Author(s):
Gavaskar Basani, Madhusudan Rao Yamsani, Ramya Sri Sura
Email(s):
gavaskarbasanipharma@gmail.com
DOI:
10.52711/0974-360X.2021.00927 
Address:
Gavaskar Basani1*, Dr. Madhusudan Rao Yamsani2, Ramya Sri Sura3
1Department of Pharmacy, Jawaharlal Nehru Technological University, Kukatpally, Hyderabad, Telangana, 500085, India.
2Department of Pharmaceutics, Vaagdevi College of Pharmacy, Warangal, Telangana, 506005, India.
3Department of Pharmacy, University College of Technology, Osmania University, Hyderabad, Telangana, 500007, India.
*Corresponding Author
Published In:
Volume - 14,
Issue - 10,
Year - 2021
ABSTRACT:
The aim of current work was to grow extended release multiple unit pellets of Tamsulosin Hydrochloride, is an alpha-blocker, used for the healing of the symptoms of a prostate gland condition called BPH (benign prostatic hyperplasia) by extrusion- spheronization (E/S) and solution/suspension layering (S/S) method. In the Extrusion-Spheronization, A ratio of 75:25, 67:33, 64:36 Tamsulosin Hydrochloride and Microcrystalline cellulose were mixed for making drug pellets and extended release (ER) coating was performed in fluidized bed processor (FBP) by solution/suspension layering with Ethyl cellulose (aqueous. dispersion, 4 cps and 7 cps) and Hypromellose (5cps) with different ratios % weight buildups accordingly. In the Solution/suspension layering (S/S) method, Tamsulosin Hydrochloride drug pellets were prepared by layering onto MCC spheres in FBP. These drug pellets were further coated for extended release with HPMC, 5cps and EC, 7cps. In drug coating stage, drug and different binder (Hypromellose, 5 cps) concentrations 8, 10, 12, 14 mg/unit were coated onto the cores for optimization of binder concentration. The weight of MCC spheres were optimized for further formulations. For all the drug coated pellets, ER coating was given with EC, 7cps and HPMC, 5 cps at a coating level of 8% weight by weight. In the extrusion- spheronization (E/S) Optimization of Drug pellets: Among the trials TD3 (Tamsulosin HCl and MCC) showed good mechanical strength with better yield due to increased MCC concentration. Optimization of Extended Release Coating: Optimized TD3 drug pellets were coated with ER coating using water insoluble polymer (Aq.EC 25% dispersion/ EC, 4cps/ EC, 7cps) and water soluble polymer (HPMC, 5cps). Among these polymers, extended release coating was optimized (TD3E14) with the combination of EC, 7cps and HPMC, 5cps at 8% weight build up. In the Solution/Suspension layering: Optimization of binder concentration in drug coating stage: HPMC, 5cps with 12 mg/unit for TF7 was optimized based on %yield. Optimization of MCC spheres in drug coating stage in formulation of ER pellets with different weight drug pellets: The weight of MCC spheres (160, 170, 180, 190 mg/unit) used in the drug coating stage with binder HPMC, 5cps (12 mg/unit). These drug pellets were given with ER coating at 8% weight buildup by using EC, 7cps and HPMC, 5cps. Among these trials, TF7E7 was optimized. Based on the investigations of the present study, conclusions was. formulating low dose, high soluble, BCS class I drug- Tamsulosin Hydrochloride ER formulation by extrusion-spheronization showed flexibility for batch processing and cost effectiveness while solution/suspension layering was process feasible but time consuming due to high drug loading.
Cite this article:
Gavaskar Basani, Madhusudan Rao Yamsani, Ramya Sri Sura. Formulation Development and Evaluation of Multiple Unit Pellet System of Tamsulosin Hydrochloride. Research Journal of Pharmacy and Technology. 2021; 14(10):5319-4. doi: 10.52711/0974-360X.2021.00927
Cite(Electronic):
Gavaskar Basani, Madhusudan Rao Yamsani, Ramya Sri Sura. Formulation Development and Evaluation of Multiple Unit Pellet System of Tamsulosin Hydrochloride. Research Journal of Pharmacy and Technology. 2021; 14(10):5319-4. doi: 10.52711/0974-360X.2021.00927 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2021-14-10-45
REFERENCES:
1. Vogelson CT. Modern Drug Discovery. Advances in drug delivery systems; 4th ed. 2001: 49–52.
2. Bechgaard H, Nielsen GH. Controlled- Release Multiple-Units and Single-Unit Doses a Literature Review. Drug Dev Ind Pharm 1978; 1: 53-67. doi.org/10.3109/03639047809055639.
3. Kishore Manoharan, Navya Ajitkumar Bhaskaran, Lalit Kumar. Pellets and Techniques of Pelletization. Research J. Pharm. and Tech. 2019; 12(12): 6157-64. doi.org/ 10.5958/0974-360X.2019.01070.9
4. Ghebre Sellassie - I., Pellets: A General Overview, Pharmaceutical Pelletization Technology.1989; 241-65.
5. Susmit S. Diggikar, Tanaji D. Nandgude, Sushilkumar S. Poddar. Formulation of Modified Release Pellets of Montelukast Sodium. Research J. Pharm. and Tech. 2018; 11(1): 31-7. doi.org/ 10.5958/ 0974-360X.2018.00006.9.
6. Sapkal SR, Jaiswal SB, Chandewar AV, Gaikwad SB, Pathan AM. Pellets as Controlled Release Drug Delivery System: A Review. Research J. Pharma. Dosage Forms and Tech. 2009; 1(3): 179-83. Available on: https://rjpdft.com/ HTMLPaper.aspx?Journal=Research%20Journal%20of%20Pharmaceutical%20Dosage%20Forms%20and%20Technology;PID=2009-1-3-2.
7. Naik JB, Mokale VJ, More DB, Bari MM, Chavhan RB, More BB. Failure of Functionality of Coated Pellets into Tablets – Problems and Solutions. Research J. Pharm. and Tech. 2011; 4 (1): 43-6. Available on: https://rjptonline.org/ AbstractView.aspx?PID=2011-4-1-28.
8. Nanda RK, Gaikwad J, Prakash A. Simultaneous Spectrophotometric Estimation of Tamsulosin in Pharmaceutical Dosage Form. Asian J. Research Chem. 2009; 2(1): 63-5. Available on: https://ajrconline.org/ AbstractView.aspx?PID=2009-2-1-17.
9. Mihir K Raval, Riddhi V Ramani, and Navin R Sheth. Formulation and evaluation of sustained release enteric-coated pellets of budesonide for intestinal delivery. Int J Pharm Investig. 2013; 3(4): 203–11. doi.org/ 10.4103/2230-973X.121294.
10. O'Leary MP. Tamsulosin: current clinical experience. Urology 2001; 58: 42-8.
11. Xiong Zhang, Xing Tang, and Rui Yang. Development of a Tamsulosin Hydrochloride Controlled-Release Capsule Consisting of Two Different Coated Pellets. Drug Development and Industrial Pharmacy. 2009; 35: 26–33. doi.org/10.1080/ 03639040802144203.
12. Y. Surkha, P. Venugopalaiah, K. Gnan Prakash, M. Gobinath. Design and Characterization of Enteric Coated Delayed Release Pellets of Rabeprazole Sodium. Research J. Pharm. and Tech. 2013; 6(12): 1380-86. Available on: https://rjptonline.org/ AbstractView.aspx?PID=2013-6-12-5.
13. D. V. Madat, M. C. Gohel, A.Ramkishan. Development of Venlafaxine Hydrochloride Controlled Release Pellets Prepared Employing the Blend of Ethyl Cellulose and Polyethylene Oxide. Research J. Pharm. and Tech. 2012; 5(10): 1289-92. Available on: https://rjptonline.org/AbstractView.aspx?PID=2012-5-10-40.
14. 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):1757-61. doi.org/ 10.5958/0974-360X.2020.00317.0
15. Sangram M. Patil, Rakesh V. Mishra, Satish V. Shirolkar. Development and Evaluation of Sustain Release Simvastatin Pellets. Research J. Pharm. and Tech. 2017; 10(8): 2467-73. doi.org/ 10.5958/0974-360X.2017.00436.X
16. Tushar M. Patel, Mukesh C. Gohel. Development of Extended Release Pellets of Quetiapine Fumarate by using HPMC and Eudragit RSPO. Research J. Pharm. and Tech. 2014; 7(7): 771-5. Available on: https://rjptonline.org/ AbstractView.aspx?PID=2014-7-7-17.
17. United States Pharmacopeia: <616> Bulk Density and Tapped Density of Powders, USP 32, 226.
18. Indian pharmacopoeia, (1996) Vol I & II, The controller of publications, Delhi, 137-8.
19. G.T. Kulkarni, B. Gowthamarajan, B. Suresh, Stability testing of pharmaceutical products-An overview, Ind. J Pharm. Educ. 2004; 38(4): 194-8.
20. Stability testing of active pharmaceutical ingredients and finished pharmaceutical products, Annexure 2, WHO Technical Report Series, 2009; 953.
21. John Lennon, Handbook of Stability Testing in Pharmaceutical: Development Regulations, Methodologies and Best Practices, Kim Huynh-Ba, Pharmalytik Newark, Delaware, 2008.
22. Thorat Punam, Warad Shubhangi, Solunke Rahul, Ashok Sargar, Anagha Bhujbal, Asha Shinde. Stability Study of Dosage Form: An Innovative Step, World Journal of Pharmacy and Pharmaceutical Sciences. 2010; 3(2): 1031-50. Available on: https:// www.wjpps.com/Wjpps_controller/abstract_id/798.
23. Viswanadham Manasa, K.Vanitha, M. Venkataswamy, P. Prabhakar, Alluri Ramesh. Formulation and Evaluation of Aqueous Enteric Coated Delayed Release Omeprazole Pellets. Res. J. Pharm. Dosage Form. & Tech. 2016; 8(1): 01-4. doi.org/ 10.5958/0975-4377.2016.00002.1
24. Hardik B. Rana, Mukesh C. Gohel, Mansi S. Dholakia, Tejal R. Gandh, Abdelwahab Omri, Vaishali T. Thakkar. Development of Sustained Release Pellets of Galantamine HBr by Extrusion Spheronization Technique Incorporating Risk based QbD Approach. Research J. Pharm. and Tech 2018; 11(11): 4899-910.doi.org/ 10.5958/0974-360X.2018.00892.2