• Forum Janak Jalundhwala Shobhaben Pratapbhai Patel School of Pharmacy and Technology Management, SVKM's NMIMS, Mumbai, India
  • Vaishali Londhe Shobhaben Pratapbhai Patel School of Pharmacy and Technology Management, SVKM's NMIMS, Mumbai, India
  • Jnanadeva Bhat Formulation Development Department, ACG Associated Capsules Pvt. Ltd., Mumbai, India
  • Surya Singh Formulation Development Department, ACG Associated Capsules Pvt. Ltd., Mumbai, India


Objective: The primary objective of the project was to formulate and evaluate hard capsule containing the solution of ibuprofen. It also included enhancement of solubility of ibuprofen in hydrophilic solvents to obtain a unit dose capsule acceptable for human consumption.

Methods: Solution of ibuprofen was developed by the salt formation of partial drug using potassium hydroxide in PEG 600 and water. The solution was encapsulated in hard capsules with band sealing. The final formulation was evaluated for uniformity of weight, disintegration, drug content and stability. The dissolution profile was compared with that of available marketed tablets and softgels.

Results: The capsules were evaluated and found compliant as per specifications mentioned in general monograph of capsules in IP 2014. The uniformity of weight of the batch of capsules was found to be 734.8 mg (±0.58). The disintegration time of these capsules was observed to be 4.45 min. The drug content was found to be 100.03% and the product is stable over three months of test period under room temperature as well as accelerated conditions. The dissolution profile showed that softgels take longer time to release the drug whereas marketed tablets showed a dissolution profile comparable with that of formulated capsules.

Conclusion: The developed capsule is a unit dose of liquid containing solubilized ibuprofen delivering the drug directly into the gastrointestinal tract (GIT). These are newer solid oral dosage forms with higher patient compliance and ease in manufacturing. They require lesser steps and manufacturing area when compared to the manufacturing of compressed tablets.

Keywords: Dissolution, Hard gelatine capsules, Ibuprofen, Ionizing agent, Solubility enhancement


Download data is not yet available.


1. Rabia Bushra Mhs, Nousheen Aslam, Masud-Ur-Rehman Dha. Formulation development and optimization of ibuprofen tablets by direct compression method. Pak J Pharm Sci 2008;21:113-20.
2. Abraham P, KI KD. Nitro-arginine methyl ester, a non-selective inhibitor of nitric oxide synthase reduces ibuprofen-induced gastric mucosal injury in the rat. J Dig Dis 2005;50:1632-40.
3. Wood DM, Monaghan J, Street P, Jones AL, Dargan PI. Fatality after deliberate ingestion of sustained-release ibuprofen; a case report. Crit Care 2006;10:R44.
4. Potthast H, Dressman JB, Junginger HE, Midha KK, Oeser H, Shah VP, et al. Biowaiver monographs for immediate release solid oral dosage forms: ibuprofen. J Pharm Sci 2005;94:2121-31.
5. Lodha A Patel, J Dalal. Formulation and evaluation of transparent ibuprofen soft gelatine capsule. J Pharm Bioallied Sci 2012;4:S95–97.
6. Rinkesh M Patel, Hema N Patel, Dhaval G Gajjar, Pravinkumar M Patel. Enhanced solubility of non-steroidal anti-inflammatory drugs by hydroxyl terminated s-triazine based dendrimers. Asian J Pharm Clin Res 2014;7:156-61.
7. Linghui Dian, Zhiwen Yang, Li F. Cubic phase nanoparticles for sustained release of ibuprofen: formulation, characterization, and enhanced bioavailability study. Int J Nanomed 2013;8:845–54.
8. PK Lakshmi, Marka Kranthi Kumar, Aishwarya Sridharan, Shyamala Bhaskaran. Formulation and evaluation of ibuprofen topical gel: a novel approach for penetration enhancement. Int J Appl Pharm 2011;3:25-30.
9. Shyamala Bhaskaran, Pradeep GC, Lakshmi PK. Formulation and evaluation of diphenhydramine hydrochloride and ibuprofen soft gelatine capsules. J Appl Pharm Sci 2011;1:188-90.
10. Rubendra Kurmi, Dinesh Kumar Mishra, Dinesh Kumar Jain. Solid dispersion: a novel means of solubility enhancement. J Crit Rev 2016;3:1-8.
11. Murtha JL, Ando HY. Synthesis of the cholesteryl ester prodrugs cholesteryl ibuprofen and cholesteryl flufenamate and their formulation into phospholipids microemulsions. J Pharm Sci 1994;83:1222–8.
12. Abbaspour MR, Sadeghib F, Garekani HA. Design and study of ibuprofen disintegrating sustained-release tablets comprising coated pellets. Eur J Pharm Biopharm 2008;68:747–59.
13. Abdelazim Zaghloul Ana, Ibrahim Khattab. Development, characterization and optimization of ibuprofen self-emulsifying drug delivery system applying face centered experimental design. Int J Pharm Technol 2011;3:1674-93.
14. Bharat Bhushan Subudhi, Surjyanarayan Mandal. Self-microemulsifying drug delivery system: formulation and study intestinal permeability of ibuprofen in rats. J Pharm Sci 2013;6. DOI:10.1155/2013/328769
15. M Saquib Hasnain, Amit Kumar Nayak, Bulgarian. Solubility and dissolution enhancement of ibuprofen by solid dispersion technique using peg 6000-Pvp K 30 combination carrier. Bulgarian J Sci Education 2012;21:118-32.
16. Shravan Kumar Patel, Dinesh Kumar, Amol P, Waghmod, Avinash S Dhabale. Solubility enhancement of ibuprofen using hydrotropic agents. Int J Pharm Life Sci 2011;2:542-5.
17. Tapan Kumar Giri, Hemant Badwaik, Amit Alexander, Dulal Krishna Tripathi. Solubility enhancement of ibuprofen in the presence of hydrophilic polymer and surfactant. Int J Appl Biol Pharm Technol 2010;1:793-800.
18. Amit Chaudhary UN, Neha Gulati, VK Sharma, RL Khosa. Enhancement of solubilization and bioavailability of poorly soluble drugs by physical and chemical modifications: a recent review. J Adv Pharm Edu Res 2012;2:2249-3379.
19. Monzurul Amin Roni, Reza-Ul Jalil. Comparative study of ibuprofen solubility in synthetic and natural lipid vehicles. DUJPS 2011;10:65-6.
20. Varun Raj, Vemula VL, Srikanth Lingala. Solubility enhancement techniques. Int J Pharm Sci Rev Res 2010;5:41-51.
21. Arif Budiman, Elis Nurlatifah, Saeful Amin. Enhancement of solubility and dissolution rate of glibenclamide by cocrystal approach with solvent drop grinding method. Int J Curr Pharm Res 2016;7:248-50.
22. Manfred Lahner, Klaus Posselt. Ibuprofen-containing soft gelatine capsules and process for preparing same. US Patent 4,690,823; 1987.
23. Rasenack N, Muller BW. Ibuprofen crystals with optimized properties. Int J Pham 2002;245:9-24.
24. Harsha Kathpalia, KS Gaurav Doshi. Recent trends in hard gelatine capsule delivery system. J Adv Pharm Edu Res 2014;4:165-77.
25. Martin Kuentz, Dieter Rothlisberger. Determination of the optimal amount of water in liquid-fill masses for hard gelatine capsules by means of texture analysis and experimental design. Int J Pharm 2002;236:145-52.
26. Joseph A Pace, Two Piece Hardshell. Soluble and digestible liquid containing gelatine capsule. U. S. Patent 4,281,763; 1981.
27. Ewart T. COLE liquid filled and sealed hard gelatine capsules. Capsugel Library 1986;12:11-3.
28. Stephen Brown. Liquid-fill based formulation: advances and challenges. Ingredients, Formulation and Finishing; 2004. p. 64-8.
29. Dennis. Two-piece hard capsules for pharmaceutical formulations. Pharmaceutical Processes; 2013.
30. Man SYu, Rochester NY Foo. Solvent system enhancing the solubility 0f pharmaceuticals for encapsulation. U. S. Patent 5,071,643; 1991.
31. Shyamala Bhaskaran. Formulation and evaluation of diphenhydramine hydrochloride and Ibuprofen soft gelatine capsules. J Appl Pharm Sci 2011;1:188-90.
32. Riddhi Gondalia RM, Pankaj Savaliya. Development and validation of spectrophotometric methods for simultaneous estimation of ibuprofen and paracetamol in soft gelatine capsule by simultaneous equation method. Int J Chemtech Res 2010;2:1881-5.
33. Zareena Yasmeen Tm, Heena Farheen, Husna Kanwal Qureshi. Dissolution method development and validation for combination of ibuprofen and paracetamol tablets. Asian J Pharm Clin Res 2013;6:164-8.
34. Nilufer Yuksel A, Arzu E, Kan?k B, Tamer Baykara. Comparison of in vitro dissolution profiles by ANOVA-based, model-dependent and-independent methods. Int J Pharm 2000;209:57–67.
240 Views | 361 Downloads
How to Cite
Jalundhwala, F. J., V. Londhe, J. Bhat, and S. Singh. “NOVEL ORAL DELIVERY OF IBUPROFEN SOLUTION IN HARD GELATIN CAPSULES”. International Journal of Pharmacy and Pharmaceutical Sciences, Vol. 11, no. 6, June 2019, pp. 50-55, doi:10.22159/ijpps.2019v11i6.32659.
Original Article(s)