MOD 1 PHARMACEUTICS Flashcards

1
Q

Study that concern itself with the physical, chemical and biological factors which influenced the formulation, manufacture, stability and effectiveness of pharmaceutical dosage forms

A

PHARMACEUTICS

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2
Q

an AGENT intended for use in diagnosis, mitigation, treatment, cure and prevention of disease in man or animal

A

DRUG

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3
Q

Are dosage forms in which drugs are PREPARED BY THE PHARMACISTS for administration in the treatment of disease

This may be done extemporaneously compounded or manufactured for immediate distribution

A

PHARMACEUTICAL PREPARATIONS

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4
Q

DOSAGE FORMS are also known as

A

PHARMACEUTICALS

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5
Q

It is prepared by adding an ACTIVE ingredient and a NON-THERAPEUTIC ingredient usually called as excipients which comprises a vehicle or formulation matrix

A

DOSAGE FORMS / PHARMACEUTICALS

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6
Q

active ingredients are also known as

A

active pharmaceutical ingredients (API), therapeutic ingredients, or Pharmacologically active

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7
Q

non-therapeutic ingredients are also known as

A

INERT / INACTIVE ING.

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8
Q

inactive ingredients are usually called as

A

EXCIPIENTS

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9
Q

Means the production, preparation, propagation, conversion, or processing of a drug or device, either directly of indirectly, by extraction from substances of natural origin or independently by means of chemical or biological synthesis

A

MANUFACTURING

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10
Q

The PREPARATION OF COMPONENTS into a drug product;
(1) As the result of a practitioner’s prescription drug order based on the practitioner/patient/pharmacist relationship in the course of professional practice, or
(2) For the purpose of, or as an incident to, research, teaching, or chemical analysis and not for sale or dispensing

A

COMPOUNDING

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11
Q

(according to what)
Compounding is the preparation, mixing, assembling, altering, packaging and labeling of a drug, drug delivery device, or device in accordance with a licensed practitioner’s prescription, medication order, or initiative based on the practitioner-patient-pharmacist-compounder relationship in the course of professional Practice

A

UNITED STATES OF PHARMACOPEIA (USP CHAP 795)

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12
Q

is the preparation, mixing, assembling, altering, packaging and labeling of a drug, drug delivery device, or device in accordance with a licensed practitioner’s prescription, medication order, or initiative based on the practitioner-patient-pharmacist-compounder relationship in the course of professional Practice

A

COMPOUNDING

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13
Q

Pharmacists may compound, in reasonable quantities, drug preparations that are commercially available in the marketplace if a _______________ relationship exists and a valid prescription is presented

A

PHARMACIST-PATIENT-PRESCRIBER

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14
Q

Pharmacists may compound, in reasonable quantities, drug preparations that are commercially available in the marketplace if a pharmacist–patient–prescriber relationship exists and a _________ is presented

A

VALID PRESCRIPTION

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15
Q

Pharmacists may compound nonprescription medications in commercially available dosage forms or in alternative dosage forms to accommodate patient needs as allowed by ______________ of pharmacy.

A

INDIVIDUAL STATE BOARDS

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16
Q

Pharmacists may compound _________ medications in commercially available dosage forms or in alternative dosage forms to accommodate patient needs as allowed by individual state boards of pharmacy.

A

NONPRESCRIPTION

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17
Q

Pharmacists should NOT OFFER compounded medications to _________ for resale

A

OTHER PHARMACIES

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18
Q

a practitioner may obtain compounded medication to administer to patients, but it should be labeled with:
(6)

A

For office use only
date compounded
use-by date
name
strength
quantity of active ingredients

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19
Q

Compounding pharmacies and pharmacists may _____ or otherwise ________ the fact that they provide prescription compounding services

A

advertise / promot

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20
Q

REASONS why pharmacists have increased the practice of compounding patient-specific medications:

Many patients need drug dosages or strengths that are ______________

A

NOT COMMERCIALLY AVAILABLE

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21
Q

REASONS why pharmacists have increased the practice of compounding patient-specific medications:

Many patients are ______ to excipients in commercially available products

A

ALLERGIC

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22
Q

REASONS why pharmacists have increased the practice of compounding patient-specific medications:

__________ must be prepared as liquids, flavored to enhance compliance, and prepared in alternative dosage forms, such as lozenges, gumdrops, popsicles, and lollipops.

A

CHILDREN’S MEDICATIONS

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23
Q

REASONS why pharmacists have increased the practice of compounding patient-specific medications:

Some medications are not very _____ and require preparation and dispensing EVERY FEW DAYS; they are NOT SUITABLE TO BE MANUFACTURED products.

A

STABLE

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24
Q

REASONS why pharmacists have increased the practice of compounding patient-specific medications:

Many physicians desire to deliver products in ________ ways, and pharmacists can work with them to solve medication problems

A

INNOVATIVE

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25
Q

REASONS why pharmacists have increased the practice of compounding patient-specific medications:

Most products are not available for _________ patients and must be compounded.

A

VETERINARY

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26
Q

REASONS why pharmacists have increased the practice of compounding patient-specific medications:

_________ has resulted in new approaches to pain management and higher concentrations and combinations of drugs that are now used

A

HOSPICE CARE

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27
Q

REASONS why pharmacists have increased the practice of compounding patient-specific medications:

Many drugs are reported in the literature but are _____________, so pharmacists can compound them for their physicians’ and patients’ use

A

NOT YET MANUFACTURED

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28
Q

Devised to make possible the administration of medication in measured prescribed amount

A

DOSAGE FORMS / PHARMACEUTICS

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29
Q

Steps in Compounding

A
  1. Calculation
  2. Prepare/Weigh/Measure ingredients
  3. Prepare the label/Select appropriate container
  4. Compounding
  5. Packaging/Labeling
  6. Submit worksheet and the product
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30
Q

device that HOLDS A DRUG and is or may be, IN DIRECT CONTACT with the drug

A

CONTAINERS

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31
Q

in direct contact with the drug AT ALL TIMES; e.g. closure

A

IMMEDIATE CONTAINER

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32
Q

Types of container According to Their Ability to Protect their Contents from External Conditions

A

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

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33
Q

Types of container According to Content or Capacity

A

Single Dose
Multiple Doses

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34
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

35
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 RECLOSURE

A

TIGHTLY-CLOSED CONTAINER

36
Q

It is IMPERVIOUS TO AIR or any other gas under the ordinary or customary conditions of handling, shipment, storage and distribution; Intended for INJECTION or PARENTERAL preparation

A

HERMETIC CONTAINER

37
Q

Known as UNIT DOSE PACKAGE; 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
Examples: [Ampules, Prefilled syringes or cartridges, Blister pack, Foil]

A

SINGLE DOSE CONTAINER

38
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
Examples: [Vials; Bottles]

A

MULTIPLE DOSE CONTAINER

38
Q

Used primarily for LIQUID DOSAGE FORMS

A

ROUND BOTTLE

39
Q

Used for dispensing liquids of LOW VISCOSITY

A

Rx BOTTLE

40
Q

Used for BULK POWDERS; large
quantity of tablets/capsules

A

WIDE MOUTH BOTTLE

41
Q

Used for applying LIQUID MEDICATION to a wound or skin surface

A

APPLICATOR BOTTLE

42
Q

Used for powders to be APPLIED BY SPRINKLE

A

SIFTER-TOP CONTAINER

43
Q

Used for OPHTHALMIC and OTIC preparation

A

DROPPER BOTTLE

44
Q

Used to dispense SEMI-SOLID dosage forms

A

OINTMENT JAR, COLLAPSIBLE TUBE

45
Q

Used to dispense liquid contents as a MIST or FOAM

A

AEROSOL CONTAINER

46
Q

RULES IN LABELLING

A

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

47
Q

MANUFACTURER’S LABEL INFORMATION

A

– Generic name
– Brand name
– Use
– Quantity
– Dosage strength
– Dose
– Storage condition
– Formulations
– Special instructions
– Manufacturer’s information
– Expiry date
– Manufactured date
– Lot/Batch number
– Registration number

48
Q

labelling includes desired condition of _________ to ENSURE STABILITY of a pharmaceutical preparation for the period of its intended shelf life

A

STORAGE

49
Q

5 Types of Stability

A

– Physical
– Chemical
– Microbiological
– Therapeutical
– Toxicological

50
Q

Type of STABILITY:
– Appearance, palatability, uniformity, dissolution, suspendability

A

PHYSICAL

51
Q

COLD

A

not exceeding 8°C

52
Q

COOL

A

between 8 - 15°C

53
Q

Controlled Room Temperature

A

15 - 30°C

54
Q

Official Room Temp

A

25°C

55
Q

WARM TEMP

A

between 30 - 40°C

56
Q

EXCESSIVE HEAT

A

above 40°C

57
Q

Refers to the LENGTH OF TIME that a drug produced may remain on the pharmacist’s shelf in the original packages and under usual environmental condition

A

SHELF LIFE

58
Q

RETAIN an acceptable level of its original potency and overall quality

A

SHELF LIFE

59
Q

If storage condition are not met, either physical degradation or chemical deterioration may occur

A

SHELF LIFE

60
Q

Solid dosage forms (Tab & Cap) SHELF LIFE

A

5yrs from the date of preparation

61
Q

Liquid dosage forms; dispersed systems-aerosols, emulsions; semi-solid (Oint & Supp)

A

SHORTER SHELF LIFE

62
Q

SHELF LIFE:
Non-preserved aqueous

A

14 DAYS

63
Q

SHELF LIFE:
Preserved aqueous

A

35 DAYS

64
Q

SHELF LIFE:
Nonaqueous

A

90 DAYS

65
Q

SHELF LIFE:
Solid dosage forms

A

180 days

66
Q

Latest date at which the product is EXPECTED TO BE STABLE physically, chemically, therapeutically, identity, strength, quality and purity until that date if storage condition are met

A

EXPIRY DATE / BEYOND USE DATE

67
Q

Non-proprietary name

A

GENERIC NAME

68
Q

Proprietary name

A

BRAND NAME, TRADE NAME

69
Q

Classification of Drugs

A

– OTC (Over the Counter)
– Legend Drugs-ethical drug
– Dangerous Drugs

70
Q

use of yellow prescription

A

DANGEROUS DRUGS

71
Q

TYPES OF DANGEROUS DRUGS

A

PROHIBITED
REGULATED

72
Q

ethical drug

A

LEGEND DRUGS

73
Q

has label Rx

A

LEGEND DRUGS

74
Q

Swallowing via mouth

A

PER-ORAL

75
Q

Injected into the body

A

PARENTERAL

76
Q

Inserted into the rectum

A

RECTAL

77
Q

Applied to a certain area of the skin

A

TOPICAL

78
Q

Inserted into the vagina

A

VAGINAL

79
Q

inhaled through mouth or nose

A

INHALATION

80
Q

under the tongue

A

SUBLINGUAL

81
Q

beside the cheek

A

BUCCAL

82
Q

administered by application to the tongue (tip)

A

PERLINGUAL