| Chhanda Da |
Blister packaging is a versatile option and has the capacity to provide optimum protection with availability of wide range packaging components comprising different barrier properties. However, for the same reason, identifying the most suitable blister packaging material is complex. There are various issues involved in selecting the right material as well optimising the machine parameters. It needs a very good understanding of the film properties vis-à-vis application/ machine parameters for getting an optimal packaging performance.
Each drug is made up of molecules of different structures and nature. Even the same drug is formulated with various kinds of excipients. Hence, it is quite natural that each formulation behaves differently on environmental changes and hence packaging needs of each formulation are different from others.
It is a normal practice to imitate the packaging of innovative products and also of other established brands, but never succeeds in getting the suitable packaging as the packaging requirements are different with different formulation even if the active ingredients are same. This could lead to failure in the stability study and also can cause recalls due to the failure in the market.
Therefore it is of prime importance to understand each formulation for its environmental sensitiveness and design the packaging according to its needs. This is the prime draw back of conventional packaging development method, which is based on a trial and error method. Even the size and shape of the dosage form are trivial factors in deciding the film complex used for blister packaging. Any packaging selection done without understanding these factors is prone to failure.
ICH stability study is often the method employed to decide on the packaging of pharmaceutical products. Formulators usually follow the innovators for presumed surety of passing the stability tests which is not scientific enough to yield ideal packing and leads in most cases to over protection or under protection not fully realising a product’s true barrier requirement. Also, as ICH stability does not cover product marketed under wider climatic conditions (tropical conditions), it may cause loss of markets, delay in product launch, higher developmental and packaging costs. An optimal packaging with respect to all techno-commercial aspects provides clear, quantifiable benefits to the product. Often these benefits are not been quantified and documented correctly. Hence, its importance is not understood properly.
For new products it is presumed to be safe practice pack in highest barrier package to ensure that there is no failure in the stability study in order to avoid any delay in the launch of the product. However, in many cases this could be counterproductive. As an example, products with a tendency to release gas need a breathable film and it could be disastrous if one selects a high barrier packaging. Same with oxygen sensitive products, an expensive popular choice for highest moisture barrier film has lower oxygen barrier property and is surely not an option for product sensitive to oxygen also. If the initial moisture content is the triggering factor for auto-degradation, then even a 100 per cent barrier film cannot ensure stability.
Study of absorption isotherm studies shows that products absorb higher moisture under low-temperature and high humidity conditions that prevail in the field than the high-temperature and high humidity conditions used in accelerated stability studies. Hence, a higher rate of degradation may be observed in moisture-sensitive products under the actual conditions rather than those observed under accelerated conditions.
BilcareOptima offers the pharma industry a reliable tool for scientific identification of the most optimum packaging that decrease the time to market and packaging cost without any fear of stability failure at the first attempt, in a span of 40 days only. It covers physical and chemical forced degradation tests of complete formulation, a software simulation of the blister geometry using finite element analysis and all about the available/ innovative barrier packaging materials.
It has been proven on various studies involving few major brands in pharma industry that cost reductions of about 30 per cent have been achieved not considering the internal savings on trials/first to file/launch of the product and finally advantage of selection of right materials.
So with BilcareOptima, Bilcare Research bridges the gap between the pharma and the packaging industry, by providing the testing facilities and the required knowledge about the packaging process and the materials.
(The author can be contacted at chhanda.das@bilcare.com)