Super Mega Uber Cool Awesome DDS Study Set: IE 4

In the context of the Biopharmaceutical Classification System, what is the solubility and permeability for each class?

• Class 1: High solubility & high permeability

• Class 2: Low solubility & high permeability

• Class 3: High solubility & low permeability

• Class 4: Low solubility & low permeability

What is an advantage of capsules over liquid oral dosage forms, in terms of stability?

Higher chemical stability

Why are _________ usually the dosage form of choice for clinical trials performed using the oral administration route?

Capsules because they are easier to make & they completely hide the active ingredient which helps the study stay double blind

What kind of drugs are not suitable to be filled in capsules?

Drugs that are:

• Susceptible to moisture

• Interact with gelatin

• Hygroscopic or deliquescent (solubilized by environmental moisture)

For hard gelatin capsules, what is the smallest and the largest size?

000 is the largest & 5 is the smallest

*see image

What is the disintegration test?

Capsule shell should disintegrate with no core remaining in less than 15 to 30 minutes

What are the Compendial Requirements for capsules?

• Disintegration test

• Dissolution test

• Weight variation

• Content Uniformity

• Content Labeling Requirement

• Stability Testing

• Moisture Permeation Test

What is being tested in the moisture permeation test?

The container, not the drug

Are lozenges/troches used for local or systemic effects?

Both

What kind of medications are used when making chewable tablets?

They’re useful for larger doses

Who usually benefits from chewable tablets?

• Pediatric

• Veterinary

An effervescent tablet begins as a tablet and is intended to turn into a ___________ after broken up.

Solution

Do effervescent tablets require a disintegrant?

Naur

What is the rationale for extended-release dosage forms?

To maintain a steady therapeutic blood concentration, focus on the formulation rather than the drug's physical or pharmacokinetic properties.

Why is there an increase in patient compliance with extended-release dosage forms?

There is a reduction of frequency in dosing

What are some disadvantages with extended-release dosage meds?

• Hard to adjust the dose

• Takes longer to kick in

• Risk of dose dumping (sudden release of the drug)

What kind of lipophilic character is required for passive transdermal drug delivery?

High lipophilicity

What melting point is required for passive transdermal drug delivery?

<250°C

What molecular weight is required for passive transdermal drug delivery?

<500 Da

What Log K is required for passive transdermal drug delivery?

1-5

What kind of water solubility is required for passive transdermal drug delivery?

≈0.05 to 1 mg/mL

What are some disadvantages for transdermal drug delivery?

• Possible contact dermatitis

• It takes a while for it to kick in

• It is only suitable for potent drugs

Sterile products largely constitute products administered via the __________ route.

parenteral

What is the difference between a bactericide and bacteriostatic?

A bactericide will KILL bacteria whereas a bacteriostatic PREVENTS growth go bacteria

What is an antiseptic?

A microorganism inhibitor that halts growth and activity without killing them

Disinfection doesn't completely destroy everything. What does it leave behind?

Usually the spores are not destroyed

What must be absent for something to be sterile?

There must be a complete destruction of microorganisms AND their spore forms

What does USP Chapter 800 cover?

Hazardous drugs

What does USP chapter 795 cover?

Non-sterile preparations

What does USP chapter 797 cover?

Sterile preparations

What is the difference between [Drug] Injection and [Drug] for injection?

• [Drug] Injection: Liquid preparations that are drug substances or solutions

  thereof

• [Drug] for injection: dry solids that, upon the addition of suitable vehicles,

  produce a solution for injection

What is considered Low-risk CSP?

• Manufactured under ISO5 conditions

• Aseptic transfer of sterile products by the manufacturer using sterile equipment for compounding IV admixtures

• Does not involve open systems

• No more than 3 components

What is considered medium risk CSP?

• Similar to Low-risk CSP but with additional criteria:

• IV admixture contains more than three components

• Lacks antimicrobial preservatives and is administered over more than 2 days

• Involves complex preparation

What is considered high risk CSP?

• Similar to Low-risk CSP but with additional conditions:

• Compounding non-sterile manufactured ingredients followed by terminal sterilization

• Compounding conducted in conditions outside ISO5

What are the two isotonic solution examples we should know?

Sodium chloride (0.9%), dextrose (5%)

What is the bubble test?

It tests the pore size of microporous filters to check the filter integrity

In the context of secondary engineering controls (SEC), what are the ISO classes needed in their areas?

Direct compounding area (DCA) represents ISO classes 3 or 4

What is the difference between horizontal and vertical laminar flow hoods?

• Horizontal: Increased turbulence with large items raises the risk of contaminants blowing into the operator's face

• Vertical: Less cross-contamination among items placed in the workspace

Do laminar air flows protect the operator?

Naur, they’re intended to be used to protect the product but the higher classes of biosafety cabinets offer some protection to the operator

What is the relationship between gauge number and the thickness of the needle tip?

The larger the gauge number the thinner the needle

• Example: 27 gauge needle finer than 13 gauge needle

What are the charges associated with α and β particles?

• α particles: Positive

• β particles: Negative

Which charge is more penetrating, α or β particles?

β particles

Which charge is more ionizing, α or β particles?

α particles

Are α particles dangerous to humans?

They are extremely harmful and can cause damage to the DNA BUT they cannot penetrate the outer layer of the skin so if the particle is outside the skin you’re fine

Which scan results in better contrast and spatial resolution, PET or SPECT scans?

PET

What is the most common route of administration for radioimmunotherapy?

Intravenous but sometimes oral is done too

Can we use γ rays for targeted radiotherapy?

FUCK NO, they’re used for imaging ❤

Is the EPR mechanism applicable to small molecules?

Naur, only large ones

Does endocytosis require energy?

Yeth

For a zero-order reaction: a ________ line is obtained when amount of drug versus time is plotted on a linear graph

Straight

*not graphing the log concentration

Describe the relationship with concentration for the zero order and the first order reactions.

• Zero Order: Rate of a reaction is independent of the concentration or the amount of the drug

• First Order: Rate of a reaction is proportional to the amount or concentration of the drug

For a first-order reaction: when the _____________________of a drug versus time is plotted on a linear graph, a straight downwards line is obtained.

Log of amount or concentration

What are the differences in equations for zero order and first order?

See image