The excipient – Parteck MXP – is stable at temperatures of up to 200 degrees Celsius and can achieve active pharmaceutical ingredient (API) loads of more than 30% by weight. Most commercially available HME excipients have load capacities in the 10 – 15% range.
Germany-based Merck has used the excipient to develop formulations of a range of APIs, including ibuprofen, indomethacin and itraconazole.
Rachel Bloom-Baglin, Head of External & Executive Communications at the life science business of Merck, told us the high loading capacity has potnetial benefits for patients and manufacturers.
“Most of the products on the market have some limitation in the amount of API which can be loaded."
“Having a high drug load leads to fewer limitations on the dose strength that can be made into a single tablet,” she said, adding “It also leads to smaller pill size, fewer number of pills which need to be taken in a dose and cost efficiencies in manufacturing because more tablets and capsules can be made from each batch.”
Partech MXP will be manufactured at Merck's site in Darmstadt, Germany according to Bloom-Baglin, who told us "The cost of the product is comparable to other polymers used in HME processes."