F-MELT: The Cost-Effective Solution For Producing High-Quality Orally Disintegrating Tablets (ODTs)

See the sixth issue of Fuji Chemical Industries Technical Newsletter:

Directly compressible excipient system for fast-Disintegrating oral tablets*,
F-MELT® formulations are designed with a focus on three important characteristics of ODTs: tablet hardness, mouthfeel, and acceptable oral disintegration times.

ODT is a rapidly developing market, with new technologies emerging that offer distinct advantages. However, direct compression remains the preferred choice due to its use of conventional equipment and materials, which help to maintain lower manufacturing costs.

F-MELT® is a spray-dried granulation composed of five pharmaceutical grade excipients, including carbohydrates, inorganic ingredients, and disintegrants. It is available in two grades, F-MELT® Type C and F-MELT® Type M. The individual excipients which are contained in F-MELT® conform to either USP-NF, EP or JP standards.

Physical Properties of F- MELT®**

The Cost-Effective Solution For Producing High-Quality Orally Disintegrating Tablets_while

While F-MELT® can provide the desired tablet hardness and mouthfeel, in many cases, additional organic or inorganic excipients may be necessary to achieve the desired outcome. The following examples illustrate how F-MELT® can be combined with other excipients to maintain a higher tablet hardness and improve the overall mouthfeel.

Formulation Example

Example 1. F- MELT® Type C – Acetaminophen and Aspirin ODT formulations with focus on tablet hardness, mouthfeel and acceptable oral disintegration times.

CMC – Carboxymethyl Cellulose, MCC – Microcrystalline Cellulose, Mg-St -Magnesium Stearate. Tablet of 200 mg with 8 mm diameter were manufactured on a rotary tabletting machine. In case of acetaminophen and aspirin as API, a combination of CMC or Kollidon CL with F-MELT® Type C provided hard tablets with very good mouth feel and satisfactory oral disintegration times.

Example 2. F- MELT® Type M – Acetaminophen ODT formulations with focus on tablet hardness, mouthfeel, and acceptable oral disintegration times.

At a higher drug load of 40%, MCC in combination with F-MELT® Type M allowed working at relatively low compression forces and yielded tablets with good hardness and a relatively low disintegration time. When used in combination with corn starch, F-MELT® Type M provided hard tablets with good mouthfeel and excellent oral disintegration time for acetaminophen.

Example 3. Working with sticky, sour APIs: L-Ascorbic Acid formulations with focus on tablet hardness, mouthfeel, and acceptable oral disintegration times.

Continue reading and see the full Pharmaceutical Technical Newsletter on “Issue 06 – The Cost-Effective Solution For Producing High-Quality Orally Disintegrating Tablets (ODTs)” here:

(click the picture to download the technical newsletter)