Are there ways to expedite drug stability tests for oral dose products so that proper packaging can be determined in a tight timeframe?
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pharmamanufacturing Manufacturing Community Member 151 Posts
Re: Drug stability tests for oral dose products21 December 2015 at 11:12am Last edited: 21 December 2015 at 11:20amAjith Nair, Ph.D, Sr. Vice President of Research & Quality for Bilcare Research one of the world’s leading manufacturers of pharmaceutical and medical blister films and foils.
Absolutely. Tests that determine the optimum blister film barrier properties for packaging certain pharmaceutical products can take as little as 15 business days. These sort of expedited drug stability tests help packaging engineers and formulators at global pharmaceutical companies overcome the time and resource crunch they face when attempting to achieve successful stability studies.
The aforementioned 15-day timeframe is enough to look at the predefined “usual suspects” – the key indicators of a given drug’s stability. The vast majority of packaging related stability failures can be ascertained by systematically analyzing the product’s physical attributes, as opposed to more stringent, time-consuming chemical testing.
The 15-day process – which my company, Bilcare Research, has named FastPack™ - determines a product’s susceptibility to various environmental factors, most prevalently humidity, temperature, light and oxygen, through scientifically designed experiments. It puts products through a variety of forced degradation testing from hygroscopcity to drug release property. It also provides a optimum blister cavity drawing, Permeability data of the formed blister, packaging cost analysis with material specifications and testing methods, and samples of recommended packaging materials.
This expedited process-introduced about an year ago, is based on research findings from our more than decade old BilcareOptimaTM service , the first scientific packaging development and sensitivity profiling method following QbD principles). It has proved not only sufficient in identifying a product’s optimal packaging materials in terms of cost and barrier protection, but also in yielding a greater than 90% certainty of passing a packaging stability study. For pharmaceutical manufacturers, this means reduced risk of both FDA approval delays due to insufficient package barrier properties and, conversely, wasteful and costly over-packaging.