Pharmaceutical terms and definitions

Pharmaceutical terms and definitions

 

A

• Absorption: The process by which a drug is taken up from the site of administration (e.g., gastrointestinal tract) into the bloodstream.

• Acceptance Quality Limit (AQL): A statistical measure for determining the maximum acceptable number of defects in a sample during quality control.

• Active Pharmaceutical Ingredient (API): The active substance in a drug that is responsible for its therapeutic effect.

• Adsorption: The process by which molecules adhere to the surface of a solid or liquid material, such as activated carbon removing impurities.

• Aggregation: The clustering of particles, proteins, or molecules that can lead to instability in the product, particularly in biologics.

• Ampoule: A small, sterile glass or plastic container used to store liquids, powders, or gels for injection.

• Analgesic: A drug used to relieve pain without affecting consciousness.

• Annex 1: A section of the EU GMP guidelines specifying requirements for sterile manufacturing processes.

• Antibiotic: A drug used to combat bacterial infections by killing or inhibiting the growth of bacteria.

• Aseptic Manufacturing: A sterile manufacturing process that prevents contamination by microorganisms or particles.

• Autoclaving: A sterilization method using pressurized steam to kill microorganisms.

 

B

• Batch: A specific quantity of a product that is produced under identical conditions and exhibits uniform quality.

• Bioequivalence: The demonstration that two drugs with the same active ingredient have the same bioavailability and therapeutic effect.

• Bioassay: A test used to determine the biological activity of a drug by measuring the response of living organisms or cells.

• Biologics: Drugs derived from living cells or organisms, such as vaccines or monoclonal antibodies.

• Bioavailability: The proportion of a drug that reaches the systemic circulation and is available to exert its therapeutic effect.

• Blister Packaging: A packaging format where medications (e.g., tablets) are sealed in individual pockets made of plastic or aluminum.

• Blood Concentration Curve: A graph depicting the concentration of a drug in the blood over time to analyze pharmacokinetic parameters.

• BSE/TSE (Bovine/Transmissible Spongiform Encephalopathy): Measures to prevent contamination of pharmaceutical products with pathogenic proteins from animal sources.

• Bulk Goods: Unpackaged pharmaceutical products that are later filled into their final packaging.

 

C

• CAPA (Corrective and Preventive Action): A process to identify, investigate, and resolve quality issues and prevent recurrence.

• Cell Culture Technology: The process of growing living cells in controlled environments, particularly for producing biologics.

• Charge Documentation: Written records of all manufacturing and testing steps for a batch to ensure quality control and traceability.

• Chromatography: An analytical method for separating, identifying, and quantifying components in a mixture.

• Cold Chain: A controlled temperature chain for sensitive products like vaccines to maintain their stability.

• Compliance: Adherence to legal, regulatory, and internal standards in the pharmaceutical industry.

• Cross-Contamination: The unintended transfer of substances between different drugs or production processes.

• CQA (Critical Quality Attributes): Essential product characteristics that determine the quality, safety, and efficacy of a drug.

• cGMP (current Good Manufacturing Practice): Current standards and regulations to ensure the quality and safety of drugs during manufacturing.

• Cytostatics: Drugs that inhibit cell growth or division, particularly used in cancer treatment.

 

D

• Declaration: A list of ingredients and their quantities on a drug’s packaging according to legal requirements.

• Decontamination: The process of removing or destroying microorganisms or chemical residues.

• Depot Formulation: A drug that releases its active ingredient slowly over an extended period, such as injections or implants.

• Disintegration Test: A test to determine how long it takes for a tablet to dissolve completely in a liquid.

• Diffusion: The passive transport of molecules along a concentration gradient, important for drug release.

• Dissolution Test: A test to determine the speed and amount of a drug that dissolves from a solid form into a solution.

• DMF (Drug Master File): A confidential document containing detailed information on the manufacturing, quality, and control of an active ingredient or excipient.

• Dose: The precise amount of a drug to be administered to achieve the desired therapeutic effect.

• Dosage Aerosol: A drug form where the medication is released as a spray using a propellant.

 

E

• Emulsifier: A substance that helps maintain the stability of emulsions, such as in creams or injectable products.

• Endotoxin: Toxins released from bacteria that can cause harmful reactions in sterile products.

• Endotoxin Testing: A test to quantify bacterial endotoxins that might be toxic in sterile pharmaceutical products.

• Enteric Coating: A special coating applied to tablets or capsules to prevent the drug from dissolving in the stomach, ensuring it disintegrates in the intestines.

• Ex-vivo: Tests or experiments conducted on tissues or organs outside a living organism.

• Excipients: Inactive substances included in a pharmaceutical formulation along with the active ingredient, such as fillers, binders, preservatives, or flavorings.

• Extraction: The process of obtaining active ingredients from natural raw materials, such as plants or microorganisms.

 

F

• Filtration: A method to remove particles or microorganisms from liquids or gases by passing them through a filter.

• First-Pass Effect: The metabolism of a drug in the liver after oral administration before it enters systemic circulation.

• Formulation: The process of developing a drug by combining the active ingredient with excipients into an appropriate dosage form.

• Filling Machine Validation: The process to ensure that a filling machine delivers consistent and accurate doses.

• Filling Volume Testing: A test to ensure that the contents of a vial, ampoule, or container match the declared amount.

 

G

• Galenics: The science of developing and manufacturing pharmaceutical formulations and dosage forms.

• Freeze-Drying (Lyophilization): A process to remove water from a solution or suspension by sublimation, often used for sensitive products like biologics.

• Content Testing: Determining the amount of active ingredient in a drug to ensure the correct dosage.

• Glass Corrosion: The chemical alteration of the inner surface of glass containers due to interactions with the drug product.

 

H

• High-Performance Liquid Chromatography (HPLC): A precise analytical method used to determine the purity, identity, and content of an active ingredient.

• Homogeneity: The even distribution of an active ingredient or excipient in a formulation.

• Human-Compatible Matrix: Material compatible with human tissue, used in implants or drug delivery systems.

 

I

• Identity Testing: A test to confirm that a drug or active ingredient matches the specified characteristics.

• Immunogenicity: The ability of a biologic drug to provoke an immune response, which is critical for biologics such as monoclonal antibodies.

• Impurities: Undesirable substances that may be present in an active ingredient or drug product.

• Indication: The medical condition or disease for which a drug is used.

• Inhaler: A device used to administer medications in the form of aerosol or powder directly into the airways.

• In-Process Control (IPC): Quality checks performed during manufacturing to ensure that the process is under control.

• Isotonicity: A solution that has the same osmotic pressure as human plasma to avoid damage to cells (e.g., for intravenous fluids).

 

J

• Just-in-Time Manufacturing: A production strategy that minimizes inventory and increases efficiency by producing drugs only when needed.

 

K

• Calibration: The process of ensuring that a measuring device or system produces accurate and consistent results.

• Capsule: A solid dosage form in which the active ingredient is enclosed in a gelatin-like shell.

• Clinical Trial: Human research conducted to evaluate the safety, efficacy, and dosage of a drug.

• Contamination Control: Measures to prevent contamination in drugs and production environments.

• Critical Control Points (CCP): Points in the manufacturing process where risks to quality can be minimized or eliminated.

 

L

• Laminar Flow Workbench: A workspace with directed airflow used to create a sterile working environment.

• Shelf-Life Study: A long-term study to determine the expiration date of a drug product.

• Solubility: The ability of a substance to dissolve in a solvent, which affects its bioavailability.

• Lyophilization (Freeze-Drying): A process to dehydrate a product by freezing and sublimating the water content.

 

M

• Microbiological Testing: Tests to ensure that a drug product is free from unwanted microorganisms.

• Monograph: A detailed description of the specifications, testing methods, and acceptance criteria for an active ingredient or drug product in a pharmacopoeia.

• Molecular Weight: The sum of the atomic weights of the atoms in a molecule, which affects the drug’s absorption, distribution, and metabolism.

 

N

• Nanoparticles: Tiny particles used in drug delivery systems for targeted delivery and controlled release.

• Nebulizer: A device that converts liquid medication into a fine mist for inhalation.

• Non-Clinical Testing: Preclinical studies conducted to assess the safety and pharmacological properties of a drug in vitro or in animal models.

• NDA (New Drug Application): A regulatory filing submitted to health authorities for approval to market a new drug.

 

O

• Osmolality: A measure of the concentration of solute particles in a solution, important for formulations like injections.

• Out-of-Specification (OOS): A result that falls outside the established limits for a given test or quality control.

 

P

• Particle Size: An important parameter affecting the solubility, bioavailability, and stability of a drug.

• Pharmacokinetics: The study of how a drug is absorbed, distributed, metabolized, and excreted by the body.

• Pharmacopoeia: An official reference containing standards and specifications for drugs and their ingredients (e.g., EP, USP, JP).

• Placebo: An inactive substance used as a control in clinical trials.

• Primary Packaging: The packaging that directly contacts the product, such as vials, ampoules, or blisters.

 

Q

• Quality Control (QC): Measures to ensure that a drug meets the specified standards.

• Quality Risk Management (QRM): A systematic approach to evaluating, controlling, and monitoring risks to product quality.

• Quarantine: The storage of raw materials or products awaiting release after quality testing.

 

R

• Cleaning Validation: Demonstration that cleaning procedures are effective in preventing cross-contamination between products.

• Sustained Release: A drug formulation designed to release the active ingredient over an extended period.

• X-ray Crystallography: An analytical method used to determine the molecular structure of a drug, particularly in crystalline solids.

 

S

• Stability Study: Tests to evaluate the shelf life and stability of a drug product under various storage conditions.

• Sterilization: A process to eliminate all microorganisms from a product, such as autoclaving, filtration, or irradiation.

• Suspension: A liquid dosage form in which solid particles are dispersed but not dissolved.

 

T

• Tablet: A solid dosage form made by compressing powders or granules into a compact shape.

• Therapeutic Index: The ratio between the minimum effective dose and the minimum toxic dose of a drug.

• Titration: A quantitative analytical method used to determine the concentration of a substance in a solution.

 

U

• Ultrafiltration: A membrane process to separate molecules of different sizes, used in protein purification or drug concentration.

• Uniformity of Dose: Ensuring that each dosage unit of a drug contains the correct amount of active ingredient.

 

V

• Validation Report: Documentation of the results and conclusions from process or system validation.

• Viscosity: The resistance of a liquid to flow, a factor in formulating solutions, suspensions, or gels.