How can you improve the stability of a new drug?

1 Choose the right formulation

The formulation of the drug is the combination of the active ingredient and the excipients, which are the substances that help deliver, protect, or enhance the drug. The formulation can influence the stability of the drug by affecting its solubility, dissolution, absorption, distribution, metabolism, and elimination. To improve the stability of a new drug, you should choose the appropriate formulation that minimizes the degradation, aggregation, oxidation, hydrolysis, or racemization of the drug. For example, you can use buffers, stabilizers, antioxidants, preservatives, or coating agents to prevent or reduce the chemical reactions that compromise the drug.

2 Optimize the manufacturing process

The manufacturing process of the drug involves various steps, such as synthesis, purification, drying, milling, blending, filling, and packaging. Each step can introduce stress factors that can affect the stability of the drug, such as heat, light, oxygen, moisture, or mechanical forces. To improve the stability of a new drug, you should optimize the manufacturing process by controlling the temperature, pressure, time, pH, and other parameters that can alter the drug. For example, you can use aseptic techniques, freeze-drying, spray-drying, or lyophilization to preserve the integrity and activity of the drug.

3 Perform stability testing

The stability testing of the drug is the evaluation of the drug's quality and performance under different environmental conditions over time. The stability testing can provide information on the shelf-life, storage conditions, and expiration date of the drug. To improve the stability of a new drug, you should perform stability testing according to the regulatory guidelines and standards that apply to your product. For example, you can follow the International Conference on Harmonisation (ICH) guidelines for stability testing of new drug substances and products, which specify the test methods, protocols, and acceptance criteria for various climatic zones and regions.

4 Monitor the distribution and storage

The distribution and storage of the drug are the final stages of the product lifecycle, where the drug is transported and stored until it reaches the end-user. The distribution and storage can expose the drug to various environmental factors that can affect its stability, such as temperature fluctuations, humidity changes, light exposure, or physical shocks. To improve the stability of a new drug, you should monitor the distribution and storage of the drug by using appropriate packaging materials, labels, and devices that can protect the drug from external influences. For example, you can use cold chain systems, desiccants, tamper-evident seals, or smart sensors to maintain the quality and safety of the drug.

5 Implement quality management systems

The quality management systems (QMS) are the set of policies, procedures, and tools that ensure the quality and consistency of the drug throughout the product lifecycle. The QMS can help you improve the stability of a new drug by establishing the standards, specifications, and requirements for the design, development, production, testing, and distribution of the drug. To implement QMS, you should follow the good manufacturing practices (GMP), good laboratory practices (GLP), and good distribution practices (GDP) that apply to your product. For example, you can use documentation, validation, verification, calibration, training, or audits to ensure the compliance and traceability of the drug.