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Dosage (Lec) > MODULE NO.1 INTRODUCTION TO DRUGS AND PHARMACEUTICAL FORMULATION CONSIDERATIONS > Flashcards

MODULE NO.1 INTRODUCTION TO DRUGS AND PHARMACEUTICAL FORMULATION CONSIDERATIONS Flashcards

1
Q

WHAT IS A DRUG?
⦿Is an agent intended for use in the;

A

✔Diagnosis
✔Mitigation
✔Treatment
✔Cure
✔Prevention
of disease in humans or in other animal (DiMiTreCuP)

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2
Q

ANO ANG GAMOT??

A

⦿G - Inhawa (mitigation)
⦿A - lisin ang sanhi (cure)
⦿M - aibalik sa normal (treatment)
⦿O (U) - miwas sa sakit (prevention)
⦿T - ukuyin ang dahilan (diagnosis)

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3
Q

⦿Also known as Pharmaceuticals
⦿Are preparations designed to contain a specified quantity of medication for ease and accuracy of dosage administration

A

DOSAGE FORMS

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4
Q

A PHARMACEUTICAL FORMULATION CONTAINS;

A

⦿ACTIVE INGREDIENTS
⦿NON-ACTIVE INGREDIENTS

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5
Q

 Active Pharmaceutical Ingredients (API)
 Pharmacologically active
 Therapeutic ingredients

A

⦿ACTIVE INGREDIENTS

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6
Q

 Inert
 Inactive ingredients
 Additive
 Excipients

Give the formulation its unique composition and characteristic physical appearance

A

⦿NON-ACTIVE INGREDIENTS

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7
Q

◼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

A

CONTAINER

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8
Q

the one that is in direct contact with the article at all times

A

immediate container

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9
Q

CONTAINER TYPES o According to

  1. Their Ability to Protect their Contents from External Conditions
A

o Well-closed
o Tightly-closed
o Hermetic container
o Light-resistant
o Child-resistant
o Tamper-proof container

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10
Q

CONTAINER TYPES

  1. According to Content or Capacity
A

o Single Dose
o Multiple Doses

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11
Q

It protects the content from
extraneous solids and from loss of the article under ordinary conditions of handling, shipment, storage and distribution

A

WELL-CLOSED CONTAINER

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12
Q

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

A

TIGHTLY-CLOSED CONTAINER

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13
Q

⦿It is impervious to air or any other gas under the ordinary or customary conditions of handling, shipment, storage and distribution

A

HERMETIC CONTAINER

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14
Q

⦿It provides protection from the degradative effects of light by reducing light transmission

A

LIGHT-RESISTANT CONTAINER

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15
Q

⦿Also known as “amber” bottle

A

LIGHT-RESISTANT CONTAINER

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16
Q

LIGHT-RESISTANT CONTAINER

Ultraviolet absorbers added to decrease the transmission of short ultraviolet rays

A

⦿Light resistant opaque plastic

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17
Q

LIGHT-RESISTANT CONTAINER

⦿USP standard on limit if light transmission between wavelengths??

A

290-450nm

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18
Q

⦿Intended for injection or parenteral preparation

A

HERMETIC CONTAINER

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19
Q

CHILD-RESISTANT CONTAINER

+ Four basic designs

A

⚫Align the arrows
⚫Press down and turn
⚫Squeeze and turn
⚫Latch top

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20
Q

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

A

CHILD-RESISTANT CONTAINER

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21
Q

⦿ Specially for children 5 years and below

A

CHILD-RESISTANT CONTAINER

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22
Q

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

A

TAMPER-EVIDENT CONTAINER

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23
Q

◉Film wrapper
◉Blister or strip pack
◉Bubble pack
◉Shrink seal or band
◉Foil, paper or plastic pouch

A

TAMPER-EVIDENT CONTAINER

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24
Q

◉Bottle seal (inner cap)
◉Tape seal
◉Breakable cap
◉Sealed Tube
◉Sealed carton
◉Aerosol container

A

TAMPER-EVIDENT CONTAINER

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25
Q
A
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26
Q

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

A

Single Dose

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27
Q

◼Examples:
ð Ampules
ð Prefilled syringes or cartidges

A

Single Dose

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28
Q

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

A

MULTIPLE DOSE

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29
Q

◼Examples:
ð Vials

A

MULTIPLE DOSE

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30
Q

CONTAINER MATERIALS

A
  1. Glass
  2. Plastic
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31
Q
  • highly-resistant borosilicate glass
  • Parenteral products
  • Most resistant
A

Type I Glass

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32
Q
  • treated soda-lime glass
  • Parenteral products
A

Type II Glass

33
Q
  • soda lime glass
  • Parenteral products
A

Type III Glass

34
Q
  • general purpose soda-lime glass
  • Other preparations
A

Type IV or NP Glass

35
Q

PLASTIC CONTAINERS
Plastic materials used are:

A

⦿ polyvinyl chloride (PVC)
⦿ polyethylene terephthalate (PET)
⦿ amorphous polyethylene terephthalate glycol (APET)
⦿ polyethylene terephthalate glycol (PETG)

36
Q

have excellent transparency and luster can be sterilized with gamma radiation

A

APET and PETG

37
Q
  • rigid and has good clarity; useful in blister packaging of tablets and capsules
  • not suitable when gamma sterilization is required
A

⦿ polyvinyl chloride

38
Q

CONTAINER MATERIALS
⦿Plastic
◼Advantages

A

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

39
Q

CONTAINER MATERIALS
⦿Plastic
◼Disadvantages

A

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)

40
Q

◼Label on immediate container
◼Package inserts
◼Company literature
◼Advertising and promotional
materials

A

LABELING

41
Q

⦿With Rx symbol, or the Legend: ………
Act prohibits dispensing without prescription (#6)

A

PRESCRIPTION DRUG LABEL

42
Q

⦿For Controlled substances - The statement: “Warning - May be habit forming” (#12)

A

PRESCRIPTION DRUG LABEL

43
Q

⦿Statement of pharmacologic category;
No Rx symbol

A

OTC LABEL

44
Q

PRESCRIPTION DRUG LABEL

A

◼Nonproprietary and Proprietary name of the drug
◼Name and address of manufacturer
◼Dosage strength or potency
◼Type of dosage form

45
Q

PRESCRIPTION DRUG LABEL

A

◼Net content
◼Prescription logo and Legend statement
◼Label reference to see the accompanying package insert
◼Special storage instructions

46
Q

PRESCRIPTION DRUG LABEL

A
47
Q

OTC DRUG LABEL

A
48
Q

OTC DRUG LABEL

A
49
Q

OTC DRUG LABEL

A

◼Storage conditions
◼Description of tamper-evident feature
◼Lot number and expiration date

50
Q

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”

A

DIETARY SUPPLEMENT

51
Q
  • should state specific parts of the plant used
    (Supplement Facts)
A

HERBAL PRODUTS

52
Q

USP verified program
NSF Certification Program
Consumer Laboratories

A

PRODUCT
STANDARDIZATION

53
Q

assurance of product safety but not guarantee effectiveness

A

SEAL

54
Q

ð Any temperature not exceeding 8
degrees Celcius
⚫Refrigerator (2 to 8C)
⚫Freezer (-25 to -10C)

A

Cold Temperature

55
Q

2 to 8C

A

Refrigerator

56
Q

-25 to -10C

A

Freezer

57
Q

Any temperature between 8 to 15C

A

Cool Temperature

58
Q

The temperature prevailing in a working
area

A

Room Temperature

59
Q

Temperature between 20 to 25C or
sometimes 15 to 30C

A

Controlled Room Temperature

60
Q

Warm Temperature

A

Any temperature between 30 to 40C

61
Q

Excessive Heat

A

Any temperature above 40C

62
Q

◼Protection from Freezing

Risks of freezing:

A

breakage of the container;
loss of potency/strength;
destructive alteration of the dosage form

63
Q

Treat ?

A

Symptoms

64
Q

Cure ?

A

Disease

65
Q

No therapeutical reaction

A

Inert

66
Q

LADMERT

A

Liberation
Absorption
Distribution
Metabolism
Excretion
Response
Toxicity

66
Q

Pharmaceuticals; study of

A

Liberation, pharmaceutics

67
Q

Main ingredient in a drug causes main effect in body

A

API - active pharmaceutical ingredient

68
Q

API + excipient ()

A

Syrup base

69
Q

Direct contact w/ drug
Ex. Syrup bottle

A

Immediate container

70
Q

Prescription drug is also called

A

Ethical drug, legend drug

70
Q

No direct contact w/ drug
Ex. Box of syrup medicine

A

Secondary container

70
Q

Can be melted with gamma

A

PVC

71
Q

Examples are IV AND IM
- sterile like bodily fluids
- paraenteral

A

Parenteral

71
Q

Box label
Package insert

A

Secondary label

72
Q

business name

A

Propriety name

73
Q

Generic name is ___ the box

A

Inside

74
Q

Used for storage of pfizer vaccine (4-8 hrs to use)

A

Ultrafreezer

75
Q

Vaccine

A

Prevention

Dosage (Lec) (2 decks)

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