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195 Cards in this Set
- Front
- Back
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What is the definition of DRUG?
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Drug is an agent intended for use in the diagnosis, mitigation, treatment, cure or prevention of disease in humans or in other animals
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What is the definition of PHARMACY?
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Art and science of preparing and dispensing medications and the provision of drug related information to the public
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In what two form have drugs long existed?
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Vegetation
Minerals |
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During the Babylon Period, the words "asipu" and "asu" means?
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Asipu: magical healer
Asu: empirical healers that uses herbs |
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What does USP and NI stand for?
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United State Pharmacopeia
National Formulary |
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Who created USP?
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Lyman Spalding
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What purpose did the USP and NF served?
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They were legal documents containing standards for drug substances, pharmaceutical ingredients, and dosage forms, provide suitable test and assay procedures for demonstrating the compliance.
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How often are the USP and NF revised?
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Every 5 years
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Until what year did the government address "falsifying advertisements and claims?"
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1912 Amendment
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Who is consider the FATHER OF USP?
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Lyman Spalding
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What did the PURE FOOD AND DRUG ACT of 1906 established?
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For preventing the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors, and for regulating traffic therin, andf or other purposes
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What act was established in 1938, requiring any kind of pharmacological and toxicological studies demonstrated that the drug product is safe?
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Food, Drug, and Cosmetic Act
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What were some of the stipulation of the FOOD, DRUG, AND COSMETIC ACT of 1938?
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Extended control to cosmetic and therapeutic/medical devices
Require filing of NDA and approval from FDA prior to marketing Required new drugs to be demonstrated as safe before marking Provide STANDARDS AND SAFE TOLERANCES AUTHORIZED FACTORY INSPECTIONS |
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What was one disadvantage of Food, Drug, and Cosmetic Act of 1938?
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The law did not require the drugs to be EFFICACIOUS
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Which act categorized drugs into Over the Counter Drugs and Prescription Drugs?
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Durham-Humphrey of 1952
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What did the Durham-Humphrey of 1952 established?
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Drugs approved for marketing b the FDA are categorized according to the manner in which they may be legally obtained by the patient
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What drug was able to relieved many morning sickness symptoms in pregnant women, but was later found to have catastrophic results like birth defects and nerve disorder?
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Thalidomide
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Why was thalidomide able to cause birth defects like cleft plate, blindness, and disfigurement in children when the fact is the mother was taking the drug?
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Thalidomide is able to cross the placental wall
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What act also stated prescriptions for legend drugs may not be refilled without the express consent of the prescriber
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Durham-Humphrey of 1952
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Which amendment ensure that drug manufacturers were required to PROVE DRUG EFFECTIVENESS AND SAFETY TO THE FDA BEFORE MARKETING?
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Kefauver-Harris Amendment of 1962
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What did the Kefauver-Harris Amendment of 1962 established?
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Drug manufacturers were required to prove drug effectiveness and safety to FDA before marketing
Advertisements must show complete info on benefits and risk Adverse effects must be reported to FDA |
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Which act labeled SCHEDULE 1 drugs as having the most potential for abused?
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Comprehensive Drug Abuse Prevention, and Control Act
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Which act required all drugs to have a NDC code?
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Drug listing act of 1972
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Comprehensive Drug Abuse, Prevention, and Control Act of 1970 is now enforced by who?
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DEA
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Which act gave way to the Revolution of Generic Drugs?
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Price and Patent Restoration Act of 1984
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Which act prohibit dietary supplements from campaigning "cure" or "prevention"?
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Dietary Supplement Health and Education Act
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True or False: Dietary Supplements are currently regulated by the FDA
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False
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What are the 3 Major stages in drug development?
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Drug discovery and pre-clinical research and development
Clinical research and development After the compound is on the market, a possible "post marketing or Phase IV" |
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Identify some sources of drug?
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Plant
Animal Mineral Semi-synthetic Synthetic |
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Definition of PHARMACEUTICS?
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Pharmaceutics is the scientific endeavor concerned with the design, fabrication, evaluation and use of dosage form.
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Define DOSAGE FORM?
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The physical form in which drug substances are formulated/ administered to patient.
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What are some advantages of DOSAGE FORM?
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Enhances the stability of API in external environment
Protects the API degradation at the site of administration |
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Yes or No: Can API cause local irritations or injury?
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Yes
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Identify one ways, you as a pharmacist can prevent local irritations or injury with API?
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Enteric coating of tablets
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What does API stands for?
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Active Pharmaceutical Ingredients
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Identify 2 bad characteristics of API?
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API may cause local irritations or injury
API can have unpleasant organoleptic qualities (taste, ordor) |
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If an API have unpleasant organoleptic qualities, what can you do to overcome such problem?
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Tablets can be sugar coated or non functional coating
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What are some DESIRABLE PROPERTIES OF DOSAGE FORM?
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Convenient to handle, use and store
Stable: high stability Different drug strengths Therapeutic effect Protect the drug substance Economical to manufacture Easy identification |
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During the formulation of dosage form the the following properites of the API should NOT be affected?
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Therapeutic property
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Drugs are typically classified based what?
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Dosage form
Use Site of Application Physical State Route of Administration |
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Identify the 4 PHYSICAL STATE of drugs?
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Solid
Liquid Semi-solid Gaseous |
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What are some dosage form of SOLID?
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Powders
Tablets Capsules Granules Pills Troches |
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What kind of physical state are LOZENGES?
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Solid
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What are some ADVANTAGES of SOLID?
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Convient
Relatively stable Easy to administer Palatable Flexible in dosing Gastric irritation of drugs can be minimized or prevented by use of special solid dosage form |
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What are some DISADVANTAGES of SOLIDS?
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Difficulty in swallowing, epecially for children and older people
Lag time in the onset |
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Why is there a lag time for SOLID form?
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The reason for lag time is because dosage form is disintegrated into granules and if necessary may be further deaggregated into fine particles and then finally proceeding to a solution where it can be absorbs
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Identify 3 Types of Liquid dosage form?
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Solutions
Suspension Emulsion |
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What are some ADVANTAGES of LIQUID dosage form?
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Homogeneity
Prompt action (no lag time) Ease of administration Versatile Reconstituted lyophilzed Flexibility in dosing is max. |
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Define HOMOGENEITY?
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Ensure the drug is distributed uniformly
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Define RECONSTITUTED LYOPHILIZED?
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Free powder until usage then combination with solution and immediately administer
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What are some DISADVANTAGES OF LIQUID DOSAGE FORM?
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Bulky and high cost of transportation
Stability |
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Ointments, Pastes, Creams, and Lotions are in what kind of physical state category?
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Semi-solid
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What are some ADVANTAGES of SEMI-SOLID dosage forms?
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Application of drug to skin
Product stability Drug Absorption Emollient Versatile |
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Define ABSORPTION?
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Transdermal can by pass the liver and directly goes into the blood stream
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Suppositories are in which kind of physical state?
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Semi solid
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Define EMOLLIENT?
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Soothing, relaxing, or relieving
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What are some DISADVANTAGE of SEMI-SOLIDS dosage form?
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Pastes are not suitable for application to hairy parts
Occlusive May be difficult to remove from the skin Incorporation of certain drug: often apply heat, melt it to base to incorporate the drug, heat can degrade Phase separation |
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Identify a type of GASEOUS?
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Aerosols
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What are some ADVANTAGEOUS OF GASEOUS Dosage form?
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A portion of medication can be withdrawn from the package without contamination or exposure to the remaining material
Topical application: uniformity Hermetic Clean process Efficacy |
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Define HERMETIC?
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Highly air tight, non contamination
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Definition of EFFICACY?
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Gaseous dosage are every high because of the particle size
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What two disadvantage of Gaseous Dosage Form?
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Proper advice by the pharmacist is a must: require proper patient coordination
- coordination between release and inhalation Environmental concern |
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Which type of Application is most appropriate to BRONCHI?
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Spray
Inhalation Aerosols |
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Which type of Application is most appropriate to Eyes, Nose, and Ears?
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Mostly solutions
Ointment and gels |
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Which type of Application is most appropriate to Vagina?
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Tablets
Capsules Pessaries Vaginal forms |
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What is VAGINAL FOAMS?
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Vaginal foam is a disperse systems that has liquid as the external phase and gaseous as the internal form
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Which type of Application is most appropriate for the RECTUM?
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Suppositories
Gels and Creams Enemas |
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Classification of dosage form can be either INTERNAL or EXTERNAL, identify the some internal use forms?
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Solutions
Suspensions Emulsions Tablets Capsules |
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Classification of dosage form can be either INTERNAL or EXTERNAL, identify the some external use forms?
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Lotions
Creams Ointments Pastes Bulk Powders |
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What are 4 advantages of solutions?
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Easier to swallow (children and geriatrics)
More quickly effective than tablets and capsules Homogenous, thus give uniform dosage than suspension or emulsion which needs shaking before use Diluted irritant action of some drugs |
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What are some disadvantages of SOLUTIONS?
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Bulky and hence difficult to transport and store and costlier
Unpleasant taste or odors are difficult to mask Needs an accurate spoon/device to measure the dose Less stable than solid dosage forms |
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What are some MAJOR SIGNS OF INSTABILITY?
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Color change
Precipitation Microbial growth Chemical degradation |
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One of the fundamental considerations in dosage form design is whether the drug is intended for _____ or _____ _____
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Local or systemic action
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True or False: The route of administration that is chose WILL NOT have a profound affect upon the SPEED and EFFICIENCY with which the drug acts?
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False: it will have an affect on the speed and efficency
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The possible routes of drug entry into the body may be divided into two classes, which are?
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Enteral
Parenteral |
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Define ENTERAL?
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Place directly in the GI Tract
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What are 4 ENTERAL ROUTE OF ADMINISTRATION?
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Sublingual: under the tongue
Buccal: held in cheek Oral: swallow through the esophagus Rectal: place directly into the rectum and absorption take place through rectum |
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Disintegration time for buccal tablets?
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4 hours
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Which dosage form is DESIGNED TO DISSOLVED SLOWLY and ABSORBED INTO THE SYSTEMIC CIRCULATION?
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Buccal tablets
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What is the DISINTEGRATION TIME for Nitroglycerin?
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2 MINS
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What is Nitroglycerin use for?
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Rapid relief of angina
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What are some ADVANTAGES of ENTERAL ROUTE (SUBLINGUAL AND BUCCAL)?
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Rapid absorption
Drug stability Avoid first pass effect Neutral pH of mouth |
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What is the difference between SUBLINGUAL and BUCCAL's plasma concentration versus time?
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Tablets disintegrated near the buccal have a gradual peak in plasma concentration and remain over an extensive period of time
Sublingual, however, is the opposite, it's plasma concentration quickly rises but dramatically drops |
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Definition of FIRST PASS EFFECT?
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Cannot completely control 100% of the drug from being swallow and drug absorbed are initially transported to the liver
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What are two factors to consider when using the oral route?
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Dissolution rate
Absorption, how permeable it is? |
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Give an example of a BUCCAL TABLET and a SUBLINGUAL TABLET?
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Bucal tablet
-Nicotine Sublingual tablet -Nitroglycerine |
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What are some ADVANTAGE OF ORAL route?
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Convenient: self administered, pain free, easy to take
Absorption: take place along the whole length of the GI tract Cheap: compared to most other parenteral routes |
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What are some DISADVANTAGES OF ENTERAL (SUBLINGUAL/BUCCAL)?
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Inconvenient
Small doses required Unpleasant taste of some drugs May subject to first pass effect |
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What is the equation for DISSOLUTION RATE?
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(D*S/ V*h) (Cs-C1)
D: diffusion coefficient S: dissolution surface area V: volume of sol (constant) h: aque. boundary thick (const) Cs: solubility C1: [ ] in dissolution media |
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Higher surface area equals _____ ______ and higher _____ ____
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Higher surface area equals higher dissolution rate and higher absorption rate
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What are some DISADVANTAGES of Oral route administration?
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Sometime inefficient: only part of the drug may be absorbed
First pass effect: drugs absorbed orally are initially transported to the liver via the portal vein Irritation to gastric mucosa Unable to use in unconscious patient or children Food effect Destruction of drugs by gastric acid and gastrointestinal enzymes, thus it is necessary to take drug with plenty of food and water to avoid gastrointestinal irritation Effect too slow for emergencies Unpleasant taste of some drug |
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The higher the concentration gradient, the higher the ___ ____?
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Dissolution rate
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True or False: Tablet dosage have higher surface area compare to powder?
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False
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Where should COATED TABLET be release?
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Coated tablets should not be release in the gastrointestinal but rather in AREAS OF HIGH pH
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What is the reason why CAPSULE WITH COATED DRUG PELLETS release continuously?
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Because not all pellets will disintegrate at the same time
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Absorption from the stomach and upper intestine through oral administration is mainly affected by what FACTORS?
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Surface area
Blood flow to site of absorption Physical state Water solubility [site of absorption] Rate of dissolution Rate of disintegration: higher rate of disintegration, the higher the absorption Particle size: Bigger particles, the slower the disintegration rate and dissolution rate Food: interaction of food and drug, will result in the drug to be inhibit or slow absorb |
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The administration through the rectal has about 50% of the dose by pass the liver, why is this possible?
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The veins draining the rectum lead directly to the general circulation thus by passing the liver
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Define ERRATIC ABSORPTION?
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Unpredictable absorption once melt or soften in the rectal area
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Which route would you choose, if the patient is unable to take drugs orally, they're children, unconscious, and nausea/vomiting patients/
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Rectal
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What are some DISADVANTAGE of Rectal administration?
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Erratic absorption
Not well accepted...may cause discomfort Irritating drugs are contraindicated |
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Which route of administration has around 50% of the dose by pass the liver?
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Rectal
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What are the advantages of administrating drug RECTALLY?
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By pass the liver
Given to individual who cannot take solid forms Easy to terminate the exposure Good for drugs affecting the bowel |
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Define the following: IV, IM, and SC
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IV: Intravascular: injection to the vein
IV: Intramuscular: injection to the deep muscle SC: subcutaneous: injection tot he subcutaneous tissue |
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Which type of injections is characterized by the advantage of having its absorption phase by passed (100% bioavailability)?
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Intravascular
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Which type of injection is PRECISE, ACCURATE, AND ALMOST IMMEDIATE ONSET OF ACTION?
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Intravascular
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Which type of injection has very rapid absorption of drugs in aqueous solution?
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Intramuscular
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Which type of injection is deliver slowly but occurs at a constant absorption?
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Subcutaneous
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Which type of injection is mainly use for CHRONIC TREATMENT?
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Intramuscular
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Which type of injection delivers small volumes as well as larger volumes through continuous infusion?
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Intravascular
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Which type of injection provide greater predictability of peak plasma concentration?
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Intravascular
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Which type of injection delivers large volumes?
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Intramuscular
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Which type of injection has repository (depot) and slow release preparation?
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Intramuscular
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Which type of injection has high predictability with smaller doses and thus can be measured
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Intravascular
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Absorption from IM depot is more predictable than _____?
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Subcutaneous
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Why is the absorption from IM depot more predictable than SC?
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Because region of the SC that contains the amount of blood vessel is not predictable (whether it has low or high vasculation)?
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What the DISADVANTGES OF INTRAVASCULAR?
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Greater risk of adverse effects
High concentration attained rapidly Risk of phlebitis, necrosis Drug Shock Cost (sterile preparation and medical supervision) |
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Define NECROSIS?
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Death of vein where injection took place
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Define DRUG SHOCK?
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Reach an area of high concentration very quickly
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What are the DISADVANTAGES of INTRAMUSCULAR?
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Pain and irritation at injectionsites
Medical supervision is required |
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What are the DISADVANTAGES OF SUBCUTANEOUS injection?
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Absorption is limited by blood flow, affected if circulatory problem exists
Only small volumes can be administered Concurrent administration of vasoconstrictors will slowly absorbs because a vasoconstrictors will constrict the vein and reduce the blood flow resulting in lower absorption Medical supervision is however is not always required |
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What is OCUSERT?
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Implant placed on the cul de sac of the eye
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What are the ADVANTAGES OF INHALATION?
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Rapid onset of action due to rapid access to circulation
Lung based transfer may get drug to brain in a small amount of time Large surface area High blood flow |
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What are some characteristics of Trandermal/Topical?
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Potent
Short Half Life Metabolized by liver Non irritating |
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The type of ROUTE OF ADMINISTRATION is determine by which factors?
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Type of describe effect like systemic or local
Physiochemical properties such as soluble or insoluble Time of onset of action Quality of effect Condition of patient, such as conscious or unconscious or vomiting Preferred or convenient route at the moment Need to bypass hepatic metabolism and achieve high concentration at particular sites |
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True or False: No single method of drug administration is ideal for all drugs in all circumstances?
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True
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During which stage of Drug Development Process is "SCREENING" involve?
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Stage 1 Drug Discovery
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During which stage of Drug Discovery Process is their "Fortuitous Discover?"
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Stage 1 Drug Discovery
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During Stage 2 of Pre-Clinical, the BIOLOGICAL CHARACTERIZATION is determine for the drug, identify some of its characterisitcs?
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Pharmacology
Drug Metabolism Toxicology |
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Define PHARMACOLOGY?
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Pharmacology is the biochemical and physiologic effects, mechanism of action
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During what stage of development process is the "INITIAL PRODUCTION FORMULATED?"
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Stage 2 Pre Clinical
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Which characteristics are conducted during PRE-FORMULATION?
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Drug solubility
Partition coefficient Dissolution rate Physical form Stability |
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During which stage of Drug Discovery Process is there "MECHANISM BASE DRUG DESIGN?"
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Stage 1 Drug Discovery
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Under the FD&C act, the sponsor of a new dug is required to file with the _____ and _____ before the drug may be given to human subject?
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FDA
IND |
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During which stage of Drug Discovery Process is there "MOLECULAR MODIFICATION?"
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Stage 1 Drug Discovery
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True or False: All IRBs must have IND approval?
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False: All INDs must have IRB approval
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What does IND and IRB stand for?
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Investigational New Drug
Institutional Review Board |
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What is the purpose of IND Submission?
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To ensure investigational plan is sound and is designed to achieve the stated objectives.
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Between the CDER and CBER, which agency is responsible for reviewing chemical agents and biologics?
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CDER: Chemical agents
CBER: Biologics |
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The FDA classified drugs based on 3 systems, identify it?
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By chemical type
By therapeutic classification Additional classifications |
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Stage 3 Clinical, composes of how may phases?
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Phase 1
Phase 2 Phase 3 |
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During which stage of drug development is human trial appropriate to conduct?
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Phase I of Stage 3
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What is the purpose of Phase I of Stage 3?
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Designed to assess the safety and its pharmacokinestics and pharmcodynamics
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Once Phase I of Stage 3 is complete, these results can establish what kind of rough idea?
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Maximum safety
Tolerated Dose General side effects |
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During which stage of drug development, is the initial pilot studies for dosage range determination?
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Phase II of Stage 3
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During Phase II of Stage II, where are trials conducted, on which population, and duration?
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Trials are conducted in specialized centers
Occurs in restricted population Short/Medium range |
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During which stage of drug development are trials conduct on health patients ONLY?
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Phase I of Stage 3
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Drug candidates who are able to move in the EFFICACY TRIAL, have essential criteria in which categories?
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Potency
Safety Pharmacokinetics Acceptable formulation |
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What are some secondary criteria to move into the EFFICACY TRIAL?
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Mechanism of action
Cost Ease of Manufacture Access/ IP |
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What is the objective of Phase III of Stage III?
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Safety
Effectiveness Dosage |
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What is the purpose of NDA submission?
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Gain permission to market the drug product in the US
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Which agency carefully review the completed NDA?
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FDA
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What does NDA stand for?
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New drug application
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As a part of the NDA submission, what do drug developers have to present?
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Complete presentation on all the pre-clinical and clinical results that the sponsor has obtained during investigation of the drug
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True or False: Even when an NDA is approved unconditionally regulatory scrutiny of a drug does not end?
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True
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True or False: As long as the drug mains on the market, these agencies independently monitor drug safety
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True
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What happens when the drug is on the market for several years, but recently the FDA found out there is a safety issue of the product, what will happen?
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FDA may demand the withdrawl of the drug from the market
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True or False: The US is the only country that requires yearly safety reports must be filed with the applicable regulatory agencies ?
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False; most countries require it
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Base on Dr. Dutta, what are consider Primary Literature?
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Scientific Journal
Databases |
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Give some examples of DATABASES?
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PubMed
MedLine Embase EBM |
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Base on Dr. Dutta, what are consider Secondary Literature?
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Textbook
Trade Literature |
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Give some examples of TRADE LITERATURE?
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MicroMedex
Pharmacopeias DrugDex |
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Acids produce what ion in water?
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H+
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What are four properties of acids discussed in lecture?
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Acids are electrolyyes
Have a sour taste Corrode metals React with bases to form salts and water |
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Bases produce what ion in water?
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OH-
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What are four properties of bases discussed in lecture?
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Taste bitter or chalky
Are electrolytes Feel soapy and slippery react with acids to form salts and water. |
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What is the Arrehenius definition of an acid?
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Acids produce H+ in solution
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What is the arrhenius definiton of a base?
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Produce OH- in solution.
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What is the Bronsted Lowery definiton of an acid?
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H+ donors
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What is the Bronsted Lowery definiton of an base?
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H+ acceptors
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What is the Lewis definiton of an acid?
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Proton acceptors
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What is the Lewis definiton of an base?
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Proton donors
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What is the Ka of this weak acid? HAc + H2O ↔ H3O+ + Ac-
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Ka = [H3O+][Ac-]/[HAc]
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What is the Ka of this weak base? B + H2O ↔ OH- + BH+
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Kb = [BH+]]OH-]/[B]
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What are the conjugated acid and base pairs of this equation?
HAc + H2O ↔ H3O+ + Ac- |
Pair I: HAc & Ac-
Pair II: H2O & H3O+ |
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What is the relationship between Ka and Kb?
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Kb=Kw/Ka
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What does Ka measure?
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The strength of an acid
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Is there a Ka for HCl? Explain.
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No because it completely dissociates.
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What is the dissociation constant of weak acids using pka values?
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pka=-log Ka
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What is the pka range for most weak acids?
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0-14
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What is the relationship between pka and the strength of weak acids?
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As pka increases the weaker the weak acid. As pka decreases the stronger the weak acid.
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Why does the electronic conductivity of pure water never reaches zero?
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Self-ionisation/autoprotolytic reaction of water.
H2O + H2O↔ H3O+ + OH- |
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How is the ionic product of water related to the dissociation constants of pka and pkb of an acid and its conjugate base respectively?
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pka+pkb=pkw=14 at 25 C
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Express pH as a log function.
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pH = -log (H3O+)
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Express pOH as a log function.
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pH = -log (OH-)
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What does pH + pOH equal?
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Pkw
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What is a buffer?
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Compounds or mixture of compounds that by their presence in the solution, resist changes in pH upon addition of a small quantities of acid or alkali.
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What is the composition of a buffer?
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A weak acid and its conjugate base or a weak base and its conjugate acid
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What is Henderson-Hasselbalch equation of a weak acid and its salt?
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pH = pka + log [salt]/[acid]
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What is Henderson-Hasselbalch equation of a weak baseand its salt?
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pH = pka + log [base]/[salt]
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Buffer capacity depends on what two factors?
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1. Total concentration of acid and salt
2. Ratio of salt & acid |
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What the three factors that influence pH of buffer solutions?
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1. Excess of strong acids and bases, Neutral Salts
2. Dilution 3. Temperature |
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What is the most important buffer for maintaining acid-base balance in the blood?
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Carbonic-Acid-Bicarbonate Buffer
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Is ionized form a drug more water soluble than the unionized form?
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Yes
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Is the unionized form a drug more lipid soluble than the ionized form? Why?
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Yes because it has no charge and is able to pass through biological membranes.
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What are the pharmaceutical applications of buffers?
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They can be used to a maintain solubility, where a drug is absorbed, ensure the stability of a drug by maintaining its pH. Buffers can be used to reduce tissue irritation.
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