1.2 Drug Sources, Forms, and Names
5 min read•june 18, 2024
Drugs come from various sources, including nature, labs, and biotech. They're made into different forms like pills, liquids, and . This variety allows for tailored treatments and easier administration, making medications more effective and user-friendly.
Drug standards and approval processes ensure safety and quality. The FDA's rigorous testing and monitoring protect patients from harmful or ineffective drugs. Understanding these processes helps healthcare providers make informed decisions about prescribing medications.
Drug Sources and Forms
Drug sources and forms
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- sources provide drugs derived from living organisms
- Plants yield compounds like digitalis (heart conditions), atropine (eye exams), and morphine (pain relief)
- Animals provide substances such as insulin (diabetes) and heparin (anticoagulant)
- Minerals supply essential elements like iron (anemia) and iodine (thyroid function)
- sources involve manufacturing drugs in laboratories
- Aspirin (pain relief) and acetaminophen (fever reduction) are common
- utilizes genetic engineering to create drugs
- Human insulin (diabetes) and monoclonal antibodies (cancer treatment) are biotech products
- Drug forms determine the route of administration and drug delivery
- Solid forms include (oral), (oral), (topical), and (oral)
- Liquid forms encompass (injectable), (oral), (topical), and (oral)
- Semisolid forms consist of creams (topical), (topical), (topical), and (topical)
- Gaseous forms include (inhalation) and (inhalation) for respiratory delivery
Key drug standards
- (USP) establishes standards for drug purity, potency, and quality
- Ensures consistent drug manufacturing and performance across different producers
- (NF) provides guidelines for and drug compounding
- Excipients are inactive ingredients that improve drug stability, absorption, or
- (GMP) outline requirements for drug manufacturing, processing, and packaging
- Ensures drug safety, quality, and consistency throughout the production process
- Drug standards are crucial for protecting patient safety and promoting trust in healthcare
- Consistent drug quality and efficacy enable informed decision-making by healthcare professionals
FDA drug approval process
- studies involve laboratory and animal testing to assess drug safety and efficacy
- (IND) application is submitted to the FDA to request permission for human
- Clinical trials are conducted in three phases:
- Phase 1 assesses drug safety and dosing in a small group of healthy volunteers
- Phase 2 evaluates drug efficacy and side effects in a larger group of patients with the target condition
- Phase 3 confirms drug safety and efficacy in a large, diverse patient population
- (NDA) is submitted to the FDA for review and approval, including data from preclinical and clinical studies
- FDA review and approval process evaluates drug safety, efficacy, and manufacturing processes
- Additional studies or labeling changes may be required before approval
- involves ongoing monitoring of drug safety and efficacy after approval
- The rigorous FDA approval process helps ensure that only safe and effective drugs reach the market
- Standardized testing and evaluation prevent unsafe or ineffective drugs from being prescribed to patients
Pharmacokinetics and Pharmacodynamics
- describes how the body processes a drug (absorption, distribution, metabolism, and excretion)
- plays a crucial role in determining a drug's effectiveness and duration of action
- influences dosing frequency and duration of drug effects
- explains how a drug affects the body (mechanism of action and therapeutic effects)
- can occur when multiple medications affect the same physiological processes
- studies how genetic variations influence individual responses to drugs
- Genetic differences can impact drug metabolism and effectiveness, leading to personalized treatment approaches
Drug Nomenclature and Classification
Types of drug names
- describe the drug's chemical structure and composition
- Often complex and difficult to remember (N-acetyl-p-aminophenol for acetaminophen)
- are assigned by the United States Adopted Names (USAN) Council
- Simpler and more consistent than (acetaminophen)
- Used in scientific and medical communication to avoid confusion
- are proprietary names given by drug manufacturers
- Often more memorable and marketable than (Tylenol for acetaminophen)
- May vary between different manufacturers for the same generic drug
Prescription vs over-the-counter medications
- drugs require a prescription from a licensed healthcare provider
- Used to treat more serious or complex medical conditions (antibiotics for infections)
- Higher risk of side effects or interactions due to potency and mechanism of action
- Regulated more strictly by the FDA to ensure safe and appropriate use
- (OTC) medications are available without a prescription
- Used to treat minor or self-limiting conditions (acetaminophen for headaches)
- Generally safer and have fewer side effects than prescription drugs
- Regulated by the FDA but with less stringent requirements compared to prescription drugs
Traditional drugs vs biologics vs alternatives
- Traditional drugs are chemically synthesized small molecules
- Produced through standardized manufacturing processes (aspirin, antibiotics, statins)
- are derived from living organisms or contain components of living organisms
- Often larger and more complex than traditional drugs (vaccines, monoclonal antibodies, gene therapies)
- May be more targeted and effective for certain conditions but also more expensive
- Alternative therapies are complementary and integrative approaches to healthcare
- Include herbal remedies (echinacea), dietary supplements (fish oil), and mind-body practices (meditation)
- Often lack rigorous scientific evidence for safety and efficacy compared to traditional drugs and
- Not regulated as strictly as traditional drugs or biologics, leading to potential quality and consistency issues
Generic vs brand name equivalents
- Generic equivalents contain the same active ingredients as drugs
- to brand name drugs in terms of safety and efficacy (generic ibuprofen vs Advil)
- Often less expensive than brand name drugs, increasing access to medications for patients
- Brand name equivalents are the original patented versions of drugs
- May have slightly different inactive ingredients than generic equivalents (fillers, coatings)
- Often more expensive than generic equivalents due to marketing and development costs
- May be perceived as more trustworthy or effective by some patients despite bioequivalence
- Healthcare providers should consider patient preferences and financial constraints when prescribing medications
- Generic equivalents provide cost-effective alternatives for patients without compromising efficacy
- Brand name equivalents may be necessary for patients with specific allergies or sensitivities to inactive ingredients
- Educating patients about the equivalence of generic and brand name drugs can improve medication adherence and outcomes
- Addressing misconceptions and concerns about generic drugs helps patients make informed decisions
Key Terms to Review (75)
Aerosols: Aerosols are fine solid or liquid particles suspended in a gas, typically air. They are an important consideration in the context of drug sources, forms, and names, as they represent a common method of drug delivery and administration.
Bioavailability: Bioavailability refers to the degree and rate at which a drug or other substance is absorbed and becomes available at the site of action in the body. It is a crucial pharmacokinetic property that determines the effectiveness and safety of a medication.
Bioequivalent: Bioequivalence is a term used in pharmacology to describe two drug products that are pharmaceutically equivalent and whose bioavailability (the rate and extent to which the active ingredient is absorbed and becomes available at the site of action) is similar to such a degree that their effects can be expected to be essentially the same.
Biologics: Biologics are complex drugs derived from living organisms, used to treat various medical conditions. They include proteins, nucleic acids, or cells that mimic natural substances in the body.
Biologics: Biologics are a class of drugs derived from living organisms, such as proteins, antibodies, or other biological substances. They are designed to target specific molecules or processes in the body, often used to treat complex diseases like autoimmune disorders, cancer, and infectious diseases.
Biosimilars: Biosimilars are biologic medical products that are highly similar to an already approved reference product, with no clinically significant differences in terms of safety, purity, and potency. They undergo rigorous testing and regulatory review to ensure they match the original biologic.
Biotechnology: Biotechnology is the use of living organisms, such as cells, tissues, or microorganisms, to develop or create products for practical applications in fields like medicine, agriculture, and environmental management. It encompasses a wide range of techniques and technologies that harness the power of biological systems to solve problems and improve human well-being.
Brand name: A brand name is the proprietary name assigned to a drug by its manufacturer. It is often trademarked and used for marketing purposes.
Canada’s drug laws: Canada’s drug laws regulate the control, distribution, and use of pharmaceutical drugs within the country. These laws aim to ensure public safety and effective therapeutic outcomes.
Canadian Food and Drugs Act: The Canadian Food and Drugs Act is federal legislation that governs the safety, efficacy, and quality of food, drugs, cosmetics, and medical devices in Canada. It provides the framework for regulating the development, approval, marketing, and sale of these products.
Capsules: Capsules are a type of solid dosage form that consists of a shell, usually made of gelatin, that contains a powdered or liquid drug formulation. They are designed to protect the drug from degradation, mask unpleasant tastes or odors, and facilitate the administration of medications.
Center for Drug Evaluation and Research (CDER): The Center for Drug Evaluation and Research (CDER) is a branch of the U.S. Food and Drug Administration (FDA) responsible for ensuring that drugs marketed in the United States are safe and effective. CDER evaluates new drugs before they can be sold and monitors existing drugs to ensure continued safety.
Chemical names: Chemical names describe the precise molecular structure of a drug using standard chemical nomenclature. They provide detailed information about the atomic and molecular composition.
Chemical Names: Chemical names are the systematic, scientific names given to chemical compounds and substances. These names provide a standardized way to identify and classify different chemicals based on their molecular structure and composition.
Children: Children are individuals in the developmental stage between infancy and adolescence. Their physiological and psychological characteristics impact how they respond to various pharmacological treatments.
Clinical Trials: Clinical trials are research studies that evaluate the safety and effectiveness of new medical interventions, such as drugs, devices, or procedures, in human participants. They are a critical step in the development and approval process for new healthcare products, ensuring they meet rigorous standards before being made available to the public.
Complementary and alternative medicine (CAM): Complementary and Alternative Medicine (CAM) encompasses a variety of medical practices that are not typically part of conventional medicine. These practices are used in addition to or instead of standard treatments.
Counterfeit drugs: Counterfeit drugs are medications that are fraudulently produced or mislabeled to deceive consumers about their authenticity and effectiveness. These drugs can contain incorrect ingredients, improper dosages, or harmful substances.
Creams: Creams are a type of topical pharmaceutical preparation that are thick, spreadable, and water-based. They are designed to be applied to the skin for various therapeutic purposes, such as delivering active ingredients, providing moisturization, or protecting the skin.
Drug Enforcement Administration (DEA): The Drug Enforcement Administration (DEA) is a United States federal law enforcement agency under the Department of Justice tasked with combating drug smuggling and use within the U.S. It regulates controlled substances by enforcing laws related to drugs and chemical diversion.
Drug Half-Life: Drug half-life is the time it takes for the concentration or amount of a drug in the body to be reduced by one-half. It is a critical pharmacokinetic property that determines how long a drug remains active and how frequently it needs to be administered to maintain a therapeutic effect.
Drug Interactions: Drug interactions occur when the effects of one drug are altered by the presence of another drug, food, or other substance in the body. These interactions can lead to changes in the drug's intended therapeutic effects, side effects, or both, potentially impacting the overall safety and efficacy of the medication regimen.
Drug Metabolism: Drug metabolism is the process by which the body breaks down and eliminates drugs and other foreign substances. It involves a series of chemical reactions that transform the drug into more water-soluble metabolites, facilitating their excretion from the body. This process is crucial in determining the duration, intensity, and effects of a drug within the body, and it can be influenced by various factors related to the drug, the individual, and the environment.
Drug Supply Chain Security Act: The Drug Supply Chain Security Act (DSCSA) is a law enacted to enhance the security of the pharmaceutical supply chain in the United States. It aims to prevent counterfeit drugs and ensure that medications are safe for consumers.
Emulsions: Emulsions are a type of heterogeneous mixture where one liquid is dispersed as small droplets throughout another liquid, typically an oil-in-water or water-in-oil system. They are an important pharmaceutical drug form that can enhance the bioavailability and stability of certain medications.
Enteral administration: Enteral administration involves delivering medication directly into the gastrointestinal (GI) tract, typically through oral or feeding tube methods. It is a common route for systemic drug delivery.
Excipients: Excipients are inactive ingredients in a drug formulation that are added to the active pharmaceutical ingredient (API) to enhance the drug's stability, bioavailability, or ease of administration. They play a crucial role in the overall drug delivery and effectiveness.
Food and Drug Administration (FDA): The Food and Drug Administration (FDA) is a U.S. government agency responsible for regulating food, pharmaceuticals, medical devices, and other health-related products. It ensures the safety, efficacy, and security of drugs and medical products available to the public.
Gels: Gels are a semi-solid or jelly-like dosage form that consists of a network of cross-linked polymers dispersed in a liquid medium. They are commonly used in the pharmaceutical industry as drug delivery systems, topical applications, and personal care products due to their unique physical and rheological properties.
Generic names: Generic names are standardized names assigned to a drug, often derived from its chemical composition. They are universally recognized and not protected by trademark.
Generic Names: Generic names, also known as nonproprietary or international nonproprietary names (INNs), are the official, non-branded names assigned to pharmaceutical drug substances. These names are used to identify the active ingredient in a medication, regardless of the manufacturer or brand name.
Glucose tablets: Glucose tablets are chewable tablets containing glucose that provide quick relief from hypoglycemia. They are commonly used by people with diabetes to rapidly increase blood sugar levels.
Good Manufacturing Practices: Good Manufacturing Practices (GMP) are the practices required to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food, drug products, and active pharmaceutical ingredients. GMP is a system for ensuring that products are consistently produced and controlled according to quality standards, to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
Inhalers: Inhalers are portable medical devices used to deliver medication directly into the lungs, typically for the treatment of respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD). They provide a targeted and efficient way to administer various types of medications, including bronchodilators, corticosteroids, and combination therapies, directly to the affected areas of the respiratory system.
Investigational New Drug: An Investigational New Drug (IND) is a pharmaceutical product that is under investigation for human use and has not yet been approved for marketing by regulatory authorities. It is the first step in the drug development process, allowing for the clinical evaluation of a new drug's safety and efficacy before it can be submitted for marketing approval.
Kefauver-Harris Amendments: The Kefauver-Harris Amendments, passed in 1962, are U.S. federal laws that require drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval. These amendments were enacted to ensure more rigorous testing and transparency in drug development.
Lozenges: Lozenges are a solid, medicated dosage form that is designed to be dissolved slowly in the mouth. They are typically small, flat, and diamond-shaped, made from a mixture of active ingredients and excipients that allow for a controlled release of the medication.
MedWatch: MedWatch is the FDA's reporting system for monitoring adverse events and product problems associated with medical products. It aims to ensure patient safety and improve the quality of healthcare.
National Association of Pharmacy Regulatory Authorities (NAPRA): The National Association of Pharmacy Regulatory Authorities (NAPRA) is a Canadian organization that sets standards for pharmacy practice and ensures public safety. It collaborates with provincial regulatory bodies to maintain consistent practices across the country.
National Council Licensure Examination (NCLEX): The National Council Licensure Examination (NCLEX) is a standardized exam that nurses must pass to obtain licensure to practice nursing in the United States. It assesses the knowledge, skills, and abilities essential for safe and effective nursing practice.
National Formulary: The National Formulary is an official publication that provides detailed information and standards for the composition, quality, and purity of pharmaceutical drug products in the United States. It serves as a comprehensive reference guide for healthcare professionals, particularly in the context of drug sources, forms, and names.
Natural: In the context of drug sources, forms, and names, the term 'natural' refers to substances or compounds that are derived from or found in nature, without any significant human-made modifications or synthetic processing. These natural substances can serve as the basis for the development of various pharmaceutical drugs and medicinal products.
New Drug Application: A New Drug Application (NDA) is a formal request to the U.S. Food and Drug Administration (FDA) to approve a new pharmaceutical drug for marketing and sale in the United States. It is the final and most comprehensive step in the drug development process, providing detailed information about the drug's safety, efficacy, and manufacturing.
Off-label prescription drug use: Off-label prescription drug use refers to the practice of prescribing medications for an indication, dosage, or patient group that is not included in the approved labeling by regulatory agencies. It is a common practice often based on clinical judgment and scientific evidence.
Ointments: Ointments are semi-solid preparations, typically made of oils or fats, that are applied topically to the skin or mucous membranes. They are designed to provide a protective, emollient, or therapeutic effect when applied to the affected area.
Over-the-counter: Over-the-counter (OTC) refers to pharmaceutical drugs and medications that can be purchased without a prescription from a healthcare provider. These products are generally considered safe for self-medication and are available for direct consumer access in pharmacies, grocery stores, and other retail outlets.
Over-the-counter (OTC) drugs: Over-the-counter (OTC) drugs are medications available without a prescription. They are used for self-care and treatment of common health issues.
Parenteral administration: Parenteral administration is the delivery of medications by injection through routes such as intravenous (IV), intramuscular (IM), and subcutaneous (SC). It bypasses the gastrointestinal tract, allowing for faster absorption and onset of action.
Parenteral route: The parenteral route involves administering medication by bypassing the gastrointestinal tract, typically through injections. Common methods include intravenous (IV), intramuscular (IM), and subcutaneous (SC) injections.
Pastes: Pastes are a semisolid dosage form that are typically applied topically to the skin or mucous membranes. They are formulated with a high proportion of solid ingredients, such as powders, dispersed in a suitable vehicle, creating a thick, spreadable consistency.
People of color (POC): People of Color (POC) is a collective term used to describe individuals who identify as non-white. It encompasses a wide range of racial and ethnic backgrounds.
Percutaneous administration: Percutaneous administration involves delivering drugs through the skin or mucous membranes. It aims for localized or systemic effects depending on the drug formulation.
Pharmacodynamics: Pharmacodynamics is the study of how drugs affect the body, including mechanisms of action and drug-receptor interactions. It examines the relationship between drug concentration and effect.
Pharmacodynamics: Pharmacodynamics is the study of the biochemical and physiological effects of drugs and their mechanisms of action within the body. It examines how drugs interact with the body's biological systems to produce their desired therapeutic effects or undesired side effects.
Pharmacogenomics: Pharmacogenomics is the study of how an individual's genetic makeup influences their response to drugs. It aims to develop safer and more effective medications by understanding how genetic variations affect drug metabolism, efficacy, and side effects.
Pharmacokinetics: Pharmacokinetics is the study of how the body affects a drug, including the processes of absorption, distribution, metabolism, and elimination. It examines the movement of drugs within the body and how these processes impact the drug's concentration and duration of action.
Post-market Surveillance: Post-market surveillance refers to the ongoing monitoring and evaluation of a drug or medical product's safety, effectiveness, and quality after it has been approved and made available for public use. This process is crucial for identifying any previously unknown or emerging risks associated with the product, as well as ensuring its continued safe and appropriate use.
Powders: Powders are a finely divided solid form of a drug or pharmaceutical preparation. They are commonly used as a means of delivering medications, enhancing the bioavailability of active ingredients, and improving the stability and shelf-life of certain drug products.
Preclinical: Preclinical refers to the early stages of drug development that occur before a new drug candidate is tested in human clinical trials. This phase involves extensive research, testing, and evaluation of a drug's safety, efficacy, and potential for further development.
Prescription: A prescription is a written order from a licensed healthcare provider, such as a doctor or nurse practitioner, that authorizes the dispensing of a specific medication or treatment to a patient. It serves as the legal and medical documentation for the patient's drug therapy.
Prescription medications: Prescription medications are drugs that legally require a medical prescription from a licensed healthcare provider to be dispensed. They are used to treat, manage, or prevent specific health conditions.
Racial and ethnic minorities: Racial and ethnic minorities are groups of people who differ in race or ethnicity from the majority population. In healthcare, they often face disparities in access, treatment, and outcomes.
Solutions: A solution is a homogeneous mixture composed of two or more substances, where a solute is dissolved in a solvent. Solutions are ubiquitous in the context of drug sources, forms, and names, as they play a crucial role in the preparation, delivery, and administration of pharmaceutical products.
Subcutaneous injections: Subcutaneous injections involve administering medication into the layer of fat below the skin using a short needle. This route is commonly used for vaccines and medications that need to be absorbed slowly.
Suspensions: Suspensions are heterogeneous mixtures in which finely divided insoluble particles are dispersed throughout a liquid medium. They are an important pharmaceutical dosage form that allows for the delivery of insoluble or poorly soluble drugs.
Synthetic: Synthetic refers to something that is artificially created or produced, rather than occurring naturally. In the context of drug sources, forms, and names, synthetic describes drugs that are manufactured in a laboratory or industrial setting, as opposed to being derived from natural plant or animal sources.
Synthetic drugs: Synthetic drugs are chemically manufactured substances designed to mimic the effects of natural drugs. They are created in laboratories and often used for medical purposes or recreationally.
Syrups: Syrups are thick, viscous liquid preparations that contain a high concentration of dissolved sugars or other sweetening agents. They are commonly used in the pharmaceutical industry as drug delivery vehicles, providing a smooth, palatable, and easy-to-swallow dosage form, particularly for pediatric and geriatric patients.
Tablets: Tablets are a solid dosage form of medication that are typically taken orally. They are made by compressing or molding a mixture of active pharmaceutical ingredients and excipients, such as binders, disintegrants, and lubricants, into a compact and convenient form for administration.
Teratogenic: Teratogenic refers to substances or agents that can cause malformations or defects in a developing embryo or fetus. These agents can lead to congenital abnormalities when exposure occurs during pregnancy.
Trade Names: Trade names, also known as brand names or proprietary names, are the unique, often catchy names given to pharmaceutical products by the companies that manufacture them. These names are distinct from the generic or chemical names of the active ingredients in the drugs. Trade names are an important aspect of drug sources, forms, and naming conventions in the field of pharmacology.
U.S. Adopted Names Council: The U.S. Adopted Names Council (USAN) is responsible for selecting simple, informative, and unique nonproprietary names for drugs. These names are used to ensure clear communication among healthcare professionals and avoid medication errors.
United States Pharmacopeia: The United States Pharmacopeia (USP) is an official public standards-setting authority for all prescription and over-the-counter medicines and other healthcare products manufactured or sold in the United States. It plays a crucial role in ensuring the quality, safety, and efficacy of drug products by establishing standards for their identity, strength, quality, and purity.
United States Pharmacopeia National Formulary (USP-NF): The United States Pharmacopeia National Formulary (USP-NF) is a compendium of drug standards used to ensure the quality, purity, strength, and consistency of medications. It is recognized by the FDA and sets enforceable standards for all prescription and over-the-counter medicines.
Verified Internet Pharmacy Practice Site (VIPPS): A Verified Internet Pharmacy Practice Site (VIPPS) is an accreditation provided by the National Association of Boards of Pharmacy (NABP) to online pharmacies that meet specific safety and quality standards. VIPPS-accredited pharmacies assure consumers of the legitimacy and reliability of their pharmaceutical services.