Formulation of pantoprazole enteric coated tablets

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Overview of pantoprazole

Pantoprazole is a proton pump inhibitor (PPI) used to treat conditions caused by excess stomach acid, such as gastroesophageal reflux disease (GERD) and peptic ulcers. It works by reducing the amount of acid produced in the stomach, leading to relief of symptoms and promoting healing of the affected areas.

Pantoprazole is a benzimidazole derivative and acts by selectively inhibiting the H+/K+-ATPase enzyme system at the secretory surface of the gastric parietal cell. This inhibition leads to a reduction in both basal and stimulated gastric acid secretion.

The drug is commonly prescribed in the treatment of acid-related disorders due to its effectiveness and good safety profile. Pantoprazole is available in various formulations, with enteric-coated tablets being one of the preferred options for delayed-release and targeted delivery of the medication to the intestine.

Key Features of Pantoprazole
Proton pump inhibitor
Reduces stomach acid production
Used for GERD and peptic ulcers
Well-tolerated and effective

Formulation

The formulation of pantoprazole enteric coated tablets involves precise combination of active and inactive ingredients to ensure the effectiveness and stability of the medication. Pantoprazole, the active ingredient, is a proton pump inhibitor that works by reducing the amount of acid produced in the stomach.

Key ingredients:

  • Pantoprazole: The main active ingredient that inhibits the proton pump and reduces gastric acid secretion.
  • Lactose monohydrate: An inactive ingredient used as a filler and to enhance tablet disintegration.
  • Crospovidone: A superdisintegrant that aids in the quick breakdown of the tablet in the stomach.
  • Magnesium stearate: An anti-adherent to prevent sticking during the compression process.
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By carefully selecting and combining these ingredients in the right proportions, the formulation of pantoprazole enteric coated tablets ensures the desired therapeutic effect and quality of the medication.

Ingredients used

Pantoprazole enteric coated tablets are comprised of several key ingredients that play a crucial role in their formulation and efficacy. The following table outlines the main ingredients used in the production of pantoprazole tablets:

Ingredient Function
Pantoprazole sodium sesquihydrate Active ingredient that inhibits gastric acid secretion by specifically blocking the proton pump in the parietal cells of the stomach
Microcrystalline cellulose Acts as a binder to help the tablet maintain its shape and integrity
Methacrylic acid copolymer Used in the enteric coating to protect the drug from the acidic environment of the stomach and ensure it is released in the intestines
Triethyl citrate Plasticizer that improves the flexibility of the enteric coating
Colloidal silicon dioxide Anti-caking agent that prevents the active ingredients from clumping together
Hydroxypropyl cellulose Disintegrant that helps the tablet break down and release its contents in the gastrointestinal tract

Each of these ingredients contributes to the overall effectiveness and stability of pantoprazole enteric coated tablets, ensuring reliable and consistent treatment for acid-related disorders.

Enteric Coating Process

Enteric Coating Process

Enteric coating is a process where a special coating is applied to oral medications to prevent them from dissolving in the stomach. Instead, the tablets pass through the stomach intact and dissolve in the small intestine.

Process Overview:

The enteric coating process involves the application of a polymer coating to the tablet core using a coating machine. The coating protects the tablet from the acidic environment of the stomach and ensures that the medication is released in the intestines where it can be absorbed into the bloodstream.

  • Step 1: Tablet cores are prepared with the active ingredient and excipients.
  • Step 2: The tablet cores are loaded into the coating machine.
  • Step 3: The enteric coating solution is sprayed onto the tablet cores as they tumble in the coating drum.
  • Step 4: The coated tablets are dried to remove excess moisture.
  • Step 5: Quality control checks are performed to ensure uniform coating thickness and integrity.
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Benefits of Enteric Coating:

Enteric coating offers several advantages, such as:

  1. Protection of the medication from stomach acid degradation.
  2. Prevention of gastrointestinal irritation.
  3. Targeted release of the drug in the small intestine for optimal absorption.
  4. Improved bioavailability of the medication.

Benefits of enteric coating

Enteric coating on pantoprazole tablets offers several advantages:

  • Protection of the active ingredient: Enteric coating protects pantoprazole from the acidic environment of the stomach, ensuring that the drug reaches the small intestine intact.
  • Reduced risk of gastric irritation: By bypassing the stomach, enteric-coated tablets minimize the potential for irritation and side effects in the stomach lining.
  • Improved bioavailability: Enteric coating allows the drug to be absorbed effectively in the intestine, leading to better bioavailability and therapeutic outcomes.

Tablet manufacturing

Tablet manufacturing

The tablet manufacturing process involves several key steps to ensure the high quality of pantoprazole enteric coated tablets.

Mixing and granulation:

The active pharmaceutical ingredient, pantoprazole, is mixed with excipients to form a homogenous mixture. This mixture is then granulated to obtain uniform granules.

Compression:

The granules are compressed into tablets using a tablet press machine. The tablet press exerts pressure to compact the granules into a solid tablet form.

Tablet coating:

After compression, the tablets go through an enteric coating process. The enteric coating provides protection to the tablet from stomach acid and ensures that the active ingredient is released in the intestines.

Quality control:

Each batch of tablets undergoes rigorous quality control tests to ensure that they meet the required specifications for dissolution, disintegration, and content uniformity.

Compression process

The compression process is a critical step in the manufacturing of pantoprazole enteric coated tablets. During this stage, the granulated mixture is compressed into tablet form using a high-pressure tablet press. The compression process ensures that the ingredients are compacted together to form a solid tablet that is uniform in size and weight.

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Benefits of compression:

  • Uniformity: Compression helps in achieving uniformity in the size, weight, and dosage of the tablets, ensuring consistency in dosage delivery to patients.
  • Tablet hardness: The compression process increases the hardness of the tablets, preventing them from breaking or crumbling during handling and transportation.
  • Dissolution rate: Proper compression ensures that the tablets have the desired dissolution rate, which is crucial for the effective release of pantoprazole in the stomach.

Overall, the compression process plays a vital role in creating high-quality pantoprazole tablets that meet the required standards for pharmaceutical use.

Quality control

In order to ensure the highest standards of quality for our pantoprazole enteric coated tablets, rigorous quality control measures are implemented throughout the manufacturing process.

Raw materials testing: Before production begins, all raw materials, including active ingredients and excipients, undergo strict testing to verify their quality and purity.

Process monitoring: Throughout the formulation and manufacturing process, various parameters such as mixing time, granulation particle size, and compression force are closely monitored to maintain consistency and quality.

Finished product testing: Once the tablets are produced, they undergo extensive testing to ensure they meet the predetermined specifications for characteristics such as weight uniformity, hardness, and disintegration time.

Stability testing: Samples of the finished product are stored under different conditions to assess their stability over time and ensure the product maintains its efficacy throughout its shelf life.

Compliance: Our quality control procedures adhere to regulatory requirements and guidelines to guarantee the safety and efficacy of our pantoprazole tablets.