eprintid: 10205435
rev_number: 7
eprint_status: archive
userid: 699
dir: disk0/10/20/54/35
datestamp: 2025-02-28 11:17:27
lastmod: 2025-02-28 11:17:27
status_changed: 2025-02-28 11:17:27
type: article
metadata_visibility: show
sword_depositor: 699
creators_name: Jalil, Banaz
creators_name: Heinrich, Michael
title: Pharmaceutical quality of herbal medicinal products and dietary supplements – a case study with oral solid formulations containing Lavandula species
ispublished: pub
divisions: UCL
divisions: B02
divisions: C08
divisions: D10
divisions: G09
keywords: disintegration, herbal medicinal products, Lavandula, Oral dosage forms, pharmaceutical performance, soft gel capsules
note: Copyright © 2025 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/bync-nd/4.0/).
abstract: The effectiveness and safety of regulated herbal medicinal products and dietary/food supplements are key areas of research. However, limited evidence exists of their pharmaceutical performance quality (including the standard in the respective Pharmacopeial monographs). We evaluated the applicability of the European Pharmacopoeia general chapter protocols for disintegration testing of oral dosage forms using 73 products containing Lavandula species. Several Lavandula species, hybrids and cultivars are important medicinal plants globally in the phytopharmaceuticals and dietary/food supplement industry, including L. angustifolia Mill., traditionally used to treat conditions linked to nervousness and sleep disorders. We evaluate the pharmaceutical performance quality, particularly the in vitro disintegration and the 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). There was also considerable variability of the main marker compounds between products, with some containing 'often/sometimes undeclared' and significant amounts of rapeseed and sunflower oils as excipients. 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). Pass rates for gelatine-based capsules were higher than for non-gelatine (cellulose-based) capsules. Overall, our findings highlighted problems with the pharmaceutical performance and phytochemical quality of the investigated products. These results have implications for the interpretations of the benefits and risks of phytopharmaceuticals used as compared to dietary/food supplements.
date: 2025-05-01
date_type: published
publisher: Elsevier BV
official_url: https://doi.org/10.1016/j.ejps.2025.107042
oa_status: green
full_text_type: pub
language: eng
primo: open
primo_central: open_green
verified: verified_manual
elements_id: 2364265
doi: 10.1016/j.ejps.2025.107042
medium: Print-Electronic
pii: S0928-0987(25)00041-7
lyricists_name: Jalil, Banaz
lyricists_id: BJALI32
actors_name: Booker, Anthony
actors_name: Harris, Jean
actors_id: AJBOO99
actors_id: JAHAR68
actors_role: owner
actors_role: impersonator
full_text_status: public
publication: European Journal of Pharmaceutical Sciences
volume: 208
article_number: 107042
event_location: Netherlands
issn: 0928-0987
citation:        Jalil, Banaz;    Heinrich, Michael;      (2025)    Pharmaceutical quality of herbal medicinal products and dietary supplements – a case study with oral solid formulations containing Lavandula species.                   European Journal of Pharmaceutical Sciences , 208     , Article 107042.  10.1016/j.ejps.2025.107042 <https://doi.org/10.1016/j.ejps.2025.107042>.       Green open access   
 
document_url: https://discovery.ucl.ac.uk/id/eprint/10205435/1/1-s2.0-S0928098725000417-main.pdf