Formulation and Evaluation of Tamsulosin Hydrochloride Sustained Release Capsules Using Pelletization Technique
Tamsulosin HCl is an αq-1 adrenergic receptor antagonist that is primarily used to treat benign prostatic hyperplasia (BPH), a disease defined by an enlarged prostate. The aim of this project is to develop, analyze, and compare the developed formulations to the innovator product (Flomax). The formulations were prepared by integrating Eudragit L100-55 as enteric polymers in various formulations, Drug coat L30D as a sustained release coating polymer, and PEG 6000 as pore forming in distinct quantities. The formulation F8 exhibited %CDR of 98.8%, comparable to the Flomax (innovator product) and the similarity factor (f2) was calculated and found to be 94.3% marking this formulation equivalent to the innovate product. The improved formulation was tested for stability for the 1st month at 40 ± 2°C and 75 ± 5% RH, as per ICH guidelines. The regression results of the improved formulation led to an inference that F8 indicates first-order kinetics with an estimated regression value of 0.926, and it was concluded that the drug had been released through diffusion mechanism.
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Materials
Tamsulosin HCl was obtained a sample from Cohance Lifesciences, Hyderabad, India. Sugar pellets (20#25) were obtained as a sample from Arun Pharma, Hyderabad, Telangana, India. Eudragit L 100-55 was obtained as a sample from Evonik Company, Mumbai, Maharashtra, India. Drug Coat L30-D was obtained as a sample from Vikram Thermo, Ahmedabad, Gujrat, India. PEG 6000 and Triethyl citrate were obtained as a sample from Clariant Pharma, Mumbai, Maharashtra, India. Iso-propyl alcohol was obtained as a sample from Deepak Pharma, Bengaluru, Karnataka, India.
Formulation Table Showing Design of Tamsulosin HCl
| S. No | Ingredients | Category | F1 %w/w | F2 %w/w | F3 %w/w | F4 %w/w | F5 %w/w | F6 %w/w | F7 %w/w | F8 %w/w |
|---|---|---|---|---|---|---|---|---|---|---|
| 1. | Tamsulosin HCl (mg) | API | 0.12 | 0.12 | 0.12 | 0.12 | 0.12 | 0.12 | 0.12 | 0.12 |
| 2. | Sugar spheres (mg) | Core | 90.48 | 89.48 | 88.48 | 87.28 | 86.18 | 85.18 | 83.98 | 82.98 |
| 3. | Eudragit L100-55 (mg) | S.R polymer | 3.0 | 3.0 | 4.0 | 4.0 | 5.0 | 5.0 | 6.0 | 6.0 |
| 4. | PEG 6000 (mg) | Pore former | 0.2 | 0.2 | 0.2 | 0.2 | - | - | - | - |
| 5. | Triethyl citrate (mg) | Plasticizer | - | - | - | - | 0.3 | 0.3 | 0.4 | 0.4 |
| 6. | Isopropyl alcohol(ml) | Solvent | Q. S | Q. S | Q. S | Q. S | Q. S | Q. S | Q. S | Q. S |
| 7. | Purified water (ml) | Solvent | Q. S | Q. S | Q. S | Q. S | Q. S | Q. S | Q. S | Q. S |
| Enteric coating | ||||||||||
| 8. | Drug coat L-30D (mg) | E.C polymer | 6.0 | 7.0 | 7.0 | 8.0 | 8.0 | 9.0 | 9.0 | 10.0 |
| 9. | Triethyl citrate (mg) | Plasticizer | 0.2 | 0.2 | 0.2 | 0.4 | 0.4 | 0.4 | 0.5 | |
| 10. | Isopropyl alcohol(ml) | Solvent | Q. S | Q. S | Q. S | Q. S | Q. S | Q. S | Q. S | Q. S |
| 11. | Purified water (ml) | Solvent | Q. S | Q. S | Q. S | Q. S | Q. S | Q. S | Q. S | Q. S |
| Total (mg) | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 |
Ayesha Mohammed Abdul Moin, Dr. S. Shobha Rani, Dr. K.A. Vijetha, M. Nagarjuna, Formulation and Evaluation of Tamsulosin Hydrochloride Sustained Release Capsules Using Pelletization Technique, Saudi Journal of Medical and Pharmaceutical Sciences, ISSN 2413-4929 (Print), ISSN 2413-4910 (Online), Scholars Middle East Publishers, Dubai, United Arab Emirates, Journal homepage: https://saudijournals.com, DOI: https://doi.org/10.36348/sjmps.2024.v10i09.002, Received: 28.07.2024, Accepted: 02.09.2024, Published: 05.09.2024
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