Ambroxol + Terbutaline HCl + Guaiphenesin + Menthol Expectorant

Weighing and Mixing:

• According to the formulation requirements, precise quantities of ambroxol, terbutaline HCl, Guaiphenesin, and menthol are weighed accurately.
• These active pharmaceutical ingredients (APIs) are mixed thoroughly in a designated blending vessel to ensure uniform distribution under controlled conditions.

Preparation of Syrup Base:

• The syrup base is prepared by dissolving sugar or other sweeteners in purified water and adding preservatives and flavoring agents to enhance palatability.
• The solution is heated and stirred until all components are completely dissolved, and then the mixture is cooled to room temperature under controlled conditions.

Addition of Active Ingredients:

• The blended mixture of Ambroxol, Terbutaline HCl, Guaiphenesin, and Menthol is gradually added to the prepared syrup base with continuous mixing to achieve homogeneity.
• The addition process is carefully monitored to ensure accurate dosing and uniform distribution of the active ingredients throughout the syrup.

Homogenization and Filtration:

• The combined mixture undergoes homogenization to ensure further uniform dispersion of the active ingredients in the syrup base.
• Subsequently, the homogenized syrup is passed through a series of filters with progressively finer mesh sizes to remove particulate matter or impurities.

Sterilization and Filling:

• The filtered syrup is then sterilized using validated methods, such as heat or filtration, to ensure microbial safety.
• Sterile syrups are filled into sanitized glass or plastic bottles using automated filling equipment under controlled conditions to minimize contamination risks.

Sealing and Labelling:

• The filled bottles are securely sealed with tamper-evident closures to maintain product integrity and prevent tampering.
• In compliance with regulatory requirements, each bottle is labeled with essential information, including product name, dosage strength, batch number, expiry date, and manufacturing details.

Quality Assurance and Packaging:

• Finished syrup batches undergo comprehensive quality assurance testing, including physical, chemical, and microbiological analysis, to verify compliance with specifications.
• Approved batches are packed into secondary packaging, such as cartons, with appropriate labelling and batch documentation before storage or distribution.

Storage and Distribution::

• Finished Ambroxol + Terbutaline HCl + Guaiphenesin + Menthol Expectorant Syrup are stored in designated warehouses under controlled conditions, including temperature and humidity monitoring, to maintain stability and shelf-life.
• Distribution of the finalized Ambroxol + Terbutaline HCl + Guaiphenesin + Menthol Expectorant Syrup is conducted by Good Distribution Practices (GDP), ensuring proper handling and transportation to customers while preserving product quality.

Patients who have had previous experiences with ambroxol, guaifenesin, or terbutaline hypersensitivity shouldn't take this combination. Additionally, thyrotoxicosis (an excess of thyroid hormones in the blood) and cardiovascular problems should not be treated with it.

Den Mark Pharmaceuticals Pvt. Ltd. prioritizes patient safety and product quality throughout the manufacturing process, adhering to WHO GMP guidelines and regulatory standards to deliver top-quality pharmaceutical solutions to consumers worldwide.