Balancing the time, cost and risk of drug development. Christina Gustafsson, PhD Pharm, Formulation Scientist at Pharmaceutical Development, APL

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1 Balancing the time, cost and risk of drug development Christina Gustafsson, PhD Pharm, Formulation Scientist at Pharmaceutical Development, APL

2 Communicating vessels Risk Time Cost

3 Communicating vessels Risk Time Cost

4 From drug substance to Investigational Medicinal Product (IMP)

5 From drug substance to Investigational Medicinal Product (IMP) Formulation Manufacturing process Analytical method Packaging Efficasy Safety Stability Uniformity of dosage Appearance Price Patient acceptability Ability to patent

6 Our experiences being a CRO/CMO what does the customer want? Keep it as simple as possible we only want to show proof of concept Skip excipients as far as possible Low cost But the choice of formulation may affect clinical results and the possibility of further scale up and manufacturing

7 Risk assessment during formulation A simple formulation in early clinical trials may be acceptable, but then work in parallell to develop a formulation suitable for scale up, later clinical phases and for commercial manufacturing Be aware of the drug substance (DS) batch to batch variation is common during process development and scale up of manufacturing of DS! How robust/forgiving is your formulation, will it compensate for changes in DS? Particle size and particle size distribution Particle shape and surface roughness Polymorphs, changes in crystallinity/amorphous content Solubility

8 Example No 1: Batch variations and robustness of formulation Particle size distribution of DS changed between first and second manufacturing of clinical material for capsule formulation When DS particle distribution changed, mixing with excipients did not result in homogenous powder mixture anymore Customer did not want to change excipients since one clinical trial already had been performed Need for micronization -> delay of 6 months

9 Example No 2: A quick solution may be costful Capsule formulation where a new lower dose of the drug is wanted quickly Earlier development had shown lump formation during mixing of lower dose filled in the same capsule size Solution: Use excisting powder mixture but fill in smaller capsule size and modify mixing process Result: IMP possible to manufacture but problems to obtain robust filling process due to low filling weight causing deviations and need for capsule weight sorting What would we have done if we had more time: Developed new composition without tendency of lump formation

10 Example No 3: Development is not full scale a) A gel developed in small scale Customer wants to take the risk to do scale up to 4 kg directly -> Results: Mixing technique showed to be insufficient to prevent lump formation b) Ointment developed in small scale During scale up to 50 kg batch size, one excipient in the formulation is burned at the higher temperatures generated during mixing in larger scale

11 Example No 4: Do not discard alternatives to early Formulation development of semi-solid where customer chooses to put only one of five developed formulations on stability study Accelerated stability study 40 C for one month show no deviations The product shows to turn granular when stored in room temperature after 2 months, i.e. before 3 months stability pull point Consequence: Restart with three new compositions that are manufactured and put on stability study

12 Example No 5: The importance of compatibility studies Compatibility study performed with potential excipients for oral product suggested to be wet granulated in order to develop both capsule and tablet formulation Stability study shows that wet granulated formulation is not stable in any composition with suggested excipients No delay since dry mixing compositions also was included the rather extensive compatibility testing matrix

13 Conclusions Balance the formulation development work based on the what the DS needs and requirements of the final product Work if possible in parallel with development for larger scale if very simple formulation is chosen initially What is gained in time with simple formulation for quick start Balance of clinical trials may easily be lost or reduced in value if the DS is changed or the manufacturing process shows not to work in formulation development lager scale DS with is always work based on the when what the knowledge needs of the final product

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