Creating a pharmaceutical drug is long and complex, with many steps and different people involved. It involves scientists who are experts, pharmacists who create the formulas, and manufacturers who make the final product. This article will look at how drugs are created from start to finish.
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Length of the Drug Development Process
It’s no surprise that pharmaceutical drugs are expensive. The process of developing a new drug takes years and is highly costly. According to data from the Biotechnology Innovation Organization’s research, it takes an average of 10.5 years to get a new drug into the market.
Moreover, it can cost billions of dollars. As mentioned in an article published in the JAMA Network journal, drug development can cost around $1 billion or more. But why does it take so much time? Well, drug development involves many factors, including drug manufacturing, trials, approvals, etc.
Sterile Vs. Non-Sterile Pharmaceutical Manufacturing
The first step in the manufacturing process is ensuring that the drug meets all its specifications. This includes testing for purity, potency, and other physical characteristics like color and smell.
To make sterile drugs, a manufacturer must maintain a certain level of cleanliness during production. This means that everything from equipment to packaging materials should be clean. In addition, any people involved in making or testing these drugs must wear unique protective clothing explicitly designed for this purpose.
You can use cleanrooms to manufacture sterile drugs. Cleanrooms offer a clean and controlled environment that ensures the drug is not contaminated. But this comes down to setting up a suitable cleanroom, according to your requirements. You can seek help from cleanroom manufacturing experts. They will have the right expertise to build and install cleanrooms suitable for developing sterile pharmaceutical drugs.
Non-sterile pharmaceutical manufacturing also requires strict adherence to protocol, but it does not require high cleanliness levels as with sterile products.
Preparing the Drug
There are two main ways that drugs are prepared:
- Natural sources. Drugs can be extracted from naturally occurring substances, such as herbs or animal parts. For example, penicillin, a common antibiotic that fights bacterial infections in humans and animals, is produced by molding bread with the fungus Penicillium Notatum. The mold produces a penicillin G chemical, which can then be isolated and purified into an injectable form that kills bacteria without harming human cells.
- Synthesis from chemicals. Drugs can also be synthesized from chemicals like coal tar derivatives to create new compounds with unique properties. Pharmaceutical companies often use this process when they want to develop medications based on existing drugs but with slight variations in formula or dose levels so that patients receive only what they need without experiencing side effects caused by overdose.
Clinical Trials
Clinical trials are a necessary part of the drug development process. These trials are used to test the safety and efficacy of drugs, which is why the FDA requires them before a drug can be sold. The number of clinical trials depends on the type of drug being tested, but generally speaking, there are two types:
- Phase 1: This phase tests how well a drug works in people without serious illnesses or common medical conditions. The phase 1 trials are easier and last for only 6 months.
- Phase 2: This phase usually tests how well a new medication works compared with an existing treatment. The phase 2 trials are the biggest challenge in drug development, according to Pharma Intelligence. According to it, only 9% of candidates head to the third phase by completing this phase successfully.
- Phase 3: These are the last trials conducted before the FDA approval. Hence, these trials are extensive and the most expensive.
FDA Approval
The FDA is the agency that regulates drugs. Before a drug can be sold, it must go through clinical trials and be approved by the FDA. This is an important stage of the drug development cycle. Many companies send their drugs for approval. However, only a few get approved by the FDA.
In 2021, FDA approved 50 new novel drugs. This means that you must ensure your pharmaceutical drug is effective and has no side effects. Basically, it should pass all three trial phases.
Drug Patent
A drug patent prevents anyone else except you from manufacturing, using, or selling a product. This period includes the time it takes for a drug to be approved and available on the market. However, most pharmaceutical companies keep their research and development (R&D) costs low by developing drugs based on existing compounds that are already well-known in their respective fields. These compounds are known as molecular analogs or active pharmaceutical ingredients (API).
A patent can also extend if you use your medication in pediatric populations or if a new formulation of an existing drug is available. But these options usually only apply when patents are about to run out. Otherwise, they would simply expire earlier than expected.
Marketing the Pharmaceutical Drugs
The marketing of pharmaceutical drugs is a complex process. In the United States, drug companies can market their products directly to consumers through television commercials and advertisements in magazines and newspapers. However, they cannot promote them as “therapeutic” or “medicinal” because that would require approval by the Food and Drug Administration (FDA).
Instead, drug companies sell their products as treatments for specific conditions like cancer or heart disease. It’s up to doctors to decide which medications best meet those individual needs. For example, if your doctor diagnoses you with hypertension, he may prescribe an ACE inhibitor such as lisinopril or an angiotensin receptor blocker such as valsartan.
Drug companies are careful about advertising these types of medications so that they don’t imply that using them will certainly cure the disease. This is to avoid any personal injury lawsuits. Side effects of drugs can significantly impact someone else’s health, who may go on to file a lawsuit against the manufacturer. Hence, most drug manufacturing companies are very strict with their advertisements.
Conclusion
We hope we have helped shed some light on how pharmaceutical drugs are made. The process is complex and can take years to complete. Before any drug reaches the market, there are many steps, from initial research and development through clinical trials and FDA approval.
