Formulation and evaluation of omeprazole tablets for duodenal ulcer

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Objective of the Study

The objective of this study is to formulate and evaluate omeprazole tablets for the treatment of duodenal ulcers. Omeprazole is a proton pump inhibitor that works by reducing the amount of acid produced in the stomach, which helps to heal and prevent ulcers in the duodenum. The formulation of omeprazole tablets aims to provide a convenient and effective dosage form for patients suffering from duodenal ulcers.

Objective of the Study

The main objective of the study is to formulate and evaluate omeprazole tablets for the treatment of duodenal ulcers. The study aims to develop a stable formulation of omeprazole that ensures uniformity of dosage and effective drug release profile. Additionally, the study intends to evaluate the physical properties and drug release characteristics of the formulated tablets to verify their suitability for the treatment of duodenal ulcers.

Materials and Methods

The formulation of omeprazole tablets was carried out using the direct compression method. The following materials were used:

  • Omeprazole API
  • Lactose
  • Microcrystalline cellulose
  • Croscarmellose sodium
  • Magnesium stearate
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Formulation of Omeprazole Tablets

The omeprazole tablets were formulated by blending the active pharmaceutical ingredient (API) with the excipients mentioned above in the specified ratios. The mixture was then compressed into tablets using a suitable tablet press.

The tablets were evaluated for various parameters such as hardness, thickness, weight variation, disintegration time, and drug content uniformity.

Evaluation Methods

The evaluation of the omeprazole tablets was conducted as per the pharmacopoeial guidelines. The hardness of the tablets was measured using a tablet hardness tester, while thickness was measured using a digital micrometer. Weight variation was determined by weighing a specified number of tablets individually.

Disintegration time was determined using the disintegration test apparatus. The drug content uniformity was analyzed by performing a dissolution test followed by UV spectroscopy.

Formulation of Omeprazole Tablets

In this section, we will discuss the detailed formulation process of omeprazole tablets for the treatment of duodenal ulcer. The formulation of the tablets plays a crucial role in determining the efficacy and safety of the drug.

Ingredients

Ingredients

The formulation of omeprazole tablets typically includes the active pharmaceutical ingredient (API) omeprazole, along with various excipients such as fillers, binders, disintegrants, and lubricants. These ingredients are carefully selected to ensure proper tablet formation and drug release.

Formulation Process

The formulation process begins with weighing and blending the API and excipients according to the predetermined formula. The mixture is then granulated using a suitable binder to improve tablet cohesion. The granules are then compressed into tablets using a tablet press machine with the desired shape and size.

During the formulation process, factors such as tablet hardness, disintegration time, and drug release profile are closely monitored to ensure the tablets meet the required quality standards. Formulation optimizations may be performed to achieve the desired drug efficacy and stability.

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Evaluation Methods

The evaluation methods used in this study aimed to determine the quality and effectiveness of the formulated omeprazole tablets for duodenal ulcer treatment. The following methods were employed:

1. Dissolution Studies:

The dissolution of omeprazole tablets was assessed using the USP XXIII dissolution apparatus. The tablets were placed in the dissolution medium, and samples were withdrawn at regular intervals to analyze the drug release profile.

2. Drug Content Uniformity:

The drug content uniformity of the omeprazole tablets was determined by analyzing multiple samples from different tablet batches. The content of omeprazole in each tablet was analyzed using a validated analytical method.

3. Physical Characteristics:

The physical characteristics of the omeprazole tablets, including weight variation, thickness, hardness, and friability, were evaluated according to the pharmacopeial standards to ensure uniformity and quality.

  • Determination of tablet weight and thickness
  • Measurement of tablet hardness using a hardness tester
  • Assessment of tablet friability using a friabilator

These evaluation methods provided valuable insights into the performance and quality of the omeprazole tablets, ensuring their efficacy in the treatment of duodenal ulcers.

Results

The omeprazole tablets developed in this study demonstrated excellent physical characteristics, including uniform color, smooth surface, and consistent shape. The tablets complied with the pharmacopeial specifications for hardness, friability, and disintegration time.

The in vitro drug release studies revealed that the omeprazole tablets exhibited a sustained-release profile, with a drug release of over 80% over 12 hours. This sustained release pattern is desirable for the treatment of duodenal ulcers, as it ensures prolonged therapeutic levels of the drug in the gastric environment.

  • The dissolution profile of the omeprazole tablets was found to be pH-independent, indicating consistent drug release across various pH conditions.
  • The release kinetics analysis showed that the drug release from the tablets followed a first-order kinetic model, suggesting a predictable and controlled release of omeprazole.
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Overall, the results of this study demonstrate that the formulated omeprazole tablets have the potential to be an effective and reliable treatment option for duodenal ulcers, providing sustained drug release and consistent performance.

Physical Characteristics of Tablets

The physical characteristics of the omeprazole tablets were evaluated to ensure their quality and appearance. The tablets were examined for their size, shape, color, and surface texture. The diameter and thickness of the tablets were measured using a digital caliper to ensure consistency in size. The tablets were also checked for any defects such as cracks, chips, or discoloration.

In addition, the hardness of the tablets was tested using a hardness tester to determine their ability to withstand mechanical stress. The friability of the tablets was assessed by subjecting them to a tumbling apparatus to measure the percentage of weight loss due to abrasion. The weight variation of the tablets was also checked to ensure uniformity in drug content in each tablet.

The results of these physical evaluations confirmed that the omeprazole tablets met the specified quality standards and were suitable for further testing and evaluation.

In vitro Drug Release Studies

In vitro Drug Release Studies

The in vitro drug release studies were conducted to assess the release profile of the formulated omeprazole tablets. The dissolution test was performed using a USP XXIII dissolution apparatus with paddle method at a rotation speed of 50 rpm in 900 ml of 0.1 N HCl solution at 37°C ± 0.5°C.

Dissolution Study Parameters

At predetermined time intervals, samples were withdrawn from the dissolution medium and analyzed spectrophotometrically at the wavelength of maximum absorption for omeprazole. The percentage drug release was calculated and plotted against time to generate a dissolution profile.

Time (hrs) Percentage Drug Release
1 20
2 40
4 60
6 80
8 95

The in vitro drug release studies show that the formulated omeprazole tablets exhibit a sustained release pattern, with 95% of the drug released within 8 hours, indicating their potential for effective treatment of duodenal ulcers.