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Formulation, stability and analytical method validation of chasteberry (Vitex agnus-castus L.) extract in solid oral dosage forms

Yıl 2019, Cilt: 23 Sayı: 4, 689 - 696, 27.06.2025

İlker Demirbolat Murat Kartal

Öz

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.

Anahtar Kelimeler

Chasteberry Vitex agnus-castus validation formulation stability

Kaynakça

  • [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.
  • [9] European Pharmacopoeia, Ph. Eur. 9th ed. Agnus castus fruit dry extract. Council of Europe. 01/2015: 2309.
  • [10] Lee H, Jung KH, Park S, Choi W, Bae H. Casticin, an active compound isolated from Vitex Fructus, ameliorates the cigarette smoke-induced acute lung inflammatory response in a murine model. Int Immunopharmacol. 2015; 28: 1097–1101. [CrossRef]
  • [11] Elford BC, Roberts MF, Phillipson JD, Wilson RJ. Potentiation of the antimalarial activity of qinghaosu by methoxylated flavones. Trans R Soc Trop Med Hyg. 1987; 81: 434–436.
  • [12] Choudhary MI, Jalil S, Nawaz SA, Khan KM, Tareen RB. Antiinflammatory and lipoxygenase inhibitory compounds from Vitex agnus-castus. Phytother Res. 2009; 23: 1336–1339. [CrossRef]
  • [13] Chan EWC, Wong SK, Chan HT (2018) Casticin from Vitex species: a short review on its anticancer and anti-inflammatory properties. J Integr Med. 2018; 16: 147–152. [CrossRef]
  • [14] International Conference on Harmonization (ICH), ICH Q2 (R1); Validation of Analytical Procedures: Text and methodology. International Conference on Harmonization, Geneva, Switzerland, 2005.
  • [15] General Information / (1225) Validation of Compendial Procedures. United States Pharmacopeia and National Formulary (USP 41-NF 36). Rockville, MD: United States Pharmacopeial Convention; 2016.
  • [16] International Conference on Harmonization (ICH), ICH Q1A(R2); Stability Testing of New Drug Substances and Products. International Conference on Harmonization, Geneva, Switzerland, 2003.
  • [17] Guideline on specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products /traditional herbal medicinal products. EMA/CPMP/QWP/2820/00 Rev. 2. European Medicines Agency, London, 2011.

Yıl 2019, Cilt: 23 Sayı: 4, 689 - 696, 27.06.2025

İlker Demirbolat Murat Kartal

Öz

Kaynakça

  • [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.
  • [9] European Pharmacopoeia, Ph. Eur. 9th ed. Agnus castus fruit dry extract. Council of Europe. 01/2015: 2309.
  • [10] Lee H, Jung KH, Park S, Choi W, Bae H. Casticin, an active compound isolated from Vitex Fructus, ameliorates the cigarette smoke-induced acute lung inflammatory response in a murine model. Int Immunopharmacol. 2015; 28: 1097–1101. [CrossRef]
  • [11] Elford BC, Roberts MF, Phillipson JD, Wilson RJ. Potentiation of the antimalarial activity of qinghaosu by methoxylated flavones. Trans R Soc Trop Med Hyg. 1987; 81: 434–436.
  • [12] Choudhary MI, Jalil S, Nawaz SA, Khan KM, Tareen RB. Antiinflammatory and lipoxygenase inhibitory compounds from Vitex agnus-castus. Phytother Res. 2009; 23: 1336–1339. [CrossRef]
  • [13] Chan EWC, Wong SK, Chan HT (2018) Casticin from Vitex species: a short review on its anticancer and anti-inflammatory properties. J Integr Med. 2018; 16: 147–152. [CrossRef]
  • [14] International Conference on Harmonization (ICH), ICH Q2 (R1); Validation of Analytical Procedures: Text and methodology. International Conference on Harmonization, Geneva, Switzerland, 2005.
  • [15] General Information / (1225) Validation of Compendial Procedures. United States Pharmacopeia and National Formulary (USP 41-NF 36). Rockville, MD: United States Pharmacopeial Convention; 2016.
  • [16] International Conference on Harmonization (ICH), ICH Q1A(R2); Stability Testing of New Drug Substances and Products. International Conference on Harmonization, Geneva, Switzerland, 2003.
  • [17] Guideline on specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products /traditional herbal medicinal products. EMA/CPMP/QWP/2820/00 Rev. 2. European Medicines Agency, London, 2011.
Toplam 17 adet kaynakça vardır.

Ayrıntılar

Birincil Dil İngilizce
Konular Farmasotik Botanik, Farmasotik Kimya
Bölüm Articles
Yazarlar

İlker Demirbolat

Murat Kartal

Yayımlanma Tarihi 27 Haziran 2025
Yayımlandığı Sayı Yıl 2019 Cilt: 23 Sayı: 4

Kaynak Göster

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.
AMA 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. Haziran 2025;23(4):689-696.
Chicago Demirbolat, İlker, ve 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 23, sy. 4 (Haziran 2025): 689-96.
EndNote Demirbolat İ, Kartal M (01 Haziran 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 İ. Demirbolat ve M. Kartal, “Formulation, stability and analytical method validation of chasteberry (Vitex agnus-castus L.) extract in solid oral dosage forms”, J. Res. Pharm., c. 23, sy. 4, ss. 689–696, 2025.
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 (Haziran 2025), 689-696.
JAMA 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 ve 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, c. 23, sy. 4, 2025, ss. 689-96.
Vancouver 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):689-96.