INTRODUCTION:

Peptic ulcer refers to an excoriated or damaged portion of the mucosal lining of stomach or intestines, principally caused by the digestive actions of the gastric acids or secretions from the upper small intestine.¹The primary factors leading to the development of this peptic ulcer disease are infections with Helicobacter pylori and the consumption of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).² Drugs used for the management of such disorders can be divided into two classes: gastric acid neutralizers (e.g. antacids) and gastric acid secretion inhibitors (e.g. proton pump inhibitors and H₂ receptor blockers).

Drugs used for the management of such disorders can be divided into two classes: gastric acid neutralizers (e.g. antacids) and gastric acid secretion inhibitors (e.g. proton pump inhibitors and H₂ receptor blockers). In the early 1960s, the administration of antacids was the conventional treatment strategy for the neutralization of gastric acids in the stomach and dose was quite large that may lead to undesirable side effects.³ Moreover, the relief offered by antacids was merely short-lived and patients were often recommended to adhere to strict dietary guidelines.³ Though the H₂-receptorantagonists have shown remarkable success in the management of ulcers until the early 1990s, they have largely been replaced by the proton pump inhibitors (PPIs) since then.⁴ The PPIs are administered as inactive prodrug, which undergoes molecular conversion (in the presence of acid) to the active form that can lead to the formation of a covalent bond with the H+/K+ATPase, inactivating the enzyme and obstructing the end stage of acid production, resulting in the reduced secretion of gastric acids.⁵ These are administered either alone for the treatment of NSAID-induced peptic ulcers or in conjunction with antibacterial medications to treat ulcers induced by the H. pylori.⁶

Omeprazole was the first proton pump inhibitor to be marketed in the world.⁷ This drug possesses superior antisecretory activity in contrast to the H₂-receptor antagonists but is acid labile and undergoes rapid degradation, often within minutes, in the acidic conditions of the stomach.⁸This pharmacological property required omeprazole to be formulated as delayed release, acid-resistant enteric-coated tablets or capsules. This coating prevents the degradation of omeprazole by gastric acid, as well as delays its absorption, so that the peak plasma concentration (C_max) is typically not achieved until five hours following oral administration of this drug.⁹ Moreover, the drug undergoes extensive first pass metabolism and its oral bioavailability in humans is only about 40 to 50%. Furthermore, patients taking enteric coated, delayed-release omeprazole may experience nocturnal gastric acidity and nighttime symptoms of heartburn despite adequate therapeutic dosing (including twice-daily administration) of the drug.^10-11 To address these challenges associated with the oral administration of omeprazole, liquid formulations have been extemporaneously compounded by incorporating the sodium bicarbonate solution with the omeprazole granules. But these formulations have a very short shelf life and may require the use of syringe or feeding tube during administration, potentially leading to clogs and making administration difficult.¹² These limitations make omeprazole as a promising candidate for mucoadhesive buccal drug delivery. This drug delivery system involves administration of the drug to be absorbed via buccal mucosa and administered directly into the systemic circulation, which enables the drug to circumvent the hepatic first-pass metabolism and degradation by gastric acid, eliminating the need for an enteric coating.^13-15It can also reduce the dose frequency and dose related side effects. Moreover, it promotes enhanced drug release, leading to faster absorption, better therapeutic outcomes, improved oral bioavailability and greater patient convenience.^13-15 As a result, omeprazole has been chosen as the model compound for this study.

The present study aims to design and characterize the directly compressed mucoadhesive buccal tablets of omeprazole using croscarmellose sodium as super-disintegrant for improved drug release and varying concentrations of mucoadhesive polymers like HPMC K4M, carbopol 934P and xanthan gum for satisfactory mucoadhesive strength. The study also intends to investigate the impact of various types of polymers and their concentrations upon the drug release rate and mucoadhesive characteristics of the prepared tablets.

MATERIALS AND METHODS:

Materials and Reagents:

Omeprazole powder, carbopol 934P, HPMC K4M and xanthan gum were gifted by the Incepta Pharmaceuticals Ltd. (Dhaka, Bangladesh). Microcrystalline cellulose, aerosil 200, croscarmellose sodium, sodium hydroxide, lactose monohydrate, talc and potassium dihydrogen phosphate were collected from Loba Chemie, India. The distilled water was sourced from the own research laboratory of the University of Asia Pacific.

Formulation of Mucoadhesive Buccal Tablets:

The mucoadhesive buccal tablets of omeprazole were formulated employing the direct compression technique as per the compositions listed in Table 1. A total of nine formulations were prepared. For each formulation batch, all the formulation ingredients were accurately weighed and blended together for about 15 minutes in a stainless-steel bowl. After that, lubrication was performed by incorporating talc into the above mixture and blending thoroughly for 2 minutes. This dry mixture was subsequently compressed into omeprazole tablets utilizing an automatic tablet machine. The total time allowed before releasing the compression pressure was 20 seconds.

Table 1. Compositions of formulated mucoadhesive buccal tablets of omeprazole

Ingredients (mg/tablet)	Formulation Code
Ingredients (mg/tablet)	F1	F2	F3	F4	F5	F6	F7	F8	F9
Omeprazole	20	20	20	20	20	20	20	20	20
Carbopol 934P	30	35	40	-	-	-	-	-	-
HPMC K4M	-	-	-	30	35	40	-	-	-
Xanthan gum	-	-	-	-	-	-	30	35	40
Microcrystalline cellulose pH 101	20	20	20	20	20	20	20	20	20
Aerosil 200	2	2	2	2	2	2	2	2	2
Talc	1	1	1	1	1	1	1	1	1
Croscarmellose sodium	10	10	10	10	10	10	10	10	10
Lactose	27	22	17	27	22	17	27	22	17
Weight per tablet	110	110	110	110	110	110	110	110	110

Physical Assessment of Powder Blends:

The powder blends of omeprazole tablets were assessed for bulk density, tapped density, carr’s compressibility index, angle of repose and hausner ratio.¹⁶

Characterization of Formulated Mucoadhesive Buccal Tablets:

The developed tablets and market products were assessed for several in-process quality control parameters (e.g. hardness, thickness, disintegration, time friability, weight variation etc.), ex-vivo mucoadhesive strength, in-vitro dissolution and FTIR analysis.¹⁷

Weight variation test:

The individual weights of 20 randomly selected tablets were measured and the mean weight was calculated. Finally, the percentage of the weight variation was determined.¹⁷

Hardness:

The hardness of randomly selected 20 tablets was computed utilizing a hardness tester.¹⁷

Thickness:

A digital vernier caliper was used to measure the thickness of the prepared tablets and the average thickness was subsequently calculated. 20 randomly selected tablets were picked for the measurement.

Friability:

Randomly selected 20 tablets from every batch were primarily weighed and placed into the drum of the friabilator. After rotating for 4 minutes at 25 rpm or after 100 revolutions, the tablets were recovered and weighed. Friability was computed from the following equation:

% Friability = {(Preliminary weight – Final weight) / Preliminary weight} × 100

In-vitro disintegration test:

The disintegration test was conducted at 37±0.5°C in 0.1 N HCl by using disintegration tester (ED-2L, Electro lab, India). Six tablets were picked at random from every batch and one tablet was inserted into one of the six tubes of the disintegration apparatus basket, followed by recording of the disintegration time.¹⁷

Drug content:

A random selection of twenty tablets was made from each formulation batch and ground into a fine powder. The powder equivalent to about 10 mg of omeprazole was weighed and dissolved in phosphate buffer solution of pH 6.8 in a 100 ml volumetric flask. The resulting solution underwent filtration. After that, 10 ml of the filtrate was placed into another 100 ml volumetric flask and diluted to the volume, yielding a final concentration of 10 µg/ml. The drug content was quantified spectrophotometrically at 302 nm.

In-vitro dissolution study:

The dissolution profile of omeprazole from the developed tablets and market products were assessed using the USP-II dissolution testing apparatus (paddle type) in 900 ml of phosphate buffer medium, maintained at 37±0.5°C with a paddle speed of 50 rpm. The spectrophotometrical analysis was done to measure the amount of released drug.¹⁸

Determination of release kinetics:

The obtained dissolution data were fitted into various kinetic models, such as - zero-order, first-order, higuchi and korsmeyer-peppas models, to interpret the rate and mechanism of omeprazole release from the formulated batches. The R² values were calculated and nearing 1 considered as the best fitted kinetic model.¹⁷

Ex-vivo mucoadhesive strength:

Omeprazole's mucoadhesive strength was assessed using a modified physical balance. The loose tissues and underlying fat of a goat’s stomach were removed to separate the mucosal membrane. Using cyanoacrylate glue, a fragment of goat intestinal mucosa was adhered to a glass container. Additionally, one side of the tablet was adhered to the glass vial using adhesive. The vial was then left in touch with the mucous membrane surface for two minutes by lightly pressing with the fingertip. After attaching the vial to the mucosal surface, weight was gradually added to the pan on the left until the vial separated from the mucosal surface. The weight in grams required to detach the vial including the tablet from the membrane surface provided the measurement of mucoadhesive strength. The analysis was conducted in triplicate for every formulation and the mean values were documented.¹⁹

Fourier transform infrared spectroscopic analysis:

The IR spectra of mucoadhesive polymers, pure drug and optimized tablet formulations were assessed to check the chemical integrity of the drug in the formulated tablets. FT-IR spectra were obtained employing a Shimadzu 8400S spectrophotometer within the 4000–400 cm⁻¹ wavelength range.

Statistical Analysis:

Microsoft Excel Software 2007 was used to apply descriptive statistics to the data that was gathered. Graphical representations of the results included means, standard deviations (SD), and percentages.

RESULTS:

Characterization of powder blends:

The experimental data showed that the bulk density of the powder blends of omeprazole mucoadhesive buccal tablets ranged between 0.29 and 0.36 g/mL, while their tapped density fell within 0.33 to 0.39 g/mL (Table 2). Again, all the formulations of omeprazole powder blends showed the readings of carr’s compressibility index varying from 6.06% to 11.42%. Moreover, the readings of the angle of repose were identified between 23.74° to 29.24°, suggesting free flow properties of the blends.

Evaluation of properties of formulated mucoadhesive buccal tablets:

In case of weight variation test, the tablet weights ranged from 112.05 ± 1.39 mg to 113.07 ± 1.66 mg. The thickness of formulated tablets was consistent across all the batches and the friability of the formulated tablets was reported to be between 0.32-0.50%. Additionally, all batches exhibited a disintegration time of <1 minute (Table 3).

Table 2. Precompression evaluation parameters of various powder blends (Mean ± SD)

Formulation code	Bulk Density (gm/ml)	Tapped Density (gm/ml)	Hausner’s Ratio	Carr’s Index (%)	Angle of Repose (°)
F1	0.31 ± 0.01	0.33 ± 0.15	1.06 ± 0.37	6.06 ± 0.02	25.64 ± 0.03
F2	0.32 ± 0.15	0.35 ± 0.02	1.09 ± 0.16	8.57 ± 0.01	27.47 ± 0.06
F3	0.29 ± 0.01	0.33 ± 0.03	1.13 ± 0.06	12.12 ± 0.03	23.74 ± 0.16
F4	0.35 ± 0.03	0.39 ± 0.04	1.11 ± 0.03	10.25 ± 0.32	29.24 ± 0.31
F5	0.33 ± 0.01	0.36 ± 0.01	1.09 ± 0.02	8.33 ± 0.44	23.74 ± 0.02
F6	0.31 ± 0.04	0.35 ± 0.01	1.13 ± 0.23	11.42 ± 0.23	27.47 ± 0.01
F7	0.34 ± 0.02	0.38 ± 0.04	1.12 ± 0.06	10.52 ± 0.01	25.64 ± 0.06
F8	0.36 ± 0.16	0.39 ± 0.17	1.08 ± 0.02	7.69 ± 0.03	25.64 ± 0.15
F9	0.30 ± 0.02	0.33 ± 0.21	1.1 ± 0.18	9.09 ± 0.01	29.24 ± 0.02

Table 3. Properties of formulated mucoadhesive buccal tablets of omeprazole (Mean ± SD)

Formulation code	Weight variation (mg)	Hardness (KgF)	Thickness (mm)	Friability (%)	Disintegration time (seconds)	Drug content (%)
F1	112.05 ± 1.39	1.2 ± 0.089	2.041 ± 0.013	0.49 ± 0.010	26 ± 0.061	96.97 ± 0.010
F2	113.07 ± 1.66	1.47 ± 0.121	2.053 ± 0.019	0.50 ± 0.121	32 ± 2.110	95.45 ± 0.006
F3	112.37 ± 1.89	1.67 ± 0.121	2.036 ± 0.011	0.32 ± 0.006	35 ± 0.610	96.36 ± 0.021
F4	112.87 ± 1.58	2.28 ±0.214	2.046 ± 0.014	0.47 ± 0.021	41 ± 0.550	98.48 ± 0.037
F5	112.75 ± 1.51	2.55 ± 0.187	2.035 ± 0.009	0.37 ± 0.010	44 ± 3.360	93.93 ± 0.017
F6	113 ± 1.71	3.2 ± 0.322	2.058 ± 0.010	0.44 ± 0.015	47 ± 2.681	97.58 ± 0.006
F7	112.83 ± 1.75	3.55 ± 0.105	2.045 ± 0.017	0.45 ± 0.006	52 ± 0.211	99.39 ± 0.003
F8	112.15 ± 1.44	3.82 ± 0.172	2.051 ± 0.026	0.43 ± 0.021	55 ± 2.021	98.79 ± 0.011
F9	112.45 ± 1.9	3.98 ± 0.147	2.041 ± 0.010	0.40 ± 0.032	59 ± 1.302	97.88 ± 0.021

Evaluation of ex-vivo mucoadhesive strength:

The experimental data showed that formulation F1 containing 30 mg of carbopol 934P showed the highest mucoadhesive strength and force of adhesion (Table 4), while the mucoadhesive strength and adhesion force was found to be minimal in case of formulation F9 containing xanthan gum.

Table 4. Evaluation of mucoadhesive strength and mucoadhesive force of prepared tablets

Mucoadhesive Polymer	Formulation code	Mucoadhesive strength (gm)	Mucoadhesive force (N)
Carbopol 934P	F1	90	8.829
	F2	82	8.044
	F3	77	7.554
HPMC K4M	F4	50	4.905
	F5	46	4.513
	F6	39	3.823
Xanthan Gum	F7	30	2.941
	F8	26	2.551
	F9	21	2.060

In-vitro drug release of omeprazole from formulated mucoadhesive buccal tablets:

The findings of the dissolution studies revealed that tablets formulated with 30 mg (F-1), 35 mg (F-2) and 40 mg (F-3) of carbopol 934P released 94.09%, 90.23% and 89.44% of omeprazole at the end of 3, 4 and 4 hours respectively (Table 5). Similar trends were observed in case of tablets formulated with the other two polymers, where F-4 formulation exhibited the maximum percentage of drug release among the three formulations containing HPMC K4M and in case of formulations containing xanthan gum, the amount of drug release of F-7 was found to be the highest. However, the formulation F-1 containing 30 mg of carbopol 934P showed the best results in terms of drug release among the 9 formulations.

Table 5. Cumulative percent of drug release from the mucoadhesive buccal tablets of omeprazole

Time (Hour)	F-1	F-2	F-3	F-4	F-5	F-6	F-7	F-8	F-9
0	0	0	0	0	0	0	0	0	0
1	49.46± 10.65	39.04± 0.389	38.59 ± 0.480	26.41±5.02	22.16±0.70	17.98±0.53	18.4±0.24	7.93±0.39	6.77±0.24
2	82.40± 1.868	52.04 ± 0.398	52.28 ± 0.498	41.70±4.99	31.81±1.78	24.29±0.29	20.77±0.10	18.54±0.64	15.13±0.46
3	94.09± 1.127	70.11 ± 2.004	71.03 ± 0.128	52.54±5.58	42.23±2.60	29.51±0.97	24.59±0.24	26.18±0.23	20.48±0.26
4		90.23 ± 0.320	89.44 ± 0.350	57.71±4.21	46.89±3.01	33.81±0.48	36.44±0.45	35.21±0.68	26.57±0.12
5				66.28±2.98	53.70±0.49	43.79±0.42	43.67±0.25	42.02±0.67	36.22±0.12
6				74.28±5.49	62.31±1.71	53.54±0.98	58.55±0.24	51.01±0.26	42.9±0.16
7				79.47±5.34	70.01±5.46	61.29±0.30	72.43±0.98	60.8±0.35	51.04±0.27
8				89.86±5.08	78.81±3.23	73.15±0.08	82.91±0.89	70.48±1.94	58.02±0.24

Figure 1: Release kinetics of formulated omeprazole mucoadhesive buccal tablets containing different amounts of a) carbopol 934P, b) HPMC K4M, c) xanthan gum

Table 6. Interpretation of the release kinetics of formulated mucoadhesive buccal tablets containing different polymers

Formulation Code	Zero order Plot		First Order plot		Higuchi Plot		Korsmeyer Plot
Formulation Code	K₀	R²	K₁	R²	K_H	R²	n	K	R²
F1	31.94	0.917	0.768	0.986	59.25	0.982	0.706	0.513	0.814
F2	20.50	0.968	0.410	0.907	44.14	0.967	0.536	0.407	0.511
F3	20.75	0.971	0.410	0.928	44.59	0.966	0.568	0.396	0.523
F4	9.512	0.943	0.238	0.956	31.38	0.993	0.422	0.346	0.578
F5	8.435	0.969	0.172	0.969	27.30	0.982	0.407	0.295	0.490
F6	7.970	0.974	0.013	0.932	24.85	0.916	0.414	0.238	0.398
F7	9.832	0.981	0.142	0.891	30.04	0.886	0.614	0.183	0.516
F8	8.586	0.997	0.120	0.962	26.58	0.925	0.695	0.144	0.529
F9	7.201	0.996	0.093	0.975	22.18	0.915	0.665	0.124	0.468

Determining the best formulation among F1-F9:

Among the various formulations evaluated, the F-1 formulation containing 30 grams of carbopol 934P demonstrated the maximum release rate of 94% over a period of 3 hours. Additionally, it exhibited the greatest mucoadhesive strength, with a satisfactory mucoadhesive force of 8.829 N. The release pattern of this formulation was identified as non-fickian and it showed the best correlation with the first order release model, achieving an R2 value of 0.985. Therefore, it can be interpreted that the F-1 formulation was optimized for better release and strong mucoadhesion.

Market product testing for comparative analysis:

In-vitro drug release of marketed products of omeprazole and interpretation of their release patterns:

For comparative analysis with the formulated tablets, the dissolution studies were conducted on a marketed tablet of a renowned pharmaceuticals of Bangladesh, which contained 20 mg of enteric-coated delayed-release omeprazole and referred to as T1. The dissolution studies showed that T1 achieved a release rate of 82.4% after 3 hours (Table 7). The release behavior of the marketed product showed the best fittings with the zero-order kinetics model, having R2 value of 0.9901 (Table 8).

Comparing the release rate of the optimized mucoadhesive buccal tablets (F-1) with the marketed products of omeprazole:

From the results of the dissolution studies as represented in table 9, it was observed that the marketed tablets of omeprazole denoted as T-1 released 82.4% of omeprazole within 3 hours, whereas the optimized mucoadhesive buccal tablets of omeprazole (F-1) containing 30 mg of carbopol 934P released 94.09% of omeprazole within the same period. Moreover, F-1 showed a significantly faster release rate, with over 80% of the drug being released in just 2 hours, potentially resulting in a faster onset of action and quicker attainment of peak plasma concentration. In contrast, T-1 released only 61.85% in 2 hours (Table 9).

Table 7. Cumulative percentage of drug release of marketed brands of omeprazole

Time (Hour)	T1
0	0
1	30.51±1.03
2	61.85±3.70
3	82.4±2.81

Table 10 represents the dissolution profile comparison of the optimized omeprazole mucoadhesive buccal tablet (F1) with the marketed tablet (T1), highlighting parameters such as the similarity factor (f2), difference factor (f1), dissolution efficiency (%DE) and the time required for different percentages of drug release (MDT, T25%, T50%, T80%, T90%).

Drug-polymer compatibility studies by FT-IR:

The FTIR spectra of pure omeprazole (A), carbopol 934P (B), HPMC K4M (C), xanthan gum (D), F-1 (E), F-4 (F) and F-7 (G) are shown in Figure 2. The FTIR analysis of the samples showed no significant shifts in the positions and intensities of the characteristic peaks of the drug and mucoadhesive polymers in the formulations of omeprazole buccal tablets that incorporated varying types of mucoadhesive polymers.

DISCUSSION:

The physicochemical parameters of omeprazole powder blends showed satisfactory results. Variations between the bulk and tapped densities of the powder blends were determined as statistically non-significant (P>0.05), suggesting good flowability of the powder blends with uniform particle size distribution and packing properties. Also, the angle of repose values ensured free flow properties of the blends. The FTIR study showed structural integrity of the drug and polymers within the formulations of buccal tablets and it indicated no evident chemical interactions between omeprazole and the selected polymers, signifying the excellent compatibility of the drug with the mucoadhesive polymers.²⁰

The numerical data for all the quality control parameters such as hardness, weight variation, friability, thickness, disintegration time were observed to be within the acceptable limit specified by the pharmacopoeia. Weight variation remained within the permissible limit set by the Indian Pharmacopeia (a deviation of 7.5%), as well as the thickness and friability data of the formulations were within the acceptable limit specified by the pharmacopoeia (less than 1%), which indicated the excellent compactness and ability of the formulated tablets to withstand the mechanical shock and abrasion.²¹ Disintegration time of less than a minute indicated suitability for improved release and the drug content for each formulation batch fell within the USP specified range of 90-110%.¹⁷

The experimental data of the current study also revealed that formulation F-1 containing carbopol 934P possessed the highest mucoadhesive strength showing consistency with the findings conducted on meclizine hydrochloride, ondansetron hydrochloride, ranitidine hydrochloride, resperidone, valsartan and azithromycin dihydrate.^22-27On the other hand, it was found to be minimal in case of formulations containing xanthan gum. This is because carbopol is a water swellable polymer which forms hydrogel in aqueous solution, also there exists strong chemical interaction between the functional groups of it.²⁸

The dissolution data revealed decreased release of drug with the increasing concentration of polymer. This phenomenon may be due to the formation of a denser matrix around the drug particles at higher polymer concentrations, which could create additional barriers that may impede the dissolution and release of the drug particles.^28-29The values of release exponent of formulations containing Carbopol 934P and xanthan gum indicated non-fickian release pattern (0.45<n<0.89), while the values of n (0.45≤n) for formulations containing varying amounts of HPMC K4M followed fickian diffusion release pattern.³⁰

From the comparative analysis with the market product (T-1), it can be interpreted that our optimized mucoadhesive buccal tablet (F-1) outperformed the marketed omeprazole tablets in terms of drug release profile. The data from Tables 9 and 10 highlighted significant differences in the drug release profiles and dissolution characteristics of the optimized mucoadhesive buccal tablets (F-1) from the marketed omeprazole tablet (T-1). F-1, formulated with 30 mg of carbopol 934P, demonstrated a faster and more efficient drug release compared to T-1. Notably, F-1 achieved over 80% drug release in just 2 hours, compared to 61.85% for T-1, indicating a significantly faster release rate. This suggested that F-1 could lead to a quicker onset of action and faster attainment of peak plasma concentration, making it more suitable for applications requiring rapid therapeutic effects. Further analysis from Table 10 revealed that F-1 had a higher dissolution efficiency (%DE) of 61.63%, compared to 45.68% for T-1, and a shorter mean dissolution time (MDT) of 1.035 hours, versus 1.337 hours for T-1. Additionally, the f1 value of 32.19 and f2 value of 39.21 indicated moderate differences in the dissolution profiles of the two formulations. Furthermore, F-1 exhibited faster fractional dissolution times (e.g., T50% = 1.356 hours for F-1 vs. 1.691 hours for T-1), further confirming its rapid release profile. The release kinetics also differed, with F-1 following first-order kinetics (concentration-dependent release) and T-1 following zero-order kinetics (constant release rate). These findings highlighted the potentiality of the optimized F-1 formulation for providing a faster therapeutic effect compared to the marketed product. Hence, this F-1 formulation can be a promising alternative, potentially offering better therapeutic benefits through its mucoadhesive properties by circumventing the first-pass metabolism, while maintaining improved release profile compared to the marketed tablets.

CONCLUSION:

The current study was carried out to design and evaluate a mucoadhesive buccal tablet of omeprazole with improved release properties to achieve improved patient’s compliance for the treatment of peptic ulcer. Among the 9 different batches formulated with varying types and amounts of mucoadhesive polymers, formulation F-1 demonstrated improved drug release, better mucoadhesive strengths and adhesion force. The physicochemical characteristics of this formulation also complied with the specified standards set by the pharmacopoeia. Moreover, this optimized mucoadhesive tablet was found to outperform the marketed tablets of omeprazole in terms of release profiles and successive fractional dissolution times. Therefore, it can be an effective alternative to prevent the first-pass effect and improve the bioavailability of omeprazole through the mucosal membrane. Further experiments involving suitable animal models are necessary to establish their efficacy as buccal tablet.

CONFLICT OF INTEREST:

No conflicts of interest are declared by the authors regarding this study.

AUTHOR CONTRIBUTIONS :

Sumaiya Khan and Nasiba Binte Bahar contributed equally to this work and should be regarded as joint first authors.

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Received on 24.02.2025 Revised on 16.06.2025

Accepted on 30.09.2025 Published on 13.01.2026

Available online from January 17, 2026

Research J. Pharmacy and Technology. 2026;19(1):269-277.

DOI: 10.52711/0974-360X.2026.00038

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

Batch Code	Zero Order Model	First Order Model	Higuchi Model	Korsmeyer-Peppas Model		Best Fitted Model	Drug Release Mechanism
Batch Code	R²	R²	R²	R²	n	Best Fitted Model	Drug Release Mechanism
T1	0.9901	0.9733	0.9342	0.9739	0.883	Zero Order	Non-fickian

Time (Hour)	% Drug Release of F-1	% Drug Release of T-1
0	0	0
1	49.46±10.65	30.51±1.03
2	82.40±1.868	61.85±3.70
3	94.09±1.127	82.4±2.81

Formulation code	Difference factor (f1)	Similarity factor (f2)	Dissolution efficiency (%DE)	MDT	T_25%	T_50%	T_80%	T_90%	Release kinetics
F1	32.19	39.21	61.63	1.035	0.678	1.356	2.170	2.441	First order
T1 (Ref)	-	-	45.68	1.337	0.846	1.691	2.706	3.044	Zero order