Assuring optimum functionality for your products
Orally disintegrating tablets (ODT) formulated with Pharmaburst® are easily manufactured utilizing your standard direct compression process. The active(s) are blended with Pharmaburst, flavors, sweeteners, colors, and the lubricant is then added in the final step and blended for a minimum of five minutes.
Lubripharm® sodium stearyl fumarate (SSF) is the lubricant of choice since it is less hydrophobic than magnesium stearate, requiring less compaction force to obtain similar tablet hardness. This results in a more porous tablet that disintegrates quickly.
Typical method of preparation
1. Sieve all ingredients through a 30-mesh screen.
2. Weigh and place the ingredients in a blender.
3. Blend for 10 minutes.
4. Add the desired lubricant and blend for five minutes.
5. Transfer blended material to the tablet press and compress at a suitable hardness.
The quantity of Pharmaburst required in your ODT formulation will depend upon the type and level of active per tablet. Initial studies should be carried out on your potential formulation by varying the Pharmaburst percentage from 40% to 80%.
Pharmaburst has a smooth mouth feel that can help to minimize grittiness of many actives in your orally disintegrating formulation. Be aware that changing the relative proportion of the ingredients through dilution or adding additional excipients may significantly alter the positive attributes of the Pharmaburst ODT tablet formulation system.
When you partner with SPI Pharma, you can be assured of high-quality materials, expert service, and support to simplify your formulation process.