Benzalkonium chloride, choline salicylate, and lignocaine hydrochloride are medications classified as analgesics and antiseptics. These medications treat mouth ulcers and inflammation of the oropharynx, or middle region of the throat. Mouth ulcers, called canker sores, are tiny, excruciating lesions that develop near the gum line or within the mouth. These may cause you to feel uneasy when conversing, eating, and drinking. They are not transmissible and often recover in a few weeks.
Den Mark Pharmaceuticals Pvt. Ltd., A quality stringent & safe pharmaceutical manufacturer in India, manufactures a high-quality Choline Salicylate + Lignocaine Hydrochloride + Benzalkonium Chloride Gel (8.70% + 2.0% + 0.01% w/w) following strict WHO GMP (Good Manufacturing Practice) guidelines. This process ensures product consistency, quality, and safety for the end user.
Manufacturing Process
1. Preparation:
- All personnel must wear appropriate personal protective equipment (PPE) like gloves, goggles, and lab coats.
- The manufacturing area must be sanitized according to GMP protocols.
- All materials and equipment must be verified against specifications and batch records.
2. Weighing:
- Each API and inactive ingredient is accurately weighed using a calibrated balance. Quantities are documented in the batch record.
3. Dissolution:
- Choline Salicylate and Lignocaine Hydrochloride are dissolved in a portion of purified water under constant stirring.
- Benzalkonium Chloride solution is added at a pre-determined concentration.
- Disodium Edetate (if used) is added to chelate metal ions and improve stability.
4. Gel Base Preparation:
- The gel base components are mixed according to the manufacturer's instructions.
5. Mixing :
- The API solution is slowly incorporated into the gel base under continuous high-shear mixing, ensuring a uniform medication distribution throughout the gel.
6. Homogenization:
- The mixture is passed through a homogenizer to create a smooth, uniform gel with a consistent particle size.
7. Maturation (Optional):
- The Choline Salicylate + Lignocaine Hydrochloride + Benzalkonium Chloride Gel (8.70% + 2.0% + 0.01% w/w) may require a resting period for complete hydration and gelling.
8. Filling:
- The finished Choline Salicylate + Lignocaine Hydrochloride + Benzalkonium Chloride Gel (8.70% + 2.0% + 0.01% w/w) is transferred to a sterile filling machine and dispensed into pre-sterilized containers.
9. Labeling:
- Each container is labeled with the product name, ingredients, dosage instructions, expiry date, and batch number.
10. Quality Control:
- Samples from the batch are sent for microbiological testing to ensure sterility.
- Additional tests may be performed to confirm pH, viscosity, and drug content.
11. Quarantine:
- The finished Choline Salicylate + Lignocaine Hydrochloride + Benzalkonium Chloride Gel (8.70% + 2.0% + 0.01% w/w) batch is quarantined until all test results are satisfactory.
12. Release:
- The batch is released for packaging and distribution after completing all tests.
Documentation
- All stages of the manufacturing process are documented in a detailed batch record.
- Deviations from the standard process must be documented and justified.
Conclusion By following this GMP-compliant manufacturing process, Den Mark Pharmaceuticals Pvt. Ltd. ensures the production of a high-quality Choline Salicylate + Lignocaine Hydrochloride + Benzalkonium Chloride Gel that is consistent, safe, and effective for the intended use.