Knowde Enhanced TDS
Identification & Functionality
- Pharma & Nutraceuticals Functions
- Technologies
- Ingredients
- Waxy Rice Starch
- MCC
- Fujicalin®
Features & Benefits
- The challenges and opportunities of ODTs
A patient-centric drug delivery system to deliver specialized medicines to the aging population is very critical to any pharmaceutical drug development program. Difficulty in swallowing is a major problem of the aged patient populations with specific diseases. One of the best choices to overcome the problem associated with swallowing difficulties is an ODT drug delivery system. For ODTs, the key challenges are producing tablets with optimum tablet hardness, rapid disintegration and overcoming the bitter taste exhibited by many actives. F-MELT® addresses these challenges with ease and offers the pharmaceutical companies opportunity to take the product to market quickly.
- Features
- Ready to use excipient system for ODTs
- Oral disintegration time less than 30 seconds
- Spherical particle with high flowability
- Directly compressible
- API loading more than 50% possible
- Tablet hardness more than 50 N possible with little or no sticking/capping
- Pleasant mouth feel
- Easy handling and storage of ODTs with low friability
- No special equipment required for tabletting
- No royalty or license fees required
Applications & Uses
- Applications
- Dosage Form
- Manufacturing Technology
- Nutraceutical application of F-MELT® Type F1
- Vitamin B12 formulation with F-MELT® F1: Oral disintegrating Vitamin B12 (500 μg) nutraceutical tablets were prepared with F-MELT® F1.
- Improvement of commercially available multivitamin-mineral tablet with F-MELT® F1: Sugars and cellulose in original formulation were replaced with F-MELT® F1. Iron, Copper, VB12 tablet: ø 8 mm, 240 mg per tablet (4 tablets per day).
- Improvement of Zinc commercial tablet with F-MELT® F1: Sugars and cellulose in original formulation were replaced with F-MELT® F1. Zinc, Selenium, Chrome tablet: ø 8 mm, 250 mg per tablet (4 tablets per day)
Properties
- Typical Properties
| Value | Units | Test Method / Conditions | |
| Loss on Drying | 5.9 | % | — |
| Mean Particle Size Distribution | 139 | μm | — |
| Angle of Repose | 31 | ° | — |
Regulatory & Compliance
- Certifications & Compliance
- Grade
- Patent status
- Patent: Composition for rapid disintegrating tablet in oral cavity
- Content: Principal compositions of F-MELT® (Carbohydrates, disintegrants and inorganic excipients)
- Status: Patented in Japan, USA, India, China and Korea. Patent pending in EU.
Technical Details & Test Data
- Strategy for preparing high performance F-MELT® tablets
F-MELT® is a directly compressible excipient. Depending on the actives, ODTs can also be prepared through wet granulation with F-MELT® and suitable solvents. Furthermore, if ODT quality does not meet requirement, formulators can improve the quality by adding other excipients and/or changing the lubricant. This flow chart helps the formulator to choose the appropriate route for preparing high performance ODTs with F-MELT®.
- F-MELT® Type C and M Formulation F-MELT®
Lubricant: Sucrose esters S-370F
Contents: : F-MELT® 99.6% + lubricant 0.5%
Tabletting condition: ø 8 mm x 9R, 200 mg/Tab, 15 rpm
Safety & Health
- Safety
- F-MELT® F1 is for nutraceutical/food applications.
- TSE/BSE, Non-GMO, Allergen free certificates are available upon request. F-MELT® does not contain any residual organic solvent.
Packaging & Availability
- Packaging
- Commercial size: 20 kg net in aluminum bag in carton box
- Sample size:1 kg net in aluminum bag