When you hear the term “pharmaceutical industry,” you probably immediately think of businesses that make drugs. There are numerous businesses that create pharmaceuticals all around the world. From large pharmaceutical firms like Novartis, Pfizer, and Johnson & Johnson to neighborhood pharmacies, which can occasionally produce medications on a patient-level. Naturally, everything in between as well. What, though, are APIs?
What are Active Pharmaceutical Ingredients?
People use drugs to treat, diagnose, prevent, or cure diseases. Drugs are composed of various components, with the most important one being the active pharmaceutical ingredient (API). The API is the part of the medication that actually works in your body.
For example, the API in aspirin is acetylsalicylic acid, which effectively treats headaches and feverish pain. Some drugs are named after their API, such as paracetamol, which contains the API paracetamol. However, creating a pill requires more than just the API. Other components called excipients are used to give the pill different characteristics, such as volume, a sweet taste, or a specific color.
When and where are APIs made?
The API market is already enormously profitable. Large manufacturing facilities with several steps in a complex chemical process are where APIs are primarily produced. Starting materials, which can be either raw materials or intermediates, are used to create these APIs. Pharmaceutical firms used to manufacture and synthesize APIs and medications in their native nations.
However, in recent years, a lot of businesses have decided to outsource the production of their APIs to Asia in an effort to cut expenses. India and China are now the top two producers of API. Aurobindo, Dr. Reddy’s, Cipla, and SUN Pharma are a few of the biggest suppliers that were either created or have their headquarters in India.
However, China is the world’s main producer of APIs because it produces the majority of the raw ingredients. APIs are often produced in powder form and then sold in significant quantities to pharmaceutical companies.
Types of active pharmaceutical ingredients
There are two primary categories of APIs: natural and synthetic. Depending on the synthesis technique utilized, synthetic APIs can also be divided into innovative and generic categories. A sizeable component of the pharmaceutical market is made up of synthetic chemical APIs, commonly referred to as tiny molecules.
Small molecule medicines are widely used in commerce. Biologics are being manufactured using natural APIs, which are gaining popularity on the market. Biologics are currently less accessible than small molecule medications nonetheless. The solubility of APIs can also be used to classify them; certain APIs are insoluble while others are soluble.
Active Pharmaceutical Ingredient Manufacturing Process
Since they go through intricate chemical processes during synthesis, APIs are not the starting materials for medications. In the past, pharmaceutical firms made APIs in their own nations, but now they are made abroad to save money. There are various steps involved in the manufacture of APIs.
The first step is the feed handling stage, which entails preparing and conveying the required raw materials. After that, chemical processes are used to transform these materials into APIs. Depending on the chemistry of the API, many production techniques may be used, including chemical synthesis or biotechnology. APIs can be made chemically using loop reactors, batch reactors, or specialized batch autoclaves.
On the other hand, biological processes mimic reactions that occur in living organisms, with fermentation being a major biotechnology used in API production. After the reactions, the resulting product contains APIs as well as other by-products. Various recovery methods are employed to separate the active pharmaceutical ingredients from these by-products. These methods include distillation, membranes, filtration, and crystallization, among others.
Examples of Active Pharmaceutical Ingredients
- Ibuprofen: An API used as a pain reliever and anti-inflammatory agent, found in medications like Advil and Motrin.
- Simvastatin: This API is used to lower cholesterol levels and is present in drugs like Zocor.
- Sertraline: An antidepressant API present in medications like Zoloft.
- Omeprazole: This API is used to reduce stomach acid and can be found in medications like Prilosec.
- Metformin: An API commonly used to treat type 2 diabetes, found in medications like Glucophage.
The Best Way to Locate an API on a Drug Label
The Drug Facts label for over-the-counter (OTC) drugs displays the active ingredient and the amount per dose at the top. The health effect is listed next to this information. Prescription drug labels show the brand name (if applicable) above the generic name, which is also the active ingredient. If you have the generic version, the label may indicate the usual brand name.
For instance, Amphetamine 10MG is the generic for Adderall 10MG. The generic name of a drug is usually derived from its chemical name, which is less commonly used. For example, acetylsalicylic acid is the chemical name for aspirin.
Why You Should Consider Looking for APIs
Knowing the APIs (active pharmaceutical ingredients) of the medications you take can be highly beneficial in various situations.
Here are a few examples:
Duexis is a prescription medication used to treat arthritis. It contains ibuprofen, an anti-inflammatory, and famotidine, which protects against ulcers. Ibuprofen is also available over-the-counter as Advil, Motrin, and in generic form. Famotidine can be found over-the-counter as Pepcid.
Robitussin DM is an over-the-counter medication commonly used to alleviate symptoms of the common cold. This medication contains dextromethorphan, a cough suppressant, and guaifenesin, an expectorant. Guaifenesin is also the API in Mucinex, while dextromethorphan is the API in Delsym.
If you are unaware that these APIs are present in different medications and brands, you may unintentionally consume excessive amounts of them.
Conclusion
The primary purpose of an API is to ensure that a drug has the intended effect on a patient’s body. Failing to achieve this can have negative consequences for the patient’s health, so it is crucial to maintain efficacy and quality. Various factors such as unhealthy lifestyles, poor eating habits, and an aging population have contributed to a rise in chronic diseases. Additionally, the post-pandemic period has witnessed a significant increase in health-consciousness among certain populations.