Paediatric Oral Dispersive tablets

J. Smith Viridian Pharma Ltd, UK

Pharmaceutical technologists are developing age appropriate dosage forms and there is a specific requirement for suitable paediatric systems. The oral route is the preferred administration option and oral liquids provide the answer in most circumstances. However, oral solutions do have limitations; they are expensive to produce, bulky to transport, difficult to measure and administer, they create stability, storage, palatability problems and often contain undesirable excipients.

Oral dispersive tablets (ODTs) can answer to some of these problems. ODTs are oral solid dosage forms that disintegrate rapidly in saliva and enable oral administration without water or chewing [1]. Original ODTS were manufactured using lyophilisation technologies, put it is now possible to manufacture ODTs using direct compression technologies. A number of commercial companies prepare direct compression excipients for ODT formulations. These are usually presented as granules comprising a sugar alcohol, for example mannitol and a disintegrant such as starch or crospovidone. With the additional of a glidant, such as magnesium stearate, an active substance and flavours a simple basic compressible tablet can be formulated. It is possible to manually compress individual tablets using a manual single punch system. However, these are not very practical and small semi-automated single punch tablet presses are available.

While basic formulations are relatively simple to produce ODTs can present challenges. These tables are hydroscopic and fragile so specialist packaging is required. Films and coatings can be applied but present problems due to the rapid dissolution and friability of these tables. Taste masking of unpleasant tasting active substances (AS) may be required. If these tablet are to be placed directly on the tongue, then they must be pleasant tasting. Taste can be masked by the addition of sweetening agents and flavours, but more sophisticated methods such as spray coating the active substance may be required. Dosage is limited by tablet size and the percentage of AS that can be incorporated easily into the formulation. Finally, in small children choking may be a limitation [2]. Methods to overcome this are size of the tablet, and speed of dissolution.

Oral dispersive tablet manufacture presents challenges, but may be an opportunity for a specialist hospital unit to develop a new and useful dosage formulation.

[1FDA, CDER data standards manual (C-DRG-00201 Version 008), www.fda.gov/Drugs/ DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ DataStandardsManualmonographs/ ucm071666.htm, accessed Sept. 3, 2016.

[2McLaughlin, R., Benbury. S. and Crowley, K. Oral disintegrating tablets – The effect of recent FDA guidance on ODT technologies and applications. Pharmaceutical Technology, Sept 2009. http://www.pharmtech.com/orally-disintegrating-tablets-effect-recent-fda-guidance-odt-technologies-and-applications, accessed Sept. 3, 2016.

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