Dosage Forms Overview 9

Question 1

Routes of Administration

USP

Answer 1

1. GI
2. Injection
3. Mucosal
4. Topical Transdermal
5. Inhalation

Question 2

Dosage Forms

Answer 2

TOTAL 28

Question 3

Dosage Form Objectives

Answer 3

1. Bioavailability
2. Stability
3. Compliance
4. Marketing / Commercial Consideration

Question 4

Dosage Form Components

Answer 4

1. API (active drug)
2. Excipients
3. Packaging
4. Administration Device

Question 5

Form 483

Answer 5

• Drug Company Penalties / Laws

1. ​Form 483
2. Warning Letter
3. Consent Decree + FINE
4. DEBARRED

Question 6

Quality Systems Approach to GMP

(good manufacturing practice)

Answer 6

1. Management Responsibilites
2. Resources
3. Manurfacturing
4. Evaluation activities

Question 7

Pharmaceutical Compounding Process

Answer 7

1. RX Receipt
2. Design Dosage Form
3. Infrastructure Review
4. RX preparation/label/documentation/final review
5. Dispensing and Counseling
6. Post Preparation
7. Post Dispensing Monotoring

Question 8

RX Receipt

Answer 8

• Patient Considerations
  
  • ​Identification of patients
  • Drug Indications and dosage / diagnosis ALLERGIES
  • AVAILABILITY commercially?
  • Special population for compounding
• Drug Considerations
  
  • ​Indications use and dosage consistancy
• Dosage Form Considerations
  
  • ​chemical/physical incompatabilities
• MEDICATION SAFETY
  
  • ​Drug name confusion/indication
  • HIGH ALERT MEDICATION
  • calculations / handwriting errors / look alikes

Question 9

Design Dosage Form

&

Compounding Procedure

Answer 9

• Objective of the RX
  
  • ​Bioavailability stability compliance / administration
• Dosage Form Design Approach
  
  • ​Quality Control / Drug Properties
• Design Dosage form for drug & Indication​
• Calculations
• Compounding Procedure
• Technician Directions
• BUD (beyond use dating) of compounded product
• Dosage form QC / QA

Question 10

Infrastructure Review

Answer 10

• Equipment / Facilities / Utilities / Associated Procedures Review
• Personnel Review
• Materials Review

Question 11

RX Review

Answer 11

• RX Preparation
• RX Label
• Documentation
  
  • ​Material records
• Review and Approval
• Quality Control Post Preparation

Question 12

Dispensing and Counseling

Answer 12

• Dispensing / Patient Counseling
• Drug Considerations
• Chemotherapy special considerations
• Training for caregiver

Question 13

Post Preparation

Answer 13

• Cleaning
• Waste Disposal
• Inventory

Question 14

Post Dispensing Monitoring

Answer 14

• Follow up on Complaints
• Adverse Events
• Investigations
  
  • ​Formula / Stability