These are the most commonly used oral dosage forms in the pharmaceutical industry due to their stability, ease of administration, and cost-effectiveness.
1. Tablet Manufacturing Process
a. Pre-formulation Studies
Determine drug properties (solubility, stability, flowability, etc.).
Choose suitable excipients.
b. Granulation
Wet Granulation: Binds powders with a liquid to form granules.
Dry Granulation: Used when the drug is moisture-sensitive.
Direct Compression: Suitable for drugs with good flow and compressibility.
c. Compression
Granules are compressed into tablets using a tablet press.
d. Coating (optional)
Film coating or sugar coating for taste masking, stability, or controlled release.
e. Packaging
Blister packs or bottles, labeled and sealed for distribution.
2. Capsule Manufacturing Process
a. Filling
Capsules (usually gelatin-based) are filled with powders, pellets, granules, or liquids.
b. Sealing (for liquid-filled)
Ensures the capsule content remains intact and stable.
c. Polishing & Inspection
Capsules are cleaned and checked for defects.
d. Packaging
Packed similarly to tablets for distribution.
3. Ensuring Quality in Manufacturing
a. GMP Compliance
Following Good Manufacturing Practices (GMP) ensures safety and consistency.
b. In-Process Quality Checks
Weight variation, disintegration, hardness, and friability testing.
c. Stability Studies
Determine shelf-life under various environmental conditions.
d. Microbiological Testing
Ensures the product is free from harmful microorganisms.
4. Supplying Quality Pharma Products
Key Considerations:
Regulatory Compliance: Meet national/international standards (like WHO-GMP, USFDA, EU-GMP).
Proper Documentation: Batch records, CoAs (Certificates of Analysis), MSDS.
Cold Chain Management (if required): For temperature-sensitive products.
Reliable Distribution Network: Ensures timely and safe delivery.
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