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Drug Development: Formulation & Biopharmaceutical Considerations Quiz

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Questions and Answers

What is the definition of dissolution?

Dissolution is the loss of cohesion of a solid within a liquid leading to division in the molecular or ionic state, where the solid-solvent attraction forces are greater than the solid-solid cohesion forces.

What condition must be met for a drug substance to be absorbed by the body?

Generally, a drug substance must be in solution in order to be absorbed by the body.

Define the term 'solubility' in the context of dissolution.

Solubility is the maximum concentration of a substance that may be completely dissolved in a given solvent at a given temperature and pressure, representing a stationary equilibrium.

What term is used to describe the affinity between liquids in the context of solubility?

Miscibility is the term used to describe the affinity between liquids in the context of solubility. Signup and view all the answers

Give an example of a substance that is classified as 'very soluble' according to the USP terms of solubility.

A substance that requires 10,000 parts of solvent for 1 part of solute is classified as 'very soluble' according to the USP terms of solubility. Signup and view all the answers

What is the concentration of a saturated solution of glucose at 25°C?

The concentration of a saturated solution of glucose at 25°C is 909 g/L. Signup and view all the answers

How does the partition coefficient of an active pharmaceutical ingredient (API) influence its diffusion across biological membranes?

The partition coefficient, which measures the distribution of a substance in a lipophilic/hydrophilic system, influences the ability of an API to diffuse across biological membranes (composed of proteins and lipids) that act as lipophilic barriers. Signup and view all the answers

Explain the difference between an unsaturated solution and a saturated solution.

An unsaturated solution contains less solute than the maximum amount that can be dissolved in the solvent at a given temperature and pressure, while a saturated solution contains the maximum amount of solute that can be dissolved under those conditions. Signup and view all the answers

What are the three key steps involved in the absorption of a drug substance by the body?

The three key steps involved in the absorption of a drug substance by the body are dissolution, diffusion, and absorption. Signup and view all the answers

What is the significance of the active ingredient being in solution for a drug substance?

The active ingredient being in solution is significant because it allows for dissolution, diffusion, and absorption, which are necessary steps for the drug substance to have a pharmacological response in the body. Signup and view all the answers

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