History of the USP
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Questions and Answers

What are the two main components of dosage forms?

  • Active pharmaceutical ingredient and drug additives (correct)
  • Inactive ingredients and active ingredient
  • Drug delivery systems and drug formulations
  • Active pharmaceutical ingredient and multiple drugs

    • The term 'drug product' refers to an unfinished dosage form.

    False

    What is the primary purpose of pharmaceutical preparations?

    To make a drug entity ready for use.

    Amoxicillin belongs to the _____ group.

    <p>B-lactam</p> Signup and view all the answers

    Match the following terms with their definitions:

    <p>Drug entity = Active pharmaceutical ingredient Drug additives = Inactive ingredients that assist in drug formulation Dosage form = Means of administering drug preparations Pharmaceutical preparation = Set of procedures for drug readiness</p> Signup and view all the answers

    Who is known as the father of the USP?

    <p>Lyman Spalding</p> Signup and view all the answers

    The National Formulary was established after the USP.

    <p>False</p> Signup and view all the answers

    What is the primary purpose of the USP?

    <p>Standardization of medicine</p> Signup and view all the answers

    The Pure Food and Drug Act was signed by _____ in 1906.

    <p>Theodore Roosevelt</p> Signup and view all the answers

    What was the first name of the National Formulary?

    <p>National Formulary of Unofficial Preparations</p> Signup and view all the answers

    Match the following terms with their definitions:

    <p>Monograph = A scientific document providing drug standards Assay = Method to determine potency or strength Purity = Assessment of impurities or contaminants Packaging = Guidelines for storage and temperature</p> Signup and view all the answers

    The latest editions of USP and NF are the USP 42nd and NF 37th.

    <p>True</p> Signup and view all the answers

    The _____ assesses the physicochemical properties of a substance like pH and dissolution.

    <p>Quality</p> Signup and view all the answers

    What is one of the main functions of dosage forms?

    <p>To protect the drug from destruction by oxygen or humidity</p> Signup and view all the answers

    Additives or excipients in dosage forms can include anti-oxidants.

    <p>True</p> Signup and view all the answers

    What is the purpose of providing a controlled-release dosage form?

    <p>To achieve a consistent rate of absorption over time.</p> Signup and view all the answers

    The method designed to transport a pharmaceutical compound into the body is known as the _____ system.

    <p>drug delivery</p> Signup and view all the answers

    Match the following terms to their definitions:

    <p>Film coated tablets = Conceal unpleasant taste/odor Solid dosage form = Provide rate-controlled drug action Intravenous (IV) = Bolus or infusion route Delayed-release = Stay in stomach for a while</p> Signup and view all the answers

    Which of the following routes of administration is included in the extravascular category?

    <p>Intramuscular (IM)</p> Signup and view all the answers

    Pharmaceutical compounds cannot be administered intravascularly.

    <p>False</p> Signup and view all the answers

    What is one reason for film coating a drug?

    <p>To protect it from moisture and enhance swallowability.</p> Signup and view all the answers

    Which study focuses on determining the effects of a compound on gene mutation?

    <p>Genotoxicity or Mutagenicity Studies</p> Signup and view all the answers

    Reproductive Studies are conducted to evaluate the effects of compounds on mammalian reproduction.

    <p>True</p> Signup and view all the answers

    What is the main goal of pre-formulation studies in the drug development process?

    <p>To produce an optimum drug delivery system</p> Signup and view all the answers

    Studies aimed at collecting basic information on the _____ and _____ characteristics of the drug substance are part of the pre-formulation process.

    <p>physical, chemical</p> Signup and view all the answers

    Match the following drug characteristics with their definitions:

    <p>Solubility = Ability of the drug to dissolve in a solvent Dissolution Rate = Speed at which a drug dissolves in a given medium Stability = The drug's ability to maintain its integrity over time Partition Coefficient = Ratio of concentrations of a compound in two immiscible solvents at equilibrium</p> Signup and view all the answers

    Which characteristic is NOT associated with a Goal Drug?

    <p>Minimum pricing</p> Signup and view all the answers

    High-throughput screening can examine up to 15,000 chemical compounds per week.

    <p>True</p> Signup and view all the answers

    What is the primary aim of random or untargeted screening in drug discovery?

    <p>To test large numbers of compounds for biological activity without specific knowledge of their target.</p> Signup and view all the answers

    Bioassays are used to differentiate the effect and __________ of the test agent.

    <p>potency</p> Signup and view all the answers

    Match the methods of drug discovery to their descriptions:

    <p>Random Screening = Testing large numbers of compounds without specific targets Bioassays = Differentiating effects and potency of agents High-throughput Screening = Examining large volumes of compounds using numerous assays Molecular Modification = Chemical alteration of a known compound</p> Signup and view all the answers

    What is a key downside of random screening methods?

    <p>Potential to overlook some effective compounds</p> Signup and view all the answers

    Molecular modification involves the chemical alteration of previously defined lead compounds.

    <p>True</p> Signup and view all the answers

    What kind of testing does high-throughput screening utilize?

    <p>Biologic assays</p> Signup and view all the answers

    Study Notes

    USP Overview

    • Established in 1820 to standardize medicine in the U.S., enhancing public health and safety.
    • Initially listed almost 563 drugs over 272 pages.
    • Aimed to achieve consistent quality and therapeutic merit in pharmaceuticals.

    National Formulary

    • Created as a compendium for pharmaceutical standards, first known as the National Formulary of Unofficial Preparations in 1888.
    • Renamed National Formulary in 1906 after the Pure Food and Drug Act was enacted.
    • Purchase of NF by USP in 1975 unified the two compendia, latest editions being USP 42nd and NF 37th.

    Monographs

    • A monograph defines the standards for the identity, strength, purity, and consistency of a drug substance.
    • Includes identification tests, assay methods, purity assessments, physicochemical quality measures, and storage requirements.
    • Crucial for ensuring correct packaging and labeling of pharmaceutical products.

    Dosage Forms

    • Defined as formulated preparations for administering drugs, consisting of active pharmaceutical ingredients (APIs) and additives.
    • Protects drug entities from environmental damage and provides an optimal means for drug delivery.
    • Types include solid dosage forms, which can be controlled-release or delayed-release for consistent absorption rates.

    Drug Delivery Systems

    • Methods to transport pharmaceutical compounds into the body efficiently.
    • Route of administration can be intravascular (e.g., intravenous) or extravascular.

    Goal Drug Characteristics

    • A theoretical drug ideally meeting treatment criteria: desired effects, preferred administration route, minimal dosage, optimal action duration, and no side effects.

    Drug Discovery Methods

    • Random or Untargeted Screening: Tests numerous compounds for biological activity without specific targets, though some compounds may be missed.
    • Bioassays: Differentiate effects and potency of test agents using cell cultures.
    • High-Throughput Screening: Evaluates up to 15,000 compounds weekly with multiple assays.
    • Molecular Modification: Involves chemical alterations of known compounds to improve efficacy or safety.

    Pre-Clinical Studies

    • Pre-formulation studies gather essential information on drug characteristics, aiming to develop an optimal delivery system.
    • Focus on physical and chemical properties including solubility, stability, and dissolution rates.

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    Related Documents

    Introduction to Dosage Forms and Delivery System PDF

    Description

    Explore the origins and significance of the United States Pharmacopeia (USP), established in 1820. This quiz covers its foundational principles, key reasons for standardization, and the importance of quality in medicine. Test your knowledge on the precursors of the USP and its impact on pharmaceutical standards.

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