Do you realise what active ingredients must be in the medicines you consume? As you delve into the world of drug development, you must often get confused about two terms: Active Pharmaceutical Ingredient (API) and Drug Formulation. Although both of these ingredients are actively included in the medicines we take, they represent distinct stages and components.
API is mainly the raw and pure chemical substance that produces the desired health effect in your body. You may think of it as the “working part” of medicine. API is basically a specific component or molecule that is specifically designed to interact with your body’s system so that it can cure, treat, and help prevent diseases.
What is an API (Active Pharmaceutical Ingredient)?
When we’re thinking about what makes a medicine work, we’re probably referring to the Active Pharmaceutical Ingredient (API). Well, API is basically defined as a core biologically active ingredient that is present in a drug. It is a single active component which interacts with your body’s system so that an intended pharmaceutical effect can be created in your body.
Whether a medication is designed to curb headaches, lower down the blood pressure, reduce inflammation or fight any infection, it is the API which works behind the curtains to perform the crucial therapeutic action. When the API is eliminated or not present in a medication, the medication would be essentially inert, offering no benefit at all.
Types of APIs
1. Synthetic Chemicals
Among many, quite a lot of them are created using synthetic chemical processes. This means that they’re built from simpler chemical raw materials in a laboratory as well as in the industrial setting. This involves ample of precisely controlled chemical reactions, often multi-step, where the molecules are purified, modified, and combined. The essentialness of synthetic APIs is that they have good control over their purity, structure, and consistency, enabling predictable manufacturing on a large scale.
Some common examples of medications with synthetic chemicals include ibuprofen, paracetamol, and atorvastatin.
2. Biotech-based Compounds
A rapidly growing class of API comprises the biotech based compounds, which are also known as biologics or biopharmaceuticals. Unlike the synthetic chemicals, such biotech based APIs are obtained from living organisms as well as their compounds like yeast, bacteria or mammalian cells, through advanced biotechnological methods like recombinant DNA technology and genetic engineering.
Some common examples include insulin, monoclonal antibodies, and various vaccines.
3. Natural Extracts
Ample of medications that originate from the natural extracts continue to be a source of valuable APIs. Such compounds are usually isolated and hence are purified directly from the natural sources like animals, plants or microorganisms. Moreover, the natural extracts offer unique and complex chemical structures which can be difficult to synthesise artificially. Moreover, their production can be challenging due to the variability in the quality of raw materials.
What is Drug Formulation?
Well, just like APIs, Drug Formulation is another essential compound which is used in order to create usable medicines. It is basically defined as the process of combining the API with various other substances in order to produce the final drug product. These “other substances” are also known as inactive ingredients.
Types of Formulations
1. Solid Formulations
Solid formulations are probably the most common and familiar type of drug product. This category mainly includes capsules and tablets, but also encompassess granules and powders. Tablets are solid dosage forms that are prepared by compressing the API into a defined shape. Solid formulations are basically popular as they’re easy to manufacture, are stable, have precise dosing, and convenient oral administration. On the other hand, capsules consist of plant based or gelatin enclosing the API.
2. Liquid Formulations
Liquid formulations are suspensions and solutions where the API is dispersed or dissolved in a liquid vehicle. Some of the most common instances of liquid formulations include suspensions, syrups, elixirs, and emulsions. Syrups are concentrated sugar solutions that are often used for pediatric medications due to the palatability.
3. Semi-solid Formulations
Well, semi-solid formulations are preparations that have a consistency between liquid and solid, and hence are designed primarily for topical applications to the mucous membranes and the skin. This group mainly includes ointments, pastes, creams and gels.
Key Differences Between API and Drug Formulation
1. Function
The API is the engine of a car and hence its main job is to provide the therapeutic effect to the medicine. It is the main component in medicine which actually makes the person feel better and aids in fighting illnesses.
On the contrary, drug formulation is like the rest of the car, steering, wheels, and the body. Moreover, its job is to ensure that the medicine gets to the body part which would make you feel better and aids in fighting the illnesses.
2. Composition
Well, API is a core and a pure active substance and hence it is one of the most special ingredients which does the entire healing work in the body.
On the other hand, drug formulation is an amalgamation of the API as well as the other inactive ingredients, which are also known as excipients. This is an extra ingredient that helps the API that works well which makes the medicine stable.
Conclusion
The API and Drug Formulation are both distinct but interconnected entities in the entire world of medicine. The API is basically a pure and fundamental chemical which is directly responsible for the therapeutic effect.
On the contrary, the drug formulation is the finished product, which combines the API with varied inactive ingredients to create user-friendly medicine.