Understanding the science of drug dissolution is a must
Drug dissolution is a key attribute for determining the bioavailability of a drug. It’s the one which is least understood, and can affect the quality of the product. Taking the popular dosage form, hard capsules, for instance, when swallowed, it first disintegrates, which is always predictable within a few minutes. After that comes the process of dissolution which can be extremely variable depending on a number of factors.
The failures and problems of some Indian companies with the US FDA authorities are being caused partly due to dissolution failures and variability. This has been serious enough to result in a recall of products from the market. This is not only expensive, but affects the reputation of the company as well. So, the science of dissolution needs to be studied and understood thoroughly. One solution is to consider the use of robotic equipment which are now available, wherein results are recorded online. This brings more accuracy and integrity, and is an effective way to give the inspectors the assurance they look for. Another important trend is the use of artificial intelligence (AI) which is already appearing in the pharma industry. In due course, robotics systems tend to become inevitable. Such work handled by human beings is subject to variability and skill levels.
Bu hikaye Express Pharma dergisinin November 16-30, 2019 sayısından alınmıştır.
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Bu hikaye Express Pharma dergisinin November 16-30, 2019 sayısından alınmıştır.
Start your 7-day Magzter GOLD free trial to access thousands of curated premium stories, and 8,500+ magazines and newspapers.
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