Cefixime + Ofloxacin Tablet Manufacturing Process for Den Mark Pharmaceuticals Pvt. Ltd.
Combining Cefixime and Ofloxacin in a single tablet offers broad-spectrum coverage against different types of bacteria, making it particularly useful in treating mixed infections or cases where the specific causative agent is unknown. The top-quality formulation ensures accurate dosage and bioavailability of the active ingredients, maximizing efficacy while minimizing the risk of adverse effects.
Den Mark Pharmaceuticals Pvt. Ltd. follows stringent guidelines by the World Health Organization (WHO) Good Manufacturing Practices (GMP) to ensure the production of top-quality Cefixime + Ofloxacin tablets. The manufacturing process involves several critical steps to guarantee the final product's efficacy, safety, and consistency.
Materials:
- Active Pharmaceutical Ingredients (APIs): Cefixime Trihydrate and Ofloxacin
- Excipients: Lactose Monohydrate, Microcrystalline Cellulose, Sodium Starch Glycolate, Magnesium Stearate, and Opadry (coating)
- Purified Water
Pre-Production
- Material Receipt and Quarantine: All incoming raw materials (APIs and Excipients) undergo strict inspection against predetermined specifications. They are quarantined until approved for production.
- Weighing: Accurately weighed quantities of Cefixime and Ofloxacin, and each excipient is dispensed based on the approved master formula.
- Blending: Weighed materials are transferred to a blender and mixed uniformly to ensure a homogenous distribution of drugs and excipients.
Granulation:
- Wet Granulation (Optional): If required for efficient tableting, the blend is moistened with a granulating solution and granulated using a suitable granulator.
- Drying: Granules are dried to a predetermined moisture level in a fluid bed or tray dryer.
- Milling: Dried granules are milled to a uniform particle size using a grinder.
Tableting:
- Lubrication: The milled blend is lubricated with Magnesium Stearate to improve flowability during tableting.
- Compression: A high-speed tableting machine compresses the lubricated blend into tablets. Critical parameters like compression force and tablet weight are continuously monitored and adjusted for consistent quality.
- Weight Control: Individual tablets are weighed electronically to meet the weight specification. Non-conforming tablets are automatically rejected.
Coating:
- Coating Preparation: Opadry coating solution is prepared according to the manufacturer's instructions.
- Coating Process: Cefixime + Ofloxacin Tablets are loaded into a coating pan and sprayed with the Opadry solution to achieve a uniform, aesthetically pleasing coat. The coating process parameters like spray rate, pan speed, and inlet/outlet temperature are precisely controlled.
Post-Production
- In-Process Quality Control: Throughout manufacturing, samples of Cefixime and ofloxacin tablets are collected for testing against pre-defined specifications, ensuring the tablets meet all quality attributes.
- Packing: Conformed Cefixime + Ofloxacin tablets are counted by automated machines and filled into blister packs. Each blister pack contains product information, expiry date, and batch number.
- Finished Product Quarantine: Packed Cefixime + Ofloxacin tablets are quarantined until final product release is authorized after successful testing, per WHO GMP guidelines.
- Storage and Distribution: The finished Cefixime + Ofloxacin tablets that are released are stored under controlled conditions and distributed through approved channels.
Documentation:
- All activities are meticulously documented throughout the manufacturing process, including material weights, blending times, compression forces, coating parameters, and quality control test results. This detailed documentation ensures process traceability and facilitates continuous improvement.
Conclusion:
Den Mark Pharmaceuticals Pvt. Ltd. adheres to stringent WHO GMP guidelines to manufacture high-quality Cefixime + Ofloxacin Tablets. This comprehensive process ensures consistent product quality, safety, and efficacy.