DEVELOPMENT AND OPTIMIZATION OF LASER-DRILLED OSMOTICALLY CONTROLLED NIFEDIPINE EXTENDED-RELEASE TABLETS BY RESOLUTION IV 24-1FRACTIONAL FACTORIAL DESIGN

Authors

  • ABHISHEK SHARMA University Institute of Pharma Sciences, Chandigarh University, Gharuan-140413, Mohali, Punjab, India
  • ATUL KABRA 1. University Institute of Pharma Sciences, Chandigarh University, Gharuan-140413, Mohali, Punjab, India https://orcid.org/0000-0003-2890-1575
  • MD. KHALID ANWER Department of Pharmaceutics, College of Pharmacy, Prince Sattam Bin Abdulaziz University, P.O. Box 173, AlKharj-11942, Saudi Arabia https://orcid.org/0000-0002-5227-3954
  • MOHAMMED F. ALDAWSARI Department of Pharmaceutics, College of Pharmacy, Prince Sattam Bin Abdulaziz University, P.O. Box 173, AlKharj-11942, Saudi Arabia

DOI:

https://doi.org/10.22159/ijap.2026v18i3.57691

Keywords:

Nifedipine, Tablet, Osmotically controlled, Laser-drilling, Extended release, Factorial design

Abstract

Objective: The purpose of this investigation was to create a tablet containing nifedipine for extended-release by laser drilling technique using a resolution IV 24-1 fractional factorial design.

Methods: The extended-release tablet formulation bearing nifedipine was developed by the wet granulation method. The A resolution IV 24-1fractional factorial design was employed to optimize the nifedipine extended-release tablets. The ratio of sodium chloride (NaCl) to polyox water soluble resin (WSR) NEO, the ratio of NaCl to polyox WSR Coagulant LEO in the push layer, the ratio of polymer and plasticizer in extended release (ER) coat, and % weight gain in the extended-release coat were taken as independent variables, and the percentage of drug dissolved was taken as the dependent variable. The resolution IV 24-1 fractional factorial design was utilized to optimize the formulation, which was subsequently assessed for its performance such as mean weight, thickness, hardness, and friability. Finally, optimized laser-drilledtablets were compared with the undrilled nifedipine extended-release tablets for percent drug release.

Results: The mean weight of the optimized formulation was found to be 718 ± 2.5 mg, the mean thickness was measured to be 7.51± 0.2mm, the hardness of the tablet was found to be 130 ± 5 N, tablet friability was measured as 0.9 ± 0.1% and finally the drug release study of tablets having précised orifice shows controlled drug release over a period of time.

Conclusion: The developed nifedipine extended-release formulation demonstrated controlled drug release following laser drilling. The laser-drilled tablets exhibited a sustained release profile over the study period. The results indicate that laser drilling is a feasible approach for modulating drug release from extended-release tablets.

References

1. Mills KT, Bundy JD, Kelly TN. Global disparities of hypertension prevalence and control: a systematic analysis of population-based studies from 90 countries. Circulation. 2016;134(6):441-450. doi:10.1161/Circulationaha.115.018912.

2. Sayer G, Bhat G. The renin-angiotensin-aldosterone system and heart failure. Cardiol Clin. 2014;32(1):21-32. doi:10.1016/j.ccl.2013.09.002.

3. World Health Organization. Hypertension [Internet]. 2024 [cited 2026 Feb 14]. Available from: https://www.who.int/news-room/fact-sheets/detail/hypertension

4. Hazra PK, Mehta A, Desai B, Pandey U, Mehta KD, Bajpai S, et al. Long-acting nifedipine in the management of essential hypertension: a review for cardiologists. Am J Cardiovasc Dis. 2024;14(6):396.

5. Rahman MU, Hussain HR, Akram H, Gulzar F, Nouman M, Farooq H, et al. Nifedipine's synergistic therapeutic potential: overcoming challenges and embracing novel applications in pharmacotherapy. Prospect Pharm Sci. 2025;23(2):101-115. doi:10.56782/pps.344.

6. Wheless JW, Phelps SJ. A clinician's guide to oral extended-release drug delivery systems in epilepsy. J Pediatr Pharmacol Ther. 2018;23(4):277-292. doi:10.5863/1551-6776-23.4.277.

7. Bhowmik D, Bhanot R, Kumar KP. Extended release drug delivery-an effective way of novel drug delivery system. Res J Pharm Dos Forms Technol. 2018;10(4):233-244.

8. Balasankar A, Anbazhakan K, Arul V, Mutharaian VN, Sriram G, Aruchamy K, Oh TH, Ramasundaram S. Recent Advances in the Production of Pharmaceuticals Using Selective Laser Sintering. Biomimetics. 2023;8(4):330. doi: 10.3390/biomimetics8040330.

9. Mantas A, Mihranyan A. Immediate-Release Nifedipine Binary Dry Powder Mixtures with Nanocellulose Featuring Enhanced Solubility and Dissolution Rate. Pharmaceutics. 2019 Jan 18;11(1):37. doi: 10.3390/pharmaceutics11010037..

10. Gupta BP, Thakur N, Jain NP, Banweer J, Jain S. Osmotically controlled drug delivery system with associated drugs. J Pharm Pharm Sci. 2010;13(4):571-88. doi: 10.18433/j38w25.

11. Adepu S, Ramakrishna S. Controlled Drug Delivery Systems: Current Status and Future Directions. Molecules. 2021;26(19):5905. doi: 10.3390/molecules26195905.

12. Lou J, Duan H, Qin Q, Teng Z, Gan F, Zhou X, Zhou X. Advances in Oral Drug Delivery Systems: Challenges and Opportunities. Pharmaceutics. 2023;15(2):484. doi: 10.3390/pharmaceutics15020484.

13. Verma RK, Mishra B, Garg S. Osmotically controlled oral drug delivery. Drug Dev Ind Pharm. 2000;26(7):695-708. doi: 10.1081/ddc-100101287.

14. Quodbach J, Preis E, Karkossa F, Winck J, Finke JH, Steiner D. Novel Strategies for the Formulation of Poorly Water-Soluble Drug Substances by Different Physical Modification Strategies with a Focus on Peroral Applications. Pharmaceuticals (Basel). 2025;18(8):1089. doi: 10.3390/ph18081089.

15. Savjani KT, Gajjar AK, Savjani JK. Drug solubility: importance and enhancement techniques. ISRN Pharm. 2012;2012:195727. doi: 10.5402/2012/195727.

16. Nandi S, Banerjee A, Reza KH. Formulation and Evaluation of Enteric Coated Elementary Osmotic Tablets of Aceclofenac. Turk J Pharm Sci. 2021;18(4):498-509. doi: 10.4274/tjps.galenos.2020.03443.

17. Arafat M, Sakkal M, Yuvaraju P, Esmaeil A, Poulose V, Aburuz S. Effect of Excipients on the Quality of Drug Formulation and Immediate Release of Generic Metformin HCl Tablets. Pharmaceuticals (Basel). 2023;16(4):539. doi: 10.3390/ph16040539.

18. Omari D, Sallam A, Al-Hmoud H, Rashid I. Modafinil-excipient compatibility study using differential scanning calorimetry. J Adv Pharm Technol Res. 2023;14(2):75-81. doi: 10.4103/japtr.japtr_663_22.

19. Murillo-Fernández MA, Montero-Zeledón E, Abdala-Saiz A, Vega-Baudrit JR, Araya-Sibaja AM. Interaction and Compatibility Studies in the Development of Olmesartan Medoxomil and Hydrochlorothiazide Formulations under a Real Manufacturing Process. Pharmaceutics. 2022;14(2):424. doi: 10.3390/pharmaceutics14020424.

20. Nigusse B, Gebre-Mariam T, Belete A. Design, development and optimization of sustained release floating, bioadhesive and swellable matrix tablet of ranitidine hydrochloride. PLoS One. 2022;16(6):e0253391. https://doi.org/10.1371/journal.pone.0253391.

21. Butreddy A, Sarabu S, Dumpa N, Bandari S, Repka MA. Extended release pellets prepared by hot melt extrusion technique for abuse deterrent potential: Category-1 in-vitro evaluation. Int J Pharm. 2020;587:119624. doi: 10.1016/j.ijpharm.2020.119624.

22. Patel M, Shelke S, Surti N, Panzade P, Al-Keridis LA, Upadhyay TK, Alshammari N, Saeed M. Design, preparation, and in vitro evaluation of gastroretentive floating matrix tablet of mitiglinide. Front Pharmacol. 2023;15(14):1140351. DOI: https://doi.org/10.3389/fphar.2023.1140351.

23. Gunda RK, Manchineni PR, Duraiswamy D, Gsn KR. Design, Development, Optimization and Evaluation of Ranolazine Extended Release Tablets. Turk J Pharm Sci. 2022;19(2):125-131. doi: 10.4274/tjps.galenos.2021.58047.

24. Issa MG, de Souza NV, Jou BWC, Duque MD, Ferraz HG. Development of Extended-Release Mini-Tablets Containing Metoprolol Supported by Design of Experiments and Physiologically Based Biopharmaceutics Modeling. Pharmaceutics. 2022;14(5):892. doi: 10.3390/pharmaceutics14050892.

25. Asif AH, Desu PK, Alavala RR, Rao GSNK, Sreeharsha N, Meravanige G. Development, Statistical Optimization and Characterization of Fluvastatin Loaded Solid Lipid Nanoparticles: A 32 Factorial Design Approach. Pharmaceutics. 2022;14(3):584. DOI: https://doi.org/10.3390/pharmaceutics14030584.

26. Dakin HA, Gray AM, MacLennan GS, Morris RW, Murray DW. Partial factorial trials: comparing methods for statistical analysis and economic evaluation. Trials. 2018;16;19(1):442. doi: 10.1186/s13063-018-2818-x.

27. Kumar AK, Rathnam G. Development and evaluation of controlled porosity osmotic tablets of candesartan cilexetil using inclusion complex system. Asian J Pharm Clin Res. 2025;18(1):46-51. doi:10.22159/ajpcr.2025v18i1.53194.

28. Ullah G, Nawaz A, Latif MS, Shah KU, Ahmad S, Javed F, Alfatama M, Abd Ghafar SA, Lim V. Clarithromycin and Pantoprazole Gastro-Retentive Floating Bilayer Tablet for the Treatment of Helicobacter Pylori: Formulation and Characterization. Gels. 2023;9(1):43. DOI: https://doi.org/10.3390/gels9010043

29. Ghourichay MP, Kiaie SH, Nokhodchi A, Javadzadeh Y. Formulation and Quality Control of Orally Disintegrating Tablets (ODTs): Recent Advances and Perspectives. Biomed Res Int ;2021: 6618934. DOI: https://doi.org/10.1155/2021/6618934

30. Khan NA, Khan A, Ullah R, Ullah M, Alotaibi A, Ullah R, Haider A. Preparation and Characterization of Hydrophilic Polymer Based Sustained-Release Matrix Tablets of a High Dose Hydrophobic Drug. Polymers (Basel). 2022;14(10):1985. DOI: https://doi.org/10.3390/polym14101985.

31. Aldawsari HM, Naveen NR, Alhakamy NA, Goudanavar PS, Rao GK, Budha RR, Nair AB, Badr-Eldin SM. Compression-coated pulsatile chronomodulated therapeutic system: QbD assisted optimization. Drug Deliv. 2022;29(1):2258-2268. doi: 10.1080/10717544.2022.2094500.

32. Gupta SK, Huneza A, Patra S. Formulation, development and in vitro evaluation of tramadol extended release tablets. Int J Pharm Pharm Sci. 2019;11(7). doi:10.22159/ijpps.2019v11i7.32100.

33. Kim Y, Park EJ, Kim TW, Na DH. Recent Progress in Drug Release Testing Methods of Biopolymeric Particulate System. Pharmaceutics. 2021;13(8):1313. DOI: https://doi.org/10.3390/pharmaceutics13081313.

34. Suhail M, Vu QL, Wu PC. Formulation, Characterization, and in vitro Drug Release Study of β-Cyclodextrin-Based Smart Hydrogels. Gels. 2022;8(4):207. DOI: https://doi.org/10.3390/gels8040207

35. Gupta R, Chen Y, Sarkar M, Xie H. Surfactant Mediated Accelerated and Discriminatory In Vitro Drug Release Method for PLGA Nanoparticles of Poorly Water-Soluble Drug. Pharmaceuticals (Basel). 2022;15(12):1489. DOI: https://doi.org/10.3390/ph15121489.

36. Arafat M, Sarfraz M, Bostanudin MF, Esmaeil A, Salam A, AbuRuz S. In Vitro and In Vivo Evaluation of Oral Controlled Release Formulation of BCS Class I Drug Using Polymer Matrix System. Pharmaceuticals (Basel). 2021;14(9):929. DOI: https://doi.org/10.3390/ph14090929.

37. Wadher KJ, Kakde RB, Umekar MJ. Formulation and evaluation of a sustained-release tablets of metformin hydrochloride using hydrophilic synthetic and hydrophobic natural polymers. Indian J Pharm Sci. 2011 Mar;73(2):208-15. doi: 10.4103/0250-474x.91579.

38. Madriwala B, Suma BV, Jays J. Molecular docking study of hentriacontane for anticancer and antitubercular activity. Int J Chem Res. 2022;6(4). doi:10.22159/ijcr.2022v6i4.208.

39. González-González O, Ramirez IO, Ramirez BI, O'Connell P, Ballesteros MP, Torrado JJ, Serrano DR. Drug Stability: ICH versus Accelerated Predictive Stability Studies. Pharmaceutics.2022;14(11):2324.

40. Tiwari KS, Pandey P, Dureja H, Garg M. Enhancing manufacturing efficiency with notch-enabled tooling: Cost-effective osmotically controlled release tablets using metformin HCl. J Appl Pharm Sci. 2025;15(08):165-177. http://doi.org/10.7324/JAPS.2025.234050.

Published

23-03-2026

How to Cite

SHARMA, A., KABRA, A., ANWER, M. K., & ALDAWSARI, M. F. (2026). DEVELOPMENT AND OPTIMIZATION OF LASER-DRILLED OSMOTICALLY CONTROLLED NIFEDIPINE EXTENDED-RELEASE TABLETS BY RESOLUTION IV 24-1FRACTIONAL FACTORIAL DESIGN. International Journal of Applied Pharmaceutics, 18(3). https://doi.org/10.22159/ijap.2026v18i3.57691

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