Stability Considerations in Dosage Form Design

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What is stability in the context of dosage form design?

The extent to which a product retains its properties throughout its period of storage and use

Which of the following is not a factor contributing to the decomposition of drug substances?

Alkaline pH

How can drugs be classified based on their sensitivity to breakdown?

Based on their stability in different conditions

What is checked during the design of formulations to ensure drug safety?

Interactions between drugs and added excipients

Which thermal analysis technique is particularly useful for identifying possible drug-additive and drug-drug interactions?

Micro calorimetry

What has thermal analysis revealed about magnesium stearate and aspirin?

Magnesium stearate interacts with aspirin and should be avoided in formulations containing this drug

Which type of stability concern is related to the retention of antimicrobial agents' effectiveness within specified limits?

Microbiologic

What is the most frequently encountered destructive process chemically?

Hydrolysis

Which chemical group is most susceptible to the hydrolytic process?

Esters

What type of stability ensures that the original physical properties of a drug are retained?

Physical

Which type of stability concerns the retention of the therapeutic effect of a drug?

Therapeutic

What is the example given for ester hydrolysis in the text?

Formation of salicylic acid and acetic acid

What catalyzes the hydrolysis of amides?

Acids or bases

Which type of drug is too unstable to be formulated as solutions?

Penicillins and cephalosporins

What enhances the stability of drug products through the reduction or elimination of water from the pharmaceutical system?

Aqueous solution

Test your knowledge on stability considerations in dosage form design, including the extent to which a product retains its properties and characteristics over time, and factors that can cause drug substances to decompose.

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