Pharm Sci 2 Exam 2 Flashcards
3 parts of product quality paradigm
- Product performance characteristics
- Manufacturing
- Product composition
Product Performance characteristics always done after product is finished
Assay, disintegration, content uniformity, dissolution
What defines “Qualified” testing?
Telling the FDA how you are going to analyze
T/F Certificate of Analysis are given to drug-product formulas
False, given to drug-product batches
Accuracy
How close are the individual values to the desired value
Precision
How reproducible are the individual values
Weight variation uniformity
Needs greater than 25 mg of API and greater than 25% ratio of API weight to total DP weight
Content Uniformity
Assay individual units, superior to WV and can always be used
When is content uniformity always used?
Soft capsule containing suspension, emulsion, or gel
Non-film coated tablets
What happens if a batch fails the content uniformity test?
Cannot legally be sold
Describe friability
Helps to determine if the tablets can make it through the shipping process, how rough can you be before they break
Describe the use of a roche friabilator
Tablets = 6.5 g or 10 tablets if weight is greater than 650mg. Tablets dropped in and revolves
Describe the hardness test
Uses schleuniger tablet hardness tester to determine how much load can be applied before it cracks
Describe the disintegration test
In simulated GI fluid, arm moves up and down. 16/18 tablets must disintegrate and pass through the mesh screen below each cylinder
What two dissolution apparatuses are used most often?
Basket and paddle
Dissolution basket method is used for
Capsules and floating tablets
Dissolution paddle method is used for
Tablets
What are the factors of stability that are tested?
Temperature, humidity, light, formulation components, container system
How can moisture permeation be tested?
Use a color-revealing desiccant pellet and expose to moisture
Shell of soft gelatin capsules
Plasticized gelatin
Content of soft gelatin capsules
Solutions, suspensions, or semisolids
Closure of soft gelatin capsules
Hermetically sealed
Shell of hard gelatin capsules
Rigid, not plasticized
Content of hard gelatin capsules
Dry solids, semisolids, or liquids
Closure of hard gelatin capsules
Banding or mechanical interlocking
Advantages of soft gelatin capsules
accurate and precise, can be quickly filled and easily dissolve, enhanced bioavailability
Advantages of hard gelatin capsules
Better bioavailability, easier to formulate, mask taste or smell, easier to swallow
Disadvantages of soft gelatin capsules
Need special equipment, some partitioning from drug into shell, costly
Disadvantages of hard gelatin capsules
Requires blending and lubrication, hydroscopic drugs change water content and cannot be dispensed, subject to microbial growth, costly
Requirements of all hard gelatin capsule formulations
- Must be uniform
- Must release API in a form available for dissolution and subsequent absorption
- Must comply with requirements
Effect of lubricant on release
decreases the amount dissolved
Effect of disintegrate on dissolution
Decreases time needed to release
What type of capsule is widely used?
Starch capsule
What makes Quali-V capsules hypoallergenic?
HPMC
What makes Quali-V capsules better than hard gelatin capsules?
Low moisture content, less brittle, suitable to be automatically filled, less moisture uptake
Commonly used capsules are sized 0-4, what are the biggest?
0
Name four shapes of soft capsules
Spherical, ovoid, tubes, pear shaped
What is the benefit of particulate dosage forms?
Easy to inject and adapt to other routes
