Bilcare Research - Pharma needs a scientific approach to product stability

Packaging plays a crucial role in the stability of pharmaceutical formulations and, hence, the selection of the optimal packaging plays a vital part in the pharmaceutical product development cycle.


ICH stability studies are often the methods employed to decide on the packaging of pharmaceutical products. This approach leads only to a confirmation of the prior chosen set of packaging.

Innovators often pack the product in the highest barrier packaging, which gives them a perceived assurance of passing stability tests. Generic formulators usually follow the innovators for presumed surety of passing the stability tests. Thus, the process conventionally followed is not scientific enough to yield ideal packing and leads in most cases to over-protection, which is generally a consequence of not fully realising a product's true barrier requirement. Also, passing ICH stability studies alone cannot confirm the stability of the product marketed under wider climatic conditions. This approach causes pharmaceutical companies loss of markets, delays in product launch, non-optimum usage of valuable scientific resources and higher developmental cost than the obvious effects of higher packaging costs.

Limitations of high-barrier packaging

Furthermore, blindly selecting a high-barrier packaging cannot always ensure product stability, but can also lead to potential stability issues. Products with a tendency to release gas need a breathable film and it could be disastrous if one selects a high-barrier packaging. If the product is oxygen-sensitive, then it would not be stabilised by packing in the highest moisture barrier film as it has a lower oxygen barrier. If the initial moisture content present in the product before packing is the triggering factor for auto-degradation, then a 100% barrier packaging cannot ensure stability. If the product is temperature-sensitive, even a complete barrier packaging cannot ensure that the product will pass accelerated stability studies.

"BilcareOptima offers a reliable tool to decrease time to market and be cost-effective in the correct selection."

Absorption isotherm studies show that products absorb significantly higher moisture under the low-temperature and high-humidity conditions that prevail in the field than in the high-temperature and high-humidity conditions used in accelerated stability tests, and hence a higher rate of degradation can be seen in moisture-sensitive products under the actual conditions rather than those observed under accelerated conditions.

Barrier properties of the flat film are often the basis for packaging material selection; however, this does not represent the actual protection a product gets in the final blister due to the significant thinning of the barrier film during cavity formation. Thus, the dosage form and its size play a key role in selecting the barrier film.

Selecting the right packaging material

BilcareOptima offers the pharmaceutical industry a reliable tool to decrease time to market and the ability to be cost-effective in the correct selection, at the first attempt, of a packaging material for final stability testing. BilcareOptima covers the stability tests of the active ingredients and the complete formulation, a simulation of the blister geometry using finite element routines and adds the knowledge of Bilcare Research about available and innovative barrier materials.

Already proven on various drug/packaging material systems from major brands in the pharmaceutical industry, packaging material cost reductions of around 30% are the normal savings that have been achieved in the past - not taking into account internal savings by trialling various materials and the unique advantage to concentrate in advance on the right materials. Already at an early stage of developing a new drug, stability screening will lead to the right packaging material. Turnover advantages of earlier time to market scenarios are bonuses for the pharmaceutical industry.

Generic formulators can decide at an early stage to use BilcareOptima, which may, if possible, take out the cost of the current packaging design. With BilcareOptima, testing facilities as well as its knowledge of packaging materials and the packaging process, Bilcare Research bridges the expertise gap between the pharmaceutical industry and the packaging industry.

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