Knowde Enhanced TDS
Identification & Functionality
- Chemical Family
- Chemical Name
- Pharma & Nutraceuticals Functions
- CAS No.
- 9004-65-3
- EC No.
- 618-389-6
- Technologies
- Product Families
- Structural Formula
Features & Benefits
- Product Information
- Film coating with hydroxypropylmethylcellulose is a well known, established and effective technique. These coatings are now in widespread use throughout the world. BonuCel® does not interact with drugs, and it has a superior stability and non-ionic character, so it is also effective as a binder. Due to its more stable characteristics, BonuCel® can also be used instead of gelatine for cellulose capsule manufacturing.
- The high-viscosity BonuCel®-types are exclusively designed for a hydrophilic matrix agent. This is the easiest sustained release technology for oral dosage forms, consisting essentially of a drug and a watersoluble high viscous polymer.
- BonuCel® consists of highly purified cellulose fibers based on natural raw materials. Mainly renewable wood fibers are used as the primary raw material for the production of cellulose ethers.
Applications & Uses
- Applications
- Manufacturing Technology
Properties
Regulatory & Compliance
- Certifications & Compliance
- Grade
- Regulatory and Quality Aspects
BonuCel® is produced in accordance with IPEC GMP guidelines and meets all requirements of USP/NF, Ph.Eur. and JP.
Technical Details & Test Data
- Coating Conditions
Apparatus New Hi-Coater HC-130N (Freund corporation) Dimension 1300 mm Pan speed 8 min⁻¹ Spray gun Air spray gun X3 (AT type nozzle diameter 1.2 mm) Drying air 80°C Air flow rate 15 m³/min Spray speed 70 g/min x 3 Nozzle air 170 L/min Nozzle air + pattern air 250 L/min Tablet bed temperature 46°C Charge per batch 120 kg Dosage form 6.5 mm, 120 mg/Tablet - Coating Process
Our guiding principle is to provide products and processes that are always “easy, fast & reliable”. We offer the technical assistance and service of experienced coating specialists as well as consultation for the formulation of solid dosage forms and coating procedures.
1 Blower (Air in)
2 Solution/Dispersion with Pump
3 Spray Gun
4 Tablet Bed
5 Blower (Air out)
Safety & Health
- Product Safety
Hazards Identification
Classification of the substance/preparation: This product is not classified as dangerous, according to EC criteria.
Storage & Handling
- Storage and Handling
Personal Protection
- Protective gloves are needed when handling this material. Consistent with general hygienic practice for any material, skin contact should be minimized.
- Use safety glasses. Safety glasses should be consistent with EN 166 or equivalent.
- Wash hands before smoking or eating.
Storage and Handling
- Good housekeeping with respect to dust is necessary for safe handling of product. Avoid dust formation. Provide exhaust ventilation if dust forms.
- Keep away from heat, sparks and flame. No smoking open flames or sources of ignition in handling and storage area.
- Store in a dry and cool place. Keep container well closed.
Disposal
- Any disposal practice must be in compliance with all local and national laws and regulations. Do not dump into any sewers or on the ground or in the water.
- According to local regulations, empty drums or containers can be washed out for recycling. Do not allow washing water to enter inter watercourses.
- Packing must be recycled in accordance with national and local regulations for environmental protection.