Moving a compound from lead selection to clinical studies presents several challenges. One way to address these is with specialized encapsulation techniques that remove the need for pre-formulation steps and excipient compatibility testing in early clinical evaluations.
Such techniques also allow for the rapid screening of active pharmaceutical ingredient (API) candidates in a clinical setting, and reduce early-stage product development time, according to the contract development and manufacturing organization (CDMO) Lonza Pharma & Biotech.
Jan Vertommen, senior director, head of commercial development for dosage forms and delivery systems at Lonza Pharma & Biotech said “the best way forward” for compounds that may not require an improvement of its oral bioavailability is micro-dosing of the compound in a capsule.
This provides “a quick clinical read out,” enabling a decision to be made about whether further product development should be pursued, said Vertommen.
“For compounds which are likely to require an oral bioavailability enhancement, microdosing of the compound in a capsule may still be an option to get a quick clinical read out while, in parallel, development of an enhanced formulation is undertaken,” he explained.
Based on the compounds characteristics Vertommen stressed the importance of selecting the best formulation approach, or approaches. This includes particle-size reduction (micronization or nano-sizing), lipid-based formulation, or amorphous (e.g. spray dried dispersion) approaches.
As he explained, precision powder micro-dosing systems facilitate the rapid manufacture of API powder-in-capsule (PIC) drug products. Thus enabling expedited dosing of the drug product in clinical trials.
“These PIC dosage forms can reduce the amount of API required and early-stage evaluation time by eliminating the need for specific formulation steps, such as excipient compatibility testing,” Vertommen explained.
PIC programs have several benefits, he noted. “First, they streamline product development and increase efficiencies via programmable and precise dispensing of drug substance into capsules.
“Second, they provide supporting GMP documentation including weights for each capsule produced; and ensure a timely and cost-effective production.”
Beyond first in human (FIH) and Phase I studies, Vertommen said customers are using the PIC approach in later stages – “recognizing its applicability for Phase II/III studies and considering the approach for the commercial launch of new products.”
This has been particularly evident in the field of oncology, he said: “With multiple fast track programs, PIC has become an option to bring the compound from lead selection through to commercial launch in an expeditious and cost-effective way.”
At CPhI Worldwide, taking place next week in Madrid, Vincent Bechtel with Lonza will be presenting “Encapsulation best practices for early clinical studies” on 10/10 at 14:10 in Hall 1 ICSE.
