Intro to Pharmaceutics

Question 1

What are some rationale of dosage forms (4)

Answer 1

-To provide a safe and convenient means of administering an accurate dose
- To protect the drug against chemical decomposition from both external and internal
- To conceal any unpleasant odour or taste
- To ensure or control the release of drug into body to achieve a predictable therapeutic response

Question 2

What are factors involved in formulation of a dosage form (3)

Answer 2

• Drug factors: physical and chemical properties
• Therapeutic factors: dosage form design
• Biopharmaceutical factors: Absorption

Question 3

What effect do excipients have on the final product

Answer 3

• They determine the primary features
• Influence the delivery of the drug substance
  
  • Physical form, texture, stability, taste, appearance

Question 4

What does the choice of administration route depend on (4)

Answer 4

1. Disease or condition being treated
2. Condition of Patient
3. Age of Patient
4. Physical and chemical properties of the drug

Question 5

Info about Innovator drugs

Answer 5

Patent protected for 20 years
takes 10-15 years and costs $1.4B

Question 6

Preclinical phase of innovator (5)

Answer 6

1. Drug discovery: gene manipulation or synthetic chemistry
2. Identify potential candidate compound in animals for efficacy and toxicity
3. Lead candidate compounds are identified
4. Pharmaceutical experiments are conducted
5. Scale up and manufacture

Question 7

What are stages of brand name drug development process

Answer 7

Drug discovery (target selection and drug candidate synthesis and efficacy/toxicity
screening)
Preformulation, formulation and manufacturing; chronic safety studies
IND (investigational new drug)
Phase 1, 2, 3 clinical studies
NDA (new drug substance)
Phase 4 studies (post-marketing surveillance)

Question 8

What is the role of pharmaceutics and biopharmaceutics (6)

Answer 8

After lead drug candidate is identified they take place
a. Preformulation studies
b. ADME: absorption, distribution, metabolism, and excretion
c. Mechanisms of action studies
d. Dosage form, route of administration, formulation composition, stability
e. In vitro and in vivo (acute and chronic studies in animals) toxicity
f. 5. Scale-up and manufacturing process development

Question 9

What was the purpose of the Hatch-Waxman act

Answer 9

established the acceptability of using bioequivalence studies
to demonstrate the sameness of a generic product

Question 10

To gain FDA approval, what must generics have

Answer 10

Contain the same active ingredients as the brand (inactive ingredients may vary)
Be identical in strength, dosage form, and route administration
Have the same use indications
Be bioequivalent
Meet the same batch requirements for identity, strength, purity and quality
Be manufactured under the same strict standards of FDA’s regulations for brand products

Question 11

Define bioequivalence and bioavailability.
What is the acceptability criteria

Answer 11

Bioavailability: a measure of the RATE and EXTENT of absorption of drug in blood over time

Bioequivalence: 2 different products of the same drug provide the same bioavailability

Acceptability criteria: 80-125%
- 2 medicines are bioequivalent if no more than 20% difference between AUC and Cmax

Question 12

What are some uses of spray drying

Answer 12

Enhancing solubility of poorly soluble drugs
Stabilizing proteins and peptides
Producing precisely sized particles for lung and nasal delivery
Producing dry powders for filling into capsules and tablets