MODULE NO.1 INTRODUCTION TO DRUGS AND PHARMACEUTICAL FORMULATION CONSIDERATIONS Flashcards
WHAT IS A DRUG?
⦿Is an agent intended for use in the;
✔Diagnosis
✔Mitigation
✔Treatment
✔Cure
✔Prevention
of disease in humans or in other animal (DiMiTreCuP)
ANO ANG GAMOT??
⦿G - Inhawa (mitigation)
⦿A - lisin ang sanhi (cure)
⦿M - aibalik sa normal (treatment)
⦿O (U) - miwas sa sakit (prevention)
⦿T - ukuyin ang dahilan (diagnosis)
⦿Also known as Pharmaceuticals
⦿Are preparations designed to contain a specified quantity of medication for ease and accuracy of dosage administration
DOSAGE FORMS
A PHARMACEUTICAL FORMULATION CONTAINS;
⦿ACTIVE INGREDIENTS
⦿NON-ACTIVE INGREDIENTS
Active Pharmaceutical Ingredients (API)
Pharmacologically active
Therapeutic ingredients
⦿ACTIVE INGREDIENTS
Inert
Inactive ingredients
Additive
Excipients
Give the formulation its unique composition and characteristic physical appearance
⦿NON-ACTIVE INGREDIENTS
◼According to USP, it holds the article and is or maybe in direct contact with the article
◼immediate container (the one that is in direct contact with the article at all times)
◼closure
CONTAINER
the one that is in direct contact with the article at all times
immediate container
CONTAINER TYPES o According to
- Their Ability to Protect their Contents from External Conditions
o Well-closed
o Tightly-closed
o Hermetic container
o Light-resistant
o Child-resistant
o Tamper-proof container
CONTAINER TYPES
- According to Content or Capacity
o Single Dose
o Multiple Doses
It protects the content from
extraneous solids and from loss of the article under ordinary conditions of handling, shipment, storage and distribution
WELL-CLOSED CONTAINER
It protects the contents from contamination by extraneous liquids, solids or vapors, from loss of the article and from efflorescence, deliquescence or evaporation under the ordinary or customary conditions of handling, shipment, storage and, distribution and is capable of tight re-closure
TIGHTLY-CLOSED CONTAINER
⦿It is impervious to air or any other gas under the ordinary or customary conditions of handling, shipment, storage and distribution
HERMETIC CONTAINER
⦿It provides protection from the degradative effects of light by reducing light transmission
LIGHT-RESISTANT CONTAINER
⦿Also known as “amber” bottle
LIGHT-RESISTANT CONTAINER
LIGHT-RESISTANT CONTAINER
Ultraviolet absorbers added to decrease the transmission of short ultraviolet rays
⦿Light resistant opaque plastic
LIGHT-RESISTANT CONTAINER
⦿USP standard on limit if light transmission between wavelengths??
290-450nm
⦿Intended for injection or parenteral preparation
HERMETIC CONTAINER
CHILD-RESISTANT CONTAINER
+ Four basic designs
⚫Align the arrows
⚫Press down and turn
⚫Squeeze and turn
⚫Latch top
A container that is significantly difficult for children to open or to obtain a harmful amount of its contents within a measurable time and that is not difficult for normal adults to use properly
CHILD-RESISTANT CONTAINER
⦿ Specially for children 5 years and below
CHILD-RESISTANT CONTAINER
A packaging that has one or more indicators or barriers to entry which if breached or missing, can reasonably be expected to provide visible evidence that tampering has occurred
TAMPER-EVIDENT CONTAINER
◉Film wrapper
◉Blister or strip pack
◉Bubble pack
◉Shrink seal or band
◉Foil, paper or plastic pouch
TAMPER-EVIDENT CONTAINER
◉Bottle seal (inner cap)
◉Tape seal
◉Breakable cap
◉Sealed Tube
◉Sealed carton
◉Aerosol container
TAMPER-EVIDENT CONTAINER
One that holds a quantity of drug intended as a single dose and when opened cannot be resealed with assurance that sterility has been maintained
Single Dose
◼Examples:
ð Ampules
ð Prefilled syringes or cartidges
Single Dose
One that contains more than a single dose of the medication and permits the withdrawal of successive portions without changing the strength or endangering the quality or purity of the remaining portion
MULTIPLE DOSE
◼Examples:
ð Vials
MULTIPLE DOSE
CONTAINER MATERIALS
- Glass
- Plastic
- highly-resistant borosilicate glass
- Parenteral products
- Most resistant
Type I Glass
- treated soda-lime glass
- Parenteral products
Type II Glass
- soda lime glass
- Parenteral products
Type III Glass
- general purpose soda-lime glass
- Other preparations
Type IV or NP Glass
PLASTIC CONTAINERS
Plastic materials used are:
⦿ polyvinyl chloride (PVC)
⦿ polyethylene terephthalate (PET)
⦿ amorphous polyethylene terephthalate glycol (APET)
⦿ polyethylene terephthalate glycol (PETG)
have excellent transparency and luster can be sterilized with gamma radiation
APET and PETG
- rigid and has good clarity; useful in blister packaging of tablets and capsules
- not suitable when gamma sterilization is required
⦿ polyvinyl chloride
CONTAINER MATERIALS
⦿Plastic
◼Advantages
ð Lightness in weight
ð Resistance to impact
ð Versatility in container design and consumer acceptance
ð Consumer preference for plastic squeeze bottles
ð Popularity of blister packaging and unit-dose dispensing
CONTAINER MATERIALS
⦿Plastic
◼Disadvantages
ð Permeability of the container to atmospheric oxygen and to moisture vapor
ð Leaching of the constituent of the container to the internal contents
ð Absorption of drugs from the contents to the container
ð Transmission of light through the container
ð Alteration of the container upon storage (deformity)
◼Label on immediate container
◼Package inserts
◼Company literature
◼Advertising and promotional
materials
LABELING
⦿With Rx symbol, or the Legend: ………
Act prohibits dispensing without prescription (#6)
PRESCRIPTION DRUG LABEL
⦿For Controlled substances - The statement: “Warning - May be habit forming” (#12)
PRESCRIPTION DRUG LABEL
⦿Statement of pharmacologic category;
No Rx symbol
OTC LABEL
PRESCRIPTION DRUG LABEL
◼Nonproprietary and Proprietary name of the drug
◼Name and address of manufacturer
◼Dosage strength or potency
◼Type of dosage form
PRESCRIPTION DRUG LABEL
◼Net content
◼Prescription logo and Legend statement
◼Label reference to see the accompanying package insert
◼Special storage instructions
PRESCRIPTION DRUG LABEL
OTC DRUG LABEL
OTC DRUG LABEL
OTC DRUG LABEL
◼Storage conditions
◼Description of tamper-evident feature
◼Lot number and expiration date
The label should contain:
“This statement has not been evaluated by the FDA. The product is not intended to diagnose, treat, cure or prevent any disease”
DIETARY SUPPLEMENT
- should state specific parts of the plant used
(Supplement Facts)
HERBAL PRODUTS
USP verified program
NSF Certification Program
Consumer Laboratories
PRODUCT
STANDARDIZATION
assurance of product safety but not guarantee effectiveness
SEAL
ð Any temperature not exceeding 8
degrees Celcius
⚫Refrigerator (2 to 8C)
⚫Freezer (-25 to -10C)
Cold Temperature
2 to 8C
Refrigerator
-25 to -10C
Freezer
Any temperature between 8 to 15C
Cool Temperature
The temperature prevailing in a working
area
Room Temperature
Temperature between 20 to 25C or
sometimes 15 to 30C
Controlled Room Temperature
Warm Temperature
Any temperature between 30 to 40C
Excessive Heat
Any temperature above 40C
◼Protection from Freezing
Risks of freezing:
breakage of the container;
loss of potency/strength;
destructive alteration of the dosage form
Treat ?
Symptoms
Cure ?
Disease
No therapeutical reaction
Inert
LADMERT
Liberation
Absorption
Distribution
Metabolism
Excretion
Response
Toxicity
Pharmaceuticals; study of
Liberation, pharmaceutics
Main ingredient in a drug causes main effect in body
API - active pharmaceutical ingredient
API + excipient ()
Syrup base
Direct contact w/ drug
Ex. Syrup bottle
Immediate container
Prescription drug is also called
Ethical drug, legend drug
No direct contact w/ drug
Ex. Box of syrup medicine
Secondary container
Can be melted with gamma
PVC
Examples are IV AND IM
- sterile like bodily fluids
- paraenteral
Parenteral
Box label
Package insert
Secondary label
business name
Propriety name
Generic name is ___ the box
Inside
Used for storage of pfizer vaccine (4-8 hrs to use)
Ultrafreezer
Vaccine
Prevention
