You’ve run all your stability studies, and the data you gathered has helped you to determine the expiration date of each product batch or lot. Now what? Your stability data tells you how long each batch of drug compounds will be good for, but it doesn’t tell you much else—and it won’t tell you how to prevent your products from becoming unstable over time. This article will help you drug compound stability profile so that you can better understand how to prolong product stability, thereby improving patient safety and reducing risk of product recalls.
The basics of a drug compound stability profile
The stability profile is a document that illustrates the stability of your compound over time. The profile can be used for preclinical formulation development and for selecting the best time to conduct clinical trials. The stability profile should be prepared in accordance with ICH guidelines and FDA regulations and should include information on the following:
- storage conditions (temperature, humidity)
- storage duration
- containers used
- number of containers per lot
- expiration date at various temperatures/humidities.
How to interpret your results
Drug compound stability is defined as the ability of the drug to retain its quality and its original properties over time. The purpose of a stability profile is to determine how much shelf life a drug has, when it should be administered, and where along the supply chain it should be stored.
In preclinical formulation development, there are three main factors that may affect your product’s stability: pH, temperature, and light.
#1) pH – depending on what type of formulation you’re creating (tablet, injection solution) the pH will dictate how much water your product will contain. If your product contains too little water, then the active ingredient won’t dissolve in the liquid; if it contains too much, then it’ll start to precipitate out. Therefore, pH balance is critical for making sure that an inactive ingredient can mix well with an active ingredient. For example, acetaminophen is acidic in nature but needs to be mixed with an alkaline salt in order for a tablet to break down properly; if not properly balanced then it won’t dissolve.#2) Temperature- typically this refers to storage temperatures but extremes of hot or cold temperatures can also cause problems with formation or degradation respectively.#3) Light- most drugs are photosensitive which means they can break down due to UV exposure.
What factors can affect drug compound stability
There are many factors that can affect the stability of a drug compound. It is important that you take into account the following factors before moving forward with your preclinical formulation preclinical formulation development:pH, ionic strength, temperature, moisture content and light. One way to reduce these risks is by using stable intermediates or buffers such as sodium phosphate monobasic and sodium phosphate dibasic. Drug stability is the ability of a drug compound to maintain its physical, chemical, and biological properties over time. There are many factors that can affect drug stability including pH, temperature, moisture level, light exposure and different types of packaging. The stability profile for each drug compound is unique and should be considered when designing the preclinical formulation development process. Changes in any of these factors may alter the stability profile and should be taken into consideration before starting clinical trials or releasing new products on the market.
