Document Type

Oral Presentation

Location

Oxford Conference Center, Oxford MS

Event Website

https://oxfordicsb.org/

Start Date

7-4-2025 4:00 PM

Description

Several Lavandula species are important aromatic and medicinal plants with great economic value as phytopharmaceuticals, foods, in perfumery, cosmetics, and aromatherapy. The genus Lavandula comprises 39 species with many hybrids. Over 20 years ago about 400 registered cultivars were recorded (1) , with the three main cultivated species being used to produce essential oils, including fine lavender oil, spike lavender oil and lavandin oil. Lavandula angustifolia Mill. is used traditionally to treat restlessness, agitation, insomnia and intestinal discomfort linked to nervousness (2). For example, Silexan® is a high-quality fine lavender oil licensed as an active ingredient in medicines for the relief of mild anxiety disorders (3, 4). As of January 2025, 523 clinical trials with lavender as the investigational product were registered (https://trialsearch.who.int/). We evaluate the pharmaceutical performance and phytochemical quality of 73 Lavandula oral dosage forms of single and multi–ingredients with different regulatory statuses. The phytochemical quality testing showed that 63% of products contain less or none of the main marker compounds (e.g., linalool, linalyl acetate, and cineole). The pharmaceutical performance quality testing showed that 30% of oral solid formulations always failed the disintegration testing (seven soft gels, ten hard shells, and five tablets/caplets) (Figure 1). The study highlights the need for better pharmaceutical quality assurance beyond defining the chemical composition (e.g. in a pharmacopoeia) of herbal medicinal products and dietary supplements. This case study using Lavandula species highlights wider concerns. The differences in regulatory statutes governing medicinal products and dietary/food supplements on the global market (5) may contribute to a limited understanding of the potential risks/benefits of these products, particularly herbal medical products, for their utilisations in addressing global healthcare challenges.

Publication Date

April 2025

Accessibility Status

Screen reader accessible, Searchable text

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Apr 7th, 4:00 PM

The pharmaceutical quality of herbal medicinal products and dietary supplements – Assessment of products from Lavandula species

Oxford Conference Center, Oxford MS

Several Lavandula species are important aromatic and medicinal plants with great economic value as phytopharmaceuticals, foods, in perfumery, cosmetics, and aromatherapy. The genus Lavandula comprises 39 species with many hybrids. Over 20 years ago about 400 registered cultivars were recorded (1) , with the three main cultivated species being used to produce essential oils, including fine lavender oil, spike lavender oil and lavandin oil. Lavandula angustifolia Mill. is used traditionally to treat restlessness, agitation, insomnia and intestinal discomfort linked to nervousness (2). For example, Silexan® is a high-quality fine lavender oil licensed as an active ingredient in medicines for the relief of mild anxiety disorders (3, 4). As of January 2025, 523 clinical trials with lavender as the investigational product were registered (https://trialsearch.who.int/). We evaluate the pharmaceutical performance and phytochemical quality of 73 Lavandula oral dosage forms of single and multi–ingredients with different regulatory statuses. The phytochemical quality testing showed that 63% of products contain less or none of the main marker compounds (e.g., linalool, linalyl acetate, and cineole). The pharmaceutical performance quality testing showed that 30% of oral solid formulations always failed the disintegration testing (seven soft gels, ten hard shells, and five tablets/caplets) (Figure 1). The study highlights the need for better pharmaceutical quality assurance beyond defining the chemical composition (e.g. in a pharmacopoeia) of herbal medicinal products and dietary supplements. This case study using Lavandula species highlights wider concerns. The differences in regulatory statutes governing medicinal products and dietary/food supplements on the global market (5) may contribute to a limited understanding of the potential risks/benefits of these products, particularly herbal medical products, for their utilisations in addressing global healthcare challenges.

https://egrove.olemiss.edu/icsb/2025_ICSB/Schedule/13