Pharmaceutical Sciences Overview

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Questions and Answers

What is the primary requirement for a generic drug to be considered a therapeutic equivalent to its brand-name counterpart?

It must be the same price and have the same packaging as the brand-name drug.

It must have the same color and preservatives as the brand-name drug.

It must be manufactured in the same facility as the brand-name drug.

It must be pharmaceutical equivalent and bioequivalent to the brand-name drug. (correct)

Which of the following best describes the key characteristic of a drug suspension?

A sucrose-based solution.

A completely dissolved medication in an aqueous vehicle.

Insoluble drug particles dispersed in an aqueous vehicle. (correct)

A solution in a hydroalcoholic vehicle.

What is the main characteristic of an elixir dosage form?

It is a sucrose-based solution.

It is a solution in a hydroalcoholic vehicle. (correct)

It is a compressed solid dosage form.

It contains insoluble drug particles in an aqueous vehicle.

Besides the active ingredient, what other aspects must be identical between a brand-name drug and its generic version in order to be considered a pharmaceutical equivalent?

The dosage form and the amount of the active ingredient. Signup and view all the answers

What is a key advantage of the rectal route of drug administration over the oral route?

It is useful when a patient is vomiting, unconscious or cannot swallow. Signup and view all the answers

What is the primary focus of biopharmaceutics?

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

Which factor is NOT directly considered within the scope of biopharmaceutics?

The cost of manufacturing the drug product. Signup and view all the answers

How do different dosage forms primarily impact therapeutic decisions when prescribing?

By influencing the rate and extent of drug absorption. Signup and view all the answers

What is a key consideration when looking up information in a drug reference such as Lexidrug™?

The section detailing available dosage forms. Signup and view all the answers

In the context of biopharmaceutics, what does the 'rate of dissolution' refer to?

The speed at which a drug dissolves in the targeted enviroment. Signup and view all the answers

According to the content provided, which of the following should be located in a drug reference such as Lexidrug?

The section describing drug administration considerations. Signup and view all the answers

What is an important factor to determine when considering the safety of manipulating a dosage form, such as cutting or crushing?

If the dosage form is designed for controlled release. Signup and view all the answers

Which process is directly linked to the rate and extent of drug absorption?

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

Which of the following is a primary advantage of administering a drug through the parenteral route?

Ability to achieve rapid absorption and predictable drug levels. Signup and view all the answers

A patient requires a medication that must bypass first-pass hepatic metabolism. Which route would be most suitable?

Rectal Signup and view all the answers

What is a key characteristic of a transdermal patch?

It allows a very slow and sustained systemic absorption of the drug. Signup and view all the answers

What is the main purpose of modified release drug products?

To alter the timing and/or rate of release of the drug. Signup and view all the answers

An 'extended-release' medication is designed to do what?

Provide at least a twofold reduction in dosing frequency. Signup and view all the answers

What distinguishes a 'delayed-release' dosage form from an 'immediate-release' form?

Delayed-release releases a portion of the drug at a time other than immediately after administration, whereas immediate release does not delay. Signup and view all the answers

An enteric-coated tablet is an example of which type of modified release?

Delayed-release Signup and view all the answers

What is a potential disadvantage of using modified-release drug products?

Less flexibility in dose adjustments, compared to immediate release. Signup and view all the answers

What is meant by the term 'dose-dumping' in the context of modified-release drug products?

Rapid and unintended release of the entire drug dose. Signup and view all the answers

Why is it important to counsel patients not to crush or chew modified-release tablets?

To prevent a rapid release of the entire drug dose. Signup and view all the answers

What is a potential disadvantage of using drug patches?

Risk of contact dermatitis as an adverse effect Signup and view all the answers

Which clinical consideration is important when applying a drug patch?

Apply to clean, dry skin that is relatively free of hair Signup and view all the answers

What happens after the removal of a drug patch?

Some drug usually continues to diffuse from the dermal layer Signup and view all the answers

What is a common misconception about dosing with drug patches?

Only potent drugs can be delivered in a patch Signup and view all the answers

What should a patient do with the old patch before applying a new one?

Remove the old patch completely Signup and view all the answers

Study Notes

Introduction to Biopharmaceutics and Drug Dosage Forms/Databases

The presentation introduces biopharmaceutics and drug databases.
A presenter, Gretchen M. Ray, PharmD, PhC, BCACP, CDCES, Associate Professor at UNM College of Pharmacy, led the session.
The date of presentation: January 17, 2025.

Objectives

Define biopharmaceutics.
Explain pharmaceutical equivalence, bioequivalence, and therapeutic equivalence in relation to generic drugs.
Identify factors relating to counseling and prescribing various outpatient dosage forms (capsules/tablets, solutions/suspensions/elixirs, and transdermal preparations).
Locate drug administration considerations, dosage forms, and ADME characteristics in a drug reference (like Lexidrug).
Determine if it is safe to cut or crush a dosage form.

Supplemental Readings/References

Shargel L, Yu AC. Applied Biopharmaceutics & Pharmacokinetics, 7th edition (2016). Accessed: October 24, 2017.
Allen LV, Ansel HC. Ansel's Pharmaceutical Dosage Forms and Drug Delivery Systems, 10th edition (2014).

Biopharmaceutics

Biopharmaceutics explores the connection between a drug's physical and chemical properties, dosage form, and administration route on the rate and extent of drug absorption.
Key phases covered include drug release/dissolution, absorption, distribution, elimination, excretion, and metabolism and the eventual pharmacologic or clinical effect.

Biopharmaceutics (cont'd)

Key elements include the design of the drug dosage form, stability of the drug product, manufacture of the drug product, release of the drug from the product, rate of dissolution at the absorption site, and delivery of the drug to its site of action.

Generic Drug Approval

Generic and brand-name drugs are not always identical.
Once the FDA approves a new drug application (NDA), a patent is granted.
When the patent expires, other companies can produce generic versions of the drug.
Generic drug products need to follow strict parameters.
They must contain the same active pharmaceutical ingredient, same dosage form, and same route of administration as the brand-name drug.
Abbreviated New Drug Applications (ANDAs) are used for generic drug approvals.

Generic Drug Approval (cont'd)

ANDA approvals require the generic drug to be therapeutically equivalent to the brand drug.
The generic drug must be proven safe and effective.
The generic drug must be pharmaceutically equivalent to the brand drug.
Dosage forms containing the identical amount of the chemically active pharmaceutical ingredient and may contain different inactive ingredients (excipients) (like color or preservatives).
Generics are bioequivalent to the brand-name drug, and have the same rate and extent of active drug reaching the site of action.

Routes of Administration and Associated Drug Dosage Forms

Oral route is the most common.
Oral dosage forms include tablets, capsules, suspensions, solutions, and elixirs.
Other methods for delivery include rectal, parental, topical, and ocular, otic, or nasal.
Each route has its own benefits, disadvantages, and considerations.

Oral Route/Oral Dosage Forms

Tablets are compressed solid dosage forms.
Capsules contain a drug and filler, in a hard or soft gelatin shell.
Suspensions contain insoluble drug particles in an aqueous vehicle.
Most require shaking before administration.
Solutions contain soluble drug particles in an aqueous vehicle.
Elixirs are solutions in a hydroalcoholic vehicle.
Syrups use sucrose as base.

Rectal Route

Useful if patients cannot swallow.
About 50% of absorbed drug bypasses the liver via the rectal route.
Absorption is irregular and unpredictable.
Suppositories are solid dosage forms that melt/dissolve to release the medicine.

Parental Route

Drugs administered by injection.
Drugs that are rapidly destroyed by the GI tract, require rapid absorption, or have predictable levels are given with this route.
Disadvantage: difficult to remove drug in case of overdose, and sterility is crucial.
Subcutaneous, intramuscular, intravenous, and intradermal are types of parental injection.

Topical Route

Applied to the skin for local or systemic effects.
Transdermal patches are a form designed for systemic absorption, often for slow release.
Other topical forms are for local action with limited absorption (e.g., lotions, creams, ointments).

Ocular, Otic, and Nasal Routes

Used to deliver drugs to the eyes, ears, and nasal passages.

Modified Release Drug Products

Modified-release (MR) forms alter the timing or rate of drug delivery.
This leads to improved patient adherence, dosage frequency, and systemic absorption control.
Extended-release, delayed-release, enteric-coated, repeat-action, and targeted-release are examples.
Orally disintegrating tablets (ODTs) disintegrate quickly without water.

Modified Release Drugs (cont'd)

Advantages include sustained therapeutic blood levels, improved patient adherence, and improved tolerability.
Disadvantages involve dose-dumping, less flexibility in dose adjustment, and high dose difficulty administration due to size.

Clinical Considerations for Oral Modified Release Dosage Forms

Don't switch to immediate-release (IR) without considering existing blood concentration.
Tablets and capsules should not be crushed or chewed.
Non-erodible plastic matrix shells and osmotic tablets typically remain intact in stool.
Contact drug resources if unsure regarding dosage form or application technique.

Modified Release Via Transdermal Drug Delivery Systems

Allow passage of drugs from skin's surface into systemic circulation.
Advantages include avoiding first-pass liver metabolism.
Rapid drug termination by removing the patch.
Disadvantages include potential for contact dermatitis, delayed onset, and difficulties administering high doses.

Clinical Considerations When Prescribing Drug Patches

Confirm proper application site.
Apply to clean, dry skin.
Avoid lotions, and wet or moist skin.
Patients should remove old patches before applying a new one.
Discard the adhesive layer after use (safety considerations).

Practice with Drug Database

Use of a drug database, like Lexi-Comp, was highlighted.

Lexi-Comp Introduction

Lexi-comp is an open database.
Search examples provided include Amoxicillin (antibiotic), Promethazine (anti-emetic), and Pantoprazole (proton pump inhibitor).
ADME, dosage form, administration details, and clinical considerations are readily available for review using the database.

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Description

This quiz covers key concepts in pharmaceutical sciences, focusing on drug equivalence, dosage forms, and biopharmaceutics. Participants will assess their understanding of drug characteristics, routes of administration, and the importance of pharmaceutical equivalence. Test your knowledge on essential principles that govern drug formulation and therapeutic decisions.