Formulation, stability and analytical method validation of chasteberry (Vitex agnus-castus L.) extract in solid oral dosage forms
Abstract
Premenstrual syndrome (PMS) is a common condition that affects 90% of menstruating women on emotions, behaviours and physical health. Vitex agnus-castus L. also known as chasteberry or chaste tree is long being used for its health benefits on feminine problems like PMS and hyperprolactinemia. There are also some prescription medicines to ease the symptoms of PMS. While dietary supplements containing medicinal plants could be found everywhere with the lack of quality and standardisation, there are only a few registered traditional herbal medicinal products available on the market containing agnus-castus fruit extract. In this study we developed a stable film coated oral formulation and fully validated the analytical methods to quantify the extract in dosage forms to fulfil the requirements of CTD module 3 while registering the traditional herbal medicinal product according to European Union legislations.
Keywords
References
- [1] International Conference on Harmonization (ICH), ICH M4; Organisation of the common technical document for the registration of pharmaceuticals for human use, Geneva, Switzerland, 2016.
- [2] International Conference on Harmonization (ICH), ICH M4Q(R1); Organisation of the common technical document for the registration of pharmaceuticals for human use: Quality – M4Q(R1), Geneva, Switzerland, 2002.
- [3] Milewicz A, Geidel E, Sworen H, Sienkiewicz K, Jedrzejak J, Teucher T, Schmitz H. Vitex agnus-castus extract in the treatment of luteal phase defects due to latent hyperprolactinaemia. Results of a randomized placebo-controlled double blind study. Arzneimittel-Forschung. 1993; 43(7): 752-756.
- [4] Wutke W, Jarry H, Christoffel V, Spengler B, Seidlova-Wuttke D. Chaste tree (Vitex agnus-castus) – Pharmacology and clinical indications. Phytomedicine. 2003; 10(4): 348–357. [CrossRef]
- [5] Odenthal KP. Vitex agnus-castus L. - Traditional drug and actual indications. Phytother Res; 1998; 12(S1): 160-161.
- [6] He Z, Chen R, Zhou Y, Geng L, Zhang Z, Chen S, Yao Y, Lu J, Lin S. Treatment for premenstrual syndrome with Vitex agnus castus: A prospective, randomized, multi-center placebo controlled study in China. Maturitas. 2009; 63(1): 99-103. [CrossRef]
- [7] European Union herbal monograph on Vitex agnus-castus L., fructus. EMA/HMPC/606742/2017. European Medicines Agency, London, 2018.
- [8] Assessment report on Vitex agnus-castus L., fructus. EMA/HMPC/606741/2018. European Medicines Agency, London, 2018.
Details
Primary Language
English
Subjects
Pharmaceutical Botany, Pharmaceutical Chemistry
Journal Section
Research Article
Publication Date
June 27, 2025
Submission Date
March 18, 2019
Acceptance Date
April 25, 2019
Published in Issue
Year 2019 Volume: 23 Number: 4
APA
Demirbolat, İ., & Kartal, M. (2025). Formulation, stability and analytical method validation of chasteberry (Vitex agnus-castus L.) extract in solid oral dosage forms. Journal of Research in Pharmacy, 23(4), 689-696. https://izlik.org/JA22BX72XE
AMA
1.Demirbolat İ, Kartal M. Formulation, stability and analytical method validation of chasteberry (Vitex agnus-castus L.) extract in solid oral dosage forms. J. Res. Pharm. 2025;23(4):689-696. https://izlik.org/JA22BX72XE
Chicago
Demirbolat, İlker, and Murat Kartal. 2025. “Formulation, Stability and Analytical Method Validation of Chasteberry (Vitex Agnus-Castus L.) Extract in Solid Oral Dosage Forms”. Journal of Research in Pharmacy 23 (4): 689-96. https://izlik.org/JA22BX72XE.
EndNote
Demirbolat İ, Kartal M (June 1, 2025) Formulation, stability and analytical method validation of chasteberry (Vitex agnus-castus L.) extract in solid oral dosage forms. Journal of Research in Pharmacy 23 4 689–696.
IEEE
[1]İ. Demirbolat and M. Kartal, “Formulation, stability and analytical method validation of chasteberry (Vitex agnus-castus L.) extract in solid oral dosage forms”, J. Res. Pharm., vol. 23, no. 4, pp. 689–696, June 2025, [Online]. Available: https://izlik.org/JA22BX72XE
ISNAD
Demirbolat, İlker - Kartal, Murat. “Formulation, Stability and Analytical Method Validation of Chasteberry (Vitex Agnus-Castus L.) Extract in Solid Oral Dosage Forms”. Journal of Research in Pharmacy 23/4 (June 1, 2025): 689-696. https://izlik.org/JA22BX72XE.
JAMA
1.Demirbolat İ, Kartal M. Formulation, stability and analytical method validation of chasteberry (Vitex agnus-castus L.) extract in solid oral dosage forms. J. Res. Pharm. 2025;23:689–696.
MLA
Demirbolat, İlker, and Murat Kartal. “Formulation, Stability and Analytical Method Validation of Chasteberry (Vitex Agnus-Castus L.) Extract in Solid Oral Dosage Forms”. Journal of Research in Pharmacy, vol. 23, no. 4, June 2025, pp. 689-96, https://izlik.org/JA22BX72XE.
Vancouver
1.İlker Demirbolat, Murat Kartal. Formulation, stability and analytical method validation of chasteberry (Vitex agnus-castus L.) extract in solid oral dosage forms. J. Res. Pharm. [Internet]. 2025 Jun. 1;23(4):689-96. Available from: https://izlik.org/JA22BX72XE