Formulation studies involve developing a preparation of a drug that is both stable and acceptable to the patient. For orally administered drugs, this usually involves incorporating the drug into a tablet or a capsule. It is important to realize that a tablet contains a variety of other potentially inert substances apart from the drug itself, and studies have to be carried out to ensure that the encapsulated drug is compatible with these other substances in a way that does not cause harm, whether direct or indirect.
In the Pharmaceutical industry, Preformulation involves the characterization of a drug’s physical, chemical, and mechanical properties in order to choose what other ingredients (excipients) should be used in the preparation.
Following the Preformulation stage, Formulation studies then consider such factors as particle size, polymorphism, pH, and solubility, as all of these can influence bioavailability and hence the activity of a drug. The drug must be combined with inactive ingredients by a method that ensures that the quantity of drug present is consistent in each dosage unit; e.g., each tablet.
The amount of effort that goes into the Formulation stage is a testament to the commitment of the pharmaceutical industry to ensure that drugs are both safe and effective. Rigaku is proud to provide solutions to this critical area of the discovery and production of drugs. |