Exam 2- Lecture 8/9: Assay & Content Uniformity (CU)

What is a label claim (LC)?

Actual amount of drug in tablet compared to estimated

What is a label claim in?

Percentage

What is an assay?

How close the average dosage form is to LC

What do different drug products have different?

Specifications → has to meet value to be released by manufacturers

• Content uniformity

What is relative standard deviation?

Individual dose variation

• Higher value → more variation

What happens if a drug fails quality testing?

Cannot be sold

What is the assay?

Average value (mid batch)

What must occur for a drug to be delivered?

Dissolution

What is the process of drug release from a drug product?

• Capsule → dissolution of gelatin (inert vehicle)

• OR tablet → dissolution of film coat (FC)

• Composite of API & excipients → disintegration

• Aggregate particles/ granules of API & excipients → deaggregation

• Primary, individual particles of API/ excipient → dissolution

• Diffusion (absorption) → ADME processes

How do soft gelatin capsules dissolve?

• Dissolution of gelatin shell (inert solid vehicle) → individual suspended particles in liquid vehicle

• Miscible base mixes w/ GIF → not available for immediate absorption

• Primary particles dissolve into GIF (dissolution) → ADME processes

• OR dissolution of gelatin shell (inert solid vehicle) → individually dispersed molecules in liquid vehicles

• Miscible base mixes w/ GIF → ADME processes

What are safety & efficacy on?

• Purity

• Strength

• Drug release

• Stability

What are the specifications?

• Chemical, physical, or biological

• Limit, range, or distribution

What is disintegration result?

Time

What is disintegration testing?

• USP adopted an official disintegration test in 1950

• Time until disintegration occurred (aggregates fall through a screen)

• Test was incomplete

• Disintegration does not equal delivery

• An in-vitro test for delivery was needed

What are the current official USP dissolution apparatuses?

• USP 1 (basket)

• USP 5 (paddle over disk)

• USP 2 (paddle)

• USP 6 (cylinder) - transdermal

• Sample & analyze

• Temp: 37 ± 0.05 C

What are dissolution results?

• Analysis & specifications

• T & Q values (test parameters)

• How long to get certain drug released?

What are the time values?

• Time to reach a specified percent drug released

• Q = 75%

• Specification: t <30 min

What are Q values?

• Percent drug released at a given time

• t = 40 min

• Specification: Q > 80%