INTRODUCTION:

Solubility improve of drugs that don't dissolve well in water is a substantial area of investigation today. Because of this, many different methods have been advanced to help drugs dissolve better, and one of these approaches is called solid dispersion. A lot of drugs that are sold today are made using the SD method, and this has helped improve how well the body absorbs them. Solid dispersion is popular and widely used technique to increase the speed at which drugs dissolve, especially for drugs that are not very soluble or not soluble at all. One of the benefits of using SD is that it's easy to scale up for production, and it can be used to make common drug forms like tablets, capsules, taste-masked strips, and implants. Flurbiprofen is a medication accustomed to degrade pain and fever. It’s commonly specified for conditions like rheumatoid arthritis, osteoarthritis, and pain from painful periods. Flurbiprofen is grouped as a Class II drug, significance it has good absorption but poor solubility. Because of its low solubility and the way it's treated by the body (first-pass metabolism), it's a good candidate for SD formulation. The goal of this study was to see if making solid dispersions of Flurbiprofen with different types of polymers could enhance its solubility and how quickly it dissolves. The prepared solid dispersions were investigated for solubility, the amount of drug present, and in vitro dissolution study.^1-2

MATERIAL AND METHOD:

Material:

Flurbiprofen was provided by JB Chemicals Thane. HPMC, PEG 6000, PVP K30 and tween 80 were sourced from Dipa chem, Aurangabad. All other chemicals and reagents used were of analytical grade.

Method:

Solubility determination of Flurbiprofen:

Solubility of Flurbiprofen was measured by adding more than enough Flurbiprofen to 25ml of water-based solutions containing various hydrophilic materials like HPMC, PEG 6000, PEG 400, Span 40, Tween 80, and polyvinyl pyrrolidone k30 (PVP-k30). These mixtures were placed in screw-top bottles and shaken on an orbital shaker for 24hours at room temperature. After shaking, the mixtures were filtered using a 0. 45µm filter, and the resulting liquid was diluted with methanol. This diluted solution was then tested using a UV visible spectrophotometer at a wavelength of 247nm [Table 1].^3-5

Table 1: Solubility studies of drug and physical mixture

Physical Mixture	Solubility (mg/ml0
Drug	0.012±0.04
Drug + HPMC	0.175±0.014
Drug+ PEG 6000	0.148±0.017
Drug+ PVP K 30	0.168±0.32
Drug+tween 80	0.136±0.62

Preparation of Solid Dispersion:

Solvent evaporation method is used to prepare solid dispersion. The mix of ingredients in all the formulations is shown in Table 2. Five different polymers were chosen because they can dissolve the drug the best. These polymers were tested to find out how well they could dissolve the drug. Each polymer was mixed with ethanol and stirred continuously until a clear solution was formed. Then, the drug, Flurbiprofen, was added to this solution and stirred thoroughly for 45 minutes. After that, the solvent was removed by heating under lower pressure. The resulting solid dispersions were kept at room temperature in desiccators. They were then ground to make them smaller and passed through a sieve to get a uniform size.⁶

Characterization of Flurbiprofen Solid Dispersions

Solubility studies:

Solubility tests were done for pure Flurbiprofen and all the formulations.

The samples were placed in a medium with a pH of 7. 2. Each sample was shaken for 48hours in an orbital shaker at a temperature of 37°C. After shaking, the solution was filtered using Whatman filter paper. The filtered liquid was then diluted and its concentration was measured using a spectrophotometer at a wavelength of 247nm.^7-8

Particle Size Determination:

Particle size analysis was performed using a laser diffraction size analyzer (LS 13 320, Beckman Coulter, CA). For this, the samples were suspended in silicone oil and then ultrasonicated for one minute. Following this, the samples were analyzed using the laser diffraction analyzer.⁷

Drug Content:

All the different sample mixtures were put into 25ml measuring flasks, which is equal to 50mg of the drug. Then 10ml of methanol was added to each sample and mixed using sonication for 10minutes. Methanol was added again to reach the final volume. This solution was further diluted with methanol to a suitable level so that it could be easily measured using a spectrophotometer at a wavelength of 247nm.⁷

Percentage Practical Yield:

The percentage practical yield was calculated to understand how efficient or productive a method is, which helps in choosing the best method for production. The samples were collected and weighed to find the practical yield using the following formula.⁸

Dissolution Studies:

Dissolution tests were done using a Type II paddle setup. The liquid used was 900ml of a phosphate buffer solution with a pH of 7. 2, which also had 1% sodium lauryl sulfate in it. The temperature was kept at 37⁰C± 0.5 and the paddle was set to spin at 50 revolutions per minute. During the test, small portions of the sample were placed on top of the liquid. At specific times, 5 ml of the liquid was taken out and tested using a spectrophotometer to check how much Flurbiprofen was present. The test liquid was kept at the same level by adding more fresh liquid as needed.⁹

FTIR Spectroscopy:

The FTIR spectra for all the formulations were analyzed using an FTIR spectrometer called Pristige-21, made by Shimadzu in Japan. Before analysis, KBr disks were made by mixing the samples with potassium bromide. The samples were examined in the range of 4000 to 400 cm-1 with a resolution of 2 cm-1.¹⁰

X-ray Powder Diffraction:

X-ray diffraction of Flurbiprofen and the different formulations was performed using a diffractometer. This was done to find out the polymorphic form of Flurbiprofen. The measurements were taken from 3 to 1500 using a Si (Li) PSD detector with a scanning speed of 30 per minute. All the tests were carried out at 40kV and 35mA.¹¹

Scanning Electron Microscope:

The surface structure of the layered sample was studied using a scanning electron microscope (SEM) from Hitachi, Japan. A small amount of powder was manually spread onto a carbon tab, which was attached to an aluminum stub. These sample stubs were then coated with a very thin layer of gold, about 30 Å thick, before analysis. The POLARON-E 3000 sputter coater was used. The samples were looked at using a scanning electron microscope (SEM) and pictures were taken at different magnifications. The images were directly sent to a computer.¹¹

Stability Studies:

For stability testing, the prepared solid dispersions were put into sealed 40cc HDPE containers with child-resistant caps. These containers were kept in a stability chamber (Thermo Lab, India) under controlled temperature and humidity conditions. The humidity was kept at 75% ±5% RH and the temperature was set at 40± 2°C. After 1, 2, and 3 months, the samples were taken out and checked for drug content and in vitro dissolution tests.¹²

RESULT:

Preparation of Solid Dispersion:

In this study, 05 distinctive solid dispersions of Flurbiprofen were made utilize distinct amounts of polymers. The full details of each formulation are listed in Table 2. All the solid dispersions prepared were fine and easy to mix. Formulation table is shown in table 1.

Solubility Studies:

Solubility tests showed that the solubility of pure Flurbiprofen was 0.012mg/ml. However, when Flurbiprofen was combined with the polymer in solid dispersion form, its solubility increased significantly compared to the pure drug. The results are shown in Table 3.

Table 3: Solubility profile of pure drug and solid dispersion formulation

Formulation code	Solubility (mg/ml)
Flurbiprofen	0.013±0.04
F1	0.202±0.24
F2	0.255±0.50
F3	0.582±0.08
F4	0.421±0.24
F5	0.368±0.28

Particle Size:

Particle size was measured using the sieving method and was found to be between 52.84±2.36 and 78.82±2.01. Particle size analysis was done for all the SD formulations because it is important for how the drug is released. Having the right particle size is key for good drug release. Usually, smaller particles release the drug more effectively. It was noticed that the optimized final formulation, SD6, with a particle size of 52.84±2.36, showed good drug release, as shown in Table 4.

% Practical Yield:

The results of % PY for all formulations of SDs found to be 91.38±0.41–98.48±0.32%. Maximum yield was found to be 98.48±0.32% in formulation SD6. Drug content determination was carried out for control of drug quality and effectiveness of process for preparation of formulation. The drug content of various formulations was in range of 92.28–99.82% and SD6 was showing maximum drug content of 99.82%. The results confirmed the homogeneous distribution of drug within complexes and all the results are summarized in Table 4.

Dissolution Study:

In vitro dissolution studies were done on all 05 Flurbiprofen SD samples from SD1 to SD5 to check how the drug comes out of the SD formulations. The dissolution profile of pure Flurbiprofen, along with polymers in a ratio of 1:5:2 (drug: polymer: surfactant), showed the highest drug release of 99.86% in 15 minutes. The faster dissolution of the SDs is because of more polymers used in the formulation. It was clear that as the amount of polymer increased, the drug release also increased. Also, the smaller particle size of the drug increases its surface area, which makes it easier to dissolve when it comes into contact with the solution. As the carrier dissolves, it helps the drug to wet better, which improves its solubility [Figures 3-5].

Table 4: particle size, % practical yield and drug content of Flurbiprofen solid dispersion

Formulation code	Particle size	% Practical yield	Drug content
F1	57.73±1.2	91.38±0.41	92.28±0.16
F2	63.82±4.78	92.87±0.02	93.57±0.31
F3	58.82±0.25	94.83±0.24	95.27±0.41
F4	60.84±2.36	94.73±0.12	95.26±0.5
F5	78.82±2.01	96.52±0.49	97.42±0.41

FIG 1: Dissolution profile of pure drug and solid dispersion

FTIR Spectroscopy:

FTIR spectroscopy was used to check for any changes in the structure of the complexes and to see how the drug interacts with the polymers. The FTIR spectrum of the pure drug, Flurbiprofen [Figure 6], shows a clear peak at 1732.13, which indicates the presence of a carbonyl group (C=O) in a compound. There is also a peak at 1225.6, which shows the stretching of a bond. In the C-F region, there is a broad peak of Flurbiprofen between 2500 and 3300 cm–1, which is because of hydrogen bonding. The spectra of formulation SD5 [Figure 2] show the same absorption pattern as when the drug and polymers are combined.

FIG 2: FTIR spectra of pure drug and optimized solid dispersion DS 5XRD

The Flurbiprofen SD were done to check if the SDs made with different drug polymer ratios are crystalline or amorphous. The XRD pattern of pure Flurbiprofen shows many clear peaks Z, which means it is crystalline. Present as a crystalline material [Figure 8]. On the other hand, the spectrum of the optimized formulation SD6 of SD showed no diffraction peaks at all, which is a sign that it is an amorphous compound [Figure 3]. The better dissolution rate of the drug from the drug-polymer is because the drug has a much lower level of crystalline.

FIG 3: XRD of pure drug Flurbiprofen and optimized formulation SD5

Stability studies:

Stability studies were conducted on the optimized formulation SD5 under conditions of 40°C±2°C and 75% RH±5% to check its stability. The formulation was found to be stable. There were no major changes in the percentage of drug content, and the in vitro drug release remained consistent, as shown in Table 5.

Table 5: stability studies data of optimized formulation SD5

Test time for SD5	% Drug content	Drug release
0	99.79±0.43	99.36±3.87
30	98.16±0.25	98.49±0.39
60	97.32±0.37	97.79±0.40
90	96.57±0.48	97.42±0.39

CONCLUSION:

05 drug formulations were created using distinct hydrophilic carrier polymers, and each formulation demonstrated improved drug release compared to the drug alone. Flurbiprofen had the highest solubility in the polymer which was approximately 20 times higher, and this was reflected in formulation SD5, which had the highest release of 99.86% in 15 minutes, containing a 1:5:5 ratios of Flurbiprofen drug, polymer and SLS. This formulation was determined to be the best optimized. The solubility of Flurbiprofen was increased by 44 times in the SD formulation SD5 compared to the drug alone. All the formulations were evaluated, and the results were deemed satisfactory. FTIR studies proved the drug's compatibility with the polymers. XRD and SEM studies indicated that the optimized formulation was in an amorphous state, which allowed for better dissolution of the drug from the SD formulation compared to the drug alone. In conclusion, it can be concluded that SDs can improve the solubility of poorly water-soluble drugs like Flurbiprofen, resulting in enhanced drug release.

ACKNOWLEDGEMENT:

The authors are thankful to JB Pharma Thane for providing free gift sample of drug. They also convey deep gratitude to College of Pharmacy, Teerthanker Mahaveer University, Moradabad, MIT College and Valmik Naik college of Pharmacy Kannad for providing necessary facilities to conduct research work.

FINANCIAL SUPPORT:

This research study has no fund from any government or private recourses.

CONFLICT OF INTEREST:

Authors declare no financial conflict of interest in this study.

REFERENCES:

1. M H Dehghan R M Hanwate, M Saifee. Comparative dissolution study of Glipizide by solid dispersion. ch J. Pharm Sci. and Tech. 2010; 9(2): 293-297

2. Sneha Jagtap, Chandrakant Magdum, Rajesh Jagtap. Ameliorated Solubility and Dissolution of Flurbiprofen using Solubilizer Sepitrap 80 and Sepitrap 4000. Research J. Pharm. and Tech. 2021; 14(1): 21-27. doi: 10.5958/0974-360X.2021.00005.6

3. Punitha S, Srinivasa Reddy G, Srikrishna T, Lakshman Kumar M. Solid Dispersions: A Review. Research J. Pharm. and Tech. 2011; 4(3): 331-334.

4. Ranim Alrouhayyah, Tatiana F. Sheshko, Svetlana N. Suslina, Omran Aisha. Solid Dispersions: An Effective Technology for Improving Dissolution Kinetics of Poorly Soluble Drugs. Research Journal of Pharmacy and Technology. 2023; 16(12): 5701-6. doi: 10.52711/0974-360X.2023.00922

5. Komal Chandrakant Jadhav, Sourabh Sukumar Hegaje, Sadhana Uttam Jadhav, Rupesh Sopanrao Vaidhya, Mayuresh Ramesh Redkar. Formulation and Evaluation of Solid Dispersion of Poorly Soluble Drugs. Asian Journal of Pharmacy and Technology; 12(4): 309-2. doi: 10.52711/2231-5713.2022.00050

6. Hassnain F, Bashir S, Asad M, Nazir I, Qamar S, Imran M, et al. Formulation and characterization of solid dispersion of nisoldipine by solvent evaporation method. J Pharm Altern Med 2012; 2:21-8.

7. Smita Kolhe, Praveen Chaudhari, Dhananjay More. Formulation Development of Solid Dispersion Prepared by Newer Approach: A Research. Asian J. Pharm. Res. 2013; 3(4): 172-180.

8. Lakshmi K, Kumarreddy MP, Kaza R. Dissolution enhancement of telmisartan by surface solid dispersion technology. Int J Innov Pharm Res 2012; 3: 247-51.

9. Daravath B, Naveen C, Vemula SK, Tadikonda RR. Solubility and dissolution enhancement of flurbiprofen by solid dispersion using hydrophilic carriers. Braz J Pharm Sci. 2017; 53: e00010.

10. Enose AA, Dasan P, Sivaramakrishanan H, Kakkar V. Formulation characterization and pharmacokinetic evaluation of telmisartan solid dispersions. J Mol Pharm Org Process Res. 2016; 4: 131.

11. Patil A, Kumar S. Formulation and evaluation of solid dispersions of an anthelmintic drug for enhancement of dissolution rate. JIPBS. 2017; 4:71-4.

12. Vippagunta SR, Maul KA, Tallavajhala S, Grant DJ. Solid state characterization of nifedipine solid dispersions. Int J Pharm. 2002; 236:111-23

Received on 21.08.2025 Revised on 13.10.2025

Accepted on 08.11.2025 Published on 30.01.2026

Available online from February 05, 2026

Res. J. Pharma. Dosage Forms and Tech.2026; 18(1):23-27.

DOI: 10.52711/0975-4377.2026.00004

This work is licensed under a Creative Commons Attribution-Non Commercial-Share Alike 4.0 International License. Creative Commons License.

Formulation code	Flurbiprofen	HPMC	PVP K30	PEG 6000	Sodium lauryl sulphate	Methanol
F1(1:1:1)	50	50	50	50	50	qs
F2 (1:2:2)	50	100	100	100	100	qs
F3 (1:3:3)	50	150	150	150	150	qs
F4 (1:4:4)	50	200	200	200	200	qs
F5 (1:5:5)	50	250	250	250	250	qs