Description

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.