Is another ODT excipient necessary? - Pharmaceutical Technology

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PharmTech Europe

Is another ODT excipient necessary?

Pharmaceutical Technology Europe
Volume 21, Issue 9

Rapid and constant disintegration

Figure 2: Influence of tablet strength on disintegration time using Parteck ODT with 80 mg ascorbic acid, 1% magnesium stearate, 0.5% orange flavour and 0.2% sucralose.
Disintegration is a key factor for the success of an ODT formulation. In our study, we tested this using a formulation with two different grades of ascorbic acid as active. The disintegration times for Parteck ODT were shown to be well within the range expected for ODT applications. More importantly, however, producing hard and stable tablets does not cause the disintegration time to suffer. As Figure 2 shows, the disintegration time remains constant over a wide range of tablet strengths. This is a major difference from some ODT formulations on the market, which display fast disintegration only for rather soft tablets.

Dissolution not affected by active

Another key factor for any kind of formulation is the release time of the active. Experience shows that fast disintegration is not always concomitant with fast release. Some excipients retard the release of active.

Figure 3: In vitro acetaminophen release from Parteck ODT-based tablets.
Our study showed that, after 10 min, all of the acetaminophen in the two formulations was released with Parteck ODT as directly compressible excipient (Figure 3). There is no negative Parteck ODT influence observed on the acetaminophen dissolution behaviour, regardless of the grade of active.

Thus, we believe that we have shown that Parteck ODT allows the design of a robust dosage form with both fast disintegration and fast dissolution irrespective of the drug substance grade, tablet weight and tablet size.

In addition, friability over a broad strength range is exceedingly low, as it is desirable for handling during production and application. Even at a very low compaction force (e.g., 5 kN) — friability of <0.4% can be achieved. This characteristic of Parteck ODT allows the manufacture of extremely rugged tablets.

The author says...
Finally, the sensitivity of Parteck ODT added to a randomly chosen set of lubricants (PRUV sodium stearyl fumarate (2%), Dynasan 114 Powder (3%), Parteck LUB MST magnesium stearate (1%) or Polyglycol 6000 (5%)) was tested using placebo formulations. No significant effect on disintegration behaviour was observed, giving the formulator flexibility to resolve specific formulation problems.


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