Manufacturing Process of Cefpodoxime DT by Den Mark Pharmaceuticals Pvt. Ltd.
Cefpodoxime proxetil is a third-generation cephalosporin antibiotic. It works by interfering with the formation of the bacteria's cell wall, leading to their destruction. The "DT" designation indicates that the tablets are dispersible or orally disintegrating. This formulation is convenient for patients with difficulty swallowing whole tablets or who prefer a more easily administered dosage form.
Den Mark Pharmaceuticals Pvt. Ltd., in adherence to the stringent guidelines set by the World Health Organization's Good Manufacturing Practices (GMP), implements a meticulous manufacturing process to produce top-quality Cefpodoxime Dispersible Tablets (DT). Cefpodoxime DT is an essential antibiotic used to combat many bacterial infections. The manufacturing process undergoes rigorous quality control measures at every step to ensure the final product's efficacy, safety, and consistency.
Step 1: Raw Material Procurement and Testing
- The process begins with the procurement of high-quality raw materials from trusted suppliers. Each raw material undergoes thorough testing in our state-of-the-art laboratory to verify its identity, purity, and potency. Only materials meeting stringent quality standards are approved for use in production.
Step 2: Granulation
The active pharmaceutical ingredient (API), Cefpodoxime Proxetil, is carefully weighed and mixed with excipients such as microcrystalline cellulose and crospovidone. The blend is then granulated using purified water or a suitable solvent to achieve uniform particle size distribution. Granulation ensures homogeneity and facilitates proper tablet formation.
Step 3: Compression
The granules are compressed into tablets using high-precision tablet compression machines. The compression force is closely monitored to ensure consistent tablet hardness and thickness. Disintegrants such as sodium starch glycolate are added during this process to promote rapid tablet disintegration upon administration.
Step 4: Coating (Optional)
In some cases, an optional enteric coating may be applied to the tablets to protect the active ingredient from stomach acid and improve its bioavailability. The coating solution, typically composed of polymers like hydroxypropyl methylcellulose phthalate, is sprayed onto the tablets using specialized equipment.
Step 5: Quality Control
Rigid quality control checks are performed at various stages throughout the manufacturing process. Samples are collected and tested for assay, dissolution, content uniformity, and physical attributes such as weight variation and friability. Any deviations from predefined specifications are immediately addressed to maintain product quality.
Step 6: Packaging
Once the tablets pass all quality control tests, they are transferred to the packaging area. Here, they are carefully counted, blister-packed, and sealed to protect them from environmental factors such as moisture and light. Proper labeling is applied to each package, including essential information such as dosage strength, batch number, and expiry date.
Step 7: Storage and Distribution
The finished Cefpodoxime DT tablets are stored in controlled conditions to maintain their stability and efficacy until they are ready for distribution. Den Mark Pharmaceuticals Pvt. Ltd. ensures that the entire supply chain adheres to GMP guidelines to prevent any compromise in product quality during transportation and storage.
Conclusion
Custom Pharmaceutical Manufacturing, Den Mark Pharmaceuticals Pvt. Ltd. follows a comprehensive manufacturing process for Cefpodoxime DT tablets per WHO GMP guidelines. By prioritizing quality control at every stage, from raw material procurement to final packaging, we ensure that healthcare professionals and patients receive safe, effective, and reliable medication for treating bacterial infections.