Kim Pharmaceutics Exam Objectives

What determines the membrane permeability of drug substances?

Compound size

What is the characteristic of amorphous solid forms?

Random molecular arrangement

Which type of solid form involves molecules or atoms arranged in repetition in a three-dimensional lattice?

Crystalline

What is the defining characteristic of polymorphism in drug formulation?

Different physical properties despite identical composition Signup and view all the answers

What is a prodrug in relation to drug transformation?

Inactive form that needs activation Signup and view all the answers

Which type of solid form can accommodate other molecules to form salts?

Crystalline Signup and view all the answers

What is the primary function of excipients in drug formulations?

To serve as the vehicle or medium for the active drug substance Signup and view all the answers

Which of the following excipients is commonly used as a thickening agent or to form topical gels?

Carbomer Signup and view all the answers

What was the issue observed with the delavirdine mesylate tablets when exposed to high relative humidity?

The tablets exhibited poor dissolution Signup and view all the answers

Which of the following is a physicochemical property used to test chemical substances?

Both melting point depression and vapor pressure Signup and view all the answers

What is the phenomenon of melting point depression?

The reduction of the melting point of a material with a reduction in its size Signup and view all the answers

Which of the following statements about vapor pressure is true?

It does not depend on the presence of other vapors in the air Signup and view all the answers

What is the definition of a dosage form?

The physical form of a dose of drug Signup and view all the answers

What is required before a new drug can be distributed and used?

Obtaining approval from the FDA after filing a New Drug Application (NDA) Signup and view all the answers

What did the Durham-Humphrey Amendment of 1951 establish?

The distinction between prescription and over-the-counter drugs Signup and view all the answers

Which of the following is NOT one of the major federal enactments related to drug regulation and control?

The Controlled Substances Act of 1970 Signup and view all the answers

What is the purpose of the Investigational New Drug (IND) application?

To initiate clinical trials for a new drug Signup and view all the answers

What is the definition of a dosage regimen?

The frequency at which drug doses are given Signup and view all the answers

What is the main purpose of the Kefauver-Harris Amendments of 1962?

To require proof of both safety and effectiveness for FDA approval Signup and view all the answers

What did the Comprehensive Drug Abuse Prevention and Control Act of 1970 establish?

5 schedules for drugs subject to use Signup and view all the answers

What are some characteristics of a goal drug according to the text?

Optimal duration, convenient administration, no side effects, minimal dosage, minimal dosing frequency Signup and view all the answers

What does cGMP stand for in relation to pharmaceuticals?

Current Good Manufacturing Practice Signup and view all the answers

What does cGMP regulate in the pharmaceutical industry?

Packaging, labeling, and storage of pharmaceuticals Signup and view all the answers

What is the role of USP/NF as mentioned in the text?

Establishing standards for drugs and their ingredients Signup and view all the answers

Which of the following is an advantage of transdermal drug delivery?

All of the above Signup and view all the answers

Which of the following is a disadvantage of transdermal drug delivery?

All of the above Signup and view all the answers

What is the primary reason transdermal drug delivery can improve bioavailability?

It avoids first-pass metabolism in the liver Signup and view all the answers

Which characteristic is most important for a drug to be suitable for traditional transdermal delivery?

Low molecular weight and high lipophilicity Signup and view all the answers

Which of the following is NOT a characteristic of drugs suitable for traditional transdermal delivery?

High molecular weight Signup and view all the answers

What is the primary benefit of the controlled and sustained release profile provided by transdermal drug delivery?

Improved patient compliance Signup and view all the answers