Clinical packaging is a big concern for pharmaceutical companies in today's time. According to ICH guidelines the optimal amount of humidity and temperature has to be maintained while packaging, so that the formulation retains its stability. Not knowing what the exact packaging requirement for their products is, the pharma manufacturers often end up either packaging their product above or below the desired requirement. Above requirement means they purposely pack their formulation in high barrier packaging materials. This is done to reduce analytical workload and qualifying for the stability tests. However, over-packaging may unnecessarily add up to the packaging cost.
Packaging below the desired requirements means that the manufacturer is focusing only upon the ICH guidelines. However, the ICH guidelines are formulated by considering the temperature and humidity conditions in Zone I & II (USA and European regions) only. These guidelines do not necessarily assure stability of a formulation in tropical regions. If a manufacturer decides to stick to ICH guidelines only, then it may lead to catastrophic losses for him in tropical regions. Bilcare has come up with a very innovative and cost-effective solution for this problem. Bilcare Optima is a result of 11 years of incessant study and analysis of exact packaging requirements of a formulation.
This first and only scientific packaging development method understands the exact packaging requirement of the pharmaceutical formulations. This is done through a scientific study that quantifies the environmental and dimensional sensitivity of the pharmaceutical formulations. Thus, it identifies the optimum packaging of any pharmaceutical dosage by understanding the degradation pattern of the formulation and then correlating it to the barrier property of the packaging material without conducting the conventional stability studies. Bilcare then submits the report along with recommendations for primary blister packaging materials and a suitable back up packaging alternative for the product within 30 days time after initiating the study.
Bilcare Optima works on the following principles:
# Sensitive profiling of solid dosage formulations.
# Scientific identification of optimum packaging.
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