Development of a pharmaceutical product is essentially a technique
where in physicochemical properties of an active ingredients,
excipients and manufacturing process are manipulated to achieve
desired qualities in pharmaceutical finished dosage form. Certain
goals such as product specifications, ease of manufacturing cost
etc are defined for a dosage form prior to initiating the
development work. The traditional trial and error approach may be
less dependable and more time consuming and often provides an
approximately or marginally acceptable formulation and process. In
today's market optimization requires skill in understanding
physicochemical properties of their materials and effect on the
process identification and independent (cause) and
dependent(effective) variables and understanding of expected
relationship between cause and effect is crucial to the success of
this approach.
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