Amoxicillin + Clavulanate Potassium Tablet

Step 2: Granulation

• The granulation process starts with mixing Amoxicillin and Clavulanate Potassium with suitable excipients such as microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The mixture is then granulated using purified water or other appropriate solvents to form uniform granules.

Step 3: Drying

• The wet granules are dried in a fluid bed or tray dryer until they reach the desired moisture content. Proper drying is crucial to prevent tablet sticking and ensure uniformity in the final product.

Step 4: Blending

• The dried granules are then blended thoroughly to achieve homogeneity. This ensures uniform distribution of the active ingredients and excipients throughout the blend, resulting in consistent tablet potency.

Step 5: Compression

• The blended granules are compressed into tablets using high-quality tablet compression machines. The compression process applies controlled pressure to form tablets of uniform size, shape, and hardness.

Step 6: Coating (Optional)

• The tablets may undergo a coating process to improve stability, taste, or appearance. Coating materials such as hydroxypropyl methylcellulose, polyethylene glycol, and talc are applied using coating pans or fluidized bed coaters.

Step 7: Quality Control

• Rigid quality control checks are conducted at various stages throughout the manufacturing process to ensure compliance with WHO GMP standards. These checks include in-process testing of granules and tablets for attributes such as assay, dissolution, hardness, friability, and disintegration.

Step 8: Packaging

• Once the tablets pass all quality control tests, they are packaged in blister packs or bottles using automated packaging machines. Packaging materials are chosen carefully to maintain the stability and integrity of the tablets during storage and transportation.

Step 9: Labeling and Storage

• In compliance with regulatory requirements, the packaged tablets are labeled with all necessary information, including dosage instructions, expiry date, and batch number. Finished products are stored in controlled environments to maintain their quality until distribution.

Step 10: Distribution

• The finished Amoxicillin + Clavulanate Potassium Tablets are distributed to pharmacies, hospitals, and healthcare facilities following strict distribution protocols. Cold chain logistics may be employed to ensure product stability during transportation, especially in hot and humid climates.

Conclusion