Pharmaceutical companies can remove a perfectly active drug from one indication, reformulate it in a minor way without any chemical alteration (for example modifying the dose or altering the formulation), and rebrand it for a new indication at a substantially higher price.
These results demonstrated the possibilities of modulating the release profile by means of the processing parameters rather than through the classical approach of altering the formulation.
These are a few examples of how a clinically and commercially beneficial drug product could be launched in the market by altering the formulation strategies.
To achieve equivalence, there are two general strategies which can be used to modulate aerosol output and lung deposition of pMDIs; the first is altering the formulation parameters such as propellant and excipients which we have previously reviewed [ 8, 11].
Zinc II) stearate exhibit highest activity towards acceleration and its inclusion does not alter the viscosity of the formulation offering a processing advantage.
Small changes in excipients can alter the properties of a formulation (e.g. lead to differences in particle size, or modify the shelf-life) and hence affect drug efficacy and safety.
However, due to this pH dependence, the change in the formulation process could alter the disintegration and/or dissolution profile of the drug, possibly making the results of bioequivalence studies misleading.
This experiment simulates the effect of carry-over impurities from the synthesis of the adhesive polymer that could potentially alter the pH of the adhesive formulation.
