Formulation and processing factors

There are numerous reports describing the effects of formulation and processing variables on dissolution and bioavailability. All excipients used in the formulation of dosage forms and processes used 

Aspirin product Disintegration time (s) Mass drug dissolved in 10 min (mg) Mass drug excreted in urine (mg) 

Adsorption of some drugs, especially vitamins, on diluents such as kaolin. Fuller s earth or hentonite can occur in capsule and tablet dosage forms. The physical adsorption can retard dissolution and, hence, hioavailahility. Some calcium salts (e.g. dicalcium phosphate) are extensively used as diluents in tablet and capsule dosage forms. The original use of dicalcium phosphate in a tetracycline capsule formation resulted in poor bioavailability. Lactose tends to react with amine compounds causing discoloration. 

The concentration and the type of disintegrating agent used in a tablet dosage form can greatly influence the dissolution and bioavailability of a therapeutic agent. The dissolution rate is usually increased when the concentration of starch is increased in a tablet formulation. The effect of 

The dissolution of drugs from tablets can be affected by the type of starch used as a disintegrant 

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This description reflects a view from the manufacturing side— beginning with the end in mind. Therefore, the goal Product quality and performance achieved and assured by design of effective and efficient manufacturing processes is placed before Product specifications based on mechanistic understanding of how formulation and process factors impact product performance. ... 

Product specifications based on mechanistic understanding of how formulation and process factors impact product performance. 

C. Influence of Formulation and Processing Factors on Physical State of the Drug... 

Because extrusion-spheronization is a very complex manufacturing process that depends on a number of formulation and processing factors (Table 1), it has been studied extensively. Some of these studies used multifactorial statistical designs to determine the significance of the various factors identified above. Despite the extensive work that had been done, additional research is still ongoing as demonstrated by the number of publications in various scientific journals.f ... 

G Needham. Formulation and processing factor affecting residual solvent levels in TBA/water formulations. Freeze-Drying of Pharmaceuticals and Biologicals, Breckenridge, CO, August 1-4, 2001. 

The formulation and processing factors that can be tailored to customize the product attributes include ... 

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