The Active ingredient in a pharmaceutical drug is known as the active pharmaceutical ingredient (API). The active pharmaceutical ingredient(API) provides a biologically active component to a drug product like a tablet, capsule, cream, injectable, etc that produces the intended effects in diagnosing, treating, treating, or preventing diseases.
API produces a desired pharmacological effect and excipients’ role in the drug development process. Some of the drug products may contain more than one active ingredient. Any drug product mainly comprises the API and the excipients and the combination of API and excipients comprise the final finished formulation of the medicine.
Pharmaceutical excipients are substances in the drug product/formulated alongside the active ingredient of a medication which is included for the purpose of long-term stabilization to aid the manufacturing process and in handling the active substance concerns such as by facilitating powder flowability or non-stick properties etc.
The selection of suitable and proper excipients depends upon the route of administration and the dosage form and also the active ingredient and other factors. The process for optimizing and composition of the mixtures used in the drug is called Formulation.
Types of active pharmaceutical ingredients
There are several types of active pharmaceutical ingredients (APIs), which can be broadly classified into the following categories:
- Synthetic APIs: These are chemically synthesized compounds that are produced through various chemical reactions. Examples include aspirin, paracetamol, and many antibiotics.
- Natural APIs: These are active ingredients that are obtained from natural sources such as plants, animals, or microorganisms. Examples include morphine, insulin, and penicillin
- Biologic APIs: These are large, complex molecules that are produced using biotechnology methods such as recombinant DNA technology, gene editing, or cell culture. Examples include monoclonal antibodies, vaccines, and gene therapies
- Highly potent APIs: These are APIs that are used in very small quantities but have very high potency, such as certain hormones or anticancer drugs
- Radiopharmaceutical APIs: These are APIs that contain radioactive isotopes, which are used in nuclear medicine for the diagnosis or treatment of diseases such as cancer
- Combination APIs: These are APIs that combine two or more active ingredients into a single dosage form, such as combination therapies for HIV/AIDS, hypertension, or diabetes
Each type of API has its own unique properties and requires specific manufacturing and quality control processes to ensure its safety and efficacy in pharmaceutical products.
Active pharmaceutical ingredients applications
Active pharmaceutical ingredients (APIs) find application in high-quality drugs that treat many diseases pertaining to oncology, cardiology, CNS and neurology, orthopedics, gastroenterology, nephrology, ophthalmology, endocrinology, and other diseases. APIs can potentially create a more sustainable healthcare system by introducing more innovative products.
The safety and efficacy of the drug have a direct effect on the quality of active ingredients, for this reason, most countries have regulated the active ingredients. The regulation of active ingredients will increase the safety and quality of drugs for consumers and will strengthen the pharmaceutical drug supply system.
The ICH Q7 provides guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs); these guidelines will help to ensure that API meets the quality and purity. APIs are mainly manufactured by chemical synthesis, recovery from natural resources, extraction, cell culture/fermentation (specific guidance for APIs manufactured by cell culture/fermentation), or any combination of these processes.
In the manufacturing of API the key starting material (KSM), raw material, and intermediates are used in the production of API and is incorporated as an essential structural fragment into the structure of the API. API starting material has specified chemical properties and structure details. According to Q7 guidance appropriate GMP is to be applied to those intermediates and /or API manufacturing steps which includes the validation of the critical process steps which determine the quality of the API and also in the manufacturing process which proceeds from early API steps to final steps, purification, and packaging.
As mentioned the below Table, gives guidance on which API starting material is normally introduced into the process. (Ref table from the Q7 Good manufacturing practice guidance for active pharmaceutical ingredients ( https://www.fda.gov/media/71518/download)
| Type of Manufacturing | Application of this guidance to steps (shown in blue) used in this type of manufacturing | |||||
| Chemical Manufacturing | Production of the API starting material | Introduction of the API starting material into the process | Production of Intermediates(s) | Isolation and Purification | Physical processing, and packaging | |
| API derived from animal sources | Collection of organ, fluid, or tissue | Cutting, mixing, and initial processing | Introduction of the API starting material into the process | Isolation and purification | Physical processing, and packaging | |
| API extracted from plant sources | Collection of plant | Cutting and initial extractions(s) | Introduction of the API starting material into the process | Isolation and purification | Physical processing, and packaging | |
| Herbal extracts used as API | Collection of plants | Cutting and initial extraction | Further extraction | Physical Processing, and packaging | ||
| API consisting of comminuted or powdered herbs | Collection of plants and /or cultivation and harvesting | Cutting /comminuting | Physical Processing, and packaging | |||
| Biotechnology: fermentation/cell culture | Establishment of the master cell bank and working cell bank | Maintenance of working cell bank | Cell culture and /or fermentation | Isolation and purification | Physical processing, and packaging | |
| “Classical” Fermentation to produce an API | Establishment of the cell bank | Maintenance of the cell bank | Introduction of the cells into fermentation | Isolation and purification | Physical processing, and packaging | |
FAQs:
Active pharmaceutical ingredients (API) provide a biologically active component of a drug product that produces intended effects in the diagnosis, cure, treatment, or prevention of diseases. Any drug product mainly comprises API and excipients and a combination of API and excipients comprise the final finished formulation of the medicine. API produces a desired pharmacological effect and the role of excipients in the drug development process.
Excipients are substances in the drug product/formulated alongside the active ingredient of a medication which is included for the purpose of long-term stabilization to aid the manufacturing process. The selection of suitable and proper excipients depends upon the route of administration and the dosage form and also the active ingredient and other factors.
Q7 provides guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs), this guideline will help to ensure that API meets the quality and purity.
In the context of the pharmaceutical industry, API stands for Active Pharmaceutical Ingredient. It refers to the biologically active component in a drug product that produces the intended therapeutic effect. APIs can be derived from natural sources or synthesized chemically. They are the key components that make a drug effective in treating a particular disease or medical condition. Once an API is identified, pharmaceutical companies can develop it into a drug product by adding other inactive ingredients, such as excipients, to make it stable, safe, and effective for patients. APIs are subject to strict regulations and quality control measures to ensure their purity, potency, and safety for use in pharmaceutical products. They are also tested extensively to ensure their efficacy and consistency in delivering the intended therapeutic effect.
Reference:
- Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Guidance for Industry. 2016, www.fda.gov/media/71518/download.
- ICH Topic Q 7 Good Manufacturing Practice for Active Pharmaceutical Ingredients Step 5 NOTE for GUIDANCE on GOOD MANUFACTURING PRACTICE for ACTIVE PHARMACEUTICAL INGREDIENTS. 2000, www.ema.europa.eu/en/documents/scientific-guideline/ich-q-7-good-manufacturing-practice-active-pharmaceutical-ingredients-step-5_en.pdf.
- ICH Topic Q 7 Good Manufacturing Practice for Active Pharmaceutical Ingredients Step 5 NOTE for GUIDANCE on GOOD MANUFACTURING PRACTICE for ACTIVE PHARMACEUTICAL INGREDIENTS. 2000, www.ema.europa.eu/en/documents/scientific-guideline/ich-q-7-good-manufacturing-practice-active-pharmaceutical-ingredients-step-5_en.pdf.
- Office. “Q7A Good Manufacturing Practice Guidance.” U.S. Food and Drug Administration, 2019, www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-q7a-good-manufacturing-practice-guidance-active-pharmaceutical-ingredients. Accessed 23 Mar. 2023.
- Canada, Health. “Active Pharmaceutical Ingredients – Good Manufacturing Practices – Questions and Answers – Canada.ca.” Canada.ca, 2013, www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/drugs/active-pharmaceutical-ingredients-questions-answers.html. Accessed 23 Mar. 2023.
