Can APIs be used directly to treat diseases?
With the continuous development of the pharmaceutical industry, the types of drugs are becoming increasingly rich, involving APIs, finished drugs and other links. Many people have limited understanding of the concept of "API", especially the common question: "Can APIs be used directly to treat diseases?"
This question seems simple, but it actually involves many aspects of knowledge such as pharmacy, pharmaceutical technology, and regulatory supervision. This article will explore the definition, properties and functions of APIs, analyze the difference between APIs and finished drugs, explain why APIs cannot be used directly to treat diseases, and explain the scientific and regulatory reasons behind them.
1. What are APIs?
Active Pharmaceutical Ingredients (APIs) refer to pharmacologically active ingredients in drugs and are the basic substances for preparing finished drugs. They are usually purified chemicals that can play a specific therapeutic role.
For example, aspirin APIs are the pure active ingredients of aspirin. After being processed into tablets, capsules and other dosage forms, they become finished drugs that can be safely taken.
Characteristics of APIs:
High purity but usually in powder or crystal form, no dosage form design;
Usually lacking excipients and stabilizers, physical form and solubility may not be suitable for direct consumption;
There are risks of impurities and possible microbial contamination, and the final product has not been strictly controlled for quality;
Lack of dosage form regulation, such as controlling drug release rate, taste, absorbability, etc.;
No instructions for taking and safe packaging.
2. The difference between APIs and finished drugs
1. What is a finished drug?
Finished drugs are drug dosage forms that are processed by prescription design and APIs and excipients through specific preparation processes, such as tablets, capsules, injections, oral solutions, etc. Finished drugs meet the requirements for safe use by patients in terms of structure, composition and quality.
2. The core difference between the two
Project API Finished drug
Form Powder, crystal, liquid API Tablet, capsule, injection, spray, etc.
Ingredients Pure drug Active ingredient Active ingredient + excipients (excipients, stabilizers, etc.)
Safety of administration Not suitable for direct administration, there are safety hazards Design safe dosage and dosage form
Quality control focuses on purity and impurity control More comprehensive quality management (including stability, sterility, etc.)
Packaging and instructions Usually no packaging and administration instructions There are clear instructions and packaging to guide use
Efficacy performance Single active ingredient Dosage form design Ensure effective release and absorption of drugs
III. Why can't APIs be used directly to treat diseases?
1. Safety risk
Uncertain dosage: APIs are high-concentration pure substances that are not pre-packaged into reasonable doses. It is difficult for patients to accurately measure the dosage, and the risk of overdose is extremely high.
Impurity and contamination risks: APIs may contain impurities, residual solvents, microorganisms or heavy metals during production. Without preparation processing and strict inspection, direct administration may cause poisoning or infection risks.
Lack of excipient regulation: Excipients can improve drug stability, taste, absorption rate and bioavailability. APIs without excipients are not suitable for direct human use.
The dosage form is not suitable for human consumption: For example, powders are easy to inhale and cause respiratory irritation, and unsterilized APIs for injection may cause infection.
2. Effectiveness risk
Absorption problem: APIs are mostly in solid crystalline form with poor solubility, which is difficult to be effectively absorbed by the human body, and the therapeutic effect cannot be guaranteed.
Uncontrolled drug release rate: Finished drug design ensures that the drug is released at the appropriate location and time. APIs cannot control release, which may lead to unstable efficacy.
3. Regulatory supervision risk
Drug management regulations of various countries stipulate that only finished drugs that meet drug registration approval and GMP certification can be legally marketed and used. Unapproved APIs cannot be sold or taken as drugs, and there is a risk of illegality if used privately.
IV. The role of APIs in drug production
APIs are the core active ingredients of drug preparations, but to become clinically used drugs, they must go through the following steps:
Quality inspection: confirm that the purity, content, and impurity limits of APIs meet the pharmacopoeia or relevant standards;
Preparation process design: design appropriate dosage forms according to the properties of the drug, such as tablets, capsules, injections, etc.;
Addition of excipients: adding stabilizers, excipients, disintegrants, lubricants, etc. to improve the properties of the drug;
Process production: produce finished drugs through mixing, granulation, tableting, coating and other processes;
Quality control: conduct strict tests on the stability, sterility, bioequivalence, etc. of finished drugs;
Packaging and labeling: ensure that drug information is clear and easy to use safely.
Only after completing the above links can drugs be used safely, effectively and in a standardized manner for clinical treatment.
V. Special circumstances: other uses of APIs
Although APIs cannot directly treat diseases, they are still extremely important in the following areas:
1. As raw materials for research and development
Pharmaceutical companies and scientific research institutions use APIs to develop new dosage forms and new drugs, and conduct efficacy, safety studies and clinical trials.
2. As an intermediate for chemical synthesis or preparation production
APIs or their intermediates are used to synthesize other drug ingredients or as raw materials for preparation production.
3. As a product for export trade
Some APIs are exported through formal channels for preparation production, but not directly for patients.
VI. Possible risks of direct administration of APIs
In practice, accidents caused by illegal direct administration of APIs are not uncommon, for example:
Some people buy uncertified API powders and take them on their own, causing severe poisoning or death due to excessive doses;
Using unsterilized APIs for injection leads to infection or even sepsis;
Taking APIs containing high levels of impurities leads to liver and kidney damage.
These tragedies remind the public that APIs are not finished drugs and should not be used on their own.
VII. Strict management of API use by regulatory authorities
The National Medical Products Administration (NMPA) implements GMP certification management for API manufacturers to ensure standardized production processes;
Only approved finished drugs are allowed to be marketed, and unapproved API sales for clinical treatment are strictly prohibited;
Illegal sales and use of APIs are investigated and dealt with in accordance with the law to ensure public drug safety;
The public is encouraged to purchase drugs through formal channels and avoid purchasing unlicensed "APIs" or "bulk drugs".
VIII. Conclusion
In summary, pharmaceutical APIs cannot be used directly to treat diseases, which is the result of scientific and regulatory decisions. APIs are key raw materials for drug production, but lack reasonable dosage form design, dosage control and safety assurance, and direct use poses great risks. Patients should strictly follow the doctor's instructions and choose legal and compliant finished drugs.
For practitioners in the pharmaceutical industry, correctly understanding the positioning and role of APIs, complying with relevant laws and regulations, and ensuring drug quality and safety are the fundamental responsibilities for protecting patients' health.
