Manufacturing Process of Sucralfate Suspension 60ml
Den Mark Pharmaceuticals Pvt. Ltd. adheres strictly to WHO GMP guidelines to ensure the production of top-quality Sucralfate Suspension 60ml. The manufacturing process involves several critical steps, each carefully executed to guarantee the final product's efficacy, safety, and consistency.
1. Raw Material Procurement and Testing
Den Mark Pharmaceuticals procures raw materials from reputable suppliers, ensuring compliance with pharmacopeial standards. Paracetamol, Phenylephrine HCl, and Chlorpheniramine Maleate are obtained in their purest form, accompanied by certificates of analysis.
2. Dispensing and Weighing:
The approved raw materials are dispensed according to the formulation recipe. Precise weighing ensures accuracy in the suspension's composition, guaranteeing uniformity from batch to batch.
3. Preparation of Sucralfate Suspension:
The manufacturing process begins by dispersing the measured amount of sucralfate in purified water under controlled conditions. The dispersion is then homogenized to achieve a uniform particle size distribution.
4. Addition of Excipients:
Other excipients, such as suspending agents, flavouring agents, preservatives, and colouring agents, are added to the sucralfate dispersion according to the formulation requirements. Each excipient is carefully selected and tested for compatibility to maintain stability and enhance palatability.
5. Mixing and Homogenization:
The mixture undergoes thorough mixing and homogenization to ensure an even distribution of all components. This step is critical for achieving a consistent suspension with accurate dosing and optimal therapeutic effects.
6. pH Adjustment and Stability Testing:
The suspension's pH is adjusted to the specified range to optimize drug stability and bioavailability. Samples from each batch undergo stability testing to assess physical, chemical, and microbial stability over time.
7. Filtration and Sterilization:
The prepared suspension passes through sterile filters to remove particulate matter and ensure microbial sterility. Sterilization methods such as autoclaving or sterile filtration are employed to maintain product integrity.
8. Filling and Packaging:
The sterile sucralose suspension is filled into appropriate containers, such as amber glass bottles, under controlled environmental conditions to prevent contamination. Accurate filling and proper sealing mechanisms maintain product integrity throughout its shelf life.
9. Labelling and Batch Release:
Each container is labelled with essential product information, including dosage instructions, expiry date, and batch number, in compliance with regulatory requirements. Before release, each batch undergoes rigorous quality control testing to ensure it meets all specifications.
10. Quality Control and Documentation:
Throughout the manufacturing process, quality control checks are conducted at various stages to verify adherence to specifications and regulatory standards. Comprehensive documentation of all manufacturing activities, including batch records, testing results, and deviations, is maintained for traceability and regulatory compliance.
Conclusion:
Den Mark Pharmaceuticals Pvt. Ltd. is committed to upholding the highest quality and compliance standards throughout the manufacturing process of Sucralfate Suspension 60ml. By meticulously following WHO GMP guidelines, we ensure that our product consistently meets the stringent requirements of efficacy, safety, and patient satisfaction.