Active ingredient

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An active ingredient is any ingredient that provides biologically active or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the body of humans or animals. [1]

Contents

The similar terms active pharmaceutical ingredient (abbreviated as API) and bulk active are also used in medicine. [2] [3] The term active substance may be used for natural products.[ citation needed ]

Some medication products can contain more than one active ingredient. The traditional word for the active pharmaceutical agent is pharmacon or pharmakon (from Greek : φάρμακον, adapted from pharmacos ) which originally denoted a magical substance or drug.[ citation needed ]

The terms active constituent or active principle are often chosen when referring to the active substance of interest in a plant (such as salicylic acid in willow bark or arecoline in areca nuts), since the word "ingredient" can be taken to connote a sense of human agency (that is, something that a person combines with other substances), whereas the natural products present in plants were not added by any human agency but rather occurred naturally ("a plant doesn't have ingredients").

In contrast with the active ingredients, the inactive ingredients are usually called excipients in pharmaceutical contexts. The main excipient that serves as a medium for conveying the active ingredient is usually called the vehicle. For example, petrolatum and mineral oil are common vehicles. The term 'inactive' should not, however, be misconstrued as meaning inert.[ citation needed ]

Pharmaceuticals

The dosage form for a pharmaceutical contains the active pharmaceutical ingredient, which is the drug substance itself, and excipients, which are the ingredients of the tablet, or the liquid in which the active agent is suspended, or other material that is pharmaceutically inert. Drugs are chosen primarily for their active ingredients. During formulation development, the excipients are chosen carefully so that the active ingredient can reach the target site in the body at the desired rate and extent.[ citation needed ]

Patients often have difficulty identifying the active ingredients in their medication, as well as being unaware of the notion of an active ingredient. When patients are on multiple medications, active ingredients can interfere with each other, often resulting in severe or life-threatening complications. [4]

Many online services can help identify the active ingredient of most medications, such as the Medicines Database providing information on medications available in Australia. [5]

Herbal medicine

In phytopharmaceutical or herbal medicine, the active ingredient may be either unknown or may require cofactors in order to achieve therapeutic goals. This leads to complications in labelling. One way manufacturers have attempted to indicate strength is to engage in standardization to a marker compound. Standardization has not been achieved yet, however, with different companies using different markers, or different levels of the same markers, or different methods of testing for marker compounds. For example, St John's wort is often standardized to the hypericin that is now known not to be the "active ingredient" for antidepressant use. Other companies standardize to hyperforin or both, ignoring some 24 known additional possible active constituents. Many herbalists believe that the active ingredient in a plant is the plant itself. [6]

See also

Related Research Articles

The Anatomical Therapeutic Chemical (ATC) Classification System is a drug classification system that classifies the active ingredients of drugs according to the organ or system on which they act and their therapeutic, pharmacological and chemical properties. Its purpose is an aid to monitor drug use and for research to improve quality medication use. It does not imply drug recommendation or efficacy. It is controlled by the World Health Organization Collaborating Centre for Drug Statistics Methodology (WHOCC), and was first published in 1976.

<span class="mw-page-title-main">Pharmacology</span> Branch of biology concerning drugs

Pharmacology is the science of medical drugs and medications, including a substance's origin, composition, pharmacokinetics, therapeutic use, and toxicology. More specifically, it is the study of the interactions that occur between a living organism and chemicals that affect normal or abnormal biochemical function. If substances have medicinal properties, they are considered pharmaceuticals.

<span class="mw-page-title-main">Tablet (pharmacy)</span> Drug delivery form in which the ingredients are solidified for later consumption

A tablet is a pharmaceutical oral dosage form or solid unit dosage form. Tablets may be defined as the solid unit dosage form of medication with suitable excipients. It comprises a mixture of active substances and excipients, usually in powder form, that are pressed or compacted into a solid dose. The main advantages of tablets are that they ensure a consistent dose of medicine that is easy to consume.

<span class="mw-page-title-main">Medication</span> Substance used to diagnose, cure, treat, or prevent disease

A medication is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy (pharmacotherapy) is an important part of the medical field and relies on the science of pharmacology for continual advancement and on pharmacy for appropriate management.

<span class="mw-page-title-main">Over-the-counter drug</span> Medication available without a prescription

Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a requirement for a prescription from a healthcare professional, as opposed to prescription drugs, which may be supplied only to consumers possessing a valid prescription. In many countries, OTC drugs are selected by a regulatory agency to ensure that they contain ingredients that are safe and effective when used without a physician's care. OTC drugs are usually regulated according to their active pharmaceutical ingredient (API) rather than final products. By regulating APIs instead of specific drug formulations, governments allow manufacturers the freedom to formulate ingredients, or combinations of ingredients, into proprietary mixtures.

<span class="mw-page-title-main">Generic drug</span> Pharmaceutical equivalent to a brand-name product

A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire. Because the active chemical substance is the same, the medical profile of generics is equivalent in performance compared to their performance at the time when they were patented drugs. A generic drug has the same active pharmaceutical ingredient (API) as the original, but it may differ in some characteristics such as the manufacturing process, formulation, excipients, color, taste, and packaging.

<span class="mw-page-title-main">Herbal medicine</span> Study and use of supposed medicinal properties of plants

Herbal medicine is the study of pharmacognosy and the use of medicinal plants, which are a basis of traditional medicine. With worldwide research into pharmacology, some herbal medicines have been translated into modern remedies, such as the anti-malarial group of drugs called artemisinin isolated from Artemisia annua, a herb that was known in Chinese medicine to treat fever. There is limited scientific evidence for the safety and efficacy of many plants used in 21st-century herbalism, which generally does not provide standards for purity or dosage. The scope of herbal medicine sometimes include fungal and bee products, as well as minerals, shells and certain animal parts.

An international nonproprietary name (INN) is an official generic and nonproprietary name given to a pharmaceutical drug or an active ingredient. INNs are intended to make communication more precise by providing a unique standard name for each active ingredient, to avoid prescribing errors. The INN system has been coordinated by the World Health Organization (WHO) since 1953.

In pharmacology, bioavailability is a subcategory of absorption and is the fraction (%) of an administered drug that reaches the systemic circulation.

<span class="mw-page-title-main">Topical medication</span> Medication applied to body surfaces

A topical medication is a medication that is applied to a particular place on or in the body. Most often topical medication means application to body surfaces such as the skin or mucous membranes to treat ailments via a large range of classes including creams, foams, gels, lotions, and ointments. Many topical medications are epicutaneous, meaning that they are applied directly to the skin. Topical medications may also be inhalational, such as asthma medications, or applied to the surface of tissues other than the skin, such as eye drops applied to the conjunctiva, or ear drops placed in the ear, or medications applied to the surface of a tooth. The word topical derives from Greek τοπικόςtopikos, "of a place".

Excipient is a substance formulated alongside the active ingredient of a medication. Excipients serve various purposes, including long-term stabilization, bulking up solid formulations containing potent active ingredients in small amounts, or enhancing the therapeutic properties of the active ingredient in the final dosage form. They can facilitate drug absorption, reduce viscosity, or enhance solubility. Excipients can also aid in the manufacturing process by improving the handling of active substances, facilitating powder flowability, or preventing denaturation and aggregation during the expected shelf life. The selection of excipients depends on factors such as the route of administration, dosage form, and active ingredient.

Natural skin care uses topical creams and lotions made of ingredients available in nature. Much of the recent literature reviews plant-derived ingredients, which may include herbs, roots, flowers and essential oils, but natural substances in skin care products include animal-derived products such as beeswax, and minerals. These substances may be combined with various carrier agents, preservatives, surfactants, humectants and emulsifiers.

<i>Martindale: The Complete Drug Reference</i>

Martindale: The Complete Drug Reference is a reference book published by Pharmaceutical Press listing some 6,000 drugs and medicines used throughout the world, including details of over 125,000 proprietary preparations. It also includes almost 700 disease treatment reviews.

Dosage forms are pharmaceutical drug products in the form in which they are marketed for use, with a specific mixture of active ingredients and inactive components (excipients), in a particular configuration, and apportioned into a particular dose. For example, two products may both be amoxicillin, but one is in 500 mg capsules and another is in 250 mg chewable tablets. The term unit dose can also sometimes encompass non-reusable packaging as well, although the FDA distinguishes that by unit-dose "packaging" or "dispensing". Depending on the context, multi(ple) unit dose can refer to distinct drug products packaged together, or to a single drug product containing multiple drugs and/or doses. The term dosage form can also sometimes refer only to the pharmaceutical formulation of a drug product's constituent drug substance(s) and any blends involved, without considering matters beyond that. Because of the somewhat vague boundaries and unclear overlap of these terms and certain variants and qualifiers within the pharmaceutical industry, caution is often advisable when conversing with someone who may be unfamiliar with another person's use of the term.

<span class="mw-page-title-main">Compounding</span> Preparation of a custom medication

In the field of pharmacy, compounding is preparation of custom medications to fit unique needs of patients that cannot be met with mass-produced products. This may be done, for example, to provide medication in a form easier for a given patient to ingest, or to avoid a non-active ingredient a patient is allergic to, or to provide an exact dose that isn't otherwise available. This kind of patient-specific compounding, according to a prescriber's specifications, is referred to as "traditional" compounding. The nature of patient need for such customization can range from absolute necessity to individual optimality to even preference.

Pharmaceutical formulation, in pharmaceutics, is the process in which different chemical substances, including the active drug, are combined to produce a final medicinal product. The word formulation is often used in a way that includes dosage form.

A combination drug or a fixed-dose combination (FDC) is a medicine that includes two or more active ingredients combined in a single dosage form. Terms like "combination drug" or "combination drug product" can be common shorthand for an FDC product, although the latter is more precise if in fact referring to a mass-produced product having a predetermined combination of drugs and respective dosages. And it should also be distinguished from the term "combination product" in medical contexts, which without further specification can refer to products that combine different types of medical products—such as device/drug combinations as opposed to drug/drug combinations. When a combination drug product is a "pill", then it may also be a kind of "polypill" or combopill.

Chinese patent medicine are herbal medicines in Traditional Chinese medicine, modernized into a ready-to-use form such as tablets, oral solutions or dry suspensions, as opposed to herbs that require cooking.

<span class="mw-page-title-main">Thin-film drug delivery</span> Drug delivery method

Thin-film drug delivery uses a dissolving film or oral drug strip to administer drugs via absorption in the mouth and/or via the small intestines (enterically). A film is prepared using hydrophilic polymers that rapidly dissolves on the tongue or buccal cavity, delivering the drug to the systemic circulation via dissolution when contact with liquid is made.

Because of the uncertain nature of various alternative therapies and the wide variety of claims different practitioners make, alternative medicine has been a source of vigorous debate, even over the definition of "alternative medicine". Dietary supplements, their ingredients, safety, and claims, are a continual source of controversy. In some cases, political issues, mainstream medicine and alternative medicine all collide, such as in cases where synthetic drugs are legal but the herbal sources of the same active chemical are banned.

References

  1. Center for Drug Evaluation and Research (2017-11-14). "Drugs@FDA Glossary of Terms". FDA. Retrieved 2022-02-03.
  2. Lim, Sean (2022-11-23). "Drug Tablet Design: Why Pills Come in So Many Shapes and Sizes". FTLOScience. Retrieved 2023-03-05.
  3. "§ 207.1 What definitions and interpretations of terms apply to this part?". US Code of Federal Regulations. US Government Publishing Office. 2023-07-19. Archived from the original on 2023-07-25. Retrieved 2023-07-25. Active pharmaceutical ingredient means any substance that is intended for incorporation into a finished drug product and is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body. Active pharmaceutical ingredient does not include intermediates used in the synthesis of the substance.
  4. Lee, Dennis (2009-04-14). Marks, Jay M. (ed.). "Drug Interactions: Know the Ingredients, Consult Your Physician". MedicineNet .
  5. "Medicines". NPS MedicineWise. 2012-10-28. Archived from the original on 2017-04-23. Retrieved 2014-05-24.
  6. Tierra, Michael, ed. (1992), American Herbalism, Crossings Press