Phase 2: Preformulation Studies
Phase 2: Preformulation Studies contains 5 topic pages in Pharmaceutics.
Preformulation is the first substantive scientific stage of pharmaceutical product development. It comprises the systematic study of the physicochemical properties of a new drug substance, generating the information necessary to design a stable, safe, and effective dosage form. The data produced during preformulation defines the fundamental nature of the molecule and directly guides the formulation strategy, excipient selection, and storage conditions that follow. A rigorous preformulation programme substantially reduces the risk of costly late-stage formulation failures and forms the essential evidentiary basis upon which every later development decision rests.
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Drug Physical Characterisation
Physical characterisation of the drug substance establishes its fundamental solid-state identity and is typically the earliest preformulation activity...
Solubility and Dissolution Behaviour
Aqueous solubility is arguably the single most consequential physicochemical property assessed during preformulation, since a drug must dissolve before it...
pKa, LogP, LogD and Ionisation
The ionisation constant, or pKa, describes the pH at which a molecule exists in equal proportions of its ionised and un-ionised forms, and it is determined...
Excipient Compatibility Studies
Excipients are pharmacologically inert substances included in a formulation to impart bulk, aid manufacture, control release, or enhance stability, yet...
Biopharmaceutics Classification System
The Biopharmaceutics Classification System, universally abbreviated BCS, is a scientific framework that categorises drug substances according to two...