Research Journal of Pharmacy and Technology

Open Access Open Access  Restricted Access Subscription Access
Open Access Open Access Open Access  Restricted Access Restricted Access Subscription Access

Box Behnken Design for Optimization of Mirabegron Solid Dispersion by Fluidized Bed Processing


Affiliations
1 Maulana Azad Educational Trust’s Y. B. Chavan College of Pharmacy, Aurangabad, MS, India
     

   Subscribe/Renew Journal


The present study was to develop a stable mirabegron solid dispersion by FBP technique with improved solubility, dissolution and stability. The solid dispersion of mirabegron with poloxamer, PEG-6000 and PVP K-30 has been prepared with different weight ratios by using FBP technique. Saturation solubility studies showed significant effect of all polymers on solubility of mirabegron. MS9 batch showed maximum solubility 198.48 μg/ml in water. Box Behnken design was applied for the development of ER formulation of mirabegron by considering poloxamer, BHT and EC independent factors and drug content and drug release was dependent variables. MS9 exhibited 99.18% drug release indicated immediate release and run 6 exhibited 99.33% drug content and 99.45% at 24 h indicates significantly extend the release of mirabegron. These finding solid dispersion by fluidized bed processing is extremely important for the solubility and dissolution rate enhancement of mirabegron.

Keywords

Mirabegron, Solid Dispersion, Fluidized Bed Processing, Solubility Enhancement, Box Behnken.
Subscription Login to verify subscription
User
Notifications
Font Size


  • Singh D., Bedi N., Tiwary A.K. Enhancing Solubility of Poorly Aqueous Soluble Drugs: Critical Appraisal of Techniques. J. Pharm. Investig. 2018; 48: 509–526. https://doi.org/10.1007/s40005-017-0357-1

  • An, J.-H.; Lim, C.; Kiyonga, A.N.; Chung, I.H.; Lee, I.K.; Mo, K.; Park, M.; Youn, W.; Choi, W.R.; Suh, Y.-G.; Jung, K. Co-Amorphous Screening for the Solubility Enhancement of Poorly Water-Soluble Mirabegron and Investigation of Their Intermolecular Interactions and Dissolution Behaviours. Pharmaceutics. 2018; 10: 149. https://doi.org/10.3390/pharmaceutics10030149

  • Rupam A. Wagh, Rajendra K. Surawase. Formulation and Development of Sustained Release Pellets of Nifedipine by Fluidized Bed Processor. Research J. Pharm. and Tech. 2020; 13(4):1757-1761. https://doi.org/10.5958/0974-360X.2020.00317.0

  • Mandpe P., Prabhakar B., Shende, P. 23 Full Factorial Design for Optimization of Stable Amorphous Host–Guest-Based Mirabegron Complex for Extended-Release Action. J Incl. Phenom Macrocycl. Chem. 2020; 96: 111–123. https://doi.org/10.1007/s10847-019-00955-1

  • Digvisha Patel, Dhaval Patel. Physicochemical Characterization and in Vitro Dissolution Enhancement of Mirabegron Using Solid Dispersion Method. World Journal of Pharmacy and Pharmaceutical Sciences. 2018; 7(5): 973-991 http://doi.org/10.20959/wjpps20185-11502

  • K. Anusha, G. Kishorbabu. Formulation of Sustained Release Pellets of Quetiapine Fumarate by Fluidized Bed Coating Process. International Journal of Pharmaceutical Science Invention. 2013; 2(12): 20-33.

  • Dungarwal U.N., Patil S.B. Development of Orodispersible Tablets of Taste Masked Rizatriptan Benzoate Using Hydroxypropyl β Cyclodextrin. Journal of Pharmaceutical Investigation. 2016; 46: 537–545.https://doi.org/10.1007/s40005-016-0240-5

  • Mayur V. Chinchore, Pankaj D. Kothawade, Rajendra K. Surwase, Avish D. Maru. Formulation, Optimization and Evaluation of Amlodipine Besylate Sublingual Films. Research J. Pharm. and Tech. 2014; 7(8): 840-844.

  • Shojaei S., Shojaei S., Pirkamali M. Application of Box–Behnken Design Approach for Removal of Acid Black 26 from Aqueous Solution Using Zeolite: Modeling, Optimization and Study of Interactive Variables. Water Conserv. Sci Eng. 2019; 4: 13-19. https://doi.org/10.1007/s41101-019-00064-7

  • Daisy Sharma, Mohit Soni, Sandeep Kumar, GD Gupta. Solubility Enhancement – Eminent Role in Poorly Soluble Drugs. Research J. Pharm. and Tech. 2009; 2(2): 220-224.

  • Yogesh L. Jadhav, Bharat Parashar, Pankaj P. Ostwal, Manu S. Jain. Solid Dispersion: Solubility Enhancement for Poorly Water-Soluble Drug. Research J. Pharm. and Tech. 2012; 5(2): 190-197.

  • Aballea S, Maman K, Thokagevistk K, Nazir J, Odeyemi IA, Hakimi Z, Garnham A, Toumi M. Cost Effectiveness of Mirabegron Compared with Tolterodine Extended Release for the Treatment of Adults with Overactive Bladder in the United Kingdom. Clin. Drug Investig. 2015; 35(2):83-93. http://doi.org/10.1007/s40261-014-0240-z

  • Apeksha Saraf, Nidhi Dubey, Nitin Dubey, Mayank Sharma. Box Behnken Design Based Development of Curcumin Loaded Eudragit S100 Nanoparticles for Site-Specific Delivery in Colon Cancer. Research J. Pharm. and Tech 2019; 12(8):3672-3678. http://doi.org/10.5958/0974-360X.2019.00627.9

  • B.A. Bhairav, J.K. Bachhav, R.B. Saudagar. Review on Solubility Enhancement Techniques. Asian J. Pharm. Res. 2016; 6(3): 147-152. http://doi.org/10.5958/2231-5691.2016.00025.3

  • Tina Raju. Development and Evaluation of Press Coated Tablets of Carvedilol using Solid Dispersion Prepared by Spray Drying Technique. Asian J. Pharm. Tech. 2018; 8 (3):123-131. http://doi.org/10.5958/2231-5713.2018.00020.X

  • Sanjay Kshirsagar, Manisha Choudhari, Reshmi Sathyan, Shruti Dhore. Solubility Enhancement by Various Techniques based on Pharmaceutical and Medicinal Chemistry Approach: An Overview. Asian J. Pharm. Tech. 2019; 9(2):141-146. http://doi.org/10.5958/2231-5713.2019.00024.2

  • Prakash B. Mavani, Grishma M. Patel, Arun K. Shukla, Pragna K. Shelat. Design, Development and Optimization Aceclofenac Effervescence tablets by Central Composite Design. Res. J. Pharm. Dosage Form. & Tech. 2015;7(1):15-20. http://doi.org/10.5958/0975-4377.2015.00004.X

  • Alladi Saritha, Praveenachary A. Development and Characterization of Poloxamer Solid Dispersions of Cefuroxime Axetil. Research J. Pharm. and Tech.2015; 8(4): 360-364. http://doi.org/10.5958/0974-360X.2015.00060.8

  • Apeksha Saraf, Nidhi Dubey, Nitin Dubey, Mayank Sharma. Box Behnken Design Based Development of Curcumin Loaded Eudragit S100 Nanoparticles for Site-Specific Delivery in Colon Cancer. Research J. Pharm. and Tech 2019; 12(8):3672-3678. http://doi.org/10.5958/0974-360X.2019.00627.9

  • Jigar Vyas, Hemant Parmar, Himan Patel. Comparative Study of Etoricoxib Loaded Solid Dispersion and Beta-cyclodextrin Complexes for improvement of Dissolution Profile. Res. J. Pharma. Dosage Forms and Tech. 2020; 12(2): 63-67. http://doi.org/10.5958/0975-4377.2020.00011.7

  • Ashu Mittal, Shikha Parmar, Sadaf Jamal Gilani, Syed Sarim Imam, Mohamad Taleuzzaman. Optimization and Validation for Simultaneous Estimation of Citicoline and Piracetam in bulk and tablet formulations using RP-HPLC method: Analytical quality by Design Approach. Asian J. Research Chem. 2017; 10(2):198-205. http://doi.org/10.5958/0974-4150.2017.00034.7


Abstract Views: 270

PDF Views: 0




  • Box Behnken Design for Optimization of Mirabegron Solid Dispersion by Fluidized Bed Processing

Abstract Views: 270  |  PDF Views: 0

Authors

Rajendra K. Surawase
Maulana Azad Educational Trust’s Y. B. Chavan College of Pharmacy, Aurangabad, MS, India
Kamalkishor G. Baheti
Maulana Azad Educational Trust’s Y. B. Chavan College of Pharmacy, Aurangabad, MS, India

Abstract


The present study was to develop a stable mirabegron solid dispersion by FBP technique with improved solubility, dissolution and stability. The solid dispersion of mirabegron with poloxamer, PEG-6000 and PVP K-30 has been prepared with different weight ratios by using FBP technique. Saturation solubility studies showed significant effect of all polymers on solubility of mirabegron. MS9 batch showed maximum solubility 198.48 μg/ml in water. Box Behnken design was applied for the development of ER formulation of mirabegron by considering poloxamer, BHT and EC independent factors and drug content and drug release was dependent variables. MS9 exhibited 99.18% drug release indicated immediate release and run 6 exhibited 99.33% drug content and 99.45% at 24 h indicates significantly extend the release of mirabegron. These finding solid dispersion by fluidized bed processing is extremely important for the solubility and dissolution rate enhancement of mirabegron.

Keywords


Mirabegron, Solid Dispersion, Fluidized Bed Processing, Solubility Enhancement, Box Behnken.

References