Track 10: Pharmaceutical Formulation
Pharmaceutical formulation, in pharmaceutics,
is the process in which different chemical substances, including the active
drug, are combined to produce a final medicinal
product. The word formulation is often used in a way that includes
dosage form. Formulation studies involve developing a
preparation of the drug which is both stable and acceptable to the patient. For
orally administered drugs, this usually involves incorporating the drug into a
tablet or a capsule. It is important to make the distinction that a tablet
contains a variety of other potentially inert substances apart from the drug
itself, and studies have to be carried out to ensure that the encapsulated drug
is compatible with these other substances in a way that does not cause harm,
whether direct or indirect.
Preformulation involves the characterization of a
drug's physical, chemical, and mechanical properties in order to choose what
other ingredients (excipients) should be used in the preparation. In dealing
with protein pre-formulation, the important aspect is to understand the
solution behavior of a given protein under a variety of stress conditions such
as freeze/thaw, temperature, shear stress among others to identify mechanisms
of degradation and therefore its mitigation. Formulation studies then consider
such factors as particle size, polymorphism,
PH, and solubility, as all of these can influence bioavailability and hence the
activity of a drug. The drug must be combined with inactive ingredients by a method which ensures that the
quantity of drug present is consistent in each dosage unit e.g. each tablet.
The dosage should have a uniform appearance, with an acceptable taste, tablet
hardness, or capsule disintegration.
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