 2025-01-01
Series:Gels
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Online Access:https://www.mdpi.com/2310-2861/11/1/64
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author Jaenjira Angsusing
Weerasak Samee
Sarin Tadtong
Supachoke Mangmool
Siriporn Okonogi
Nopparut Toolmal
Chuda Chittasupho
author_facet Jaenjira Angsusing
Weerasak Samee
Sarin Tadtong
Supachoke Mangmool
Siriporn Okonogi
Nopparut Toolmal
Chuda Chittasupho
author_sort Jaenjira Angsusing
collection DOAJ
description Yataprasen (YTPS) remedy ethanolic spray, one of the National Thai Traditional Medicine Formulary, is extensively employed in Thai traditional healthcare to manage musculoskeletal pain and inflammation. Despite its widespread use, the quality and stability of the YTPS formulation, critical to its efficacy, safety, and patient adherence, have not been comprehensively studied. This research developed and optimized a film-forming spray (FFS) formulation of YTPS ethanolic extract and conducted a 6-month stability evaluation. The FFS shares similarities with gel formulations, particularly in its ability to form a cohesive, semi-solid film upon application, enhancing localized drug delivery and prolonged contact time. Key physicochemical properties, including density (0.8450–0.9086 g/cm<sup>3</sup>), pH (4.72–4.95), spray angle (55.58–60.10°), evaporation time (1.04–1.27 min), and theoretical film thickness (7.72–13.97 µm), were analyzed across varying storage conditions. Active components β-amyrin and stigmasterol demonstrated retention rates of 96.78% and 68.22%, respectively, under refrigerated conditions, with degradation rates accelerating at higher temperatures. Significant variations in density, spray angle, film thickness, and stigmasterol concentration were observed. Additionally, the RP-HPLC method was validated for the accurate and precise quantification of the bioactive compounds such as β-amyrin and stigmasterol, demonstrating excellent linearity within a 10–100 µg/mL range for both compounds with excellent linearity R<sup>2</sup> > 0.999. The results confirmed that YTPS-FFS exhibits good stability and that the validated HPLC method is reliable for routine quality control. These findings supported the potential of YTPS-FFS formulation as a standardized and effective dosage form for managing musculoskeletal conditions, advancing its role in modernized traditional medicine.
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spelling doaj-art-7f870c5265f448c3b2f71b23ea6623522025-01-24T13:33:59ZengMDPI AGGels2310-28612025-01-011116410.3390/gels11010064Development, Optimization, and Stability Study of a Yataprasen Film-Forming Spray for Musculoskeletal Pain ManagementJaenjira Angsusing0Weerasak Samee1Sarin Tadtong2Supachoke Mangmool3Siriporn Okonogi4Nopparut Toolmal5Chuda Chittasupho6Ph.D. Degree Program in Pharmacy, Faculty of Pharmacy, Chiang Mai University, CMU Presidential Scholarship, Chiang Mai 50200, ThailandDepartment of Pharmaceutical Chemistry, Faculty of Pharmacy, Srinakharinwirot University, Ongkharak, Nakhon Nayok 26120, ThailandDepartment of Pharmacognosy, Faculty of Pharmacy, Srinakharinwirot University, Ongkharak, Nakhon Nayok 26120, ThailandDepartment of Pharmaceutical Care, Faculty of Pharmacy, Chiang Mai University, Chiang Mai 50200, ThailandDepartment of Pharmaceutical Sciences, Faculty of Pharmacy, Chiang Mai University, Mueang, Chiang Mai 50200, ThailandDepartment of Thai Traditional and Alternative Medicine, Ministry of Public Health, Bangkok 10100, ThailandDepartment of Pharmaceutical Sciences, Faculty of Pharmacy, Chiang Mai University, Mueang, Chiang Mai 50200, ThailandYataprasen (YTPS) remedy ethanolic spray, one of the National Thai Traditional Medicine Formulary, is extensively employed in Thai traditional healthcare to manage musculoskeletal pain and inflammation. Despite its widespread use, the quality and stability of the YTPS formulation, critical to its efficacy, safety, and patient adherence, have not been comprehensively studied. This research developed and optimized a film-forming spray (FFS) formulation of YTPS ethanolic extract and conducted a 6-month stability evaluation. The FFS shares similarities with gel formulations, particularly in its ability to form a cohesive, semi-solid film upon application, enhancing localized drug delivery and prolonged contact time. Key physicochemical properties, including density (0.8450–0.9086 g/cm<sup>3</sup>), pH (4.72–4.95), spray angle (55.58–60.10°), evaporation time (1.04–1.27 min), and theoretical film thickness (7.72–13.97 µm), were analyzed across varying storage conditions. Active components β-amyrin and stigmasterol demonstrated retention rates of 96.78% and 68.22%, respectively, under refrigerated conditions, with degradation rates accelerating at higher temperatures. Significant variations in density, spray angle, film thickness, and stigmasterol concentration were observed. Additionally, the RP-HPLC method was validated for the accurate and precise quantification of the bioactive compounds such as β-amyrin and stigmasterol, demonstrating excellent linearity within a 10–100 µg/mL range for both compounds with excellent linearity R<sup>2</sup> > 0.999. The results confirmed that YTPS-FFS exhibits good stability and that the validated HPLC method is reliable for routine quality control. These findings supported the potential of YTPS-FFS formulation as a standardized and effective dosage form for managing musculoskeletal conditions, advancing its role in modernized traditional medicine.https://www.mdpi.com/2310-2861/11/1/64film-forming spraynatural productsstability studyYataprasen
spellingShingle Jaenjira Angsusing
Weerasak Samee
Sarin Tadtong
Supachoke Mangmool
Siriporn Okonogi
Nopparut Toolmal
Chuda Chittasupho
Development, Optimization, and Stability Study of a Yataprasen Film-Forming Spray for Musculoskeletal Pain Management
Gels
film-forming spray
natural products
stability study
Yataprasen
title Development, Optimization, and Stability Study of a Yataprasen Film-Forming Spray for Musculoskeletal Pain Management
title_full Development, Optimization, and Stability Study of a Yataprasen Film-Forming Spray for Musculoskeletal Pain Management
title_fullStr Development, Optimization, and Stability Study of a Yataprasen Film-Forming Spray for Musculoskeletal Pain Management
title_full_unstemmed Development, Optimization, and Stability Study of a Yataprasen Film-Forming Spray for Musculoskeletal Pain Management
title_short Development, Optimization, and Stability Study of a Yataprasen Film-Forming Spray for Musculoskeletal Pain Management
title_sort development optimization and stability study of a yataprasen film forming spray for musculoskeletal pain management
topic film-forming spray
natural products
stability study
Yataprasen
url https://www.mdpi.com/2310-2861/11/1/64
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