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What is the definition of Pharmaceutics?
Pharmaceutics is the science of dosage form design
What is the definition of 'Drugs' by the Food, Drug and cosmetic Act, 1938?
Drugs are defined as an agent intended for the use in diagnosis, mitigation, treatment, cure, or prevention of disease in humans or in other animals.
What are some examples of what drugs can be used for?
Drugs can be used to reduce fever, treat common infections, treat cancer, cardiovascular diseases, diabetes, etc.
Name the action and a drug example for these type of classes: Diuretic, Antihypertensive, CNS, and Mydriatic.
- Class: Diuretic, Action: Increases flow of urine, Ex: Furosemide
- Class: Antihypertensive, Action: Decreases blood pressure, Ex: Propreanolol
- Class: CNS, Action: Antipsychotics, Ex: Haloperidol
- Class: Mydriatic, Action: Dilate pupil, Ex:Atropine
What does USP and NF stand for?
USP is United States Pharmacopeia. NF is National Formulary
What does the term pharmacopeia stand for?
Stands for: Pharmakon: Drug, Poiein: Make
What is the Comprehensive Drug Abuse Prevention and Control Act 1970?
This act established Schedules for control of drug substances "subject to abuse"
How many Drug Schedules are their and how are they ranked?
Their are five drug schedules, and they are ranked from most addictive to least addictive via 1-5.
What is a Schedule 1 drug?
A Schedule 1 drug is a drug with no accepted medical use with a high potential for abuse. Ex: LSD, Marijuana
What is a schedule 2 drug?
A schedule 2 drug is a drug with accepted medical use BUT has a high potential for abuse, which could lead to sever psychological or physical dependence. Ex: Morphine, methamphetamine
What is a Schedule 3 drug?
A Schedule 3 drug is a drug with acceptable medical uses and potential for abuse LESS than those listed in 1 and 2, they may lead to moderate psychological or physical dependence. Ex: Codeine, Hydrocodone
What is a schedule 4 drug?
A schedule 4 drug is a drug with accepted medical use with low potential for abuse relative to 3, with limited physical or psychological dependence. Ex: Diazepam, oxasepam
What is a schedule 5 drug?
A schedule 5 drug is a drug with accepted medical uses with low potential for abuse relative to 4, it may lead to limited physical or psychological dependence. Ex: Hydrocodeine, Diphenoxylate
For any medication what are the most effective routes of administration?
Oral, Rectal, Perenteral, and Topical
What are the four types of dosages that need to be established?
Neonates, children, adults, and geriatrics.
What are the physical description of drugs?
- Pure Chemical Compound (Crystalline/Amorphous)
- Identification, Evaluation, Physical and Biological properties
What are chemical properties of drugs?
What are important biological properties of drugs?
- Site of action
- Elicit a biological Response
What does NDA stand for?
New Drug Application
How long does it take for a drug to get approval by the NDA? and What are the four phases?
- It takes on average 15 years. The four phases are the:
- NDA Review
T or F: New drug Discovery is a long process which requires knowledge
from different fields included but not limited to chemistry, biochemistry, Pharmacology, pharmacy, medicine, etc. and one person
can handle the whole process.
What are the three sources of New drugs?
- Natural sources
- Synthesized in the Laboratory
- Tireless pursuit discovered by accident
Whats considered a Natural source?
- Plants so far only a few have been tapped into so far to have a medical benefit or use.
- Ex: Vinca Rosea, Paclitaxal(Taxol)
What are the three methods of Drug Discovery?
- Random or Untargeted screening (test large compounds), looking for biological activity.
- Chemical Structure and Pharmacological activity, the first example was the beta blocker propranolo, BUT the first commercial success was the H2 receptor blcoker: Cimetidine
- Mechanisim based drug design
What is a Lead Compound?
A lead compound is a prototype of a chemical compound with desired pharmacological effects BUT may not have the desire potency, absorbability, solubility, low toxicicity, and the direction of systhesis and derivation.
What is a Pro-Drug?
A Pro-Drug is an inactive form of the drug. It rewuires metabolic biotransformation to get desired activity.
What does GMP and GCP stand for?
- GMP: Good Manufacturing Practices
- GCP: Good Compounding Practices
Who regulates GMP?Why?
GMP is regulated by FDA, this way they ensure a minimum standards are met for drug product quality in US. This also includes all aspects of manufacturing and Domestic and International suppliers.
What is the difference between compounding and manufacturing?
Compounding is made in the pharmacy specifically for each patient according for their needs. They are not regulated by the FDA most part.While Manufacturing is produced for mass market for the general population. No specifications or individualization for patients.
T or F: Current good manufacturing practices only pertain to Domestic US
manufactured products and do not regulate products from
What is active ingredient or active pharmaceutical ingredient(API)?
It is a component that is intended to furnish pharmacological activity or other direct effects in the diagnosis, cure, mitigation, treatment, or prevention of disease.
There are additional GMP regulatory requirements for Active ingredients and excipients, what are they?
- 1) The manufacturer of APIs is regulated by the requirements of GMP. The quality of the finished product depends on the quality of components.
- 2)Excipients, components of finished pharmaceutical product must be in accordance with cGMP
What three Clinical Trial Materials(CTM) must be present?
- 1) All must be according to cGMP regulations
- 2) Production of APIs
- 3) Investigational drug products
cGMP not only apply to manufacturing but also to?
- Community and Institutional Pharmacies
- Relabeling of drugs
- Drug Products
T or F: Good manufacturing practices (cGMP) regulate the Active Pharmaceutical Ingredients, however, since theexcipients in the dosage forms do not have a pharmacological effect, they are not regulated by cGMP.
Why do we have compounding?
- Compounding exists for patient specific medications are not commercially available.
- -Drug dosages or strengths not
- -Dosage forms such as suppositories,
- Oral liquids or topical
-Allergic to excipients
- -Children's medications (flavored,
- lollipops, gumdrops etc.)
- -Drugs in literature but not
- manufactured yet and needs compounding
When it comes to packaging/storage and labeling of pharmaceuticals there product stability and Efficacious use if regulated by cGMP. They use the following test for quality:
B.Light-transmission for glass or plastic
D.Leaching and/or migration
E.Vapor transmission for plastics
F.Drug stability for all packaging
What can be packed into single units or multiple unit containers?
- Capsules parenteral
- Oral liquids
What are the advantages of single unit packing?
1)Convenient and sanitary means of maintaining and using
- 2)Positive identification of each dosage unit, reduction of medication
3)Reduced contamination of drug with protective wrapping
4)Reduced dispensing time
5)Greater ease of inventory: Pharmacy/ nurse station
6)Better medication management less discarded medication
Which is the preferred packaging method, glass or plastic?
Plastic is preferred over glass because it is lightweight, resistant, transportation costs, it does not break so it does not break and cause container damage. Also, the container can be specifically designed, additionally it is accepted by the consumers. PET, APET, PETG, can be sterilized.
What are the problems with the use of plastic?
- The problems with plastic as prescription bottles are:
- •Permeability of containers to O2 and moisture vapor
•Leaching of constituents of container to internal contents
•Absorption of drugs from contents to container
•Transmission of light
•Alteration of container up on storage
Whats a problem with drugs being packaged into plastic?
Drugs packaged into plastic may be subject to oxidative degradation which may lead to greater degree of degradation, then if packaged into glass.
What is leaching?
Leaching is the movement of components from the container to the contents.
What is sorption?
Sorption is the binding of molecules to polymer materials, adsorption and absorption.
T or F:Pharmacists prefer plastic over glass for dispensing, because they are well accepted by consumers and are less expensive compared
What are the Three types of packaging?
- The two types of packaging are child resistant, which is difficult for children under 5 to open, but easy to manipulate for adults for proper use.
- The next type of packaging is Tamper Evident Packaging.
- Lastly is compliance packaging. This type of packaging is to eliminate factors associated with non-compliance. Such as, Misunderstanding the dosing schedule, confusion because of multiple medications, forgetfulness. Educational techniques are placed, such as reminder aids and devices.
When it comes to labeling by the Code of Federal Regulations, what must a Manufacturers Label contain? (8)
- 1) Name
- 2) Name of manufacturer, packer, or distributor of product
- 3) Amount
- 4) Dosage Form
- 5) Rx Only
- 6) Reference to package insert
- 7) Storage Condition
- 8) DEA Symbol
What must a prescription label contain according to the Code of Federal Regulations? (5)
- 1) Name and address of Pharmacy
- 2) Serial Number of prescription
- 3) Date of prescription, or the date of refilling, or refilling(State law to be used)
- 4) Name of prescriber
- 5) Directions for use, precautions
What are the code of federal regulations for Over-the-counter labeling (OTC)?
- 1) Product Name
- 2) Name and address of manufacturer, packer, or distributor
- 3) Statement of net quantity of the contents
- 4) Established names, quantities of all active ingredients
- 5) Names of any habit forming substances
- 6) Required storage for stability
What are the rules for Dietary Supplement Labeling?
Dietary companies are allowed to make certain claims. They must be accurate and truthful BUT they can not use these words: Prevent, Treat, Cure, Mitigate, or Diagnose a disease. They can say it improves not treats. Must contain the FDA disclaimer, this statement has not been evaluated.
T or F: Labeling of pharmaceutical products is very important and is regulated by code of federal regulations. The OTC product labels come under strict regulations, however, these products have the choice when it comes to listing the substances that may be habit
In Herbal products it is required to state what?
The part of the plant root, stem leaf, etc.
The Program that verify Herbal products is? Why?
- In herbal products it has the possibilities of contamination such as lead, arsenic, or other drugs.