Manufacturing Process of Paracetamol + Phenylephrine HCl + Chlorpheniramine Maleate Suspension (125mg+2.5mg+1mg/5ml) by Den Mark Pharmaceuticals Pvt. Ltd.
Paracetamol + Phenylephrine HCl + Chlorpheniramine Maleate Suspension (125mg+2.5mg+1mg/5ml) is used to treat a variety of respiratory tract disorders, including hay fever, the common cold, and other conditions that are associated to specific symptoms. The majority of the time, it is advised to give the child this suspension if they have a cold and any associated symptoms.
Den Mark Pharmaceuticals Pvt. Ltd. adheres to the highest standards of manufacturing practices in producing pharmaceutical products. This manufacturing process of Paracetamol + Phenylephrine HCl + Chlorpheniramine Maleate Suspension (125mg+2.5mg+1mg/5ml) syrup follows the guidelines set by the World Health Organization (WHO) Good Manufacturing Practices (GMP).
1. Raw Material Procurement
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. Weighing and Dispensing:
The raw materials are weighed accurately using calibrated weighing balances in a dedicated area. The weighed quantities are recorded meticulously to ensure the formulation's precision.
3. Mixing and Dissolution:
The weighed quantities of Paracetamol, Phenylephrine HCl, and Chlorpheniramine Maleate are added to purified water in a stainless steel mixing tank under controlled conditions. Stirring is initiated to achieve uniform dispersion, and the mixture is heated if necessary to aid dissolution.
4. Addition of Excipients:
Excipients, including sweeteners, flavoring agents, preservatives, and viscosity modifiers, are added to the solution according to a predetermined formula. Each excipient is carefully measured to ensure consistency and effectiveness.
5. Homogenization:
The mixture undergoes homogenization to achieve a uniform distribution of all components. High shear mixing is employed to break down any agglomerates and ensure a smooth, homogeneous suspension.
6. Filtration:
The homogenized suspension passes through a sterile filtration unit to remove particulate matter or microbial contaminants. This step is crucial for ensuring the purity and safety of the final product.
7. Filling and Packaging:
The filtered suspension is filled into clean, sterilized bottles using automatic filling machines. Accurate volumetric filling ensures that each bottle contains the specified dose of the active ingredients. The filled bottles are then sealed with tamper-evident closures and labeled appropriately.
8. Quality Control Testing:
Samples of producing Paracetamol + Phenylephrine HCl + Chlorpheniramine Maleate Suspension from each batch undergo rigorous quality control testing in Den Mark Pharmaceuticals' state-of-the-art laboratory. Tests include assay of active ingredients, pH determination, viscosity measurement, microbial limits testing, and stability studies to ensure product potency, purity, and strength over its shelf life.
9. Packaging and Distribution:
Once quality control tests confirm the product's compliance with specifications, the syrup bottles are packed into secondary packaging materials and labelled with batch numbers, expiry dates, and other regulatory information. The finished products are stored in controlled conditions before distribution to wholesalers and pharmacies.
Conclusion:
Den Mark Pharmaceuticals Pvt. Ltd., the most trusted Pharmaceutical Manufacturing Company, never fails to maintain the highest standards of manufacturing excellence and quality assurance in producing Paracetamol + Phenylephrine HCl + Chlorpheniramine Maleate Suspension. By following WHO GMP guidelines and implementing stringent quality control measures, Den Mark Pharmaceuticals ensures that each batch meets the highest efficacy, safety, and reliability standards.