PEMBUATAN TABLET MENURUT CPOB 2018 #farmasi #cpob #tablet

Introduction

This tutorial provides a step-by-step guide on how to create tablets according to the 2018 Good Manufacturing Practice (CPOB) standards. Understanding this process is essential for pharmacy students and professionals involved in pharmaceutical manufacturing, ensuring quality and compliance with regulations.

Step 1: Preparation of Raw Materials

• Select Active Ingredients: Choose the appropriate active pharmaceutical ingredients (APIs) based on the formulation requirements.
• Excipient Selection: Identify suitable excipients that will aid in the tablet manufacturing process, such as binders, fillers, and disintegrants.
• Measurement: Accurately measure the required quantities of each ingredient using calibrated equipment to ensure consistency and quality.

Step 2: Mixing Process

• Mixing Techniques: Use suitable mixing techniques (e.g., geometric dilution, wet granulation) to achieve a uniform blend of the APIs and excipients.
• Equipment Use: Employ appropriate mixing equipment, such as a V-blender or a planetary mixer, to ensure even distribution of ingredients.
• Quality Control: Conduct in-process controls to check the homogeneity of the blend. This may include sampling and testing for particle size and moisture content.

Step 3: Granulation

• Granulation Method: Choose between dry granulation or wet granulation depending on the properties of the materials used.
• Procedure:
  • For wet granulation:
    • Prepare a granulating solution (e.g., water, ethanol).
    • Add the solution to the powdered blend while mixing to form granules.
  • For dry granulation:
    • Compact the powder blend using a tablet press to form slugs, then break them into granules.
• Drying: If wet granulation is used, dry the granules to remove excess moisture, which can be done using a tray dryer or fluid bed dryer.

Step 4: Tableting

• Compression: Use a tablet press to compress the granules into tablets. Adjust the pressure settings according to the formulation to achieve the desired tablet hardness.
• Tooling: Ensure that the tooling (punches and dies) is clean and suitable for the tablet size and shape.
• Monitoring: Monitor the process to maintain consistent tablet weight and thickness. Record the parameters for quality assurance.

Step 5: Coating (if applicable)

• Coating Selection: Decide whether to apply a coating (e.g., sugar coating, film coating) based on the tablet’s intended use.
• Application: Use coating equipment such as a pan coater or a fluidized bed coater to apply the coating uniformly.
• Drying: Ensure proper drying after coating to prevent sticking and maintain tablet integrity.

Step 6: Quality Control and Packaging

• Quality Testing: Perform quality control tests on the final tablets, including:
  • Hardness test
  • Dissolution test
  • Content uniformity test
• Packaging: Package the tablets in suitable containers that protect them from moisture and light. Label them according to regulatory standards.

Conclusion

Creating tablets according to the CPOB 2018 standards involves careful preparation, mixing, granulation, tableting, and quality control. Following these steps ensures the production of high-quality pharmaceutical tablets that meet regulatory requirements. For further learning, consider exploring advanced topics such as tablet formulation optimization and stability testing.