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Pharm Dosage LEC > Prelim- INTRODUCTION TO DRUGS AND PHARMACY > Flashcards

Prelim- INTRODUCTION TO DRUGS AND PHARMACY Flashcards

1
Q

An agent intended for use in the diagnosis,
mitigation, treatment, cure, or prevention of disease in humans or in other animals (FDCA,1938)

A

DRUG

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2
Q

Study concerned with the formulation, manufacture, stability & effectiveness of pharmaceutical dosage forms

A

PHARMACEUTICS

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3
Q

Formulations containing a specific quantity of active ingredients in combination with one or more excipients

A

DOSAGE FORM

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4
Q

The means by which drugs molecules or substances are delivered to sites of action within the body

A

DOSAGE FORM

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5
Q

CHARACTERISTICS OF DOSAGE FORMS

A
  • facilitate administration of the drug by the selected route
  • designed to contain a specified quantity of
    medication for ease and accuracy of dosage
    administration
  • stability and continued effectiveness of the drug throughout its shelf-life is assured
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6
Q

Solutions, syrups, suspensions, emulsions, capsules, tablets

A

Oral Route

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7
Q

Suppositories

A

Rectal Route

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8
Q

Ointments, creams, paste, lotions, transdermal

A

Topical Route

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9
Q

Injections

A

Parenteral Route

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10
Q

Aerosols, inhalations, sprays, gases

A

Respiratory Route

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10
Q

Solutions, inhalations

A

Nasal Route

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11
Q

Solutions, ointments, creams

A

Eye Route

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12
Q

Solutions, suspensions, ointments, creams

A

Ear Route

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13
Q

pastes, creams, lotions, patches

A

Transdermal Route

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13
Q

solutions, suspensions, dry powder

A

Parenterals Route

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14
Q

contact lenses, ointments, solutions, suspension

A

intra-ocular route

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14
Q

solutions, sprays, inhalants, ointments

A

intra-nasal route

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15
Q

solutions, ointments, suppositories, gels

A

rectal route

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16
Q

Most frequently used
route.

A

ORAL ROUTE

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17
Q

Usually intended for
systemic effect.

A

ORAL ROUTE

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18
Q

DA: slow onset of action
and destruction of
enzymes.

A

ORAL ROUTE

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19
Q

Administered for local effect.

A

RECTAL ROUTE

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20
Q

Intended for drugs destroyed
by GIT fluids and when oral
route is not possible.

A

RECTAL ROUTE

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21
Q

Intended for drugs destroyed
by liver enzymes.

A

RECTAL ROUTE

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21
Q

1⁰ consideration: Sterility.

A

PARENTAL ROUTE

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22
Q

Injected into the body via a
needle at various sites and
depths.

A

PARENTAL ROUTE

22
Q

3 main routes: SC, IM, IV

A

PARENTAL ROUTE

22
Q

DA: Inconvenient and
absorption is difficult to
predict.

A

RECTAL ROUTE

23
Q

Other routes are
intracardiac, intrathecal,
intra-articular, intrasynovial
and intraspinal.

A

PARENTAL ROUTE

24
Q

DA: Pain and Inconvenience.

A

PARENTAL ROUTE

25
Q

Fast onset of action.

A

PARENTAL ROUTE and Respiratory route

26
Q

intended for local action(skin).

A

TOPICAL ROUTE

26
Q

Also intended for other parts of the
body- the eyes, nose and ears

A

TOPICAL ROUTE

27
Q

Can also be used for systemic delivery-
TDS

A

TOPICAL ROUTE

28
Q

The lungs provide an excellent surface
for drug absorption- alveoli.

A

Respiratory route

29
Q

Particular for the tx of respiratory
problems like asthma and COPD.

A

Respiratory route

30
Q

CHARACTERISTICS OF
DOSAGE FORMS

A
  • pharmaceutically elegant
  • effectively packaged, clearly and completely labelled according to existing legal regulations
31
Q

WHAT TO CONSIDER IN
DOSAGE FORM DESIGN?

A
  • nature of illness
  • manner of treatment
  • patient age
  • anticipated condition of patient
31
Q

RATIONALE FOR DOSAGE
FORM DESIGN

A
  • provide mechanism for safe and convenient delivery of accurate dose
  • protect from destructive influences of atmospheric oxygen or humidity
  • protect from destructive influences of gastric acid (oral route)
  • concealment of undesirable taste/odor
  • provide clear liquid forms of substances
  • provide rate-controlled drug action
  • provide optimal drug acting from topical
    administration
  • for insertion into body orifices
  • placement of drugs (directly into bloodstream)
  • for optimal drug action through inhalational therapy
32
Q

Formulation which provides a therapeutic amount of drug to the proper site in the body promptly and maintain the desired drug concentration.

A

DRUG DELIVERY
SYSTEM

33
Q

PHARMACOLOGICAL USES

A
  • Mydriatic/miotics
  • Coagulant/anticoagulant
  • Analgesic/antipyretic
  • Emetic/laxative/purgative
  • Diuretic
  • Expectorant/mucolytic
  • Anthelmintic
  • Antineoplastic
  • Antidepressants
  • Abortifacient
  • Adrenergic/ Cholinergics
  • Emollient
  • Vesicant/vaccine
  • Vasodilator/vitamin
  • Scabicide/sclerosing agent
  • Sedative/stimulant
33
Q

Products that allow for the uniform release or targeting of drugs in to the body

A

DRUG DELIVERY SYSTEM

33
Q

Laboratory and animal testing of the compound to answer basic safety question

A

Preclinical Research

34
Q

5 Processes of Drug Development

A
  1. Discovery & Development
  2. Preclinical Research
  3. Clinical Research
  4. Government Review
  5. Post-market Safety Monitoring
35
Q

Laboratory research aiming to discover and research promising compounds

A

Discovery and Development

36
Q

Safety and effectiveness of the compound is assessed by testing it on humans.

A

Clinical Research

37
Q

Drug safety is continuosly monitored once it is available for use by the public

A

Post- Market Safety Monitoring

37
Q

3-6 years

A

Discovery & Development and
Preclinical Research

37
Q

Governments thoroughly review and examine data related to the compound to decide on its approval.

A

Government review

38
Q

6 years

A

Clinical Research

38
Q

2 years

A

Government Review

39
Q

Indefinite time

A

Post- Market Safety Monitoring

39
Q

The Drug Research and Development Process

A
  1. Basic research (2-3 years)
  2. Non- clinical studies (3-5 years)
  3. Clinical studies (3-7 years)
  4. New drug application and review (Approx. 1 yr)
  5. Approval and launch
  6. Post-marketing surveillance and clinical studies (Phase IV)
40
Q

Confirmation of safety, such as side effects, in a small number of healthy persons

A

Phase 1

40
Q

Confirmation of effective, safety, such as side effects, in a small number of healthy persons

A

Phase 2

40
Q

Confirmation of efficacy and safety in comparison to existing medications in a large number of patients

A

Phase 3

40
Q
A
41
Q

Pharmacological efficacy, pharmacokinetics, toxicity studies

A

Non-clinical studies

42
Q

Pharmaceutical formulation design, developmental research for commercial production.

A

CMC(Chemistry, Manufacturing, and Controls)/ Pharmaceutical quality

43
Q

Study method development

A

CMC

44
Q

Investigational drug quality assurance

A

CMC

45
Q

Involvement in various processes ranging from basic research to NDA

A

Intellectual Property Strategy

46
Q

PHARMACEUTICAL FORMULATION

A
  • THICKENERS
  • SOLVENTS
  • SUSPENDING AGENTS
  • TABLET COATINGS
  • DISINTEGRANTS
  • ENHANCERS
  • STABILIZERS
  • PRESERVATIVES
  • FLAVORANTS
  • COLORANTS
  • SWEETENERS

Pharm Dosage LEC (7 decks)

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