Process and dosage form controlts: Formulation factors

Abstract

During the last decades, there have been considerable developments in the field of pharmaceutics, pharmaceutical technology and product manufacture.

The trend of the pharmaceutical industry is, like in most of the sophisticated industries, to produce, day after day, a better product, and as final goal, to manufacture continueously a perfect drug dosage form.

A few years ago, the defaults were counted in “percent”. After that, it was in per “thousand”. Now it is often expressed in “per million”, or even for very high series (for example empty hard gelatine capsules) the trend is “per billion”. Such an evaluation can only be achieved with a complete control of the whole manufacturing process.

The requirement for pharmaceutical dosage form are numerous (1): adequate biopharmaceutical profile, ease of manufacture, quality assurance (the dosage form must contain the correct quantity of the correct drug, and liberate it at the correct place, at the correct time, and in the correct quantity, with the correct speed), stability, …

These requirements can only be fulfilled with a perfect knowledge of the drug and the dosage form, from the beginning of the development of the dosage form (formulation) to the end of the manufacturing process (production and final product control).

It is the aim of the present lecture to show how important are the formulation factors and what is their influence on the processing and the dosage form control.