Knowde Enhanced TDS
Identification & Functionality
- Pharma & Nutraceuticals Functions
- Technologies
- Ingredients
- D-Mannitol
- Xylitol
- MCC
- Crospovidone
- 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
- Pharmaceutical application of F-MELT® Type C
- Famotidine formulations with F-MELT® Type C and M: Famotidine belongs to histamine (H2) blockers. Famotidine is bitter in taste and need taste masking in order to be acceptable to patients.
- Acetaminophen formulation with F-MELT® Type C and M: A 30-40% load of acetaminophen may bring down the tablet hardness to a region between 30 and 35 N while maintaining the oral disintegration time of 30 seconds. At higher compression forces, one can achieve a tablet hardness above 50 N. However, the oral disintegration time tends to increase slightly. A strategy to overcome this limitation was developed by Fuji scientists to maintain tablet hardness of 50 N and an oral disintegration time of 30 seconds.
- Ascorbic acid (Vitamin C) formulations with F-MELT® Type C and M: F-MELT® sample formulation with L-Ascorbic acid. Effect of 2 different lubricants (sodium stearyl fumarate and magnesium stearate) on tablet hardness, oral disintegration time and friability. Ascorbic acid, a highly hygroscopic active was successfully formulated into an oral disintegrating tablet with F-MELT®. In order to avoid the sticking/capping, 0.5% of talc was included in the formulation.
- F-MELT® sample formulations with acetaminophen (AA) and additional pharmaceutical excipients, to achieve a higher tablet hardness and shorter oral disintegration time:
- F-MELT® Acetaminophen formulations with additional excipients like corn starch, carboxymethyl cellulose (CMC), crospovidone and hydroxypropyl starch (HPS) and magnesium stearate was used as lubricant. The F-MELT® acetaminophen tablets achieved a tablet hardness of 50 N and a disintegration time of less than 30 seconds with low friability.
- F-MELT® Acetaminophen formulations with additional excipients like corn starch, microcrystalline cellulose (MCC) and change of lubricant from magnesium stearate to sodium stearyl fumarate. By changing the lubricant, one could achieve higher tablet hardness and a disintegration time of less than 30 seconds with F-MELT®.
- Nutraceutical application of F-MELT® Type C
- Vitamin B12 formulation with F-MELT® Type C: Vitamin B12 is accepted as a dietary supplement and is consumed in microgram dosages. Oral disintegrating Vitamin B12 (500 μg) nutraceutical tablets were prepared with F-MELT® Type C.
- CoQ10 formulation with F-MELT® Type C: CoQ10 is a well established dietary supplement. This example shows successful tablet formulations of 350 mg and 1,200 mg oral disintegrating tablets of CoQ10 at 17.5 to 60 mg load. Additional excipients like MCC and CMC and Talc were included to improve tablet properties.
Properties
- Typical Properties
| Value | Units | Test Method / Conditions | |
| Loss on Drying | 1.3 | % | — |
| Loose Bulk Density | 0.54 | g/ml | — |
| Tapped Bulk Density | 0.65 | g/ml | — |
| Mean Particle Size Distribution | 120.8 | μm | — |
| Angle of Repose | 34 | ° | — |
Regulatory & Compliance
- Certifications & Compliance
- Grade
- Pharmacopoeia and regulatory information
Conforms to Japanese Pharmaceutical Excipients. All components meet USP-NF, JP, and EP. US DMF Type IV filed.
- 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®
Contents: F-MELT® 99.6% + Mg-St 0.4%
Tabletting condition: ø8 mm, 200 mg tablet, 15 rpm, 33 N
Tabletting machine: HT-AP18SS-II (Manufacturer: Hata Iron Works Co., Ltd.)
Safety & Health
- Safety
The components of F-MELT® Type C and M are safe with no reports of adverse reactions when used as excipient in pharmaceutical applications.Type C is also suitable for nutraceutical/food* applications. The components of Type C have E-numbers (EU Food Directive), and are listed in USA CFR 21 and list of Acceptable Non-Medical Ingredients in Canada. The maximum daily dosage of Type C and M is 5.875 g per day.
Packaging & Availability
- Packaging
- Commercial size: 20 kg net in aluminum bag in carton box
- Sample size:1 kg net in aluminum bag
Storage & Handling
- Storage & Handling
- F-MELT® has a shelf life of 3 years from the date of manufacture.
- F-MELT® to be stored in aluminum bag with heat seal at 30˚C & 65% RH.