1.) What is the minimum order quantity?
The minimum purchasing quantity cannot be defined in general. If you are interested in a finished medicinal product, it must be millions. If you are interested in a new development, we will be pleased to provide assistance during development. In this case we will start with “empty XStraws®” – a few to several hundred pieces or maybe several thousands. Later, it is possible to install a semi-automatic or “small” production machine (max. 10 XStraw®/min) at your site or use one at a CMO’s facility for filling purposes. Naturally, there is also a production machine with a maximum capacity of 320 XStraw®/min as a potential investment or it can be used at a CMO’s facility.
2.) What are the costs compared to traditional formats such as tablets, capsules, ...
Costs for the XStraw® are higher than for standard oral administration forms such as tablets and capsules. When comparing the costs with those of modern or more elaborate administration forms like stick-packs, dry syrups with measuring spoons or dosing syringes, effervescent tablets etc., the differences are insignificant (with large quantities). There are added values associated with the XStraw® as an oral drug delivery device to keep in mind: Improved product loyalty and simplified intake. Therefore, the cost issue should not be the only decisive factor. Compared with the costs for more elaborate drug delivery devices such as pens, autoinjectors etc., the XStraw® is considerably less expensive and much simpler.
3.) What data is required to establish a business case?
- What API or medicine?
(also combinations of API possible)
- Dedicated or non-dedicated API?
- Is Formulation development (to do granules or pellets) necessary (CDO services)?
- If not, will the pellets be manufactured at clients site or is our CMO requested to manufacture them?
- Countries, where the product(s) shall be launched? (for the calculation of the license fee)
- Is exclusivity required? (which would mean that no other client is allowed to launch the same API in the same target countries)
- Estimated sales forecast per annum? Over 3 / 5 years? (in order to calculate the utilization of a production machine)
- Packaging requirements? (e.g primary packaging in aluminum pouch, secondary packaging in folding box)
- Desiccant required? (because the product is moisture sensitive)
If not all questions can be answerd upfront DS-Technology will make some assumptions accordingly.
4.) Is it worth to develop pellets only for use in the XStraw®?
In general, pellets are more expensive in manufacturing than a powder blend for tableting. But it is always the question whether or not a product achieves a lucrative margin within existing competitors which are well-established. A clear answer is difficult to provide. There are many factors to be taken into consideration:
5.) Can we get empty XStraw® or XStraw® filled with Placebo?
Yes certainly! It is our great pleasure to supply empty XStraw® to enable you to make your tests and evaluation in-house; up to 500 units, this can be done free of charge; higher volumes need to be priced as it takes some effort to manufacture them on our existing equipment;
|Same is valid for Placebo-filled XStraw®, up to 50 pieces we supply free of charge; once higher volumes are required we need to price them due to of the manufacturing effort, especially the packaging in aluminum pouches;|
Questions that can only be answered once a CDA is in place...
The Patent Situation? Who invented what and who owns the IP rights today? What patents?
How DS TECHNOLOGY is able to facilitate and support the Evaluation Process of a potential Client?
The Limitations in regard of Drugs? E.g. Drug Load or max. Volume?
The Limitation in regard of Commercial Matters?
Whether data is available showing the safety of this Drug Delivery Device?