Pharmaceutical Science Quiz

Podcast

Play an AI-generated podcast conversation about this lesson

Questions and Answers

What is the primary requirement for a generic drug to gain FDA approval?

It must be proven to be a therapeutic equivalent to the brand-name drug. (correct)

It must be administered through a different route than the brand-name drug.

It must have a lower production cost compared to the brand-name drug.

It must use the same inactive ingredients as the brand-name drug.

Which dosage form consists of insoluble drug particles dispersed in a liquid medium?

Solution

Suspension (correct)

Elixir

Tablet

What does the term 'bioequivalent' mean in the context of generic drugs?

The generic drug has a faster rate of absorption than the brand-name drug.

The generic drug has the same appearance as the brand-name drug.

The generic drug reaches the site of action at the same rate and extent as the brand-name drug. (correct)

The generic drug contains the same active ingredient with no differences in any other component.

Which route of drug administration would be LEAST suitable for a patient who is able to swallow but needs a fast drug response?

Oral Signup and view all the answers

For a drug in capsule form, what is a feature that distinguishes it from a tablet?

It can be opened and the contents poured out (if it is an unfused capsule). Signup and view all the answers

Why might transdermal drug patches be preferred over oral medications?

They bypass first-pass metabolism in the liver. Signup and view all the answers

What is a significant disadvantage of using transdermal drug patches?

There’s a lag time from application to drug action. Signup and view all the answers

How should a patient dispose of a used transdermal drug patch?

Fold it in half with adhesive sides together, then discard. Signup and view all the answers

What could accelerate drug permeation from a transdermal patch?

Application on wet or moist skin. Signup and view all the answers

When looking up a drug, what information is considered an ADME characteristic?

The drug's absorption, distribution, metabolism, and excretion. Signup and view all the answers

Which factor does biopharmaceutics primarily study?

The influence of drug properties, dosage form, and administration route on drug absorption. Signup and view all the answers

According to the provided information, what is a key aspect of biopharmaceutics?

Controlling the rate of drug release from its dosage form. Signup and view all the answers

Which of the following has the MOST direct influence on the rate of drug absorption?

The rate of drug dissolution at a specified absorption site. Signup and view all the answers

What is the role of a drug’s dosage form in the context of biopharmaceutics?

To control the rate and extent of drug absorption Signup and view all the answers

What is an important factor influencing therapeutic decisions, according to the provided information?

The route of administration and the design of the dosage form. Signup and view all the answers

Which of the following is NOT a key factor influenced by various dosage forms, according to the content?

The drug's manufacturing cost. Signup and view all the answers

According to the content, which of these steps occur in the process of drug administration?

Drug release from the dosage form, and delivery to site of action. Signup and view all the answers

According to the supplemental references, what is 'Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems' primarily focused on?

The principles of designing and manufacturing different drug dosage forms. Signup and view all the answers

What is a primary characteristic of drugs administered via the parenteral route?

They allow for predictable drug levels. Signup and view all the answers

Which of these dosage forms is specifically designed for systemic absorption when applied topically?

Transdermal patch Signup and view all the answers

What is a key difference between immediate-release and modified-release oral drug products?

Immediate-release drugs release the active drug immediately after administration. Signup and view all the answers

Which type of modified-release drug product is designed to release a portion of the drug at a time other than immediately after administration?

Delayed-release Signup and view all the answers

What is the primary benefit of extended-release formulations over immediate-release formulations?

They aim to sustain therapeutic blood levels. Signup and view all the answers

Which of the following is a potential disadvantage associated with modified-release drugs?

Dose-dumping Signup and view all the answers

What should patients be counseled about regarding modified-release tablets and capsules?

They should not be crushed or chewed Signup and view all the answers

Systemic absorption is most likely to occur when administering medication via which of the following routes?

Nasal Signup and view all the answers

Which of the following is NOT an intended purpose of the epicutaneous route?

Immediate effects via ointment absorption Signup and view all the answers

A patient is using an osmotic release tablet, what should you educate them on regarding the tablet?

They should expect to see some empty shells or ghosts in their stool. Signup and view all the answers

Study Notes

Introduction to Biopharmaceutics and Drug Dosage Forms/Databases

The presentation covers biopharmaceutics, drug dosage forms, and drug databases.
The presenter is Gretchen M. Ray, PharmD, PhC, BCACP, CDCES, an Associate Professor at the UNM College of Pharmacy.
The date of the presentation is January 17, 2025.

Objectives

Define biopharmaceutics
Explain the relationship between pharmaceutical equivalence, bioequivalence, and therapeutic equivalence, and their relationship to generic drugs.
Identify key counseling points and prescribing considerations for various outpatient dosage forms (capsules/tablets, solutions, suspensions, elixirs, transdermal).
Locate drug dosage forms information within a drug reference (Lexidrug™).
Locate information on drug administration, ADME characteristics, and safety of cutting or crushing dosage forms.

Supplemental Readings/References

Shargel L, Yu AC. Applied Biopharmaceutics & Pharmacokinetics, 7e; 2016
Allen LV, Ansel HC. Ansel's Pharmaceutical Dosage Forms and Drug Delivery Systems, 10e; 2014

Biopharmaceutics

The relationship between the physical and chemical properties of a drug, its dosage form, and the route of administration determines the rate and extent of drug absorption.
- Stages include drug release and dissolution, absorption, distribution, elimination, excretion, and metabolism, and the resulting pharmacological or clinical effect.

Biopharmaceutics (Continued)

Design, stability, manufacture, release, rate of dissolution, and drug delivery to the site of action are key factors in biopharmaceutics.
Dosage forms have varying impacts on these factors, and affect therapeutic decisions when prescribing.

Generic Drug Approval

Generic and brand-name drugs aren't always identical.
Generic drugs must contain the same active pharmaceutical ingredient, dosage form, and route of administration as the brand-name drug when the patent expires.
A new drug application (NDA) is required for approval by the FDA, followed by a patent grant.
To be equivalent, a generic drug is required by FDA rules to be a therapeutic equivalent, have similar rate and extent of drug reaching action site, and be pharmaceutically equivalent.

Generic Drug Approval (Continued)

Generic drug approval requires demonstrating therapeutic equivalence to the brand drug (safe and effective) and pharmaceutical equivalence (identical dosage form containing the same amount of active pharmaceutical ingredient).
Generic drugs can have different inactive ingredients (excipients) such as colors or preservatives.

Routes of Administration and Associated Drug Dosage Forms

Oral route is the most common.
Oral dosage forms include tablets, capsules, suspensions, solutions, and elixirs.
Rectal route is useful for unconscious patients or those vomiting.
Suppositories are solid forms for the route.
Parenteral route involves injections (subcutaneous, intramuscular, intravenous, and intradermal).
Drugs can have systemic (whole body) absorption, or local absorption with minimal systemic effects.

Oral Route/Oral Dosage Forms

Tablets are compressed solid dosage forms.
Capsules contain a drug and filler enclosed in a hard or soft gelatin shell. Unfused capsules can be opened.
Suspensions involve insoluble drug particles in a liquid vehicle (must be shaken before use).
Solutions are drug particles dissolved in a liquid vehicle.
Elixirs are solutions in a hydroalcoholic vehicle,
Syrups are sucrose-based solutions.

Rectal Route

Advantage: useful for vomiting or unconscious patients who can't swallow; approximately 50% of the drug avoids the liver.
Disadvantage: irregular and unpredictable absorption.
Suppositories are a solid dosage form designed to melt or dissolve to release the drug.

Parental Route

Advantages: rapid absorption, predictable drug levels; preferred for drugs destroyed by the gastrointestinal (GI) tract.
Disadvantages: difficult to remove drug in overdose cases, sterility is essential, and trained personnel are needed.

Topical Routes

Includes lotions, creams, and ointments.
Transdermal patches are used for systemic absorption through the skin.

Ocular, Otic, and Nasal Routes

Ophthalmic solutions, suspensions, and ointments are for the eyes. These have minimal systemic absorption.
Otic solutions and suspensions are for the ears to create prolonged contact and minimal systemic absorption.
Nasal solutions are administered as drops or mists and systemic absorption can occur leading to adverse events or drug interactions.

Modified Release Drug Products

Immediate-release (IR) products release the drug immediately after administration.
Modified-release forms alter the timing or rate of drug release.
This improves patient adherence and control of drug absorption.
Types include extended-release (controlled-release, sustained-release, long-acting).
Delayed-release releases a portion of the drug at a time other than immediately after administration, enteric coated tablets, and repeat-action.
Targeted-release releases the drug at or near its intended site of action.
Orally disintegrating tablets (ODTs) disintegrate rapidly and can be swallowed without water.

Modified Release Drugs (Continued)

Advantages: sustained therapeutic blood levels, improved patient adherence and tolerability.
Disadvantages: dose dumping (sudden large release), less flexibility in dose adjustments, and potentially larger product sizes making high-dose administrations more challenging.

Clinical Considerations for Oral Modified Release Dosage Forms

Do not switch between immediate and modified-release forms without consideration of existing blood concentrations.
Counsel patients to not crush or chew modified-release tablets or capsules. Some modified-release products contain non-erodible plastic that can be seen in the stool.
Check a drug resource in case of doubt (lexidrug™).

Modified Release via Transdermal Drug Delivery Systems (Drug Patches)

Advantages: avoids GI tract absorption, avoids first-pass liver metabolism, can provide extended therapy, and have rapid termination.
Disadvantages: only potent drugs can be delivered via patches as a dosage form, risk of skin irritation, variable absorption, delayed onset of action after application, and difficulty transitioning from patches to other formulations (like oral) medications frequently.

Clinical Considerations When Prescribing Drug Patches

Ensure patients remove old patches before applying new ones.
Apply to clean, dry skin without hair.
Do not use concurrently with lotions or emollients due to increased skin permeation.

Practice with Drug Database

Lexi-Comp is an open database that can be used to search for drug information, such as preparations, dosage forms, administration guidelines, pharmacology and pharmacokinetics, pharmacodynamics, ADME characteristics, and appropriate use/handling considerations (e.g., whether it's safe to cut a certain medication).
Examples for use include Amoxicillin, Promethazine, and Pantoprazole to search for usage information.

Studying That Suits You

Use AI to generate personalized quizzes and flashcards to suit your learning preferences.

Description

Test your knowledge on the critical aspects of pharmaceutical science, including drug formulations, bioequivalence, and administration routes. This quiz covers essential topics such as dosage forms and biopharmaceutics concepts. Perfect for students and professionals in pharmacy and medicine.