International Journal of Drug Delivery Technology
Volume 14, Issue 2

Optimization of Slugging and Compression Process for Bicalutamide Tablets

Santanu Roy*, Naresh Kalra, Gurpreet Singh

Lords University, Chikani, Rajasthan, India.

Received: 03rd May, 2024; Revised: 31st May, 2024; Accepted: 02nd June, 2024; Available Online: 25th June, 2024 

ABSTRACT

The critical nature of pharmaceutical dosage forms necessitates the optimization of manufacturing process variables to achieve the desired product quality. In this study, slugging (Dry granulation) was selected as an appropriate granulation method to mitigate poor flow properties in the final bicalutamide blend. The chosen process variables include slug hardness, mill screen size, and mill speed. A 23-factorial design was employed to investigate these variables. Process parameters were reproducible, with minimal impact on tablet properties, even when roller speeds varied. Response surface models effectively examine the relationship between response variables and quantitative parameters. The input and process variables for the compression process were predetermined based on the desired quality attributes of bicalutamide tablets. Notably, the p-value for the slugging process was not more than 0.05, indicating their insignificance in tablet content uniformity. Product quality attributes affected by the compression process step include content uniformity, disintegration time, and dissolution. The optimal hardness range was found to be 2.0 to 7.0 kp.

Keywords: Bicalutamide tablets, Factorial design, Slugging process, Dissolution, Content uniformity. International Journal of Drug Delivery Technology (2024); DOI: 10.25258/ijddt.14.2.31

How to cite this article: Roy S, Kalra N, Singh G. Optimization of Slugging and Compression Process for Bicalutamide Tablets. International Journal of Drug Delivery Technology. 2024;14(2):806-809.

REFERENCES

  1. Patil AS, Pethe AM. Quality by Design (QbD): A new concept for the development of quality pharmaceuticals. Int. J. Pharm. Qual.2013 Apr;4(2):13-9.
  2. Yu LX, Amidon G, Khan MA, Hoag SW, Polli J, Raju GK, Woodcock Understanding pharmaceutical quality by design. The AAPS journal. 2014 Jul;16:771-83. DOI: 10.1208/s12248-014-9598-3
  3. Mamidi HK, Palekar S, Nukala PK, Mishra SM, Patki M, Fu Y, Supner P, Chauhan G, Patel Process optimization of twin-screw melt granulation of fenofibrate using design of experiment (DoE). Int. J. Pharm. 2021 Jan 25;593:120101. https:// doi.org/10.1016/j.ijpharm.2020.120101
  4. Gupta N. An overview of Six Sigma: quality improvement program Int. j. tech. res. appl. 2013 Mar;1(1):29-39.
  5. Design of Experiments Guide. [Internet] JMP statistical discovery. [Cited 2019 March 23]. Available from: https:// jmp.com/support/help/Design_of_Experiments _of_ Experiments_Guide. shtml#329680
  6. Naik DCS, Bharathi 23 Full Factorial Designs for Formulation and Evaluation of Non-Steroidal Anti-inflammatory Drug. International Journal of Drug Delivery Technology. 2022;12(1):1-DOI: 10.25258/ijddt.12.1.1
  7. Kaur G, Sridhar DB, Gera M. Optimization of roll compaction/ Dry granulation (Rcdg) process for poorly flowable antiviral formulation. Am J Pharmtech Res. 2012;2:2249-3387.
  8. Park SY, Galbraith SC, Liu , et al. Prediction of critical quality attributes and optimization of continuous dry granulation process via flowsheet modeling and experimental validation. Powder Technol. 2018 May 1;330:461-70. doi:10.1016/j.powtec.2018.02.0
  9. Freeman TC, Armstrong The characterisation of granulation wet masses using powder rheometry. In5th International Granulation Workshop, Lausanne, Switzerland 2011 Jun (pp. 20-21).
  10. Loha ZH, Samanta AK, Heng PW. Overview of milling techniques for improving the solubility of poorly water-soluble Asian Journal of Pharmaceutical Sciences. 2015;10(4):255-doi.org/10.1016/j.ajps.2014.12.006
  11. Tandel FB, Pandya AJ, Prajapati BR. Process Optimization of Carvacrol Nanobeads: DoE Approach. International Journal of Drug Delivery 2023;13(2):644-648. DOI: 10.25258/ ijddt.13.2.26