Compatability study of selexipag and ezetimibe with selected excipients in formulation of bilayer tablet
Keywords:
ezetimibe, selexipag, compatibility, isothermal stress testing, bilayer tabletAbstract
Present study was carried out to study compatibility of Selexipag and Ezetimibe with selected generally regarded as safe excipients and to prepare bilayer tablet. Isothermal stress testing was performed in binary a mixture which was subjected to 50°C for 4 weeks. Isothermal stressed samples were evaluated with RP-HPLC method and FTIR analysis. A trial was conducted with single disintegrants and diluent with direct compression technique and in-vitro dissolution was carried out. To improve the release profile of Immediate Release layer of Selexipag, multiple disintegrants were used namely croscarmellose sodium (CCS), sodium starch glycolate (SSG) and Crospovidone (CP). Similarly, extended release layer of Ezetimibe was prepared by wet granulation technique. Intra and extra granulation was done with mixtures of disintegrants. Extended release layer of Ezetimibe was formulated using polymers and gums like HPMC, MCC, PVP, Talc, Gaur gum, and Xanthan gum, Magnesium stearate. The results show that Selexipag and Ezetimibe were compatible with the all the polymers used in the study. The polymers used in the present study and the formulations developed using the compatible excipients were found to be stable.
Downloads
References
Sneha Aashigari, Ramya Goud , Sneha S., Vykuntam U and Naga Raju Potnuri . Stability studies of pharmaceutical products . World Journal of Pharmaceutical Research 2019;8(1): 479-492.
Prasanna Desu , Vaishnavi G. , Divya K. , Lakshmi U. . An overview on preformulation studies . Indo american journal of pharmaceutical sciences 2015;2(10): 1399-1407.
Sanjay Bajaj, Dinesh Singla and Neha Sakhuja . Stability Testing of Pharmaceutical Products . Journal of Applied Pharmaceutical Science 2012;2(3): 129-138.
Soham Shukla, Vikram Pandya, Praful Bhardia, Nitin Jonwal, Shashank Mishra, Deepak Bhatt, Deependra Jain. Formulation and In vitro Evaluation of Immediate Release Bilayer Tablets of Telmisartan and Amlodipine Besylate . Research J. Pharma. Dosage Forms and Tech. 2013; 5(2): 79-87 .
Anand More . Review on Preformulation-Study of Drug . International Journal of Science and Research (IJSR) 2020;9(9):1090-1095.
Celine Liew , Ling Ching , Paul Wan , Ai Ling Ching . Modifying matrix micro-environmental pH to achieve sustained drug release from highly laminating alginate matrices . European journal of pharmaceutical sciences . 2008; 33(5):361-70. DOI: https://doi.org/10.1016/j.ejps.2008.01.007
Hamid Khan , Mushir Ali , Alka Ahuja , Javed Ali . Formulation and In-Vitro Evaluation of FDC Bilayer Matrix Tablets Containing Telmisartan as Sustained Release and Hydrochlorothiazide as Immediate Release . Research J. Pharm. and Tech. 2017; 10(4): 1085-1090. DOI: https://doi.org/10.5958/0974-360X.2017.00197.4
Hale Canbay, Mümin Polat , Mahmut Doğantürk . Study of Stability and Drug-Excipient Compatibility of Estriol . Bilge International Journal of Science and Technology Research . 2019, 3(2): 102-107 DOI: https://doi.org/10.30516/bilgesci.582054
Nancy Sharma , Sonia Pahuja and Navidita Sharma . Immediate release tablets: a review . International Journal of Pharmaceutical Sciences and Research 2019;10(8): 3607-3618 .
Kiran Thadkala , Prema Kumari Nanam , Bathini Rambabu , Chinta Sailu , and Jithan Aukunuru . Preparation and characterization of amorphous ezetimibe nanosuspensions intended for enhancement of oral bioavailability . Int J Pharm Investigation 2014 ; 4(3): 131–137. DOI: https://doi.org/10.4103/2230-973X.138344
Metkar Visha , Kumar Anuj , Pant Panka , Pal Deept , Sahu Shraddh , Shurngarpure Manse , Madhusudan Dutta . Formulation developmentand evaluation of Bilayer tablets of Lornoxicam . Int.J. Drug Dev. & Res. 2012; 4(2): 173-179.
Melting Point of Ezetimibe . Pub chem https://pubchem.ncbi.nlm.nih.gov/compound/Ezetimibe .
Melting point of selexipad Toront research chemical https://www.trc-canada.com/product-detail/?S253150 .
Published
How to Cite
Issue
Section
Copyright (c) 2022 International journal of health sciences
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
Articles published in the International Journal of Health Sciences (IJHS) are available under Creative Commons Attribution Non-Commercial No Derivatives Licence (CC BY-NC-ND 4.0). Authors retain copyright in their work and grant IJHS right of first publication under CC BY-NC-ND 4.0. Users have the right to read, download, copy, distribute, print, search, or link to the full texts of articles in this journal, and to use them for any other lawful purpose.
Articles published in IJHS can be copied, communicated and shared in their published form for non-commercial purposes provided full attribution is given to the author and the journal. Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
This copyright notice applies to articles published in IJHS volumes 4 onwards. Please read about the copyright notices for previous volumes under Journal History.
