Araştırma Makalesi
BibTex RIS Kaynak Göster

Formulation, stability and analytical method validations of combined St. John’s wort and valerian root dry extracts in solid oral dosage forms

Yıl 2019, Cilt: 23 Sayı: 5, 812 - 821, 27.06.2025

İlker Demirbolat , Murat Kartal

Öz

Minor depression and sleep disorders are common problems in modern societies. There are prescription medicines and herbal remedies to ease the symptoms. St. John’s wort is often used to treat mild depression and valerian root is recommended as a sedative for centuries. Nowadays there is an increasing interest for herbal medicines and therefore the herbal products are becoming more and more popular. As dietary supplement retailers selling low quality products -or even don’t contain what’s claimed on the label- quality becomes the major concern. The legislation to conventional medicines applies to traditional herbal medicines too, which makes registered herbal medicines reliable in production and quality. A CTD application dossier which contains quality data in module 3 should be provided while registering a herbal medicine in EU. In this study we developed a stable formulation and validated two separate methods to quantify the herbal extract amounts in solid oral dosage forms which contains St. John’s Wort and valerian dry extract as active ingredients to comply CTD module 3 requirements.

Anahtar Kelimeler

St. John’s Wort valerian validation formulation stability

Kaynakça

  • [1] Redvers A, Laugharne R, Kanagaratnam G, Srinivasan G. How many patients self-medicate with St John's wort? Psychiatr Bull. 2001; 25(7): 254–256. [CrossRef]
  • [2] Clement K, Covertson C, Johnson MJ, Dearing K. St. John's wort and the treatment of mild to moderate depression: A systematic review. Holist Nurs Pract. 2006; 20(4):197–203.
  • [3] Community Herbal Monograph on Hypericum perforatum L. Herba. EMA/HMPC/101304/2008. European Medicines Agency, London, 2008.
  • [4] Grieve M. A Modern Herbal. Vol 2. New York, NY: Hafner Press; 1974: 824-830.
  • [5] Blumenthal M, Goldberg A, Brinckmann J. Herbal Medicine Expanded Commission E Monographs. Newton, MA: Integrative Medicine Communications; 2000: 394-400.
  • [6] Turner W. A New Herbal, Parts II and III. Cambridge, England: Cambridge University Press; 1995: 464-466.
  • [7] Ross SM. Psychophytomedicine: An Overview of Clinical Efficacy and Phytopharmacology for Treatment of Depression, Anxiety and Insomnia. Holist Nurs Pract. 2014; 28(4): 275-280. [CrossRef]
  • [8] European Union herbal monograph on Valeriana officinalis L., radix. EMA/HMPC/150848/2015. European Medicines Agency, London, UK, 2016.
  • [9] Council of Europe. St. John's Wort Quantified Dry Extract (01/2013:1874). European Pharmacopoeia 8th edition. Strasbourg, France, 2013.
  • [10] Council of Europe. Valerian Dry Hydroalcoholic Extract (01/2011:1898). European Pharmacopoeia 8th edition. Strasbourg, France, 2013.
  • [11] International Conference on Harmonization (ICH), ICH M4; Organisation of the common technical document for the registration of pharmaceuticals for human use, Geneva, Switzerland, 2016.
  • [12] International Conference on Harmonization (ICH), ICH M4Q(R1); Organisation of the common technical document for the registration of pharmaceuticals for human use, Geneva, Switzerland, 2002.
  • [13] International Conference on Harmonization (ICH), ICH Q2(R1); Validation of Analytical Procedures: Text and methodology, Geneva, Switzerland, 2005.
  • [14] General Information / (1225) Validation of Compendial Procedures. United States Pharmacopeia and National Formulary (USP 41-NF 36). Rockville, MD: United States Pharmacopeial Convention; 2016.
  • [15] International Conference on Harmonization (ICH), ICH Q1A(R2); Stability Testing of New Drug Substances and Products, Geneva, Switzerland, 2003.
  • [16] 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, UK, 2011.

Yıl 2019, Cilt: 23 Sayı: 5, 812 - 821, 27.06.2025

İlker Demirbolat , Murat Kartal

Öz

Kaynakça

  • [1] Redvers A, Laugharne R, Kanagaratnam G, Srinivasan G. How many patients self-medicate with St John's wort? Psychiatr Bull. 2001; 25(7): 254–256. [CrossRef]
  • [2] Clement K, Covertson C, Johnson MJ, Dearing K. St. John's wort and the treatment of mild to moderate depression: A systematic review. Holist Nurs Pract. 2006; 20(4):197–203.
  • [3] Community Herbal Monograph on Hypericum perforatum L. Herba. EMA/HMPC/101304/2008. European Medicines Agency, London, 2008.
  • [4] Grieve M. A Modern Herbal. Vol 2. New York, NY: Hafner Press; 1974: 824-830.
  • [5] Blumenthal M, Goldberg A, Brinckmann J. Herbal Medicine Expanded Commission E Monographs. Newton, MA: Integrative Medicine Communications; 2000: 394-400.
  • [6] Turner W. A New Herbal, Parts II and III. Cambridge, England: Cambridge University Press; 1995: 464-466.
  • [7] Ross SM. Psychophytomedicine: An Overview of Clinical Efficacy and Phytopharmacology for Treatment of Depression, Anxiety and Insomnia. Holist Nurs Pract. 2014; 28(4): 275-280. [CrossRef]
  • [8] European Union herbal monograph on Valeriana officinalis L., radix. EMA/HMPC/150848/2015. European Medicines Agency, London, UK, 2016.
  • [9] Council of Europe. St. John's Wort Quantified Dry Extract (01/2013:1874). European Pharmacopoeia 8th edition. Strasbourg, France, 2013.
  • [10] Council of Europe. Valerian Dry Hydroalcoholic Extract (01/2011:1898). European Pharmacopoeia 8th edition. Strasbourg, France, 2013.
  • [11] International Conference on Harmonization (ICH), ICH M4; Organisation of the common technical document for the registration of pharmaceuticals for human use, Geneva, Switzerland, 2016.
  • [12] International Conference on Harmonization (ICH), ICH M4Q(R1); Organisation of the common technical document for the registration of pharmaceuticals for human use, Geneva, Switzerland, 2002.
  • [13] International Conference on Harmonization (ICH), ICH Q2(R1); Validation of Analytical Procedures: Text and methodology, Geneva, Switzerland, 2005.
  • [14] General Information / (1225) Validation of Compendial Procedures. United States Pharmacopeia and National Formulary (USP 41-NF 36). Rockville, MD: United States Pharmacopeial Convention; 2016.
  • [15] International Conference on Harmonization (ICH), ICH Q1A(R2); Stability Testing of New Drug Substances and Products, Geneva, Switzerland, 2003.
  • [16] 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, UK, 2011.
Toplam 16 adet kaynakça vardır.

Ayrıntılar

Birincil Dil İngilizce
Konular Farmakognozi, Farmasotik Botanik, Klinik Farmakoloji ve Terapötikler
Bölüm Articles
Yazarlar

İlker Demirbolat

Murat Kartal

Yayımlanma Tarihi 27 Haziran 2025
Yayımlandığı Sayı Yıl 2019 Cilt: 23 Sayı: 5

Kaynak Göster

APA Demirbolat, İ., & Kartal, M. (2025). Formulation, stability and analytical method validations of combined St. John’s wort and valerian root dry extracts in solid oral dosage forms. Journal of Research in Pharmacy, 23(5), 812-821.
AMA Demirbolat İ, Kartal M. Formulation, stability and analytical method validations of combined St. John’s wort and valerian root dry extracts in solid oral dosage forms. J. Res. Pharm. Temmuz 2025;23(5):812-821.
Chicago Demirbolat, İlker, ve Murat Kartal. “Formulation, Stability and Analytical Method Validations of Combined St. John’s Wort and Valerian Root Dry Extracts in Solid Oral Dosage Forms”. Journal of Research in Pharmacy 23, sy. 5 (Temmuz 2025): 812-21.
EndNote Demirbolat İ, Kartal M (01 Temmuz 2025) Formulation, stability and analytical method validations of combined St. John’s wort and valerian root dry extracts in solid oral dosage forms. Journal of Research in Pharmacy 23 5 812–821.
IEEE İ. Demirbolat ve M. Kartal, “Formulation, stability and analytical method validations of combined St. John’s wort and valerian root dry extracts in solid oral dosage forms”, J. Res. Pharm., c. 23, sy. 5, ss. 812–821, 2025.
ISNAD Demirbolat, İlker - Kartal, Murat. “Formulation, Stability and Analytical Method Validations of Combined St. John’s Wort and Valerian Root Dry Extracts in Solid Oral Dosage Forms”. Journal of Research in Pharmacy 23/5 (Temmuz 2025), 812-821.
JAMA Demirbolat İ, Kartal M. Formulation, stability and analytical method validations of combined St. John’s wort and valerian root dry extracts in solid oral dosage forms. J. Res. Pharm. 2025;23:812–821.
MLA Demirbolat, İlker ve Murat Kartal. “Formulation, Stability and Analytical Method Validations of Combined St. John’s Wort and Valerian Root Dry Extracts in Solid Oral Dosage Forms”. Journal of Research in Pharmacy, c. 23, sy. 5, 2025, ss. 812-21.
Vancouver Demirbolat İ, Kartal M. Formulation, stability and analytical method validations of combined St. John’s wort and valerian root dry extracts in solid oral dosage forms. J. Res. Pharm. 2025;23(5):812-21.