Manufacturing Process of Lactulose Solution (3.335gm/5ml, 10mg/15ml) by Den Mark Pharmaceuticals Pvt. Ltd.
The World Health Organization's Good Manufacturing (WHO GMP) Practices provide strict rules that Den Mark Pharmaceuticals Pvt. Ltd., an Indian Pharmaceutical Manufacturing company that manufactures high-quality drugs follows to guarantee the development of pharmaceutical items of the highest quality. Lactulose Solution Syrup is made with exacting processes that ensure uniformity, safety, and effectiveness in each batch.
Raw Material Procurement:
- The first step in manufacturing is procuring high-quality raw materials. Den Mark Pharmaceuticals sources pharmaceutical-grade lactulose, purified water, and other excipients from approved suppliers with stringent quality control measures.
Preparation of Lactulose Solution:
- Weighing and Mixing: Pharmaceutical-grade lactulose powder is accurately weighed according to the formulation (3.335gm/5ml or 10mg/15ml). It is then mixed with purified water in a stainless steel mixing vessel under controlled conditions to achieve uniform dispersion.
- Heating and Dissolution: The lactulose-water mixture is heated to a specific temperature to aid dissolution. Continuous stirring ensures complete dissolution of lactulose, forming a clear solution.
- Filtration: The dissolved solution undergoes filtration through micron filters to remove particulate matter or impurities, ensuring clarity and sterility.
Preparation of Syrup:
- Addition of Excipients: To enhance stability, taste, and palatability, appropriate excipients such as preservatives, flavoring agents, and sweeteners are added to the lactulose solution under strict adherence to the formulation.
- Mixing and Homogenization: The solution is thoroughly mixed to ensure uniform distribution of all ingredients. Homogenization is achieved through gentle agitation to prevent air entrapment and provide consistent viscosity.
- pH Adjustment: The syrup's pH is adjusted to the specified range using suitable pH regulators, ensuring optimal stability and compatibility.
- Quality Control Testing: To ensure compliance with specifications, samples from each batch are subjected to rigorous quality control tests, including pH measurement, viscosity assessment, microbial analysis, and potency determination.
Packaging and Labeling:
- Container Selection: Den Mark Pharmaceuticals selects high-quality packaging materials, such as amber glass bottles or HDPE containers, to protect the syrup from light and external contaminants.
- Filling and Sealing: The syrup is filled into the selected containers using precision filling equipment to ensure accurate dosage. Sealing is performed under controlled conditions to maintain product integrity.
- Labelling and Batch Coding: Each container contains essential information, including product name, strength, dosage instructions, batch number, manufacturing date, and expiry date. Batch coding allows for traceability and recall if necessary.
Quality Assurance:
Throughout the manufacturing process, Den Mark Pharmaceuticals implements stringent quality assurance measures, including in-process checks, environmental monitoring, and personnel training, to uphold product quality and compliance with WHO GMP guidelines.
Conclusion:
Den Mark Pharmaceuticals Pvt. Ltd. employs a careful manufacturing process for Lactulose Solution Syrup, adhering to WHO GMP guidelines at every stage.
Lactulose is used to treat constipation. In individuals with a history of chronic (long-lasting) constipation, it helps increase the number of bowel movements per day and the number of days on which bowel movements occur.
Through strict quality control measures and attention to detail, we ensure the production of top-quality pharmaceutical products that meet the needs of healthcare professionals and patients worldwide.