Pharmaceutical Formulation

Pharmaceutical formulation could be simply defined as the design of dosage forms. However, this definition is too simplistic, since it does not reflect the complexity of developing pharmaceutical dosage forms. In the past the art of formulating had as main objective to make drug administration easier and enjoyable, but probably it always had associated, albeit incipient, the concern of stability. Currently pharmaceutical formulation, in addition to facilitate drug delivery and stability must ensure adequate bioavailability. Using preformulation as starting point, biopharmacy as support, and having as a backdrop regulatory aspects and what was defined in the project development (target product profile) pharmaceutical scientist may formulate. In practice, formulating consists in selecting the excipients, the manufacturing process, and evaluating the formulations obtained using physicochemical and pharmaco technical tests. These tests allow selecting, optimizing and evaluating pharmaceutical preparations based on pre-established specifications. Formulation, which for many centuries was an art, begun, during the last century, to lose gradually this status in favor of a scientific –based approach, initially by controlling one factor at a time. Currently, almost all pharmaceutical technologists are aware of the disadvantages of one factor at time and recognize the advantages of statistical approach (Design of Experiments) in the formulation.

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Last date updated on September, 2024