Podcast
Questions and Answers
What does bioavailability refer to in pharmacology?
What does bioavailability refer to in pharmacology?
Which term describes the process by which a solid drug dissolves in solution?
Which term describes the process by which a solid drug dissolves in solution?
Which statement best describes therapeutic equivalence?
Which statement best describes therapeutic equivalence?
What is quality control in pharmaceuticals?
What is quality control in pharmaceuticals?
Signup and view all the answers
What is considered an intermediate product in pharmaceutical manufacturing?
What is considered an intermediate product in pharmaceutical manufacturing?
Signup and view all the answers
What does stability refer to in the context of a pharmaceutical product?
What does stability refer to in the context of a pharmaceutical product?
Signup and view all the answers
What is indicated by an expiration date that lists only a month and year?
What is indicated by an expiration date that lists only a month and year?
Signup and view all the answers
What is meant by expiration dating period or shelf-life?
What is meant by expiration dating period or shelf-life?
Signup and view all the answers
Which temperature range is considered room temperature for pharmaceutical storage?
Which temperature range is considered room temperature for pharmaceutical storage?
Signup and view all the answers
What is the purpose of stability studies in pharmaceuticals?
What is the purpose of stability studies in pharmaceuticals?
Signup and view all the answers
Study Notes
Drug Disintegration and Dissolution
- Disintegration: The breakdown of a solid drug into smaller particles.
- Dissolution: The process by which the active ingredient in a solid drug dissolves into a solution.
Drug Absorption and Bioavailability
- Absorption: The movement of a drug into the bloodstream.
- Bioavailability: The amount of drug that reaches systemic circulation unchanged.
Bioequivalence & Therapeutic Equivalence
- Bioequivalence: Two drugs have comparable bioavailability if they reach systemic circulation at the same rate and extent.
- Therapeutic Equivalence: Two drugs have comparable clinical effectiveness and safety.
Pharmaceutical Quality and Manufacturing
- Quality: Intrinsic characteristics of a product that meet user needs.
- Quality Control: Physical and chemical tests to ensure raw materials and finished products meet specifications.
- Manufacture: All operations involved in producing a pharmaceutical product, from raw material procurement to finished product shipment.
- Starting Material: Any substance used to produce a pharmaceutical product, excluding packaging materials.
- Intermediate Product: Partially processed material that requires further manufacturing steps.
- Finished Product: A product that has undergone all manufacturing stages including packaging and labeling.
- Returned Product: Finished products sent back to the manufacturer.
- Production: All operations involved in preparing a pharmaceutical product, from material receipt to completed product.
- Packaging: Operations involved in transforming a bulk product into a finished product, including filling and labeling.
- Validation: Demonstrating that a procedure, process, or system consistently delivers expected results.
Pharmaceutical Stability and Expiration Dates
- Stability: The ability of a pharmaceutical product in its container to maintain defined physical, chemical, microbiological, therapeutic, and toxicological specifications over time under specific storage conditions.
- Expiration Date: The date on a product container indicating the expected date when the product remains within specifications.
- Expiration Dating Period (Shelf-Life): The duration a drug product is expected to remain within specifications, determined through stability studies.
- Shelf-storage Stability: Stability of a drug product at ambient room temperature (15-30°C).
- Storage: Safekeeping of starting materials, packaging, and finished products under specified conditions.
- Storage Conditions: Specified conditions for storing a product, including temperature, humidity, container, and light.
-
Storage Temperatures: Actual storage temperature during stability studies:
- Refrigerator: 2°C to 8°C
- Freezer: Less than -10°C
- Cold Place: 8°C to 15°C
- Warm Place: 30°C to 40°C
- Room Temperature: 15°C to 30°C
Medical Terminology
- Contraceptive, Oral: A drug taken orally by women to prevent conception.
- Anti-anemic: A drug that stimulates the production of red blood cells.
- Anticholesteremic: A drug that lowers plasma cholesterol levels.
- Antihyperlipidemic: A drug that lowers plasma cholesterol and lipid levels.
- Anticoagulant, Systemic: A drug that slows blood clotting.
- Antihypertensive: A drug that lowers arterial blood pressure.
- Diuretic: A drug that promotes renal excretion of electrolytes and water.
- Hematinic: A drug that promotes hemoglobin formation by supplying iron.
- Metal Complexing Agent: A drug that binds to metals, removing them from solutions; used in treating metal poisoning.
- Systemically Acting Drug: A drug that is absorbed into systemic circulation and diffuses into all tissues.
- Anti-anginal: A coronary vasodilator used to prevent or treat angina pectoris.
- Antitussive: A drug that suppresses coughing.
- Bronchodilator: A drug that expands bronchiolar airways, used to treat asthma.
- Expectorant: A drug that decreases respiratory tract secretion viscosity and promotes its removal.
- Mucolytic: A drug that hydrolyses mucoproteins to reduce pulmonary mucous viscosity.
- Anticonvulsant: An antiepileptic drug that arrests convulsions.
- Antidepressant: A drug that induces mood elevation, used to treat depression.
- Anti-epileptic: An anticonvulsant drug that suppresses seizures.
- Hypnotic: A drug that induces sleep.
- Sedative: A drug that induces relaxation and reduces emotional tension.
- Antidiabetic: A drug that replaces or stimulates insulin secretion, used to treat diabetes mellitus.
- Antihypoglycemic: A drug that elevates plasma glucose levels, used to treat hypoglycemia.
- Analgesic: A drug that suppresses pain perception.
- Antipyretic: A drug that lowers body temperature during fever.
- Antirheumatic: A drug that alleviates inflammatory symptoms of arthritis.
- Digestive Aid: A drug that promotes digestion, usually by supplementing digestive enzymes.
- Antacid: A drug that neutralizes excess gastric acid.
- Anti-amebic: A drug that kills or inhibits Entamoeba histolytica.
- Anti-emetic: A drug that prevents vomiting.
- Emetic: A drug that induces vomiting, used to remove ingested poisons.
- Antiflatulent: A drug that reduces gastrointestinal gas.
- Antibacterial: A drug that kills or inhibits pathogenic bacteria.
- Antifungal, Systemic: A drug that kills or inhibits pathogenic fungi causing systemic and gastrointestinal infections.
- Antifungal, Topical: A drug that kills or inhibits pathogenic fungi causing topical infections.
- Antimalarial: A drug that kills or inhibits protozoa that cause malaria.
- Emollient: A topical drug that softens the skin.
- Keratolytic: A topical drug that softens the skin's keratin layer and promotes desquamation.
- Sun Screening Agent: A skin protectant that absorbs light energy that causes sunburn.
Studying That Suits You
Use AI to generate personalized quizzes and flashcards to suit your learning preferences.
Related Documents
Description
Test your knowledge on essential concepts in pharmaceutical science, including drug disintegration, absorption, and bioequivalence. This quiz covers key processes that affect drug formulation and clinical effectiveness. Perfect for students and professionals in the pharmaceutical field.