Author(s):
Ismail Bennani, Hajar Benhaddou, Ali Cherif Chefchaouni, Younes Rahali, Madiha Chentoufi Alami, Aicha Fahry, Yassir El Alaoui, Abdeslam El Kartouti, Youssef Hafidi, Abdelkader Laatiris, Nawal Cherkaoui
Email(s):
ismail.bennani@usmba.ac.ma
DOI:
10.52711/0974-360X.2024.00098 
Address:
Ismail Bennani1,2, Hajar Benhaddou3, Ali Cherif Chefchaouni3,4, Younes Rahali3,4, Madiha Chentoufi Alami5, Aicha Fahry3, Yassir El Alaoui3,4, Abdeslam El Kartouti1, Youssef Hafidi2, Abdelkader Laatiris3, Nawal Cherkaoui3
1Department of Pharmacy, Faculty of Medicine, Pharmacy and Dental Medicine of Fez, Sidi Mohamed Ben Abdellah University, Fez, Morocco.
2Department of Pharmacy, Hassan II University Hospital of Fez, Morocco.
3Faculty of Medicine and Pharmacy, Mohammed V University of Rabat, Rabat, Morocco.
4Ibn Sina University Hospital Center, Rabat, Morocco.
5Faculty of Medicine and Pharmacy of Tangier, Abdelmalek Essaâdi University.
*Corresponding Author
Published In:
Volume - 17,
Issue - 2,
Year - 2024
ABSTRACT:
This study aims to evaluate the similarity of in-vitro dissolution profiles, of commercially available generics of diclofenac sodium delayed-release tablets, of 25mg strength, with the innovator brand in Moroccan Market. Dissolution profiles for five brands were determined using the paddle method from the United States Pharmacopoeia. For the aptitude verification of the method, in our experimental conditions, linearity and accuracy tests were performed. The rate of dissolution was determined by Ultra-Violet Spectroscopy at 276nm. The assessment between the generics and the brand medicine was carried out under the similarity factor approach. We also presented an overview of the dissolution principles of tablet dosage form, and the pharmacopoeia dissolution test recommendations in our case. To compliance with US pharmacopoeia specifications, the rate of dissolution should be not more than 10% after 2hours in the acid stage, and not less than 75% at 45 minutes in the buffer stage. Furthermore, two dissolution profiles are considered similar when the f2 value is =50. According to routine quality control, evaluating the rate dissolution at the final point, all the generic medicines marketed in Morocco, meet the specification of the dissolution testing. However, using the comparison of dissolution profiles, only generic-2 is interchangeable with the innovator brand.
Cite this article:
Ismail Bennani, Hajar Benhaddou, Ali Cherif Chefchaouni, Younes Rahali, Madiha Chentoufi Alami, Aicha Fahry, Yassir El Alaoui, Abdeslam El Kartouti, Youssef Hafidi, Abdelkader Laatiris, Nawal Cherkaoui. Research Journal of Pharmacy and Technology. 2024; 17(2):631-5. doi: 10.52711/0974-360X.2024.00098
Cite(Electronic):
Ismail Bennani, Hajar Benhaddou, Ali Cherif Chefchaouni, Younes Rahali, Madiha Chentoufi Alami, Aicha Fahry, Yassir El Alaoui, Abdeslam El Kartouti, Youssef Hafidi, Abdelkader Laatiris, Nawal Cherkaoui. Research Journal of Pharmacy and Technology. 2024; 17(2):631-5. doi: 10.52711/0974-360X.2024.00098 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2024-17-2-26
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