1. INTRODUCTION:

A drug delivery system serves as a vehicle for transporting pharmaceutical compounds to the body for therapeutic effect¹. Among various approaches, SD is especially effective to significantly improve gastrointestinal uptake and systemic availability of Biopharmaceutics Classification System II API².

Among various drug delivery methods, Enteral route remain commonly utilized and Favored because of its convenience and patient compliance. However, drugs with low water solubility often face limitations in absorption due to slow dissolution rates, while those with limited membrane permeability encounter challenges due to restricted permeation across biological barriers³. Therefore, pharmaceutical research often concentrates on two key strategies For boosting the extent to which active drugs are absorbed through the oral route: Facilitating greater solubilization and faster dissolution of drugs characterized by low water solubility and enhancing the permeability of compounds with limited membrane transport⁴. EZB is an antihyperlipidemic agent used to reduce plasma cholesterol levels. Its limited Dissolution capacity, poor dissolution rate, and reduced oral bioavailability present significant challenges in developing it as a fast-release formulation⁵. One established one effective strategy for improving the drug ability to dissolve and release effectively behavior of handling poorly water-soluble compounds entails formulating them as SD. This research emphasizes the application of SD techniques to improve release behavior and, Thus improving the bioavailability of compounds with low aqueous solubility when administered orally⁶. Improving solubility can lead to better therapeutic efficacy, reduced dosage requirements, and potentially quicker onset of action⁷.

The prepared formulation involves distributing active pharmaceutical ingredients within solid, inert matrix, followed by incorporation into an aqueous medium containing a polymer, enabling molecular-level mixing⁸. Vitamin E TPGS has recently been extensively studied for its ability to act as a dispersing agent, solubilizer, emulsifier, and gelling agent for poorly water-soluble drugs, making it a promising candidate as a carrier in SD formulations⁹. In addition to its role in drug delivery, its application as a molecular biomaterial in various biomedical fields is promising, particularly due to its safety profile as an FDA-approved pharmaceutical excipient¹⁰. This study presents Vitamin E TPGS as a multifunctional excipient that enhances both solubility and drug delivery in the formulation of immediate-release Ezetimibe (EZB) tablets, a BCS Class II compound. By promoting micellar solubilization and inhibiting P-glycoprotein, TPGS improves EZB’s dissolution rate, permeability, and overall bioavailability. The effectiveness of the solid dispersion approach was supported by XRD analysis and in vitro dissolution testing.The present study aimed to enhanced dissolution profile of EZB by Vitamin E TPGS-based SD¹¹. Release behavior of EZB from formulated tablet using Vitamin E TPGSwas evaluated. It was hypothesized that Vitamin E TPGS may also function as a dissolution enhancer for a broad range of poorly soluble drug.The prepared formulation, SD of EZB were developed using a combination of Vitamin E TPGS and mannitol through the melt method¹².

2. MATERIALS AND METHODS:

2.1 Materials:

Ezetimibe (EZB) was obtained from Lupin Ltd., Mumbai. Vitamin E TPGS was procured from Cipla, Indore, Madhya Pradesh, India. Mannitol, sodium starch glycolate (SSG), Cab-O-Sil, and magnesium stearate were kindly provided by BMR Pharma and Chemicals, Indore, India.

2.2 Methods:

2.2.1 Preparation of Calibration Curve of EZB:

Ten mg of EZB dispensed into a 100mL volumetric-flask, followed by dissolution in phosphate buffer at physiological pH (7.4) mixed with 0.75% SLS. The mixture was thoroughly agitated to ensure complete dissolution, and filled to the mark on a 100mL and obtained 100µg/mL stock solution. Subsequent dilutions were obtained from the primary solution to prepare samples with 5 to 30µg/mL. Scanned different concentration solution in UV Visible spectroscopy (Shimadzu 1700) at 232nm¹³. The data of calibration curve was noted in Table 1.

2.2.2 Screening of Carrier Material for Development of SD:

Successful formulation of EZB SD using hydrophillic carriers relies heavily on selecting suitable excipient. Different hydrophillic carriers were employed to prepare EZB tablet through the melt fusion technique. Each polymer was individually heated to its respective melting point, after which EZB was incorporated in a 1:1 molar ratio. The resulting molten mixtures were subjected to constant agitation at 250rpm for 15minutes at ambient temperature to allow solidification¹⁴. The prepared to remove residual moisture, the SD were placed in a tray dryer at 35°C for half an hour. The blend was carefully packed into '0' capsules size. Each capsule containing formulation was evaluated through dissolution studies. For dissolution analysis, a USP Type II apparatus (Electrolab) under controlled conditions of 50rpm and 37±0.5°C. Testing was conducted in 900mL containing 0.75% sodium lauryl sulfate to ensure proper solubility conditions samples of 2mL were taken at scheduled time points and immediately replenished with fresh buffer to keep sink conditions stable. The withdrawn solutions were subjected to filtration through a 0.45µm pore-sized filter and scanned by UV-Vis. spectrophotometry set at 232nm¹⁵.

2.2.3 Tablet Formulation of EZB with Vitamin E TPGS:

SD of EZB was formulated using the melt method. Accurately weighed quantities of EZB, vitamin E TPGS with mannitol were used 1:1:4. Initially, Selected carrier was transferred into a beaker and mildly warmed to a temperature of 40°C until fully melted. EZB was then incorporated into the molten TPGS and mixed thoroughly. This mixture was gradually blended with mannitol under continuous stirring to ensure uniform distribution. Drying was carried out on the formulated SD to remove residual moisture using a tray dryer and stored in clean glass container¹⁴. Mannitol was selected as diluent for developing tablet during the preparation of SD. Incorporating EZB with Vitamin E TPGS in a mannitol-based matrix notably enhancement in the release rate. The formulation exhibited improved solubility attributes due to the effective role of mannitol ¹⁶. Accurately weighed quantities of EZB-SD and the excipients listed in Table 3 were passed mesh sieve 22#. After sieving, excipients were mixed uniformly for 10 minutes to ensure content uniformity. The final granules were subsequently punched into tablets by manually operated compression device. Relevant observations were documented in Table 1¹⁷.

Table 1: Formulation of Fast Release Tablet of EZB

S. No	Ingredients	Amount (mg)
1	SD of EZB-Vitamin E TPGS (1:1) and Mannitol	60 (Comparable to 10 EZB)
2	SSG	14
3	Cab-o-Sil	2
4	Magnesium stearate	8
Total weight		84

2.2.4 Evaluation of Pre-compression Parameters:

2.2.4.1 Angle of repose:

Accurately weighed quantities of EZB-SD along with the excipients detailed in Table 3 were sieved by 22#. Screened ingredients were then thoroughly blended for 10minutes to ensure consistent mixing. The final granules were molded by manually operated compression device. The Ɵ values was obtained using standard calculation equation 1 outlined below¹⁸.

tan Ɵ = h/r Eq................(1)

2.2.4.2 Bulk density:

Measured amount of sample was precisely added to a 50 mL calibrated glass cylinder, ensuring no tapping or compaction during the transfer. Initial volume occupied by the powder (bulk volume) and its weight were recorded for calculation⁹. It’s determined by following equation 2:

Bulk density =

Sample Wt / Bulk volume Eq............. (2)

2.2.4.3 Tapped density:

The measured amount weighed accurately and added into 50 mL calibrated glass cylinder, which was then placed on a tapping device. After applying tapping, the reduced capacity was measured using the standard equation 3 provided below ¹⁹.

Tapped density

= Sample Wt/Tapped volume Eq..............(3)

2.2.4.4 Hausner’s ratio:

It’s defined as proportion between bulk powder volume and its tapped volume after a predetermined number of taps.²⁰.

2.2.4.5 Carr’s Index:

It’s influenced through several factors including bulk density, material cohesiveness, surface area, particle size and shape, as well as moisture content. This measurement observed differences between bulk and tapped volumes. Standard practice includes assessing the powder’s initial volume and the compacted volume following tapping after repeated tapping, continued until the volume becomes constant.²¹. The outcome is calculated and reported as a percentage.

% Carr’s Index

= (Tapped density-Bulk density) / Tapped density X 100 Eq........(4)

2.2.5 Determination of Drug Content:

25 mg of SD equivalent to 4.15 mgof EZB, was transferred in 25 mL beaker and 15 mL methanol was emerged to dissolve contents, and volume brought up to mark with the same solvent. An aliquot (1 mL) was extracted from the stock and brought to 10 mL with diluent. The prepared sample was filtered and filtrate was analyzed at 232 nm.²².

2.2.6 X-Ray Diffraction Study (XRD):

To investigate potential alterations in the physical state of EZB particularly any shift from crystalline to amorphous form XRD analysis was performed. The study utilized a Horizontal Rotaflex rotating anode diffractometer (Bruker, Bengaluru, India) to examine EZB, Vitamin E TPGS, their physical mixture, and the prepared SD. Samples were evenly spread on slides, pressed flat for alignment, and secured in the sample holder. Scanning was conducted within the 2θ range of 5° to 50°, employing CuKα radiation at 40 kV and 50 mA and speed of 3° per minute with a 0.04° step size. The diffraction profiles were recorded as plots of intensity against 2θ to detect any structural transitions induced during SD formulation ²³.

2.2.7 Post Compression Evaluation:

2.2.7.1 Weight Variation:

From the batch, the mass of each tablet was measured after randomly selecting a group of twenty.The mean weight was then determined and used as a reference to assess variations by comparing it with the weight of each tablet to calculate the percentage deviation ²⁴.

2.2.7.2 Hardness:

Tablets must possess adequate mechanical strength and resistance to breakage or friability in order to endure handling, and transportation. Pfizer device used to analyze compression resistance of prepared tablets. ²⁵.

2.2.7.3 Friability:

The test for friability began with the pre-weighing of twenty tablets, placing them in drum of tester for 25 rpm for 4 minutes. Subsequently, the dusted material was weighed. Loss % was estimated in term of weight as per standard protocol²⁶.

% F = {1-(Wt/W)} ×100 Eq....... ......(5)

Where, % F = friability in percentage, W = Initial weight of tablets, Wt = weight of tablets after 100 revolution

2.2.7.4 Disintegration:

Each of the six tablets was introduced into a distinct tube of the disintegration tester. The beaker was contained 900 mL of aqueous solution at 37± 2 °C and assembly was operated set to oscillate between 28 and 32 strokes per minute to assess tablet disintegration behaviour ²⁷.

2.2.8 In Vitro Dissolution Rate Study of Formulated Tablets of EZB-Vitamin E TPGS:

Using Paddle dissolution (USP) apparatus, EZB-vitamin E TPGS tablets were tested in 0.75% SLS (900 mL) at 50 rpm. At scheduled intervals, 5 mL samples were removed and replenished to uphold volume and favoring conditions. Collected samples underwent diluted, assessed for drug release at 232 nm using a UV spectrophotometer ²⁸. The outcomes of the data are provided in table 6 and illustrated in figure 4.

2.2.9 In Vitro Drug Release Kinetics::

The percentage EZB dissolution data were analyzed using various kinetic models. Best-fitting was identified by correlation coefficient (R²). In this evaluation (Eq. 6 to Eq. 9): zero-order kinetics (Eq 6) involved plotting progressive release profile of the EZB versus time (t); the Higuchi plotted (Eq. 8) percentage progressive release profile against time square root; the first-order(Eq. 7)used a plot of log progressive release remaining versus t; and the Hixson–Crowell (Eq. 9) applied cube root % of EZB remaining versus t.²⁹.

The release rate was analyzed using Equation 6, which corresponds to zero-order kinetics.

Mo-Mt = Kot -------- Eq 6

For the first-order kinetic modelas described by Equation 7.

Ln(Mo/Mt) = k1t -----------Eq 7

This approach is useful for evaluating the release behavior of fast-release tablet formulations. The relevant calculations were performed using Equation 8.

Mt = k√t ----------Eq 8

The Hixson-Crowell model as represented by Equation 9.

(Wo)1/2 –(Wt) ½ = kt -----------Eq 9

Here, M₀ is defined as the initial drug load, and Mₜ is the quantity released measured at time t. Similarly, W₀ indicates the starting weight, and Wₜ corresponds to the residual drug at time t. The constants k₀, k₁, and k are rate constants calculated from linear fitting of different drug release models.³⁰.

3.0 RESULT AND DISCUSSION:

3.1 Preparation of Calibration Curve of EZB:

Linear equation was obtained by plotting the graph between Concentration Verses Absorbance. The linear equation represented in figure 1.

Figure 1: Standard Curve of EZB.

3.2 Selection of carriers for the preparation of EZB SD:

The findings confirm that increasing the polymer concentration leads to a corresponding improvement in drug solubility. All tested carriers enhanced the solubility of the drug, likely due to improved wettability. Among them, Vitamin E TPGS demonstrated the highest solubility enhancement. The obtained stability constant (Ks) value was appropriate for the development of SD, suggesting potential improvement in the drug's bioavailability (refer to Table 3). The dissolution study revealed that except for the EZB:Vitamin E TPGS dispersion, the other formulations released less than 80% of the drug within 30 minutes and were thus excluded from further development of EZB-SD (see Table 2 and Figure 2). In contrast, the 1:1 EZB:Vitamin E TPGS formulation achieved a maximum drug release of 84.11% within 30 minutes, which may be attributed to ability of vitamin E TPGS to disrupt membrane integrity and facilitate permeability. These results are consistent with previously published studies. Therefore, vitamin E TPGS was screened out as the optimal carrier for further SD development of EZB tablet.

Table 2: Release profile of EZB-SD with carriers

S. NO.	Time (Min.)	% Cumulative Drug Dissolved
S. NO.	Time (Min.)	Ezetimibe: PEG 4000	Ezetimibe: PVP K30	Ezetimibe: PEG 4000: Mannitol	Ezetimibe: PEG 6000: Mannitol	Ezetimibe: Vitamin E TPGS	Physical Mixture (Ezetimibe: Vitamin E TPGS)
EZB-Carrier		1:1	1:1	1:1:2	1:1:2	1:1	1:1
1	5	28.84±1.2%	14.91±1.5%	3.44±1.1%	27.99±2.5%	25.40±1.7%	10.39±1.7%
2	10	32.51±1.8%	18.37±1.4%	5.1±1.7%	32.05±2.0%	31.70±1.4%	22.51±0.8%
3	15	36.37±1.5%	25.50±2.5%	6.32±2.1%	40.19±1.5%	64.60±1.1%	24.93±0.5%
4	30	51.50±1.9%	41.87±0.5%	15.44±2.7%	50.55±1.8%	84.11±1.9%	30.10±1.2%
5	45	55.47±1.0%	52.00±1.5%	25.84±2.2%	55.75±1.4%	87.47±1.3%	34.97±2.5%
6	60	58.77±1.6%	67.16±1.8%	34.48±1.9%	60.40±1.9%	89.79±1.8%	58.06±1.6%

3.5 XRD Studies:

Figure 3(a) displays the XRD spectrum of pure EZB, characterized by distinct and sharp diffraction peaks at 14°, 17°, and 22°, indicative of its crystalline structure. In contrast, the XRD pattern of the EZB–Vitamin E TPGS SD shown in Figure 3(b) reveals absence these characteristic peaks, suggesting that EZB has transitioned shift from a regular, lattice-based structure to an irregular, amorphous morphology within SD. Figure 3(b) shows a loss of the distinct crystalline peaks of EZB (originally present at 14°, 17°, and 22°) in the EZB–Vitamin E TPGS SD. This disappearance indicates a significant reduction in crystallinity, implying that EZB is molecularly dispersed within the carrier matrix. The conversion to an amorphous form enhances solubility and dissolution rate due to higher energy state and lack of crystal lattice energy.

3.6 Evaluation of Post Compression Parameters:

The evaluated tablets complied with standard limits for weight variation, with deviations observed within ±4.8%, which is within the permissible ±5% range. Tablet hardness ranged between 3–4kg/cm², meeting the required specifications. Friability values remained below 1%, confirming mechanical stability. Content uniformity was determined to be 100±3.1%, indicating consistent drug distribution. The disintegration time was recorded as 9 minutes and 30 seconds. Detailed evaluation parameters are presented in table 5.

Table 5: Evaluation of prepared EZB tablet

S. No.	Evaluation Parameter	Result
1	Weight variation (%)	4.6± 0.8
2	Hardness (kg/cm²)	3.2± 0.6
3	(%) Friability	0.58± 0.4
4	Content Uniformity (%)	99 ± 2.8
5	Disintegration time	8 min. 25 sec.

3.7 Release Study of EZB-Vitamin E TPGS Tablets:

The tablet formulation exhibited a drug release of 93% within 30 minutes. This result is summarized in table 6 and illustrated graphically in Figure 4.

Table 6: Dissolution Study Data of Formulated Tablet of EZB

S. No.	Time (min.)	Cumulative % drug dissolved
1	5	65.19±1.4
2	10	72.81±1.7
3	15	84.13±1.1
4	30	93.00±2.4
5	45	96.73±2.1
6	60	99.08±1.5

Fig. 4: Release study of Formulated Tablet of EZB.

3.8 In Vitro Drug Release Kinetics:

In Figure 5A, the release profile initially exhibited a rapid drug release followed by a slower, sustained pattern characteristic of zero-order kinetics. However, the regression coefficient (R² = 0.5283) indicated that did not strictly obey zero-order. In contrast, the first-order release model (Figure 5B) demonstrated a better fit, with a regression value of 0.9442, and suggested a quick initial release phase. Among all models, the first-order kinetics showed the highest correlation, indicating that EZB dissolution was good fit by this model. The Higuchi model (Figure 5C) yielded an R² value of 0.6356, suggesting a diffusion-controlled mechanism, consistent with Case I Fickian transport. Hixson–Crowell plot (5D) gave a regression value of 0.8198, indicating a moderate fit but not suitable model. Based on the comparative analysis of regression values (R²), the dissolution of EZB from the vitamin E TPGS-SD tablets most closely followed first-order kinetics. Identifying the most suitable kinetic model is essential to understand the drug release profile. In this study, the first-order model (R² = 0.9442) provided the best correlation with the release data of Ezetimibe (EZB) from the Vitamin E TPGS-based solid dispersion, suggesting that the release rate depends on the drug concentration—favoring a rapid initial release followed by a gradual decline. Comparatively, the zero-order (R² = 0.5283), Higuchi (R² = 0.6356), and Hixson–Crowell (R² = 0.8198) models demonstrated lower correlation values, indicating they do not adequately describe the release mechanism. These findings highlight the efficiency of Vitamin E TPGS in improving solubility and facilitating a predictable, concentration-dependent drug release.

4.0 CONCLUSION:

This research outlines an effective formulation strategy aimed at improving the dissolution and potential bioavailability of Ezetimibe (EZB), a BCS Class II drug with limited water solubility, by developing a fast-releasing tablet system. Comprehensive characterization of EZB using melting point analysis, X-ray diffraction, and UV spectroscopy confirmed the drug’s identity and crystalline structure. Solid dispersions incorporating Vitamin E TPGS were prepared using the melt technique and demonstrated enhanced drug release, with approximately 93% released within 30 minutes. The incorporation of Vitamin E TPGS, serving both as a solubility enhancer and carrier, played a key role in overcoming EZB’s dissolution challenges. Overall, the formulation approach presents a practical and scalable option for improving the therapeutic effectiveness of EZB in the treatment of elevated cholesterol levels.

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Received on 17.06.2025 Revised on 11.10.2025

Accepted on 27.12.2025 Published on 01.07.2026

Available online from July 04, 2026

Research J. Pharmacy and Technology. 2026;19(7):3113-3120.

DOI: 10.52711/0974-360X.2026.00442

This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License. Creative Commons License.

S. no	Formulation	Bulk Density (g/ml)	Tapped Density(g/ml)	Angle of Repose ± SD, n=3	Carr’s Index (%)±SD, n=3	Hausner’s Ratio± SD, n=3
1.	Fast Release Formulation	0.38±0.012	0.58±1.25	25.18±0.92	14.21±0.61	1.18±1.02

S. No.	% Drug Content
S. No.	DRUG:Vitamin E TPGS: Mannitol (1:1:4) SD	Physical Mixture
1	97.82±2.1%	95.65±2.1%
2	98.64±1.5%	95.42±1.8%
3	99.18±0.98%	96.68±2.4%