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Drug Formulation

Drug Discovery

Drug Formulation Development

Determining the ideal formulation in which a drug is stable and can be administered safely and effectively can be a long, tedious process that requires large amounts of reagents. Developing a drug’s formulation consists of three phases: pre-formulation, design and testing, all of which can require large amounts of time and reagents.

The pre-formulation phase involves understanding the active ingredient’s physical, chemical and mechanical properties in order to select other inert ingredients that can be used in preparing the formulations. In this phase, researchers identify how an active ingredient responds to certain stressors, such as time, temperature, photolysis, humidity, etc., to prepare a formulation that protects or minimizes such effects.

The design phase consists of making a particular formulation that will deliver the active ingredient(s) to the site of action in the optimal form to satisfy the requirements of biological efficacy, target selectivity, application technique availability, applicator and manufacturer safety, environmental safety, as well as cost considerations.

In the design phase, formulators must determine the formulation type that will work best for each active ingredient based on the application or mode of action. However, many key factors affect this choice: the target market and the technology available for the application based on the physical properties (e.g., melting point and physical form); the chemical properties (e.g., solubility, chemical stability and reactivity); the application locus (e.g., where the product is to be applied or the route of administration); the biological properties (where the active ingredient must go to become active); the economics for the producer and the purchaser; the availability and costs of manufacturing and raw materials, including the costs of packaging materials and competitors' products; product safety to the applicator and the producer; the environmental impact of the formulation; and the packaging materials.

The testing phase consists of performing several clinical performance and conditional tests to ensure a formulation achieves acceptable results in its selectivity, bioavailability and stability. In addition to the several in vitro tests performed on the formulation, several stability tests are performed in a laboratory setting to ensure a formulation compatible and stable with various environmental factors and conditions.

The Hamilton Microlab® STAR line is an automated liquid handler that can reduce the amount of time spent and reagent costs for all three phases, and is currently doing so in laboratories all over the world. These labs enjoy a number of benefits by automating their formulation development and testing using the Hamilton Microlab STAR line:
  • Wider experimental scope
  • Huge time savings
  • Increased formulation productiveness and success
  • Improved existing products and formulations
  • Decreased amounts of raw materials needed and waste generated