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Pharmaceutics Exam 1
Review for Pharmaceutics Exam 1
| Question | Answer |
|---|---|
| May be defined as the use of drugs to diagnos, mitigate, treat, cure, or prevent disease in humans or animals | Drug Therapy |
| Drug discovery from plant and animal sources or chemical synthesis | Medicinal Chemistry |
| Drug characterization including mechanism of action and toxicity | Pharmacology |
| Drug effectiveness including proper dosing and administration for preventing or treating disease | Therapeutics |
| The study of drug delivery systems or drug products | Pharmaceutics |
| Prepared by combining drugs and pharmaceutical exipients into a particular dosage form | Drug Products |
| Drug products that have a high degree of patient acceptability are said to be | pharmaceutically elegant |
| Intimate mixtures of dry, finely divided drugs and/or chemicals that may be intended for internal or external use | Powders |
| Solid dosage forms in which the drug is enclosed within either a hard or soft soluble container or "shell" | Capsules |
| Solid dosage forms containing medicinal substances with or without suitable diluents, and classified as either compressed or molded | Tablets |
| Solid Bodies of various weights and shapes adapted for introduction into the rectal, vaginal, or urethral orifice fo the human body. | Suppositories |
| Semi-Solid preparations intended for external application to the skin or mucous membranes | Ointments (creams,lotions, gells, etc.) |
| Self contained, discrete dosage forms that, when applied to intact skin, are designed to deliver their drugs through the skin to the systemic circulation. | Transdermal Systems |
| Liquid preparations that contain one or more chemical substances dissolved in a suitable solvent or mixture of mutually miscible solvents. | Solutions |
| Liquid preparations that consist of solid particles dispersed throughout a liquid phase in which the particles are not soluble. | Suspensions |
| Two-phase systems in which one liquid is dispersed throughout another liquid in the form of small droplets | Emulsions |
| Products that are packaged under pressure and contain therapeutically active ingredients that are released upon activation of an appropriate valve system. | Aerosols |
| Preparations intended for parenteral administration or for constituting or dilluting a parenteral article prior to administration | Injections |
| Examples of Unit Dosage Forms Include: | Capsules, tablets, suppositories, and transdermal patches. |
| In ________ drug doses are limited by size and not easily adjusted. | Unit Dosage forms |
| ________ are more convenient and accurate forms of patient dosing. | Unit Dosage forms |
| Examples of Bulk Dosage Forms Include: | Powders, ointments, and liquids. |
| In _________ drug doses must be measured before administration. | Bulk Dosage forms |
| In_________ dosing is relatively inconvenient and may be inaccurate | Dulk Dosage forms |
| Upon release from a drug product, the active ingredient exerts its therapeutic effect at or near the administration site. | Locally-Acting Drugs |
| Upon release from a drug product, the active ingredient is absorbed into the circulatory system and is distributed throughout the body. | Systemically-Acting Drugs |
| ________ expose more of the body to the drug (increasing ADRs) and make it more difficult to achieve a higher concentration at the site of action (less effectiveness) | Systemically-Acting Drugs |
| What is the most preferred route of administration? | Oral (most natural and least invasive) |
| The variability of the GI environment may: | Alter drug absorption, may increase drug degradation (Due to pH, enzymes, and food content) |
| __________ creates a time limit for absorption from the GI tract that is variable and may be altered by food, drugs, or age. | GI movement |
| _________ presents a natural barrier to absorption, but it also provides a significant amount of surface area for absorption to occur. | G-I lining |
| The metabolism of drugs by intestinal or liver cells immediately after absorption from the GI tract. | First-pass metabolism |
| Most materials absorbed from the GI tract are taken directly to the _____ via the portal ven prior to entering systemic circulation. | Liver |
| __________ may decrease the amount of drug entering systemic circulation and may increase the amount of toxic metabolites | First-pass metabolism |
| Absorption through __________ avoids first pass metabolism. | Oral-mucosa |
| Topical application is primarily reserved for ______. | locally-acting drugs |
| Application to the skin or mucous membranes. | Topical |
| ________ are an exception to topical drugs being locally acting. | Transdermal Pathces |
| What dosage forms can be used Rectally/Vaginally/Urethrally? | Capsules, tablets, suppositories, ointments, liquids, and aerosols |
| Poor administration comfort and convenience and erratic and inconsistent systemic absorption are limitations of what routes of administration? | Rectal/Vaginal/Urethral |
| Inhalation into the lungs through the oral or nasal cavities. | Pulmonary |
| Limitations to the pulmonary route of administration include: | difficult administration, especially to lower lung; difficult to remove drug after administration. |
| What dosage forms can be used pulmonary? | powders, liquids, aerosols |
| Injection into the blood or body tissues | parenteral |
| Limitations of parenteral preparations include: | sterility requirements, painful administration, and difficult to remove drug after administration. |
| _______ route of administration typically requires a lower dose vs. other routes. | parenteral |
| Large-scale production of drug products for distribution and sale. | Pharmaceutical Manufacturing |
| The professonal preparation of durg products in response to prescription orders from valid practitioners for specific patients. | Pharmaceutical Compounding |
| Pharmaceutical Compounding is primarilly regulated by: | State boards of Pharmacy |
| _______% of all prescriptions are compounded products | 1-8% |
| Established the United States Pharmacopeia (USP) and the National Formulary (NF), as the legal standards to ensure drug product quality, purity, and claimed strength. | Food and Drug Act of 1906 |
| PAssed in response to over 100 deaths resulting from toxic amounts of diethylene glycol, a solvent that was used to prepare sulfanilamide solutions. | Federal Food, Drug, and Cosmetic Act of 1938 |
| Created the FDA and required the approval of a New Drug Application (NDA) prior to distribution and sale of new drug products. | Federal Food, Drug, and Cosmetic Act of 1938 |
| PAssed in response to severe birth defects resulting from a new synthetic drug (thalidomide) being used as an OTC sedative in Europe | Kefauver-Harris Drug Amendments of 1962 |
| Required manufacturers to submit and IND application, which must include extensive animal testing to demonstrate safety before clinical human testing can begin. | Kefauver-Harris Drug Amendments of 1962 |
| Mandated that drugs must be proven effective in addition to safe before the FDA will aprove marketing. | Kefauver-Harris Drug Amendments of 1962 |
| Allowed the FDA to establish the first Good Manufacturing Practices (GMPs) which regulate all aspects of pharmaceutical manufacturing. | Kefauver-Harris Drug Amendments of 1962 |
| Violations of ______ will likely result in large fines, product recalls, and even suspension. | GMPs |
| ________ was prohibited by the FD&C Act of 1938 unless from an approved site | Drug Importation |
| _______ was prohibited by the Prescription Drug Marketing Act of 1987 unless by the original manufacturer. | Drug Reimportation |
| Compounding Decision Tree | 1. Is an appropriate commercially-manufactured product available? 2. Is a therapeutic alternative commercially available? 3.Is a pharmacopoeial formula available? 4. Is a reasearched formula available? 5. Can a scientific formula be designed? |
| Dispensing or compounding instructions | Subscription |
| Directions for the use to the patient/caregiver | Signa |
| Rx | Superscription |
| Medication name, strength, dosage form, quantity | Inscription |
| Legal requirements for documenting a prescription | (on back of prescription) Rx # Date dispensed Initials of pharmacist When written generically of when a substitution is made: name of manufacturer Quantity dispensed, if different from that prescribed. |
| Additional documentation requirements for compounded preparations (on back of prescription) | On Back of Prescription: Name of all ingredients used (including brand name, strength, concentration) Source of all ingredients(manufacturer, lot number, expiration date) Accurate account of the amount of a controlled drug weighed, dispensed, and discar |
| Additional documentation requirements for compounded preparations (on separate sheet) | Calculations, compounding procedure, and the equipment used to make the prescription. Quality control methods used to ensure the identity, strength, quantity, and purity of the preparation. Containers and closures used to package the preparation. |
| USP 24, what does the number indicate? | The edition of USP used to make the official formula. |
| For topicals what expression of strenght should be used? | percentage (e.g. 10%) |
| For electrolytes what expression of strength should be used? | both milliequivalent and metric wgt. (e.g. 10 mEq (250mg)/teaspoonful) |
| The maximum weight that should be placed on the balance pan | Capacity |
| The smallest weight increment that can be read on the balance | Readability |
| The maximum load that results in a perceivable one-unit change in the indicating element | Sesitivity or Sensitivity Requirement (SR) |
| The reproducibility of the weighing measurement | Precision |
| The closeness of the measured weight to the true weight | Accuracy |
| The SR of a class III (class A) balance | 6mg |
| LWQ | (SR/Acceptable Error) X 100% |
| What is the LWQ for a balance having an SR of 5 mg if a 5% error is considered acceptable | 100mg |
| Percentage Error: | (SR/Wgt) X 100% |
| M.ft. dtd #12 supp | Mix to make such doses be given twelve suppositories |
| 1 pt = | = 2 cups |
| The retention of chemical integrity and labeled potency | chemical stability |
| The retention of sterility or resistance to microbial growth | microbial stability |
| the retention of physical properties such as appearance, taste, and uniformity | physical stability |
| Movement of compounds from the container into the dosage form | Leaching |
| Absorbing into or adsorbing onto the container | Sorption |
| Diffusing through the container | Permeability |
| ______ products can leach alkali. | Glass container |
| Reaction with a water molecule | Hydrolysis |
| Results in the addition of an oxygen atom, loss of a hydrogen atom, or loss of electrons | Oxidation |
| Oxidation occurs most often in ______. | Solution |
| Reaction due to molecular absorption of light energy. Typically results from UV light, which has high energy. | Photolysis |
| Complex formed between two different molecules | Complexation |
| The study of chemical degradation rates and how these rates are influenced by conditions such as drug concentration, humidity, and temperature. | Chemical Kinetics |
| The basis for determining how chemically stable a drug product is and predicting its shelf-life. | Chemical Kinetics |
| The loss of drug with time is directly proportional to the concentration of drug remaining | First-Order Reactions |
| The amount of time required for a compound to degrade to 1/2 its initial concentration. | Reaction half-life (t1/2) |
| The loss of drug with time is independent of drug concentration remaining | Zero-Order Reactions |
| Uses exaggerated conditions to quickly test for the most stable of several possible formulations | Short-term (or Accelerated) Stability Testing |
| The difference between the average energy of the reactants and the energy required for reaction | Activation Energy (Ea) |
| Only used to determine which formulations are most likely to have a desired stability | Short-term stability testing |
| Used to ensure the stability of the final formulations under anticipated storage conditions. | Long-term stability testing |
| The minimum acceptable potency for a manufactured product is generally: | 90% of the labeled claim. |
| Expiration dates typically represent the time needed to reach ______ of the original concentration within a manufactured product stored in its original container under recommended conditions. | 90% (T90) |
| For 1st order rxns T90 = | 0.105/K |
| For zero order rxns T90 = | 0.1Co/Ko |
| If the expiration date is indicated with only a month and year, the product expires _________. | On the last day of the month. |
| In AZ do not use beyond dates are only required on ________. | Compounded products |
| What is the USP general guideline for manufactured products repackaged in multi-dose or unit-dose containers. | No later than the manufacturer expiration date or 1 year from repackaging, whichever is earlier. |
| What is the USP general guideline for manufactured products repackaged in "Med Packs" | No later than the shortest manufacturer expiration date or 60 days from repackaging, whichever is earlier. |
| What is the USP general guideline for solid, non-aqueous formulations compounded using a manufactured product as the active ingredient source? | No later than 25% of the time remaining until the earliest manufacturer expiration date or 6 months, whichever is earlier. |
| What is the USP general guideline for Solid, non-aqueous formulations compounded using a USP or NF raw material as the active ingredient? | No later than 25% of the time remaining until the earliest manufacturer expiration date or 6 months, whichever is earlier. |
| What is the USP general guideline for water containing formulations compounded from solid ingredients? | No later than 14 days upon storage at cold temperatures. |
| What is the USP general guideline for all other compounded formulations? | No later than the intended duration of therapy or 30 days, whichever is earlier. |
| Developing the active ingredient as a less reactive pro-drug which is a non-therapeutically active form that is converted to the active form after administration protects from | Hydrolysis |
| To protect from hydrolysis you can prepare a ______ or ________ instead of solutions. | Solid dosage form; suspension |
| Including antioxidants in the formulation will help protect against _______. | Oxidation |
| Adding chelating agents helps protect against _________. | Oxidation |
| Replacing andy entrapped air within the packaging with gases such as N2 protects against __________. | Oxidation |
| Decreasing the water content in the formulation by using non-aqueous co-solvents such as glycerin or ethanol protects against _________. | Hydrolysis |
| Including dessicants within the packaging helps protect against __________. | Hydrolysis |
| Use of a buffer system to maintain optimal pH helps protects against ___________. | Hydrolysis and Oxidation |
| Using tight closures/sealed containers helps protect against _________. | Hydrolysis and Oxidation |
| Decreasing storage temperature helps protect against __________. | Hydrolysis and Oxidation |
| Relative Standard Deviation | Standard Deviation/Average Tablet Weight |
| What is the Goal of Drug Product Performance? | A SUFFICIENT AMOUNT of drug must escape the delivery system, DISSOLVE and be ABSORBED into systemic circulation within an APPROPRIATE AMOUNT OF TIME |
| How fast drug enters solution. | Dissolution Rate |
| How much drug enters solution. | Solubility |
| Most drugs are absorbed through ________. | Passive Diffusion |
| Drugs need to have a good lipophilic/hydrophilic ________ to enter the body. | Balance |
| Rate and Extent to which a drug enters systemic circulation | Bioavailbaility |
| An evaluation of Drug Product Performance that uses different apparatuses designed to mimic the in vivo conditions encountered by a particular dosage form. | In Vitro |
Created by:
chilangberto
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