Beclomethasone dipropionate Neomycin & Miconazole Cream is a medicine used to treat Runny Nose, Allergic Rhinitis, Hay Fever, Ulcerative Colitis, Inflammation In the Nose, Asthma, and other conditions.
Beclomethasone Neomycin & Miconazole Cream works by blocking the release of certain chemicals, thus curing inflammation; preventing bacterial growth by stopping the production of essential protein in the bacterial cells; preventing the development of fungi and increasing cellular permeability;
Preparation of Ingredients:
1. Beclomethasone Dipropionate (0.025% w/w):
- Weigh and measure the required quantity of Beclomethasone Dipropionate according to the formulation.
- Dissolve the Beclomethasone Dipropionate in a suitable solvent under controlled conditions to form a homogeneous solution.
2. Neomycin Sulfate (2.0% w/w):
- Accurately weigh the specified amount of Neomycin Sulfate.
- Disperse the Neomycin Sulfate into a suitable base under controlled temperature and mixing conditions to achieve uniform distribution.
3. Miconazole (0.5% w/w):
- Weigh the precise quantity of Miconazole as per the formulation.
- Mix the Miconazole thoroughly into the base using appropriate techniques to ensure uniform dispersion.
1. Preparation of Cream Base:
- Heat and melt the required quantity of cream base under controlled conditions to ensure complete melting without degradation.
- Allow the melted base to cool to a suitable temperature (~40-45°C) before further processing
2. Incorporation of Active Ingredients:
- Add the prepared Beclomethasone Dipropionate solution, Neomycin Sulfate dispersion, and Miconazole dispersion into the cooled cream base.
- Homogenize the mixture using a suitable homogenizer to ensure uniform distribution of the active ingredients within the cream base.
3. Adjustment of pH and Viscosity:
- Measure and adjust the pH of the cream to the specified range using appropriate pH modifiers under controlled conditions.
- Evaluate and adjust the viscosity of the cream to the desired consistency using suitable viscosity modifiers while maintaining uniformity.
4. Sterilization and Filtration:
- Sterilize the cream using a validated sterilization method, such as filtration through a sterile filter or autoclaving, ensuring compliance with WHO GMP guidelines.
- Perform microbial testing to ensure the cream meets the specified microbial limits post-sterilization.
5. Packaging:
- Fill the sterile cream into clean containers, ensuring accurate filling weights.
- Seal the containers using suitable closure systems to maintain product integrity and prevent contamination.
- In compliance with regulatory requirements, label each container with all required information, including product name, strength, batch number, manufacturing date, expiry date, and storage conditions.
6. Quality Control Testing:
- Collect samples from each batch for quality control testing, including assay, pH, viscosity, microbial limits, and stability studies.
- Analyze the samples using validated analytical methods to ensure product quality and compliance with specifications.
Batch Documentation and Release:
- Prepare and review batch documentation, including manufacturing records, analytical reports, and quality control documents, for compliance with WHO GMP guidelines.
- Release the batch for distribution only after it meets all quality specifications and regulatory requirements.
Adherence to WHO-GMP:
- Den Mark Pharmaceuticals Pvt. Ltd., one of the leading drug manufacturers in India, ensures strict adherence to WHO GMP guidelines throughout the manufacturing process. This includes maintaining a clean and hygienic production environment, following validated procedures, proper personnel training, and robust quality control measures.
Den Mark Pharmaceuticals Pvt. Ltd. sticks to continual improvement of its pharmaceutical manufacturing processes. This capsule-filling process is reviewed and updated regularly to ensure ongoing compliance with WHO GMP and to produce the highest quality Clopidogrel + Aspirin capsules for patient safety and well-being.