Knowde Enhanced TDS
Identification & Functionality
- Pharma & Nutraceuticals Functions
- Technologies
- Product Families
- Chemical Formula
- CaHP04
- Spray Dried Granules
- Dibasic Calcium Phosphate Anhydrous; Calcium Hydrogen Phosphate, Anhydrous
Features & Benefits
- Benefit Claims
- Product Attributes
The patented manufacturing process yields porous spheres with high specific surface area. Fujicalin® is totally synthetic and ideally suited to direct compression formulations, especially involving difficult-to-compress materials like oily actives.
It can also be used to assist flow, reduce tablet weight variation and improve content uniformity. Fujicalin®’s compressibility facilitates the design of smaller tablets. It can also be used as a partial or total replacement for microcrystalline cellulose.
- Characteristics
- Fujicalin® is a synthetic, free flowing spherically granulated Dibasic Calcium Phosphate Anhydrous (DCPA) for direct compression of tablets.
- Fujicalin®’s patented manufacturing process yields porous spheres with a high specific surface area, 20 to 70% more than conventional Dibasic Calcium Phosphate excipients.
- Fujicalin® has a low mean particle size of 120 μm. The granules are highly stable and compact to tablets of higher tensile strength.
- Fujicalin®’s smooth and spherical granules are less abrasive on tabletting machines leading to trouble free operations.
- Fujicalin®’s porosity and extremely high specific surface area allows formulators to develop oral dosage forms of oily actives. It is an ideal excipient for liquid solid system.
- Fujicalin®’s anhydrous nature results in very low water of crystallization thus making it the ideal choice for hydrolysable drugs.
- Fujicalin® makes sufficiently hard tablets at low compression forces and in addition, improves the hardness of other fillers and binders. It is an ideal excipient for manufacturing tablets of probiotic preparations.
- Fujicalin® retains porosity at high compression forces and exhibits low friability across broad compression range.
- Fujicalin® is ideal as a carrier for Self Emulsifying Drug Delivery System (SEDDS) and solid dispersion including Hot Melt Extrusion (HME).
- Fujicalin® is suitable for both pharmaceutical and food applications.
Applications & Uses
- Markets
- Dosage Form
- Manufacturing Technology
- Application
Converting Oil and extracts to free flowing Powder
- Tablets of Boiled linseed Oil: Converting oily actives into a free flowing powder which can be processed into capsules or tablets is a great challenge to formulators. The oil load may affect flowability, compactability and compressibility leading to poor quality tablets. Boiled linseed oil, a recommended oil for testing oil adsorption properties was adsorbed on to Fujicalin® and other available DCPA’s. Fujicalin® showed excellent compressibility by achieving an optimum tablet hardness of 80 to 100 N at very low compression forces.
- Tablets of Vitamin E: Vitamin E is a fat soluble vitamin like A, D and K. It is oily in physical appearance and exists either in the form of tocopherols or tocotrienols. 12.5 g of Vitamin E was diluted with same amount of ethanol and mixed well before loading on to 83.5 g of Fujicalin® or other grades of DCPAs. The mixture was dried overnight in an oven at 50ºC. Fujicalin® produced high quality Vitamin E tablets with sufficient tablet hardness (80-100 N) at low compression forces of 200-500 kgf. To achieve an optimum hardness of 80-100 N, other DCPA’s need to be compressed at higher forces.
Blending and content uniformity of active ingredients
- Blending of two different particle sizes of acetaminophen: Two different particle sizes of acetaminophen were blended using two different blending machines to study the content uniformity.
- Blending of micronized low density acetaminophen: Micronized drug substances may exhibit increased cohesiveness and have a tendency to segregate in blending. Acetaminophen tablets were prepared by direct compression with Fujicalin® and three other DCPA’s. Blending of micronized acetaminophen powder (14 μm) and DCPA’s were carried out for 30 minutes in a 2 liter V shaped low shear blender.
- Application In Probiotics
Fujicalin® is highly recommended for developing tablets of probiotics which can be stored at room temperature. The shelf life of these preparations can be as long as three years. With spherical shape and smooth surface, Fujicalin® is highly flowable and has excellent blending capacity which increases content uniformity of probiotic formulations. Working well at low compression forces, Fujicalin® allows production of hard tablets with high cell viability as less heat is produced during the tabletting process. With a card-house structure which is easily collapsed, Fujicalin® breaks down into micromeric particles on applying pressure and entraps bacteria within, thus protecting the bacterial cells against harsh conditions during tabletting as well as in the stomach. Probiotic tablets of Bacillus subtilis, Streptococcus faecalis, and Bifidobacteria with Fujicalin® are commercially available with normal bottle packaging and can be stably stored at room temperature for 3 years.
Properties
- Typical Properties
| Value | Units | Test Method / Conditions | |
| Mean Particle Size Distribution | 120 | μm | — |
| Loose Bulk Density | 0.46 | g/ml | — |
| Tapped Bulk Density | 0.54 | g/ml | — |
| Compressibility Index | 15.1 | — | — |
| Angle of Repose | 29.5 | ° | — |
| Angle of Spatula | 33.3 | ° | — |
| Carr Value | 86.5 | — | — |
| Specific Surface Area | 40 | m2/g | BET |
| Oil Adsorbing Capacity | 1.1 | ml/g | — |
| Water Adsorbing Capacity | 1.2 | ml/g | — |
| Loss on Drying | 0.5 | — | — |
| Flowability | Excellent | — | — |
| Water activity | 0.11 | — | — |
Regulatory & Compliance
- Certifications & Compliance
- Grade
- Pharmacopoeia and Regulatory Information
Fujicalin® is manufactured under strict quality control at our GMP certified facilities. Fujicalin® meets all the requirements of the current USP/NF, EP and JP. A US DMF type IV filed in 1998.
Technical Details & Test Data
- Conclusions
Fujicalin® is a dibasic calcium phosphate anhydrous designed to function as a direct compression excipient which shows exceptional flow and compression characteristics. Spray drying makes Fujicalin® highly spherical and smooth particles with considerably less abrasiveness. Fujicalin® allows formulators to develop high quality tablets of oily API’s, heat and moisture sensitive APIs, pH sensitive API’s, probiotics, solid dispersions and other problematic formulations.
Packaging & Availability
- Package Size
- Fujicalin® is available in 20 kg aluminum bag in a Kraft bag.
- Samples are available upon request.
Storage & Handling
- Stability
Fujicalin® is a stable inorganic compound and meets EP, USP/NF and JP specifications. It is stable for 3 years from the date of manufacture.