MOD 1 PHARMACEUTICS Flashcards

(83 cards)

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
REASONS why pharmacists have increased the practice of compounding patient-specific medications: Most products are not available for _________ patients and must be compounded.
VETERINARY
26
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
HOSPICE CARE
27
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
NOT YET MANUFACTURED
28
Devised to make possible the administration of medication in measured prescribed amount
DOSAGE FORMS / PHARMACEUTICS
29
Steps in Compounding
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
30
device that HOLDS A DRUG and is or may be, IN DIRECT CONTACT with the drug
CONTAINERS
31
in direct contact with the drug AT ALL TIMES; e.g. closure
IMMEDIATE CONTAINER
32
Types of container According to Their Ability to Protect their Contents from External Conditions
Well-closed Tightly-closed Hermetic container Light-resistant Child-resistant Tamper-proof container
33
Types of container According to Content or Capacity
Single Dose Multiple Doses
34
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
35
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
TIGHTLY-CLOSED CONTAINER
36
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
HERMETIC CONTAINER
37
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]
SINGLE DOSE CONTAINER
38
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]
MULTIPLE DOSE CONTAINER
38
Used primarily for LIQUID DOSAGE FORMS
ROUND BOTTLE
39
Used for dispensing liquids of LOW VISCOSITY
Rx BOTTLE
40
Used for BULK POWDERS; large quantity of tablets/capsules
WIDE MOUTH BOTTLE
41
Used for applying LIQUID MEDICATION to a wound or skin surface
APPLICATOR BOTTLE
42
Used for powders to be APPLIED BY SPRINKLE
SIFTER-TOP CONTAINER
43
Used for OPHTHALMIC and OTIC preparation
DROPPER BOTTLE
44
Used to dispense SEMI-SOLID dosage forms
OINTMENT JAR, COLLAPSIBLE TUBE
45
Used to dispense liquid contents as a MIST or FOAM
AEROSOL CONTAINER
46
RULES IN LABELLING
 Label on immediate container  Package inserts  Company literature  Advertising and promotional materials
47
MANUFACTURER’S LABEL INFORMATION
– 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
labelling includes desired condition of _________ to ENSURE STABILITY of a pharmaceutical preparation for the period of its intended shelf life
STORAGE
49
5 Types of Stability
– Physical – Chemical – Microbiological – Therapeutical – Toxicological
50
Type of STABILITY: – Appearance, palatability, uniformity, dissolution, suspendability
PHYSICAL
51
COLD
not exceeding 8°C
52
COOL
between 8 - 15°C
53
Controlled Room Temperature
15 - 30°C
54
Official Room Temp
25°C
55
WARM TEMP
between 30 - 40°C
56
EXCESSIVE HEAT
above 40°C
57
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
SHELF LIFE
58
RETAIN an acceptable level of its original potency and overall quality
SHELF LIFE
59
If storage condition are not met, either physical degradation or chemical deterioration may occur
SHELF LIFE
60
Solid dosage forms (Tab & Cap) SHELF LIFE
5yrs from the date of preparation
61
Liquid dosage forms; dispersed systems-aerosols, emulsions; semi-solid (Oint & Supp)
SHORTER SHELF LIFE
62
SHELF LIFE: Non-preserved aqueous
14 DAYS
63
SHELF LIFE: Preserved aqueous
35 DAYS
64
SHELF LIFE: Nonaqueous
90 DAYS
65
SHELF LIFE: Solid dosage forms
180 days
66
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
EXPIRY DATE / BEYOND USE DATE
67
Non-proprietary name
GENERIC NAME
68
Proprietary name
BRAND NAME, TRADE NAME
69
Classification of Drugs
– OTC (Over the Counter) – Legend Drugs-ethical drug – Dangerous Drugs
70
use of yellow prescription
DANGEROUS DRUGS
71
TYPES OF DANGEROUS DRUGS
PROHIBITED REGULATED
72
ethical drug
LEGEND DRUGS
73
has label Rx
LEGEND DRUGS
74
Swallowing via mouth
PER-ORAL
75
Injected into the body
PARENTERAL
76
Inserted into the rectum
RECTAL
77
Applied to a certain area of the skin
TOPICAL
78
Inserted into the vagina
VAGINAL
79
inhaled through mouth or nose
INHALATION
80
under the tongue
SUBLINGUAL
81
beside the cheek
BUCCAL
82
administered by application to the tongue (tip)
PERLINGUAL