On Weds 27th May, Shilpa Mistry, our head of Pharma for UK and Ireland, delivered a webinar for Making Pharma on the challenges of formulating oral-dispersible-tablets (ODTs). In this blog we provide an overview of her presentation and the featured products for anyone who missed out on the webinar or who is looking for further details.
If you missed the webinar or would just like to view the presentation again you may download the presentation PFD here.
You can also watch the recording of the webinar on this link. In addition to Shilpa’s presentation the webinar also features Nick Carter of Wessex Fine Chemicals and Karla Noortman of Cabot in conjunction with Brenntag.
What’s the challenge with ODT?
ODTs are popular because the tablet – or powder – doesn’t require water to swallow, they absorb quickly and don’t need to move through your gastric system to be absorbed.
When formulating ODT we’re focused on dispersion within 30 seconds (to suit all world markets), but we’re also looking at the following challenging factors:
- Mouth feel
- Taste masking
- Residue in the mouth
- Tablet hardness
- API compatiblity with excipients
- Stability overall
So while there are many benefits to using ODTs, especially in geriatric and paediatric applications, there are formulation challenges to overcome too. To manage these factors we need to identify products on the market which can help us overcome these challenges. At Chemlink Specialities we’re lucky enough to work with some world-leading manufacturers who have developed smart solutions for ODT formulation. Here are four such ingredients…
This product is a dual excipient which has disintegrant and binding properties, and requires a very low water uptake without peroxide, meaning it is a very stable product to use in your ODT formulation. If you’re looking for a fast disintegration time in a high-quality stable tablet, then L-HPC is a good option.
- Higher stability due to its non-ionic nature and low hygroscopicity
- Disintegration into smaller particles leading to better dissolution
- Anti-capping effect for tableting process
- Suitable for pellet extrusion as well as tableting
- A variety of grades are available depending on application
Being non-ionic, L-HPC also has the benefit of being less reactive to active ingredients than ionic alternatives. Studies show that over time L-HPC tablets remain stable, do not discolour or show surface degradation.
SmartEx is a new co-processed excipient specifically designed for ODT which contains D-mannitol (filler), L-HPC (disintegrant) and PVA (binder).
There are two grades for this excipient to meet your requirements; fast disintegration or hard tablets. This product can also be used for immediate release tablet formulations by direct compression and its use in a formulation can speed up the development of the product.
- High compressibility
- Fast disintegration
- Good mouth feeling
- Good flowability
- Excellent stability
HiSORAD™ is a state-of-the-art co-processed excipient for orally disintegrating tablets designed to have well-balanced property between oral disintegration time and tablet hardness. Consisting of two excipients and one disintegrant it is applicable for versatile ODT formulations. The unique manufacturing process provides a high functionality product with a relatively simple composition which can be combined successfully with a high API load.
- Excellent compatibility
- High API loading capacity
- Well-balanced tablet property between OD time and hardness
- Simple composition
- Fast disintegration, even with high tablet hardness (under 30 seconds)
Improving the taste of ODT is critical to patient acceptance, with APIs often producing a very bitter taste and so resolving this challenge is important for ODTs most prominent applications; geriatric and paediatric.
galenIQ™ is a highly functional filler-binder which stands out for its well-balanced sweetness to mask the unpleasant taste of APIs and plant extracts.
- Chemically stable
- Water soluble
- High flowability
- Well-defined particle size distribution
- Sugar-free but with a natural sugar-like taste (suitable for diabetics)
galenIQ™ can be used in virtually all oral pharmaceutical formats.
In conclusion, there are of course, advantages and disadvantages to each of these products, but with the help of our technical team we can help you to formulate ODT solutions per your specific requirements.
Looking For ODT Formulation Assistance?
Shilpa Mistry is available for phone or teleconference meetings to discuss your specific ODT formulation challenges. Please email her directly via this form to arrange a suitable time.
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