Exam 1 Review Based on Study Guide

What are the characteristics of USP/NF?

To provide official standards for medicines, ensure quality, strength, purity, and consistency of drug products.

What was the NF before it combined with USP?

National Formulary, a collection of standards for medicines and drug products.

What are monographs?

Detailed legal documents that describe a drug's characteristics, including its composition, identification tests, and purity criteria.

What is the topic of USP 795?

Pharmaceutical compounding for nonsterile preparations.

What is the topic of USP 797?

Pharmaceutical compounding for sterile preparations.

What is the topic of USP 800?

Handling of hazardous drugs to ensure safety for patients and healthcare workers.

What is compounding?

The process of preparing personalized medications by mixing ingredients according to a prescription.

What is the difference between a dosage form and a route of administration?

Dosage form refers to the physical form of a medication (e.g., tablet, liquid), while route of administration refers to how the medication is delivered (e.g., oral, intravenous).

What is a histogram?

A graphical representation of the distribution of particle size

What are USP sieves utilized to do?

Separate particles based on size to help determine particle distribution.

What does an ideal histogram look like?

A bell-shaped curve indicating normal distribution of data.

What is porosity?

The measure of void spaces in a material, indicative of its ability to hold liquids or gases. (pores)

What is a powder void?

An empty space in a bulk powder, contributing to the overall porosity.

What is the relationship between particle size and porosity in a batch of powder?

Smaller particles typically lead to higher porosity due to greater surface area and void spaces.

What are the 2 packing arrangements discussed?

Cubic loosest packing and rhombohedral close packing.

What is the angle of repose?

the angle of repose is defined as the maximum angle at which a pile of pharmaceutical powder can remain stable on a horizontal surface without collapsing or sliding.

Is an angle of repose above 50 deg. good or bad?

Bad

What are hindrances to powder flow?

Factors like particle size, shape, and moisture content that affect how easily a powder can flow.

Also, electrostatic attraction

What is the relationship between powder density and bulkiness?

Higher density generally means lower bulkiness; denser powders occupy less volume.

What is the definition of a drug?

A substance used to diagnose, cure, mitigate, treat, or prevent disease.

What are the desirable characteristics of powders for inhalation?

Small particle size, high surface area, and good flowability.

What are the desirable characteristics of powders for topical use?

Good adhesion, non-irritating, and appropriate particle size for absorption.

What are the desirable characteristics of powders for oral use?

Taste masking, sufficient flow, and rapid dissolution.

What are the 4 official sizes of powders according to the USPNF?

Coarse, moderately coarse, fine, and very fine.

What are the size limitations of these 4 sizes of powders?

Coarse: > 355 microns; Moderately coarse: 180-355 microns; Fine: 125-180 microns; Very fine: <125 microns.

Would most pharmaceuticals want small particle size or large? Why?

Small particle size is preferred for better solubility and absorption.

What is spatulation?

The method of mixing powders using a spatula on an ointment slab.

When is spatulation advantageous to use?

When blending small quantities of powders and avoiding excessive particle size reduction.

What is trituration?

The process of reducing the particle size of a substance by grinding. One direction**

What is micronization?

A process that reduces particle size to micrometric levels for improved drug solubility.

When particle size decreases, what happens to the surface area of the sample?

The surface area increases, enhancing dissolution and absorption.

What is geometric dilution?

A technique used to ensure uniform mixing of powders in varying quantities.

Why is geometric dilution a critical technique?

It prevents uneven distribution of active ingredients in a mixture.

What is a tumbler and when is it used?

A vessel used for mixing powders; it allows for even distribution without excessive agglomeration.

What is HLB? How is it utilized?

Hydrophilic-Lipophilic Balance; utilized in formulating emulsions by selecting appropriate surfactants.

What is the range of HLB values?

Typically ranges from 0 to 20.

What is the HLB range for hydrophilicity?

9-16

What is the HLB range for lipophilicity?

1-8

Compare and Contrast: Newtonian System and Non-Newtonian Systems.

Newtonian systems have constant viscosity, while non-Newtonian systems exhibit changing viscosity with shearing (plastic, pseudoplastic, dilatant, thixotropic, rheopectic).

What is viscosity?

A measure of a fluid's resistance to flow.

What is fluidity?

The inverse of viscosity; a measure of a fluid's ability to flow.

What effect does particle size have on viscosity?

Smaller particle size typically leads to lower viscosity due to reduced friction.

What effect does increasing solid content have on viscosity?

Increasing solid content generally raises viscosity.

What is flocculation?

The process where fine particulates aggregate to form a floc.

What is the effect of dosage form and route of administration on absorption?

Different forms (e.g., tablets, injections) and routes (e.g., oral, intravenous) affect bioavailability and absorption rates.

What is an excipient?

inactive ingredients; any other drug product other then the API

Which type of excipient is a bulk former that helps adds shape and is easily compressed

Cellulose derivatives

Sodium Lauryl Sulfate is considered a ______

surfactant

What kind of excipient lowers the surface tension of water and utilizes HLB

surfactants

What type of excipient is considered a type of surfactant that helps maintain the dispersion of drug particles.

emulsifying agents

What type of excipients are Stearates, Ooleates? An example would be Magnesium Sterate.

emulsifying agent

Antifungal preservatives are typically _______?

parabens

What do antioxidants do?

prevent the oxidation of API as it is a better substrate for oxidation than the API.

What type of excipient is sodium metabisulfite?

antioxidant

What do humectants do?

prevent drying of preparations

What are some examples of humectants?

glycerin, propylene glycol, sorbital

What are levigating agents?

liquid used to reduce particle size + begin solubilization of API before incorparation.

What do solvents do?

dissolve API

Alcohols, veggie/nut oil, water and saline are all examples of what type of excipient?

solvents

What are some examples of stiffening/thickening agents

waxes, paraffin

What do suspending agents do?

reduce the rate of sedimentation of API, increase viscosity

Clays, carboxymethyl cellulose sodium, and hydroxyethyl cellulose are examples of what type of excipient?

suspending agents

What type of excipient causes drug particles + granules to adhere to each other?

tablet binders

What are some examples of Newtonian Systems?

water, alcohol, saline, and glycerin

What are the 3 types of non newtonian flow?

plastic flow, pseudoplastic flow, dilatant flow

Gels, emulsions, liquid suspensions and ointments are all examples of what type of flow

non newtonian

Which non newtonian flow has initial resistance when force is applied (has a yield value)

plastic flow

What is a yield value?

particular force needed to start flow

Which non newtonian flow has NO constant viscosity and no yield value (shear thinning)

pseudoplastic flow

Which non newtonian flow is a system that thickens over time as more force is applied

Dilatant flow

What occurs to suspended particles as time goes on is called? (shear thinning)

Thixotropy

What is it called when viscosity increases during constant shear as time goes on

rheopexy

Why is an ideal system a mix of pseudoplastic and trixotropic system?

so viscosity remains high during storage, but when shaken viscosity reduces for pouring and the slowly goes back to more viscous state.

What is the goal of metabolism?

to make the molecule more water soluble and easier to eliminate

What is half-life

tie is takes fro a plasma drug concentration to reduce by half

What is bioavailability?

measurement of amnt of drug that reaches site of action

What is the volume of fluid cleared of a drug per unit of time?

clearance

What is the volume of fluid needed to dissolve an entire drug dose to provide observed concentration called?

Volume of distribution

What describes the total exposure of a drug to the patient?

Area under the curve

This rate has a rate constant no matter the concentration

Zero order rate

This rate depends on concentrations (changes with concentration)

First order rate