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From Core to Coating, Your Supplier of Choice www.colorcon.com Do you Need Advice on a Starting Formulation for Your Newest SOD Project? Raise your performance expectations to match your organization's development needs. With Colorcon's speciality film coatings, excipients, modified release technologies and taste-masking solutions you can achieve the optimal finished dose, plus reduce your development time and cost. Ensure peak performance and the perfect finish for your dosage form. Targeting Performance 16 July 2018 Tablets & Capsules bioavailability, i.e., a lack of detectable amounts of API in the blood. In clinical Phase I studies, you will discover that failure quite quickly, in the single ascending dose (SAD) study. Then you can terminate the formulation work or put it on hold pending further review of the project findings. It is unusual for a new oral drug candidate to fail due to unacceptable side effects in the Phase I study, but it can happen. In my experience, it is more likely that you will not detect an unacceptable side effect until partway through clinical Phase II, and such a failure is always a risk with any new drug candidate. Again, you can place any formulation work on hold pending the outcome of a clinical review of the project. I have one exception to that general rule, which concerns ongoing stability studies. If a likelihood exists that a development program will eventually resume, then it can be worthwhile continuing ongoing stability programs because you will need the data. To abandon such studies could complicate the restart of the clinical program by requiring an update of the shelf-life of clinical supplies in the field. In conclusion, some individuals tout API powder in a bottle or capsule as a quick way into clinical Phase I. Be careful! Choose the drug candidate for such an approach wisely! If you get it wrong, unless you and your backers have very deep pockets, you will kill the project prematurely. T&C Chris Moretonis vice president, pharmaceutical sciences at FinnBrit Consulting (781 894 2572, www.finnbrit.com). This article was first published in Solid Dose Digest in September 2017. newer, unit-dose filling systems, it can take several days. In any event, starting from scratch to manufacture Phase II supplies after the results of the Phase I studies—even continuing with API powder in a bottle or capsule—can take several months by the time you sign the contracts, reserve the manufacturing slot, and design, develop, make, test, and release the supplies. To avoid a prolonged delay between the end of clinical Phase I—API powder in a bottle or capsule—and the start of clinical Phase II—tablet or capsule formulation—and to produce follow-on supplies more easily, you need to start the formulation work for the clinical Phase II formulation—and possibly the clinical Phase II and III formulations—in parallel with the work to manufacture the supplies for API powder in a bottle or capsule for clinical Phase I. You will also need to undertake a bioequivalence study comparing the new formulation with the powder in a capsule or bottle formulation, which adds further expense and time. Quite simply, the lead time—several months—makes the early formulation for the later clinical phases inevitable if you do not want to have a significant delay between the end of clinical Phase I and the start of clinical Phase II. Thus, how much money can you actually save using an API powder in a bottle or capsule if you want a smooth transition from clinical Phase I to clinical Phase II? Many of you will ask, "What if my drug candidate fails in Phase I?" For oral drug candidates in clinical Phase I, the only reason for failure that I have seen was a lack of