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Evaluation Excipients and pH Effects on Impurity of Desloratadine Syrup Formulation

Yıl 2023, Cilt: 3 Sayı: 2, 35 - 40, 27.05.2023

Öz

The goal of the research work was to compare the excipient and pH effect develop a stabile pharmaceutical product which is Desloratadine syrup. A total of seven formulations were prepared and syrup to stability study. This study is used different excipients and is tried pH for improve product. To improve the stability of Desloratadine formulations (F1-F7) were evaluated with different excipients and pH during stability period. Stability studies were performed to evaluate impurity and assay of desloratine. The rate of initial and 6th months impurity results were compared to F1-F7 formulations. As a result of initial, 3rd and 6th months impurity analysis for F7 formulations were found to be within in limit. According to the evaluation results, the F-7 formulation was chosen as the stabilize and best formulation. Those results showed that the F-7 formulation was stable in the stability studies. Both of them were determined to the best formulations about impurity and pH of desloratadine.

Destekleyen Kurum

TAB İLAÇ

Teşekkür

I would like to express my gratitude to my managers and my colleagues in the study team who shared their valuable information with me in the preparation of this study. I would also like to thank my family, who have never left me alone with their financial and moral support throughout my studies.

Kaynakça

  • https://www.researchgate.net/publication/298649069_Formulation_development_and_evaluation_of_desloratadine_tabletsDrug Bank showing Desloratidine (DB00967)
  • https://sphinxsai.com/july-sept_2010_vol2.3/pharmtech/pharmtechvol2.3july-sept210/PT=70%20(2101-2106).pdf
  • Raymond C.R, Paul J.S and Sian C.O, Pharmaceutical Excipients, 255-256.
  • https://patents.google.com/patent/CN101390860A/en
  • https://patents.google.com/patent/CN104784110A/en
  • ICH Guideline, “Validation of analytical procedures: text and methodology,” in Proceedings of International Conference on Harmonization, Topic Q2 (R1), Geneva, Switzerland.
  • https://www.ema.europa.eu/en/documents/variation-report/aerius-h-c-313-x-0033-epar- assessment-report-extension_en.pdf
  • https://www.ema.europa.eu/en/documents/variation-report/aerius-h-c-313-x-0033-epar- assessment-report-extension_en.pdf
  • Development and validation of a novel revesed phase high performance liquid cromatograpy with refractive index detector method for assay of polyvinyl alcohol in an ophthalmic solution.current pharmaceutical analysis 2020
  • Raymond C.R, Paul J.S and Sian C.O, Pharmaceutical Excipients, 301-303.
  • Raymond C.R, Paul J.S and Sian C.O, Pharmaceutical Excipients, 185-187.
  • https://pubchem.ncbi.nlm.nih.gov/compound/Desloratadine
  • https://go.gale.com/ps/i.do?id=GALE%7CA252944814&sid=googleScholar&v=2.1&it=r&linkaccess=abs&issn=19950772&p=AONE&sw=w&userGroupName=anon%7E6be0a7bb
Yıl 2023, Cilt: 3 Sayı: 2, 35 - 40, 27.05.2023

Öz

Kaynakça

  • https://www.researchgate.net/publication/298649069_Formulation_development_and_evaluation_of_desloratadine_tabletsDrug Bank showing Desloratidine (DB00967)
  • https://sphinxsai.com/july-sept_2010_vol2.3/pharmtech/pharmtechvol2.3july-sept210/PT=70%20(2101-2106).pdf
  • Raymond C.R, Paul J.S and Sian C.O, Pharmaceutical Excipients, 255-256.
  • https://patents.google.com/patent/CN101390860A/en
  • https://patents.google.com/patent/CN104784110A/en
  • ICH Guideline, “Validation of analytical procedures: text and methodology,” in Proceedings of International Conference on Harmonization, Topic Q2 (R1), Geneva, Switzerland.
  • https://www.ema.europa.eu/en/documents/variation-report/aerius-h-c-313-x-0033-epar- assessment-report-extension_en.pdf
  • https://www.ema.europa.eu/en/documents/variation-report/aerius-h-c-313-x-0033-epar- assessment-report-extension_en.pdf
  • Development and validation of a novel revesed phase high performance liquid cromatograpy with refractive index detector method for assay of polyvinyl alcohol in an ophthalmic solution.current pharmaceutical analysis 2020
  • Raymond C.R, Paul J.S and Sian C.O, Pharmaceutical Excipients, 301-303.
  • Raymond C.R, Paul J.S and Sian C.O, Pharmaceutical Excipients, 185-187.
  • https://pubchem.ncbi.nlm.nih.gov/compound/Desloratadine
  • https://go.gale.com/ps/i.do?id=GALE%7CA252944814&sid=googleScholar&v=2.1&it=r&linkaccess=abs&issn=19950772&p=AONE&sw=w&userGroupName=anon%7E6be0a7bb
Toplam 13 adet kaynakça vardır.

Ayrıntılar

Birincil Dil İngilizce
Konular Eczacılık ve İlaç Bilimleri
Bölüm Research Articles
Yazarlar

Osman Ünal 0000-0001-7003-479X

Yayımlanma Tarihi 27 Mayıs 2023
Yayımlandığı Sayı Yıl 2023 Cilt: 3 Sayı: 2

Kaynak Göster

EndNote Ünal O (01 Mayıs 2023) Evaluation Excipients and pH Effects on Impurity of Desloratadine Syrup Formulation. International Journal of PharmATA 3 2 35–40.