Formulations and Bulk Drugs: Get the Basics Right

The final product of any drug manufacturing process is called a ‘Formulation’, they come in various shapes and forms like tablets, capsules, injectables or syrups. A formulation can be administered straight to patients. Bulk Drugs are known as ‘API’ or Active Pharmaceutical Ingredients. Thanks to a quick research with API manufacturers in India, we discovered that they are basically what are known as the ‘active’ constituent of any given drugs. The reaction and efficacy of the drug may vary all depending on its administered dosage. There are certain drugs which carry multiple types of Active Pharmaceutical Ingredients at once. All drugs are made up of two components, or you can say that there are two aspects to any drug.

The first aspect is also its main constituent that is the actual API or Active Pharmaceutical Ingredients. The second aspect is called an ‘excipient’. The excipient is the other inactive substance that is found inside a drug or a tablet. For example, if the medication is in a liquid state, like syrup, then the excipient is the liquid that’s being used as a carrier for the API. In short, the Active Pharmaceutical Ingredient (API) is the chemically active substance that has therapeutic qualities and the excipients are the inert or inactive matter that remains present within the drug.

There are certain unknown Active Pharmaceutical Ingredients present in certain formulations in pharma that require additional substances that can work in conjunction with APIs to create the intended pharmaceutical outcome. If you take herbal medicines as an example, these API products as a whole are more often than not a blend of numerous substances. These substances, when used in combination, turn active and start their effect in the patient’s body. In this case, the Active Pharmaceutical Ingredients are not just single agents but the coming together of various herbs and constituents. 

Manufacturers typically employ certain calculation values and yardsticks to establish the comparative potency of Active Pharmaceutical Ingredients within a drug before furnishing it to the API Suppliers. On the other hand, the method and the processes used to standardize the API potency vary as per different brands. While some Manufacturers of Pharmaceuticals may exercise a certain parameter to evaluate the Active Pharmaceutical Ingredients strength, others manufacturers might apply an altogether very different standard.