On the pathway to clinic, solubility remains one of the biggest hurdles: CDMO

By Maggie Lynch contact

- Last updated on GMT

(Image: Getty/shutter_m)
(Image: Getty/shutter_m)

Related tags: CPhI Worldwide, Solubility, CDMO, Clinical development, Preclinical contract research, Preclinical services, bioavailability, Pharmacokinetics

For CDMOs, balancing time, formulation trends, and changing technologies are some of the obstacles on the pathway from formulation to the clinic.

Ahead of CPhI Worldwide next week, we spoke to Mikael Bisrat, sales director at Recipharm who will be presenting on the challenges facing drug development and the ways in which they can be met by contract development and manufacturing organizations (CDMOs).

“The biggest challenge is often ensuring that limited time, effort and resources are spent developing a suitable formulation for Phase I, and at the same time ensure that these results pave the way for further development into Phase II/III,”​ he told us.

Bisrat said this process can be complex and requires expertise to ensure that companies do not have to change formulation later in the development process, which might lead to differing pharmacokinetic (PK) profiles.  

These challenges can be prepared for at the onset of the project, however. “We know that the active pharmaceutical ingredients (APIs) physicochemical properties, together with the intended therapy area, can have a profound effect on the choice of dosage form and the factors which affect the pharmacokinetic profiles of the API,” ​explained Bisrat.

Poor solubility and potential solutions

Poor solubility​ remains one of biggest hurdles to drug development, and is one challenge that is seemingly here to stay, says Bisrat. Yet, new drug delivery platforms and technologies are continually being developed to help remove challenges.

Many of these technologies, however, are currently best suited to preclinical and early clinical studies and would be difficult to take to a commercial scale, Bisrat explained.

Some of these techniques include the use of nanoparticles, meoporous particles containing the drug in amorphous form, among others.

Bisrat said it also is common to receive requests for new formulations based on “old” APIs, in which case the new intellectual property (IP) and market differentiation lies in the formulation and not the compound.

“In many cases this is not just incremental improvements of existing products but includes dosage forms for new administration routes and new indications​,he added.

Many of the new drugs are very lipophilic and poorly soluble in water and as mentioned there are numerous techniques being developed to meet these challenges,

Whether it is by changing solid-state properties in new and controlled ways, or by introducing new excipients to the market, Bisrat reiterated that numerous techniques being developed to meet some of the industry’s biggest challenges.

“Our challenge as a CDMO is to select and adopt these trends and technologies, introduce them across our facilities, and then offer them to our clients,”​ he said.

At CPhI Worldwide, taking place next week in Madrid, Mikael Bisrat will be presenting “Navigating the pathway from formulation to clinical trial: A Case study” on 09/10 at 16:30 in Hall 1 ICSE.  

Related topics: Preclinical Research, Preclinical

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