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The means by which delay of release is achieved is independent of the 'drug dose' formulation (the 'core' of the 'device' in Figure 2).
If the drug dose contains hydrophilic materials, it will wet and disperse/dissolve rapidly, thus providing a pulsatile delivery profile. On the other hand, if the drug dose contains hydrophobic materials it will wet only slowly and slough off (erode) at a rate dependent (in general terms) on the partition coefficient, thus providing a sustained release/delivery profile. Flexibility in the release profiles achievable is because of the independence of the payload from the mechanism for control of (delay of) release of the dose(s).
Figure 4: Examples of drug dose forms (larger images on click)
The minimum delay of release which can be achieved with the base 'formulations' we currently use is 15 days. The lower limit is because coating formulations which give delay times of less than 15 days lack structural integrity. That is, they are 'brittle' and hence not commercially viable. We anticipate being able to develop 'structurally sound' formulations with delay of release times of less than 15 days if required, given sufficient resources for the formulating program.
The maximum delay of release we have achieved is approximately 600 days. The majority of our work has been focused on delays between 15 and 120 days. As such, we have achieved delay of release times of approximately:
15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 80, 100 and 120 days.
We also have (limited) data exemplifying delay of release times in the range 150, 180, 220 and 600 days. The limited data and range of 'extended' delay times achieved is due to the turnaround time on such experiments, and our resource limitations.
Our know how provides us with sufficient understanding of the materials to enable us to formulate delay times other than those listed. By way of example, shifting the delay from 120 days to 110 days using processing parameters and/or addition of excipients.
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