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:: Volume 34, Issue 4 (winter 2024) ::
MEDICAL SCIENCES 2024, 34(4): 357-364 Back to browse issues page
Sustained release formulation of doxylamine-pyridoxine combination: a promising way to overcome nausea and vomiting of pregnancy
Fatemeh Sadat Fakhari1 , Sepideh Arbabi Bidgoli2 , Solmaz Ghaffari 3
1- Department of Pharmaceutics, Faculty of Pharmacy, Medical University, Islamic Azad University, Tehran, Iran
2- Department of Toxicology and Pharmacology, Faculty of Pharmacy, Medical University, Islamic Azad University, Tehran, Iran
3- Department of Pharmaceutics, Faculty of Pharmacy, Medical University, Islamic Azad University, Tehran, Iran , soligh@yahoo.com
Abstract:   (363 Views)
Background: Nausea and vomiting of pregnancy (NVP) are one of the most common complications affects up to 80% of future mothers. A phase III randomized clinical trial demonstrated the efficacy of the doxylamine-pyridoxine combination [under the trade names of Diclectin® in Canada]. Doxylamine succinate-pyridoxine hydrochloride sustained release combination has been considered as a safe and well-tolerated formulation by pregnant women. Due to the high prevalence of NVP in Iranian pregnant women, we aimed in this study to formulate this combination.
Materials and methods: Direct compression method was used to prepare this formulation. First, tablets containing two active agents were prepared. Eudragit L100 and L10055 were used to coat the tablets. Then the coated tablets, were exposed to acidic conditions to ensure their stability in the stomach environment. All in-vitro evaluations were done. The analysis of the APIs was done using high-performance liquid chromatography coupled with ultraviolet detection, the HPLC method was developed and fully validated.
Results: Based on the dissolution test and release profile, the formulation containing 3.5% croscarmellose in the core and Eudragit L100-55 as coating polymer showed optimum similarity to the famous brand. In the optimized formulation, no significant release was detected in pH equal to stomach and total release happened in the intestine pH, similarity and difference factors for pyridoxine and doxylamine were 78% and 3% ,71% and 4%, respectively.
Conclusion: In this study, a comparable formulation of pyridoxine and doxylamine with famous brand was prepared for the management of NVP.
 
Keywords: Pyridoxine, Doxylamine, Nausea and vomiting, Pregnancy, sustained release, Eudragit, Analytical method, Validation
Full-Text [PDF 1121 kb]   (210 Downloads)    
Semi-pilot: Experimental | Subject: Pharmacology
Received: 2023/11/27 | Accepted: 2024/02/19 | Published: 2024/11/30
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Fakhari F S, Arbabi Bidgoli S, Ghaffari S. Sustained release formulation of doxylamine-pyridoxine combination: a promising way to overcome nausea and vomiting of pregnancy. MEDICAL SCIENCES 2024; 34 (4) :357-364
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Volume 34, Issue 4 (winter 2024) Back to browse issues page
فصلنامه علوم پزشکی دانشگاه آزاد اسلامی واحد پزشکی تهران Medical Science Journal of Islamic Azad Univesity - Tehran Medical Branch
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