Study your flashcards anywhere!

Download the official Cram app for free >

  • Shuffle
    Toggle On
    Toggle Off
  • Alphabetize
    Toggle On
    Toggle Off
  • Front First
    Toggle On
    Toggle Off
  • Both Sides
    Toggle On
    Toggle Off
  • Read
    Toggle On
    Toggle Off
Reading...
Front

How to study your flashcards.

Right/Left arrow keys: Navigate between flashcards.right arrow keyleft arrow key

Up/Down arrow keys: Flip the card between the front and back.down keyup key

H key: Show hint (3rd side).h key

A key: Read text to speech.a key

image

Play button

image

Play button

image

Progress

1/61

Click to flip

61 Cards in this Set

  • Front
  • Back
Pharmaceutics
An applied science and technology based on the Physical, Chemical, Biological, and Biotechnological Principles that are used in the Preparation, Preservation, and Utilization of drug products and pharmaceutical dosage forms.
Pharmaceutics I
Homogeneous Pharmaceutical Systems : Dispersed particles (X < 1 nm), e.g., true solutions, syrups, elixir, injectable solutions.
Pharmaceutics II
Heterogeneous Pharmaceutical systems: Dispersed particles (X > 1 nm), e.g., emulsions, suspensions, creams, ointments, powders, capsules, and tablets.
Current Methods of Treating Disease
Drug Medication – Chemotherapy
Surgery
Psychotherapy
Physical Therapy
Radiation
Drugs
A chemical agent being used in the Diagnosis, Mitigation, Treatment, Cure, or Prevention of disease in human and animals.
Pharmacy
Art or scientific practice of Preparing, Preserving, Compounding, and Dispensing drugs.
Pharmaceutics smaller definition
An applied science and technology of pharmacy based on the Physical, Chemical, Biological, and Biotechnological principles
Biopharmaceutics
An advanced studies in pharmaceutics describing how the formulation and biological factors affect Absorption, Distribution, Metabolism, and Elimination of drugs in the body.
The Pharmacist's Intimate Knowledge
Drug Action
Drug Therapy
Dosage Form Design and Utilization
Available Pharmaceutical Products
Drug Information Sources
The pharmacist's contemporary role
Community Pharmacy Setting
Institutional Setting: Hospitals;Extended Care Facilities;Health Maintenance Organization (HMO)
Postgraduate Residency: Clinical Pharmacy;Industrial Pharmacy; Medicinal Chemistry;Pharmacology and Toxicology; MBA, Law, Medicine, etc
Industrial Setting: Pharmaceutical R & D; Production and Quality Assurance; Marketing; Management
Government Setting: Military Pharmacy and Services; Public Health Service; FDA; NIH
Institutional setting
Hospitals;Extended Care Facilities;Health Maintenance Organization (HMO)
Postgraduate residency
Clinical Pharmacy;Industrial Pharmacy; Medicinal Chemistry;Pharmacology and Toxicology; MBA, Law, Medicine, etc
Industrial setting
Pharmaceutical R & D; Production and Quality Assurance; Marketing; Management
Governmental setting
Military Pharmacy and Services; Public Health Service; FDA; NIH
Hippocrates
(BC 460-377): Greek Physician and Philosopher; Introduced scientific and rationalized medicine and pharmacy
Dioscorides
( approx. AD 100): Greek Physician and Botanist; Developed pharmacognosy
Claudis Galen
(AD 130-200):Greek Pharmacist and Physician; Developed pharmaceutics - Galenic Pharmacy
Fredrick II
(AD 1240): German Emperor; Issued a decree separating the health sciences into Medicine and Pharmacy
Targets Drug Delivery System
The most ideal drug delivery systems.
Deliver a drug to the site of action.
Maintain a sufficient amount of drug at the action site for a desired time period.
After showing the therapeutic effect, excretes completely out of the body.
TDDS: Liposomes and Nanoparticles
Drug Standards
United States Pharmacopoeia/National Formulary (USP/NF)
USP DI
Other Pharmacopoeias/Drug Standards
United States Pharmacopoeia/National Formulary (USP/NF)
The USP is a nongovernmental, standards-setting organization that advances public health by ensuring the quality and consistency of medicines, promoting the safe and proper use of medications, and verifying ingredients in dietary supplements.
http://www.usp.org/index.htm
Currently, USP provides standards for more than 4000 Rx and non-Rx drugs, dietary supplements, veterinary drugs, and health care products.
New USP28/NF23 available August. 2005
Example of a Monograph *Chlorambucil*
How a Chemical Becomes A Drug
New Drug: A drug substance that is required for proof of its safety and efficacy. (FDA Definition)
Food and Drug Administration (1938)
Drug Approval
The Mission of FDA is to protect the public health against risks associated with the production, distribution, and sale of food, food additives, human drugs, biologics, radio-chemicals, medicinal devices, animal drugs, animal feeds, and cosmetics.
New Drug
A drug substance that is required for proof of its safety and efficacy. (FDA Definition)
The mission of FDA
is to protect the public health against risks associated with the production, distribution, and sale of food, food additives, human drugs, biologics, radio-chemicals, medicinal devices, animal drugs, animal feeds, and cosmetics.
New Drug Development and Approval Process
Drug Discovery & Drug Design
Biological Characterization
Early Formulation Studies in Animals
The Investigational New Drug (IND) Application
Phase I, II, and III Clinical Studies
The New Drug Application (NDA)
Phase IV Studies & Postmarketing
Drug Discovery & Drug Design
Source of New Drugs
A “Goal Drug”
Methods of Drug Discovery
A “ Lead Compound”
Prodrugs
FDA’s Definition of a New Drug
Drug Nomenclature
“Goal Drug”
Produces the specifically desired therapeutic effect.
Can be administered by the most desired route at minimal dosage and minimal frequency.
Has optimal onset and duration.
Shows no side effects.
After showing the desired therapeutic effect, it is excreted efficiently and completely from the body.
Low cost.
Physically and chemically stable.
Pharmaceutically elegant.
Prodrugs
A compound that requires metabolic transformation after administration to produce the desired pharmacological effect. For examples,
Enalapril maleate --> Enalaprilat
Chloramphenicol palmitate --> Chloramphenicol
Sources of New Drugs
Isolation from Plants
reserpine, vinblastine, vincristine, paclitaxel
Extraction from Animals (tissues)
thyroid extract, insulin, estrogens, vaccines
Molecular Modification
Organic Synthesis
Genetic Engineering
Genetic Engineering
Recombinant DNA (rDNA) Technology

Monoclonal Antibody (MoAB) Technology

Human Gene Therapy
Recombinant DNA Technology
Genetic material (DNA) of higher species (human) may be transplanted to a lowly bacterium – Gene Splicing)
Gene-splicing induces the lower organism to make proteins, it would not otherwise have made.
rDNA technology can potentially produce almost any protein drug; e.g., Insulin, Growth hormone, Hepatitis B vaccine, Epoetin alpha, and Interferon.
Monoclonal Antibody (MoAB) Technology
MoABs are highly specific immunoglobulin produced against a single antigen foreign material.
MoAB production is conducted within the cells of higher animals, including the patient.
MoABs have the capacity to combat the specified target cells.
Other applications: Diagnostics, Site-directed therapies, Immunology, and Home test kits (pregnancy and ovulation prediction); Adalimumab – Rheumatoid Arthritis; Daclizumab – Prophylaxis of acute rejection in patients receiving renal transplantation.
Human Gene Therapy
Gene therapy is another new technology used to prevent, treat, cure, diagnosis, or mitigate human disease caused by genetic disorder.
Human body contains up to 100,000 genes that are involved in cell functioning and growing via protein synthesis.
In genetic-based diseases: Gene expression altered and Gene sequences mismatched.
Gene Delivery Systems
The transfer of new healthy genetic material to the cells of a patient with genetic disease.
A cloned genetic material is transferred into the cells of patients via (a) Microinjection, (b) Chemically mediated method, (c) Disabled retroviral gene delivery systems.
Applications: Adenosine deaminase deficiency (abnormal immune system); Sickle cell anemia; Malignant melanoma; Lung and colorectal cancer and AIDS
Methods of Discovery
Random or Non-Targeted Screening
Non-Random or Targeted Screening
Bio-Assays
Molecular Modification
Mechanism-Based Drug Design
Prodrugs properties
Solubility
Absorption
Biostability
Prolonged
FDA’s Definition of a New Drug
New Drug
New Formulation
New Manufacturing Method
New Combination of Drugs
Drug Nomenclature
Empirical Formula
Synthetic Chemical Name
Code Number
Nonproprietary (generic name)
United State Adopted Names Council (USAN Council)
Trade Name
Biological Characterization
Pharmacology
Drug Metabolism
First Pass Effect
Toxicology
Acute or Short-Term Studies
Sub-Acute or Sub-Chronic Studies
Carcinogenicity Studies
Pharmacology
Pharmacokinetics
Pharmacodynamics
Clinical Pharmacology
Pharmacokinetics
Studying quantitative change in ADME of drugs as a function of time.
Pharmacodynamics
Studying the biochemical and physiological effects of drugs, and their mechanisms of action as a function of time.
Clinical Pharmacology
Studying the therapeutic effects and action of drugs as a function of time using pharmacological principles.
Early Formulation Studies
Preformulation Studies
Drug Solubility
Partition Coefficient
Dissolution Rate
Physical Form
Stability
Initial Product Formulation
Clinical Trial Materials (CTM)
The Investigational New Drug (IND) Application
Content of the IND
Pre-IND meeting
FDA review of the IND Application
FDA Drug Classification System
Clinical Protocols
Phases of a Clinical Investigation
“Treatment IND”
FDA Review of the IND Application
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
Divisions of CDER
Cardio-Renal Drugs
Gastrointestinal & Coagulation Drugs
Topical Drugs
Oncology & Pulmonary Drugs
Analgesic & Anti-Inflammatory Drugs
Metabolism & Endocrine Drugs
Anti-Infective Drugs
Anti-Viral Drugs
Medical Imaging, Surgical & Dental Drugs
FDA Drug Classification System
By Chemical Type
By Therapeutic Classification
The New Drug Application (NDA)
General Content of the NDA Submission
Drug Dosage
Drug Product Data in the NDA Submission
Drug Product Labeling
FDA Review Decision, “Action Letters”
Phase 4 Studies & Postmarketing Surveillabce
Annual Reports
Drug Dosage
Age
Body Weight
Body Surface Area
Sex
Pathologic State
Tolerance
Concomitant Drug Therapy
Time of Administration
Dosage Form & Route of Administration
Drug Product Labeling
Description
Clinical Pharmacology
Indications and Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Drug Abuse & Dependence
Overdosage
Dosage & Administration
How Supplied
Supplemental, Abbreviated, & Other Applications
Supplemental New Drug Application (SNDA)
Abbreviated New Drug Application (ANDA)
Biologics License Application
Animal Drug Applications
Medical Devices
Classification of Drugs
Over-The-Counter Drugs
Legend Drug
Over-The-Counter Drugs
OTC: Drugs deemed safe enough for use by the layman in the self-treatment of simple conditions.
The over-the counter status of a drug product may be changed if more stringent control over the drug’s distribution and use is warranted later.
Legend Drug
(Prescription Drugs)
Controlled Drugs
(According to the comprehensive drug abuse prevention and control act - 1970: Five Schedules)
Controlled Drug Substances
Schedule I: Heroine, Marihuana, LSD (Lysergic acid diethylamide), THC (Tetrahydrocannabinois)
Schedule II: Morphine, Codeine, Cocaine, Methadone, Secobarbital
Schedule III: Paragoric, Nalorpine, Probarbital
Schedule IV: Diazepam, Clonazepam, Chloral hydrate
Schedule V: Burpenorphine
Drug Dosages
Usual Dose
Usual Dose Range
Usual Pediatric Dose
Single Dose
Daily Dose
Initial and Maintenance Doses, e.g., 0. 1 mg and 0.2 mg digoxin tablet: Initial dose - 4 tablets a day and then 1 tablet per day
Factors Affecting Drug Dosage
Drug Absorption Characteristics
Minimum Effective Concentration (MEC)
Minimum Toxic Concentration (MTC)
Therapeutic Window
Therapeutic Index (TI) = MTC/MEC
Drug Effect in a Population Sample
Median Effective Dose (ED50)
Median Toxic Dose (TD50)
Examples of TI for Drugs
TI less than 5: Diphenhydramine, Amytriptyline, Quinidine

TI 5 - 10: Digoxin, Diazepam, Meperidine


TI greater than 10:Acetaminophen, Meprobamate, Propoxyphene
Factors Affecting a Proper Dose of Drugs
Age
Body Weight - Clark’s Rule Children Dose =[ WLB x Dadult ]/150 LB
Body Surface Area = [BSAchild/BSAadult] x Dadult

BSAadult = 1.7 m2
Sex: Women more susceptible to certain drugs
Pathologic State: e.g., Tetracycline for renal impairment
Tolerance: e.g., Antihistamines, Narcotics
Concomitant Drug Therapy: Drug interaction and Alteration of ADME; 1. Beneficial Effect: Probenecid-Penicillin; 2. Detrimental Effect: Tetracycline-Antiacids
Time of Administration (Chronopharmacology) and Food
Dosage Forms and Route of Administration