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Pharmaceutics 2 - Winter > 1 - Intro to Dosage Form Design > Flashcards

1 - Intro to Dosage Form Design Flashcards

1
Q

Define drug

A

Agent for diagnosis, mitigation, treatment, cure, or prevention of disease

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2
Q

What are the 3 chemical classes of all medications?

A
  • Inorganic
  • Organic
  • Biological
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3
Q

What is the major goal of drug delivery?

A

To obtain the highest drug effects in the simplest administration way

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4
Q

What is a dosage form?

A
  • Physical form consisting of active ingredient(s) and pharmaceutical excipients
  • Stable, safe, attractive, easy to produce/use
  • Unit dose
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5
Q

Why do we have to design different dosage forms?

A
  • Prevent from degradation
  • Conceal flavour, taste, or odour
  • Facilitate mass production
  • Use accurate dose
  • Provide product choice
  • Enhance therapeutic outcome
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6
Q

What are the 6 stages of drug development?

A

1) New chemical entity
2) Preclinical studies
3) Investigational new drug
4) Clinical trials
5) New drug application
6) Post-marketing

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7
Q

What is involved in the “new chemical entity” stage of drug development?

A

Finding of a compound as a potential drug candidate, including chemical synthesis, extraction, separation, and purification

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8
Q

What is involved in the “preclinical studies” stage of drug development?

A
  • Preliminary investigation on the suitability of a new chemical entity as a therapeutic agent
  • Early stage includes physical and chemical characterization, pharmacological and toxicological evaluations and in vivo behaviours
  • Later stage involves long-term toxicity, formulation dev’t and assessment, and preparation for new drug product launch
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9
Q

What is involved in the “investigational new drug application” stage of drug development?

A
  • Submission of basic info of a new chemical compound for review
  • Clinical studies in humans can commence only after approval of IND application
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10
Q

What is involved in the “clinical trials” stage of drug development?

A
  • Phase 1 – drug safety in 20-100 subjects
  • Phase 2 – drug efficact in 100’s of subjects
  • Phase 3 – drug efficacy and dose evaluation in 1000’s of subjects
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11
Q

What is involved in the “new drug application” stage of drug development?

A

Submission of complete info of a chemical entity for review by health authority

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12
Q

How long does each stage of drug development take?

A

About 2-3 years, so entire process can take 10-15 years

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13
Q

What are some in vitro tests? What is the goal of these tests?

A
  • Goal = to assess basic characteristics of a chemical compound
  • Physical/chemical properties
  • Drug/excipient interactions
  • Stability considerations
  • Production feasibilities
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14
Q

What are the 4 stages that every drug undergoes?

A

Absorption, distribution, metabolism, and excretion

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15
Q

What is bioequivalency?

A

Bioavailability comparison of different formulations, products, or batches of the same active ingredient

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16
Q

What are the most popular formulations?

A
  • Tablets/capsules = 60%
  • Sterile products = 15%
  • Solutions = 15%
  • All other products = 10%
17
Q

____ formulations are always the first choice because ______

A
  • Solid

- Easy and cheap to make

18
Q

What can be accomplished by modifying drug release rate?

A
  • Sustain drug absorption in GI
  • Prolong systemic drug effects
  • Reduce administration frequency
  • Minimize potential adverse effects
19
Q

What can be accomplished by formulating an injectable?

A
  • Deliver drug directly into blood
  • Optimize drug bioavailability
  • Achieve fast drug action
20
Q

Which formulations provide the fastest absorption of nitroglycerin?

A

IV, buccal, and sublingual

21
Q

What is the easiest application of nitroglycerin?

A

Transdermal

22
Q

What are some factors that must be considered before an appropriate preparation can be put into large-scale production?

A
  • Physicochemical properties (solubility, particle size, salt form, pH, pKa)
  • Biological characteristics (ADME)
  • Route of administration
  • Excipient properties (interaction, dissolution, disintegration, drug release)
23
Q

Which characteristics do suspending agents affect?

A
  • Stability

- Dose accuracy

24
Q

What characteristics do emulsifiers affect?

A
  • Emulsion type
  • Particle size
  • Stability
25
Q

What characteristics do binders affect?

A
  • Disintegration
  • Dissolution
  • Bioavailability
26
Q

What characteristics do lubricants affect?

A
  • Dissolution

- Bioavailability

27
Q

How is most data on drug doses obtained?

A

From various animal studies and then extrapolated into doses appropriate for human applications

28
Q

What factors must be considered when deciding drug dose?

A
  • Toxic dose
  • ADME
  • Subject conditions
  • Drug interactions
  • Tolerance/dependence
  • Patient compliance
29
Q

What are advantages to computer-aid drug design?

A
  • Reduce time and resource
  • Eliminate in vivo testing
  • Focus on functional groups
  • Minimize side effects and toxicity
30
Q

What are some improvements that can be made to bioavailability?

A
  • Increase drug absorption
  • Reduce drug metabolism
  • Eliminate drug degradation
  • Prolong drug retention
  • Direct drug to specific sites
31
Q

What are advantages to controlled drug release or specific-site drug targeting?

A
  • Reduce administration frequency
  • Minimize potential adverse drug effects
  • Increase therapeutic outcomes
  • Provide more product choices
32
Q

What are the goals for dosage form development?

A
  • Most effective result
  • Most appropriate form
  • Most convenient application
  • Most acceptable approach
  • Most economic production

Pharmaceutics 2 - Winter (4 decks)

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