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

Murat Kartal

Makale detayları

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

Yazarlar:

Murat Kartal

Yayıncı:

Marmara University

Ana Başlıklar:

Pharmaceutical Botany | Pharmaceutical Chemistry

Dergi:

Journal of Research in Pharmacy Vol.23 Issue 4, pp.689-696

Belge Tipi:

Makale

Yayın Tarihi:

6/2025

Belge Dili:

İngilizce

Document ID (Org No.):

2001347687

pISSN:

2630-6344

Anahtar kelimeler:

Özet:

 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.

 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.

 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.

 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.

Makale detayları

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

Yazarlar:

Murat Kartal

Yayıncı:

Marmara University

Ana Başlıklar:

Pharmaceutical Botany | Pharmaceutical Chemistry

Dergi:

Journal of Research in Pharmacy Vol.23 Issue 4, pp.689-696

Belge Tipi:

Makale

Yayın Tarihi:

6/2025

Belge Dili:

İngilizce

Document ID (Org No.):

2001347687

pISSN:

2630-6344

Chasteberry

Vitex agnus-castus

validation

formulation

stability

Sayı

Makale detayları

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

Yazarlar: Murat Kartal

Yayıncı: Marmara University

Ana Başlıklar: Pharmaceutical Botany | Pharmaceutical Chemistry

Dergi: Journal of Research in Pharmacy Vol.23 Issue 4, pp.689-696

Belge Tipi: Makale

Yayın Tarihi: 6/2025

Belge Dili: İngilizce

Document ID (Org No.): 2001347687

pISSN: 2630-6344

Chasteberry

Vitex agnus-castus

validation

formulation

stability

Sayı

Yazarlar:

Murat Kartal

Yayıncı:

Marmara University

Ana Başlıklar:

Pharmaceutical Botany | Pharmaceutical Chemistry

Dergi:

Journal of Research in Pharmacy Vol.23 Issue 4, pp.689-696

Belge Tipi:

Makale

Yayın Tarihi:

6/2025

Belge Dili:

İngilizce

Document ID (Org No.):

2001347687

pISSN:

2630-6344