Pharmacopeial Quality Assessment of Five Commercially Available Enteric-Coated Esomeprazole Magnesium Tablets in Bangladesh

Introduction

Esomeprazole, the S-isomer of omeprazole, is a proton pump inhibitor (PPI) widely prescribed for the treatment of gastroesophageal reflux disease (GERD) and other acid-related gastrointestinal disorders due to its potent inhibition of gastric acid secretion.¹ By providing prolonged acid suppression, esomeprazole enhances mucosal healing and symptom relief, making it superior in efficacy to several other PPIs.^2,3 Its favorable pharmacokinetic profile, including higher bioavailability and an extended half-life, allows for greater acid control and therapeutic consistency.^4,5

Global usage of PPIs, particularly among elderly patients with comorbidities, has steadily increased.^6,7 This widespread consumption emphasizes the importance of quality in generic formulations, as inconsistent drug performance may compromise therapeutic outcomes. Furthermore, long-term PPI therapy has been associated with potential adverse effects such as nutrient mal-absorption, renal impairment, and drug interactions.^8,9 Consequently, regulatory authorities stress the necessity of stringent quality assessments to guarantee efficacy and safety.¹⁰

Therapeutic Indications

Esomeprazole is primarily indicated for GERD, where it alleviates heartburn, heals erosive esophagitis, and maintains remission.^11,12 It is also effective in treating peptic ulcer disease (PUD), particularly when combined with antibiotics for Helicobacter pylori eradication, thereby preventing recurrence.^13,14 In Zollinger-Ellison syndrome, a rare condition characterized by excessive gastric acid secretion, esomeprazole provides symptom control through potent acid suppression.¹⁵

Additionally, esomeprazole plays an essential role in preventing NSAID-induced gastric ulcers, particularly in high-risk patients requiring long-term NSAID therapy.¹⁶ It is also used for the management of dyspepsia and functional heartburn, providing symptomatic relief,¹⁷ and in critical care settings to prevent stress-related gastric ulceration and gastrointestinal bleeding.¹⁸

Mechanism of Action

Esomeprazole functions by selectively and irreversibly inhibiting the gastric H⁺/K⁺-ATPase enzyme system located on the luminal surface of parietal cells. Administered as a prodrug, it is absorbed in the intestine and activated within the acidic canaliculi of parietal cells, where it converts to its active sulfenamide form.¹⁹ The active compound covalently binds to cysteine residues of the proton pump, irreversibly blocking acid secretion.²⁰ This suppression leads to a significant reduction in gastric acidity, thereby increasing gastric pH and promoting mucosal healing.²¹

Pharmacokinetically, esomeprazole is rapidly absorbed with peak plasma concentrations within 1-2 hours. It undergoes hepatic metabolism primarily via CYP2C19, with a plasma half-life of 1-2 hours. Despite the short half-life, its pharmacodynamic effect is prolonged due to irreversible inhibition of the proton pump, resulting in sustained acid suppression and symptom relief.^22-24

Importance of Quality Control

Ensuring the quality of esomeprazole tablets is critical for maintaining therapeutic efficacy, safety, and patient confidence. Quality evaluation involves testing physical and chemical parameters, including dissolution rate, potency, assay, hardness, friability, and impurity levels, all of which affect clinical performance. Substandard quality can lead to treatment failure, poor symptom management, or adverse effects. Therefore, rigorous quality control and pharmacopeial compliance are necessary to uphold therapeutic reliability.^25-27

Materials and Methods

Materials

Esomeprazole Tablets

Esomeprazole magnesium trihydrate tablets (20 mg) were obtained from various Bangladeshi pharmaceutical brands, including Brand E01, Brand E02, Brand E03, Brand E04 and Brand E05. The tablets were stored under controlled temperature and humidity conditions prior to analysis.

Reagents: All reagents used were of analytical grade and included:

• Hydrochloric acid (HCl) and sodium hydroxide (NaOH) for pH adjustments.
• Phosphate Buffer for dilutions and preparations.
• Standard esomeprazole for calibration curves, obtained from pharmaceutical company
• Phosphate buffer

Apparatus:

• A UV-Visible spectrophotometer for absorbance measurements.
• A digital balance for weight measurements.
• A pH meter for pH assessments.
• A disintegration tester and a dissolution tester for relevant tests.

Methods

Identification of Esomeprazole

The identification of esomeprazole in the tablet formulations was performed using a UV-Visible spectrophotometric method. A standard solution of esomeprazole was prepared, and its absorbance was measured at the λmax of 302 nm in a suitable solvent (phosphate buffer). The samples were compared against the standard to confirm the presence of esomeprazole in the tablets.

Weight Variation

Weight variation was assessed by randomly selecting 20 tablets from each brand. Each tablet was weighed individually using a digital balance. The average weight was calculated, and the percentage deviation was determined according to the following formula:

Percentage Deviation=(Individual Weight−Average Weight)/Average Weight×100

This method followed the guidelines set by the United States Pharmacopeia (USP) (28).

Friability test

Friability of five marketed brands of enteric-coated esomeprazole tablets was assessed using a Roche friabilator (Electro Lab, India). For each brand, ten tablets were individually weighed and subjected to rotation at 25 rpm for 4 minutes (100 rotations). Following removal, tablets were de-dusted and reweighed, and friability (%) was calculated as [(initial weight – final weight)/initial weight] × 100.

Hardness

The thickness of the tablets was measured using a Monsanto hardness tester for tablet and result was recorded.^28-29

Disintegration Test

Disintegration tests were conducted using a disintegration tester according to the USP guidelines. Six tablets from each brand were tested, and the time taken for each tablet to disintegrate completely in phosphate buffer (pH 6.8) and 0.1 N HCl medium.³⁰

 Dissolution Test

Dissolution studies were performed using a paddle method dissolution apparatus. Each tablet was placed in 0.1 N HCl  and later 900 mL of phosphate buffer at 37°C with a stirring speed of 50 rpm. Samples were withdrawn at specified time intervals (15, 30, 45, and 60 minutes) and analyzed spectrophotometrically at 302 nm. The percentage of drug released was calculated.^31,32

Potency Calculation

Using the UV-Vis spectrophotometric technique, the efficacy of five commercial brands of enteric-coated esomeprazole tablets was assessed. Ten (10) tablets from each sample brand were weighed individually, and the average weight was then calculated. Using a mortar and pestle, each sample was crushed, and the necessary quantity was weighed. A 50 ml volumetric flask was filled with prepared phosphate buffer (pH 6.8). The various samples were placed in 50 ml volumetric flasks, each of which was properly labeled. After that, a small quantity of the produced phosphate buffer was added to each flask until it reached the 50 ml. To obtain a clear solution, the solutions were filtered after being sonicated for 15 minutes using a sonicator. Using a 5 ml pipette, 2.5 ml of the filtrate was taken out of each volumetric flask and transferred into a fresh 50 ml conical flask, filling it to the 50 ml mark. A small quantity was extracted from each flask and placed in a cuvette. The regular esomeprazole was then subjected to the same process. The UV spectrophotometer was used to measure the absorbance at a wavelength of 302 nm. Each sample’s amount and percentage contents were then calculated and compared to the standard. The % of the assay calculated by following formula,

% of the assay= (Absorbance of test/Absorbance of Standard) x100

 Results

Table 1: Weight variation test of five brands of Esomeprazole tablet

Table 2: Friability Test of five brands of Esomeprazole tablet

In the quality control (QC) assessment of esomeprazole 20 mg tablets, friability testing is a critical parameter for evaluating the mechanical strength of tablets during handling, packaging, and transport.

Table 3: Hardness of five brands of Esomeprazole tablet

In evaluating the hardness of 20 mg esomeprazole tablets for quality control according to USP standards, the data gathered indicates varied mean hardness values across samples (E01 to E05) tested across ten tablets (T1 to T10).

Six tablets from each brand were tested. No tablet showed disintegration during 2 h of exposure to 0.1 N HCl.

Table 4: Disintegration time of various brands of Esomeprazole tablet in phosphate buffer

The disintegration time of six esomeprazole 20 mg tablets from each brands, as shown by the data, is a crucial parameter in ensuring the quality and efficacy of the product.

Table 5: Potency table for Esomeprazole tablets (n=3)

Dissolution rate of various brands of Esomeprazole tablet

Table 6: Percent of drug release after two hours in 0.1 N HCl

Table 7: Dissolution in Phosphate buffer (pH 6.8) (n=6)

Figure 1: Dissolution Profile of Esomeprazole Tablets in phosphate buffer Click here to View Figure

Discussion

Weight variation test

The results for the weight variation analysis of 20 mg esomeprazole tablets (brands T1-T20) were evaluated according to the United States Pharmacopeia (USP) standards, which require that tablets within a batch should not deviate from the mean weight by more than a specific percentage. For tablets with an average weight between 130 mg and 324 mg, the USP specifies that the weight variation must not exceed ±7.5% of the mean weight in order to meet quality control (QC) standards.^33,34

In this study, the mean weights across each brand generally ranged from 0.251 g to 0.270 g, while standard deviation (SD) values were relatively low, indicating minimal fluctuation within each brand’s batch. The lowest SD observed was 0.00398 g, as seen in E02, suggesting good uniformity in weight distribution. Meanwhile, E4 exhibited the highest SD (0.0054 g), though still conforming to the acceptable weight variation limit.³⁵

Friability Test

According to the United States Pharmacopeia (USP <1216>), the acceptable limit for tablet friability is not more than 1.0% of weight loss during the test, as tablets must be robust enough to resist chipping or breaking under stress.^35-36 This study assesses the friability results of five different brands of 20 mg esomeprazole tablets, coded E01 to E05, to determine compliance with USP standards.

The results indicate that all brands fall within the acceptable friability range of less than 1.0%, with values ranging from 0.225% to 0.698%. Specifically, brand E03 had the highest friability result at 0.698% ± 0.004, while brand E02 exhibited the lowest at 0.225% ± 0.003. These results confirm that each tablet brand meets the USP requirements, suggesting adequate structural integrity for commercial distribution.³⁷ The variance among brands could stem from differences in excipient formulation or manufacturing processes, which can impact friability levels.

Hardness Test

The hardness mean values range from 5.443 kgf (E02) to 6.509 kgf (E03), with standard deviations between 0.323 and 0.1895, reflecting the consistency of each sample. According to USP guidelines, the recommended hardness for immediate-release tablets generally lies within 4-8 kgf, and the variability within each tablet batch should be controlled to ensure product stability, resistance to mechanical stress, and uniform dissolution profiles.³⁸ In this study, all mean hardness values fall within the USP(<1217>) acceptable range, indicating compliance with quality control standards. Sample E03 demonstrated the highest mean hardness (6.509 kgf), while E05 was the lowest (5.443 kgf). Although within limits, E02 exhibited the highest variability, suggesting a need for monitoring to avoid batch-to-batch variability that could affect tablet performance.³⁹ This data supports the quality and consistency of the esomeprazole tablets in terms of mechanical integrity, ensuring suitability for consumer use and adherence to regulatory standards.

Disintegration Time Analysis

Enteric‑coated esomeprazole tablets resist disintegration in acidic medium and disintegrate rapidly upon reaching intestinal pH, typically within approximately 20-30 min in phosphate buffer (pH 6.8), supporting appropriate site‑specific drug release The disintegration time of the tablets across various tests (T1 to T6) ranges from 24.27 to 27.32 minutes, with the mean times being 27.32 minutes for E01, 26.87 minutes for E02, 24.27 minutes for E03, 25.37 minutes for E04, and 26.02 minutes for E05. The standard deviations (SD) indicate that E02 and E03 have relatively higher variations compared to E01, E04, and E05, suggesting that the disintegration behavior in these formulations is less consistent.^40-42

Potency Assessment

Potency is an essential indicator of a tablet’s therapeutic effectiveness. The potency values ranged from 96.33% to 99.20%. All brands met the regulatory standards, indicating that they contain sufficient active ingredient levels to exert the intended pharmacological effects.⁴³ This finding supports the reliability of these formulations, though the variation in potency suggests that manufacturing processes may differ, warranting quality control measures to ensure consistency

Dissolution Rate Evaluation

The dissolution rate is critical for predicting the absorption of the active ingredient. The drug release percentages after two hours in 0.1N HCl ranged from 2.54% (E01) to 4.45% (E04), with E04 demonstrating the highest release rate. The dissolution profiles indicate that all brands have low drug release in acidic conditions which complies with the enteric coated drug characteristics.

The dissolution profiles of five brands of enteric-coated esomeprazole tablets were evaluated in phosphate buffer (pH 6.8) to assess drug release under simulated intestinal conditions. All formulations exhibited a time-dependent increase in drug release, ranging from 38.45%-44.10% at 15 minutes and 72.36%-78.90% at 30 minutes. More than 95% drug release was achieved by all brands at 45 minutes, while cumulative release reached 100.9%-102.4% at 60 minutes, indicating nearly complete drug release. Minor variations in dissolution rates were observed, with sample E03 demonstrating relatively faster release.

According to USP(<711>) specifications for delayed-release esomeprazole tablets, the drug release in the acidic stage should not exceed 10%, and at least 80% of the drug should be released in the buffer stage within the specified time. The evaluated samples showed minimal drug release in acidic medium, confirming effective enteric coating integrity. In phosphate buffer (pH 6.8), all formulations released more than 80% of the drug within 45 minutes and achieved nearly complete drug release at 60 minutes. Therefore, all tested brands complied with USP dissolution requirements for delayed-release esomeprazole tablets, indicating satisfactory formulation quality and therapeutic equivalence.

Conclusion

This study evaluated the quality parameters of esomeprazole tablets from different Bangladeshi pharmaceutical brands, focusing on friability, hardness, disintegration time, potency, and dissolution rates. The results indicate that the tablet brands exhibit variability in their physicochemical properties, which can significantly affect their therapeutic efficacy.

The weight variation test results show that the mean tablet weights across all brands ranged between 0.256-0.262 g, which is very close to the expected uniformity. The standard deviation values (0.0039-0.0054) indicate only slight fluctuations, suggesting that the tablets are within acceptable pharmacopeial limits.

The friability test results ranged from 0.225% to 0.698%, indicating that all brands met the acceptable criteria for mechanical stability. The mean hardness of the tested tablets ranged from 5.443 ± 0.323 kg/cm² (E05) to 6.509 ± 0.190 kg/cm² (E03). The relatively low SD values (0.190–0.323 kg/cm²) indicated good uniformity in tablet hardness among the tested units.

Enteric-coated esomeprazole tablets resist disintegration in acidic medium and rapidly disintegrate in phosphate buffer (pH 6.8), typically within 20-30 min, ensuring site-specific drug release. Across five brands, the mean disintegration times ranged from 24.27 min (E03) to 27.32 min (E01), with higher variability observed in E02 and E03, indicating slightly less consistent disintegration behavior in these formulations.

The dissolution tests revealed that Brand E04 had the highest drug release (4.45%) in 0.1 N HCl after two hours, which complies with the pharmacopeial requirement where indicated the value is of less than 10%. In contrast, dissolution data in phosphate buffer (pH 6.8) showed 100.9% to 102.4% indicating rapid and complete drug release within 60 minutes.

In terms of potency, all brands met or exceeded the minimum potency requirement of 90%, with Brand E03 exhibiting the highest potency at 99.2%. This suggests that it is a reliable option in terms of active ingredient concentration.

Acknowledgment

Authors offer sincere gratitude to Department of Pharmacy of Southeast University, Bangladesh for all kind of assistance.

Funding Sources

The author(s) received no financial support for the research, authorship, and/or publication of this article.

Conflict of Interest

The authors do not have any conflict of interest.

Data Availability Statement

This statement does not apply to this article.

Ethics Statement

This research did not involve human participants, animal subjects, or any material that requires ethical approval.

Informed Consent Statement

This study did not involve human participants, and therefore, informed consent was not required.

Clinical Trial Registration

This research does not involve any clinical trials.

Permission to reproduce material from other sources

Not Applicable 

Author Contributions

• Sabiha Ferdowsy Koly: Created concept and Supervised study.
• Israt Jahan Bulbul: Created concept and Supervised study.
• Owaliullah Khan Ovi: Conducted the lab experiment.
• Rejuan Kaif Rohan: Conducted the lab experiment.
• Nusratun Nahar: Drafted the manuscript.
• Sherejad Sanam: Reviewed the manuscript.

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