|
F-MELTR is a proprietary formulation of carbohydrates, disintegrants and inorganic ingredients, designed for manufacturing Oral Disintegrating Tablets (ODTs). This excipient system, produced by spray-drying process, is suitable for direct compression manufacturing of ODTs by simply blending APIs (active pharmaceutical ingredients) and lubricants.
ODTs are considered solid oral preparations that disintegrate rapidly in oral cavity with an in vitro disintegration time of 30 seconds. Additional qualities that improve marketability of ODTs are better mouth feel, hard and easy to pack tablets with low friability as well as tablets with higher API load and stability.
Fuji, with its vast experience in pharmaceutical excipients presents an ideal excipient system, F-MELTR to meet the above standard requirements. |
| Manufacturing Process of ODT |
|
The customer can easily prepare ODTs by blending F-MELTR powder with API, lubricant and direct compression. Another major advantage is that production of ODTs with F-MELTR can be carried out with conventional equipment and materials, minimizing manufacturing costs.
|
TYPE C - For faster disintegration needs
TYPE M- For improved flow and higher tablet quality needs
|
TYPE C - Pharmaceutical, Nutraceutical (EU, USA, Canada)
TYPE M- Pharmaceutical
|
| Pharmacopoeia & Regulatory |
| Type C meets all requirement of the current USP/NF, JP and EP US DMF Type IV filed in January 2007 # 20084 Type M meets all requirement of the current USP/NF, JP |
| Compressibility: Tablet Hardness vs Compression Pressure (F-MELTR placebo tablets) |
| In order to achieve ODTs with higher tablet hardness, low friability, high loading and disintegration time less than 30 seconds, the F-MELTR formulations can be modified with readily available excipients or by changing the lubricant. Examples for both approaches are given below. |
| F-MELTR-Acetaminophen formulations by adding other excipients |
| Sample formulations with Ascorbic acid (Type C and M) |
|
|
Type C and M do not contain any material, related to BSE/TSE, GMO or Allergen.
*Statement available on request. |
Type C and M do not contain any residual organic solvent. |
Japan Patent No.3841804 August 18, 2006.
International Patents pending |
| Scanning Electron Micrographs |
>>Features
| ■ |
Ready-to-use excipient for oral disintegrating tablets |
| ■ |
Oral disintegrating time less than 30 seconds |
| ■ |
Directly compressible |
| ■ |
Tablet hardness more than 50 Newton with additional excipients |
| ■ |
API loading more than 50% possible |
| ■ |
Highly flowable with little or no sticking/capping |
| ■ |
No Royalty or licensing fees required |
| ■ |
Nutraceutical applications (Type C) |
|
| Requirements for OD Tablets |
| F-MELTR- Acetaminophen formulations by changing the lubricant (Type C and M) |
| Water in pharmaceutical products may affect the chemical or physical stability of moisture sensitive products. Equilibrium moisture sorption isotherm of a product is a key |
 |
| factor governing the rate of moisture uptake by the packaged product during shelf life, besides the environmental conditions and container permeability. Up to 75% humidity, F-MELTR is quite stable as indicated by the following graphs. |
| Moisture sorption lsotherm (25°C, 7days) |
|
