Press-Coated Aceclofenac Tablets for Pulsatile Drug Delivery: Formulation and In Vitro Evaluations
Abstract
:1. Introduction
2. Results and Discussion
2.1. Pre-Formulation Studies
2.2. Pre-Compression Parameters
2.3. Bulk Density
2.4. Tapped Density
2.5. Angle of Repose
2.6. Carr’s Index
2.7. Hausner’s Ratio
2.8. Post-Compression Parameters
2.9. Diameter
2.10. Thickness
2.11. Friability
2.12. Average Weight
2.13. Hardness
2.14. Assay and Content Uniformity
2.15. Disintegration Time
2.16. FTIR Studies
2.17. In Vitro Dissolution Studies
2.18. Formulation with HPMC K100M and Avicel PH102
2.19. Formulation with HPMC K100M and Eudragit L100
2.20. Formulation with HPMC K100M and Hydroxyethyl Cellulose
2.21. Formulation with HPMC K100M and HPMC E5 with Constant Coating Weight
2.22. Formulation with HPMC K100M and HPMC E5 with Variable Coating Weight
2.23. Stability Studies
3. Methodology
3.1. Materials
3.2. Methods
3.3. Preparation of the Core Tablets
3.4. Preparation of the Press-Coated Tablets
3.5. Evaluation of the Powder Blend
3.5.1. Micromeritic Properties
3.5.2. Angle of Repose (θ)
3.5.3. Bulk Density
3.5.4. Tapped Density (Dt)
3.5.5. Carr’s Compressibility Index
3.6. Evaluation of Post-Compression Parameters
3.6.1. Hardness Test
3.6.2. Thickness
3.6.3. Friability Test
3.6.4. Weight Variation Test
3.6.5. Disintegration Time
3.6.6. Assay of Core Tablets
3.6.7. Drug Content Uniformity
3.6.8. In Vitro Dissolution Study
3.6.9. Stability Studies
4. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Description | Specification | Observation |
---|---|---|
Appearance | A white or off-white crystalline powder | Off-white crystalline powder |
Identification | FTIR | Complies |
Appearance of solution | Not more turbid than standard | Complies |
Loss on drying | ≤0.5% | 0.2% |
Melting point | 149–151 °C | 151 °C |
Assay | 99.0–101.0% | 100.1% |
Formulation | F1 | F2 | F3 |
---|---|---|---|
Bulk Density (gm/cm3) | 0.55 ± 0.015 | 0.56 ± 0.02 | 0.56 ± 0.005 |
Tapped Density (gm/cm3) | 0.60 ± 0.017 | 0.62 ± 0.05 | 0.61 ± 0.009 |
Angle of Repose (θ) | 27 ± 0.01 | 27 ± 0.20 | 28 ± 0.02 |
Carr’s Index (%) | 8.3 ± 0.012 | 9.67 ± 0.04 | 8.19 ± 0.05 |
Hausner’s Ratio | 1.09 ± 0.02 | 1.11 ± 0.02 | 1.10 ± 0.03 |
Formulation | F1 | F2 | F3 |
---|---|---|---|
Diameter (mm) | 9.01 ± 0.01 | 9.00 ± 0.01 | 9.01 ± 0.01 |
Thickness (mm) | 2.91 ± 0.02 | 2.96 ± 0.01 | 2.92 ± 0.011 |
Hardness (kp) | 5.3 ± 0.17 | 5.56 ± 0.05 | 5.53 ± 0.05 |
Average weight (mg) | 150.15 ± 1.53 | 150.1 ± 1.41 | 150.15 ± 0.81 |
Friability (%) | 0.5 ± 0.01 | 0.2 ± 0.01 | 0.2 ± 0.01 |
Assay (%) | 99.92 ± 0.04 | 99.94 ± 0.13 | 99.98 ± 0.01 |
Content uniformity (%) | 99.87 ± 0.06 | 101.25 ± 0.07 | 99.97 ± 0.02 |
Dissolution (%) | 98.91 ± 0.15 | 98.9 ± 0.14 | 99.95 ± 0.03 |
Formulation | Thickness (mm) | Hardness (kp) | Average Weight (mg) | Friability (%) |
---|---|---|---|---|
A1 | 4.38 ± 0.05 | 13.4 ± 0.02 | 502 ± 0.5 | 0.6 ± 0.01 |
A2 | 4.42 ± 0.07 | 11.8 ± 0.03 | 499 ± 1.1 | 0.6 ± 0.01 |
A3 | 4.41 ± 0.08 | 13.1 ± 0.06 | 500 ± 0.7 | 0.5 ± 0.02 |
A4 | 4.50 ± 0.06 | 11.4 ± 0.04 | 501 ± 1.0 | 0.7 ± 0.01 |
A5 | 4.25 ± 0.11 | 10.1 ± 0.03 | 501 ± 0.4 | 0.4 ± 0.03 |
A6 | 4.10 ± 0.07 | 12.5 ± 0.01 | 498 ± 0.07 | 0.4 ± 0.02 |
A7 | 4.27 ± 0.04 | 12.0 ± 0.05 | 499 ± 0.13 | 0.6 ± 0.01 |
A8 | 4.27 ± 0.05 | 13.7 ± 0.04 | 502 ± 0.6 | 0.6 ± 0.01 |
A9 | 4.34 ± 0.07 | 13.2 ± 0.04 | 501 ± 0.09 | 0.6 ± 0.01 |
A10 | 4.55 ± 0.04 | 13.5 ± 0.07 | 503 ± 0.5 | 0.4 ± 0.01 |
B1 | 4.41 ± 0.02 | 12.1 ± 0.06 | 499 ± 0.42 | 0.5 ± 0.01 |
B2 | 4.11 ± 0.04 | 12.3 ± 0.05 | 499 ± 0.33 | 0.4 ± 0.02 |
B3 | 4.47 ± 0.03 | 11.7 ± 0.04 | 501 ± 0.09 | 0.5 ± 0.01 |
B4 | 4.44 ± 0.03 | 11.5 ± 0.02 | 502 ± 0.11 | 0.7 ± 0.01 |
B5 | 4.52 ± 0.02 | 11.7 ± 0.04 | 501 ± 0.09 | 0.6 ± 0.01 |
B6 | 5.45 ± 0.01 | 12.0 ± 0.03 | 498 ± 0.11 | 0.5 ± 0.03 |
C1 | 4.34 ± 0.01 | 12.4 ± 0.08 | 501 ± 0.13 | 0.5 ± 0.02 |
C2 | 4.38 ± 0.04 | 13.0 ± 0.12 | 498 ± 1.2 | 0.4 ± 0.03 |
C3 | 4.42 ± 0.02 | 13.5 ± 0.04 | 500 ± 0.8 | 0.3 ± 0.02 |
C4 | 4.40 ± 0.05 | 12.7 ± 0.06 | 502 ± 0.17 | 0.6 ± 0.01 |
C5 | 4.51 ± 0.08 | 11.4 ± 0.06 | 502 ± 1.1 | 0.7 ± 0.01 |
C6 | 4.49 ± 0.04 | 12.2 ± 0.05 | 499 ± 0.7 | 0.6 ± 0.01 |
C7 | 4.33 ± 0.07 | 12.5 ± 0.08 | 497 ± 0.14 | 0.5 ± 0.02 |
D1 | 4.41 ± 0.06 | 12.3 ± 0.08 | 498 ± 0.14 | 0.5 ± 0.02 |
D2 | 4.5 ± 0.02 | 12.4 ± 0.10 | 501 ± 0.11 | 0.4 ± 0.03 |
D3 | 4.4 ± 0.02 | 13.4 ± 0.06 | 499 ± 0.09 | 0.6 ± 0.01 |
D4 | 4.38 ± 0.05 | 11.7 ± 0.09 | 502 ± 0.17 | 0.5 ± 0.01 |
D5 | 4.42 ± 0.01 | 11.9 ± 0.05 | 501 ± 0.14 | 0.6 ± 0.01 |
D6 | 4.53 ± 0.04 | 12.5 ± 0.06 | 501 ± 0.09 | 0.5 ± 0.02 |
D7 | 4.37 ± 0.02 | 12.4 ± 0.09 | 502 ± 1.1 | 0.4 ± 0.01 |
E1 | 4.29 ± 0.02 | 11.7 ± 0.06 | 473 ± 0.14 | 0.7 ± 0.01 |
E2 | 4.42 ± 0.04 | 12.4 ± 0.11 | 501 ± 0.23 | 0.6 ± 0.01 |
E3 | 4.59 ± 0.01 | 12.8 ± 0.09 | 524 ± 0.18 | 0.0.7 ± 0.01 |
E4 | 4.77 ± 0.01 | 13.1 ± 0.08 | 552 ± 0.09 | 0.5 ± 0.02 |
E5 | 4.87 ± 0.03 | 13.7 ± 0.06 | 574 ± 0.11 | 0.5 ± 0.02 |
E6 | 5.08 ± 0.03 | 14 ± 0.06 | 602 ± 0.14 | 0.5 ± 0.01 |
Time | Percent Drug Release (%) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Hour | A1 | A2 | A3 | A4 | A5 | A6 | A7 | A8 | A9 | A10 |
1 | 85 | 40 | 10 | 12 | 10 | 2 | 1 | 2 | 0.2 | 0.01 |
2 | 100 | 95 | 57 | 55 | 30 | 15 | 11 | 7 | 0.9 | 0.04 |
3 | 100 | 100 | 89 | 90 | 65 | 40 | 34 | 7 | 1.1 | 0.24 |
4 | 100 | 100 | 100 | 100 | 87 | 68 | 50 | 40 | 1.3 | 0.5 |
5 | 100 | 100 | 100 | 100 | 100 | 70 | 56 | 56 | 2.4 | 0.51 |
6 | 100 | 100 | 100 | 100 | 100 | 98 | 74 | 67 | 10 | 0.8 |
7 | 100 | 100 | 100 | 100 | 100 | 100 | 95 | 73 | 11 | 1 |
Time | Percent Drug Release (%) | |||||
---|---|---|---|---|---|---|
Hour | B1 | B2 | B3 | B4 | B5 | B6 |
1 | 30 | 40 | 10 | 0.2 | 0 | 0 |
2 | 40 | 95 | 57 | 0.9 | 0 | 0 |
3 | 100 | 100 | 89 | 5 | 10 | 0 |
4 | 100 | 100 | 100 | 19 | 20 | 0 |
5 | 100 | 100 | 100 | 30 | 30 | 1 |
6 | 100 | 100 | 100 | 39 | 39 | 1.2 |
7 | 100 | 100 | 100 | 45 | 50 | 4 |
Time | Percent Drug Release (%) | ||||||
---|---|---|---|---|---|---|---|
Hour | C1 | C2 | C3 | C4 | C5 | C6 | C7 |
1 | 1 | 1 | 0.2 | 0.1 | 0.01 | 0 | 0 |
2 | 2 | 3 | 1 | 0.5 | 0.1 | 0 | 0 |
3 | 10 | 7 | 1 | 0.7 | 1 | 0 | 0 |
4 | 11 | 10 | 5 | 2 | 1.7 | 0.2 | 0 |
5 | 28 | 21 | 10 | 7 | 3 | 0.9 | 0 |
6 | 52 | 61 | 30 | 11 | 6 | 5 | 1 |
7 | 69 | 78 | 56 | 21 | 10 | 7 | 2 |
Time | Percent Drug Release (%) | ||||||
---|---|---|---|---|---|---|---|
Hour | D1 | D2 | D3 | D4 | D5 | D6 | D7 |
1 | 0.02 | 11 | 0.2 | 1 | 2 | 2 | 5 |
2 | 0.9 | 13 | 1 | 5 | 7 | 5 | 22 |
3 | 6 | 19 | 1 | 17 | 10 | 6.4 | 39 |
4 | 11 | 20 | 5 | 28 | 21 | 28 | 59 |
5 | 17 | 31 | 10 | 61 | 34 | 68 | 89 |
6 | 20 | 50 | 30 | 71 | 52 | 97 | 98 |
7 | 66 | 71 | 56 | 90 | 89 | 100 | 100 |
Time | Percent Drug Release (%) | |||||
---|---|---|---|---|---|---|
Hour | E1 | E2 | E3 | E4 | E5 | E6 |
1 | 1.42 | 1.4 | 1 | 0.9 | 0.75 | 0.08 |
2 | 10.4 | 10.1 | 7.7 | 5.5 | 2.2 | 0.71 |
3 | 25.4 | 21.4 | 10.4 | 9.8 | 6.4 | 1.2 |
4 | 41.5 | 39.8 | 18.7 | 14.49 | 14.8 | 3.5 |
5 | 63 | 66.4 | 70.5 | 68.9 | 72.17 | 21.4 |
6 | 97.06 | 98.01 | 97.06 | 98.46 | 98.45 | 99.27 |
Time (Hours) | Dissolution after 1 Month (% Drug Release) | Dissolution after 2 Months (% Drug Release) | Dissolution after 3 Months (% Drug Release) | ||||||
---|---|---|---|---|---|---|---|---|---|
Temp (°C)/ Humidity (%) | 25 °C/60% | 30 °C/65% | 40 °C/75% | 25 °C/60% | 30 °C/65% | 40 °C/75% | 25 °C/60% | 30 °C/65% | 40 °C/75% |
1 | 0.09 ± 0.01 | 0.08 ± 0.04 | 0.07 ± 0.01 | 0.08 ± 0.01 | 0.07 ± 0.01 | 0.06 ± 0.04 | 0.09 ± 0.02 | 0.07 ± 0.03 | 0.08 ± 0.01 |
2 | 0.69 ± 0.03 | 0.67 ± 0.03 | 0.71 ± 0.03 | 0.68 ± 0.04 | 0.65 ± 0.03 | 0.68 ± 0.12 | 0.70 ± 0.03 | 0.67 ± 0.01 | 0.65 ± 0.04 |
3 | 1.3 ± 0.02 | 1.2 ± 0.06 | 1.0 ± 0.03 | 1.3 ± 0.06 | 1.1 ± 0.05 | 1.1 ± 0.07 | 1.3 ± 0.02 | 1.2 ± 0.01 | 1.0 ± 0.04 |
4 | 3.6 ± 0.02 | 3.4 ± 0.01 | 3.1 ± 0.07 | 3.4 ± 0.04 | 3.4 ± 0.03 | 3.3 ± 0.04 | 3.6 ± 0.07 | 3.5 ± 0.02 | 3.2 ± 0.02 |
5 | 21.1 ± 0.03 | 21.0 ± 0.02 | 20.8 ± 0.05 | 21.5 ± 0.02 | 21.2 ± 0.01 | 20.4 ± 0.02 | 21.5 ± 0.03 | 21.2 ± 0.10 | 20.7 ± 0.03 |
6 | 99.34 ± 0.03 | 99.32 ± 0.03 | 99.27 ± 0.03 | 99.38 ± 0.05 | 99.37 ± 0.04 | 99.31 ± 0.03 | 99.33 ± 0.07 | 99.33 ± 0.03 | 99.22 ± 0.02 |
Assay | Storage Conditions | ||
---|---|---|---|
25 ± 2 °C/60% ± 5% RH | 30 ± 2 °C/65% ± 5% RH | 40 ± 2 °C/75% ± 5% RH | |
Initial | 99.98% ± 0.01 | 99.98% ± 0.04 | 99.98% ± 0.02 |
After 1st month | 99.94% ± 0.03 | 99.92% ± 0.06 | 99.92% ± 0.05 |
After 2nd month | 99.90% ± 0.03 | 99.90% ± 0.05 | 99.89% ± 0.03 |
After 3rd month | 99.89% ± 0.03 | 99.83% ± 0.03 | 99.82% ± 0.08 |
Tablet Ingredient * | F1 | F2 | F3 |
---|---|---|---|
Aceclofenac | 100 | 100 | 100 |
Croscarmellose sodium | 0.75 | 1.5 | 3.75 |
Avicel PH102 | 47.6 | 46.85 | 44.6 |
Magnesium stearate | 1.5 | 1.5 | 1.5 |
Sunset yellow lake E100 | 0.15 | 0.15 | 0.15 |
Total weight of tablets | 150 | 150 | 150 |
Formulation * | HPMC K100M | Avicel PH102 |
---|---|---|
A1 (10%) | 35 | 311.5 |
A2 (20%) | 70 | 276.5 |
A3 (25%) | 87.5 | 259 |
A4 (30%) | 105 | 241.5 |
A5 (35%) | 122.5 | 224 |
A6 (40%) | 140 | 206.5 |
A7 (45%) | 157.5 | 189 |
A8 (50%) | 175 | 171.5 |
A9 (60%) | 210 | 136.5 |
A10 (99%) | 346.5 | 0 |
Formulation * % (HPMC K100M:Eudragit L100) | HPMC K100M (mg) | Eudragit L100 (mg) | Avicel PH102 (mg) |
---|---|---|---|
B1 (10:30) | 35 | 105 | 206.5 |
B2 (20:20) | 70 | 70 | 206.5 |
B3 (30:10) | 105 | 35 | 206.5 |
B4 (40:10) | 140 | 35 | 171.5 |
B5 (45:15) | 157.5 | 52.5 | 136.5 |
B6 (50:20) | 175 | 70 | 101.5 |
Formulation * % (HPMC K100M:HEC) | HPMC K100M (mg) | HEC (mg) |
---|---|---|
C1 (100:0) | 346.5 | 0 |
C2 (87.5:12.5) | 303.19 | 43.31 |
C3 (75:25) | 260.74 | 85.76 |
C4 (50:50) | 173.25 | 173.25 |
C5 (25:75) | 85.76 | 260.74 |
C6 (12.5:87.5) | 43.31 | 303.19 |
C7 (0:100) | 0 | 346.5 |
Formulation * | HPMC K100M | HPMC E5 |
---|---|---|
D1 (100:0) | 346.5 | 0 |
D2 (87.5:12.5) | 303.19 | 43.31 |
D3 (75:25) | 260.74 | 85.76 |
D4 (50:50) | 173.25 | 173.25 |
D5 (25:75) | 85.76 | 260.74 |
D6 (12.5:87.5) | 43.31 | 303.19 |
D7 (0:100) | 0 | 346.5 |
Formulation * HPMC K100M: HPMC E5 (12.5:87.5) | HPMC K100M (mg) | HPMC E5 (mg) | Magnesium Stearate (mg) | Press-Coated Tablet Weight (mg) |
---|---|---|---|---|
E1 | 40.22 | 281.53 | 3.25 | 475 |
E2 | 43.31 | 303.19 | 3.5 | 500 |
E3 | 46.406 | 324.844 | 3.75 | 525 |
E4 | 49.5 | 346.5 | 4 | 550 |
E5 | 52.59 | 368.16 | 4.25 | 575 |
E6 | 55.69 | 389.81 | 4.5 | 600 |
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Rashid, R.; Zaman, M.; Ahmad, M.; Khan, M.A.; Butt, M.H.; Salawi, A.; Almoshari, Y.; Alshamrani, M.; Sarfraz, R.M. Press-Coated Aceclofenac Tablets for Pulsatile Drug Delivery: Formulation and In Vitro Evaluations. Pharmaceuticals 2022, 15, 326. https://doi.org/10.3390/ph15030326
Rashid R, Zaman M, Ahmad M, Khan MA, Butt MH, Salawi A, Almoshari Y, Alshamrani M, Sarfraz RM. Press-Coated Aceclofenac Tablets for Pulsatile Drug Delivery: Formulation and In Vitro Evaluations. Pharmaceuticals. 2022; 15(3):326. https://doi.org/10.3390/ph15030326
Chicago/Turabian StyleRashid, Rizwana, Muhammad Zaman, Mahmood Ahmad, Mahtab Ahmad Khan, Muhammad Hammad Butt, Ahmad Salawi, Yosif Almoshari, Meshal Alshamrani, and Rai Muhammad Sarfraz. 2022. "Press-Coated Aceclofenac Tablets for Pulsatile Drug Delivery: Formulation and In Vitro Evaluations" Pharmaceuticals 15, no. 3: 326. https://doi.org/10.3390/ph15030326
APA StyleRashid, R., Zaman, M., Ahmad, M., Khan, M. A., Butt, M. H., Salawi, A., Almoshari, Y., Alshamrani, M., & Sarfraz, R. M. (2022). Press-Coated Aceclofenac Tablets for Pulsatile Drug Delivery: Formulation and In Vitro Evaluations. Pharmaceuticals, 15(3), 326. https://doi.org/10.3390/ph15030326