ISSUE NO. 38 — Achieving Optimal Preclinical Formulation and Drug Product Manufacture
Formulating and manufacturing drugs for preclinical testing is an early—and necessary—step towards pushing your molecule through to human clinical trials. At the preclinical stage, the goal is to maximize exposure for safety testing, formulating the limits of solubility and maximum volume. To optimize the formulation for preclinical testing, it’s important to consider the following for informed decision-making regarding feasibility, scale-up, and the future success of your program: route of administration, excipients selection, stability testing, scale-up plans and options, and contingency plans.
Issue 38 of The Altascientist explores the key considerations for successful formulation development and manufacture for safety assessment, alongside examining the strategies Altasciences employs to support you in planning your program.
Preclinical manufacturing involves various sub-processes, all of which are critical in overall drug development. And in this issue, you will discover these sub-processes in detail, including:
- formulation development
- manufacturing process development
- scale-up
- process validation
- analytical method development and validation
- quality assurance and control
- stability studies
- regulatory compliance
- risk management
Also included is a case study about how Altasciences helped a client get their new API through the preclinical development phase with a robust formulation at the maximum potency.
COMMON ROUTES OF ADMINISTRATION AND DOSAGE FORMS
The common route of administration for preclinical testing is oral, due to its translatability to patients, typically liquid formulations that can be adjusted easily based on the weight of the selected test systems. If suitable exposure is not possible via the gastrointestinal tract, then intravenous or subcutaneous administration may be possible using solutions. For dermal studies, creams or gels are ideal since they remain at the site of administration for the intended duration, to generate adequate exposure to the formulation.
Whatever the route of administration, determining the maximum concentrations and the maximum volumes that can be dosed in the test species provides early data regarding the feasibility of achieving appropriate doses for clinical trials. Ensuring that the selected formulation can be scaled up throughout development is a key component of formulation planning.
Many other dosage forms are possible throughout the development process, including nanomilled suspensions, solutions, creams, gels, powders, tablets, liquid- and powder-filled capsules, over-encapsulated capsules, and injectables.
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