硫酸阿托品片剂的工艺流程设计
英文回答:
Process Flow Design for Atropine Sulfate Tablets.
1. Raw Material Receiving and Inspection.
Receive and inspect active pharmaceutical ingredient (API) and excipients.
Verify compliance with specifications and release for manufacturing.
2. Blending.
Measure and blend API and excipients according to the formulation.
Ensure uniform distribution of ingredients.tablet英文
3. Granulation.
Wet granulation: Add binder solution to the powder blend and mix to form granules.
Dry granulation: Compact the powder blend under pressure to form granules.
4. Drying.
Dry the granules in a fluidized bed dryer or tray dryer to remove residual moisture.
5. Milling.
Grind the dried granules to a desired particle size distribution.
Optimize tablet compressibility and dissolution rate.
6. Lubrication.
Add lubricants and glidants to the milled granules to improve flowability and prevent sticking during tableting.
7. Tableting.
Compress the lubricated granules into tablets using a tablet press.
Control tablet weight, hardness, and dimensions.
8. Film Coating.
Optional step to protect tablets from moisture, enhance appearance, or control drug release.
Apply a polymer coating using a coating pan or fluidized bed coater.
9. Packaging.
Pack the coated tablets into blister packs, bottles, or other containers.
Ensure product stability and patient safety.
10. Quality Control.
Conduct in-process and finished product testing to ensure compliance with specifications.
Monitor tablet weight, hardness, friability, disintegration, and dissolution.
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