Introduction to Biopharmaceutics and Drug Dosage Forms
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Questions and Answers

Which of the following is a disadvantage of using transdermal drug patches?

  • They may cause contact dermatitis in some patients. (correct)
  • They allow rapid termination of drug therapy.
  • They prevent drug absorption interactions in the gastrointestinal tract.
  • They bypass first-pass metabolism in the liver.

Why is it important to apply a transdermal patch to clean, dry skin?

  • To increase drug permeation. (correct)
  • To slow down the absorption of the drug.
  • To avoid skin irritation from lotions or other substances.
  • To prevent the patch from adhering properly.

What is a crucial step to take when changing a transdermal patch to ensure safety?

  • Applying lotion to aid absorption.
  • Applying a new patch directly over the old one.
  • Cutting the patch to adjust the dosage.
  • Folding the used patch in half with the adhesive sides together before discarding. (correct)

According to the content, what should be avoided at the site of transdermal patch application?

<p>Lotion (A)</p> Signup and view all the answers

What does the term 'ADME' refer to in the context of pharmacology?

<p>Absorption, Distribution, Metabolism, Excretion (D)</p> Signup and view all the answers

What is required for a generic drug to be considered therapeutically equivalent to its brand name counterpart?

<p>It must be pharmaceutically equivalent and bioequivalent to the brand name drug. (B)</p> Signup and view all the answers

Which of the following is a key difference between a suspension and a solution dosage form?

<p>Suspensions require shaking before administration due to the presence of insoluble particles, while solutions do not. (A)</p> Signup and view all the answers

What is the primary purpose of submitting an Abbreviated New Drug Application (ANDA)?

<p>To gain approval for a generic version of a drug, after the original patent has expired. (A)</p> Signup and view all the answers

Which dosage form is most likely to be useful for a patient who is experiencing severe vomiting?

<p>Rectal suppository (A)</p> Signup and view all the answers

What do generic drugs need to have in common with their brand-name drug, according to the requirements for FDA approval?

<p>Same active ingredient, dosage form and route of administration. (C)</p> Signup and view all the answers

Which of the following best describes biopharmaceutics?

<p>The relationship between a drug's physical and chemical properties, its dosage form, and its route of administration on the rate and extent of drug absorption. (C)</p> Signup and view all the answers

According to the provided information, which factor is NOT directly considered when designing a drug dosage form?

<p>The cost of the ingredients used. (D)</p> Signup and view all the answers

What is a key process that biopharmaceutics links to therapeutic decisions?

<p>The effects of different dosage forms on the rate and extent of drug absorption. (A)</p> Signup and view all the answers

What aspect of a drug is most directly related to the rate of dissolution?

<p>The release of the drug from the drug product. (A)</p> Signup and view all the answers

What is meant by 'therapeutic equivalence' in the context of pharmaceuticals?

<p>Drugs that produce the same clinical effect in patients. (C)</p> Signup and view all the answers

According to the information, which of the following is a key area to locate within a drug reference (like Lexidrug™)?

<p>The section describing available dosage forms for a drug. (D)</p> Signup and view all the answers

Which of the following is NOT an objective listed in the introduction?

<p>Locate all therapeutic uses for the drug in a drug reference (C)</p> Signup and view all the answers

According to the information, which of the following describes a generic drug?

<p>A drug manufactured by a company other than the original producer. (C)</p> Signup and view all the answers

What is a primary disadvantage of administering drugs via the rectal route?

<p>Irregular and unpredictable absorption. (D)</p> Signup and view all the answers

Which of these routes offers the most direct access to the systemic circulation, bypassing first-pass metabolism?

<p>Intravenous injection (B)</p> Signup and view all the answers

A patient is prescribed a transdermal patch. What is the primary purpose of this dosage form?

<p>To allow for slow, sustained systemic absorption. (B)</p> Signup and view all the answers

Which dosage form is specifically designed to release some medication immediately and a second dose at a later time point?

<p>Repeat action (C)</p> Signup and view all the answers

What is a characteristic of immediate-release (IR) oral drug products?

<p>They release the entire dose of the drug immediately after administration. (A)</p> Signup and view all the answers

Which of the following is a potential disadvantage of using modified-release drug products?

<p>Less flexibility in dose adjustment due to the modified release profile. (B)</p> Signup and view all the answers

A patient is prescribed an enteric-coated tablet. What does this indicate about its release characteristics?

<p>It delays the release of drug until it reaches the more alkaline small intestine. (D)</p> Signup and view all the answers

Which term describes a modified release dosage form that allows at least a twofold reduction in dosing frequency compared to an immediate-release product?

<p>Extended-release (B)</p> Signup and view all the answers

Why should patients be educated not to crush or chew modified-release tablets?

<p>To prevent the rapid release of the entire drug dose, leading to potential toxicity. (D)</p> Signup and view all the answers

Which of the following is a characteristic of ocular drug administration?

<p>Use of highly viscous solutions for prolonged contact. (B)</p> Signup and view all the answers

Flashcards

ANDA (Abbreviated New Drug Application)

A generic drug application submitted to the FDA for approval to market a generic version of an already approved brand name drug.

Therapeutic Equivalent

A drug that is pharmaceutically equivalent (identical active ingredient, dosage form, and route of administration) and bioequivalent (same rate and extent of drug absorption) to the brand name drug.

Oral Route of Administration

Drugs taken by mouth.

Tablet

A solid dosage form made by compressing the active drug and inactive fillers.

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Capsule

A solid dosage form where the drug is enclosed in a gelatin shell.

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Biopharmaceutics

The study of how the physical and chemical properties of a drug, its dosage form, and the route of administration affect how quickly and to what extent it's absorbed into the body.

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Pharmaceutical Equivalence

Two drugs are considered pharmaceutically equivalent if they have the same active ingredient, dosage form, and route of administration. They might have different inactive ingredients.

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Bioequivalence

Two drugs are considered bioequivalent if they are absorbed at the same rate and to the same extent in the body, resulting in the same blood levels.

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Generic Drug

Generic drugs are drug products that have the same active ingredient, dosage form, strength, and route of administration as a brand-name drug and are bioequivalent. They are usually much cheaper.

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Stability of the drug within the dosage form

Refers to the stability of the drug within the dosage form during storage and manufacturing.

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Rate of dissolution of the drug at the absorption site

Refers to the release of the drug from the dosage form and its dissolution in the body.

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Delivery of drug to the site of action

Refers to the factors influencing how the drug is delivered to the site of action in the body, such as blood flow and the ability of the drug to cross membranes.

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Transdermal Patch

A drug delivery method that avoids the digestive system, thereby preventing breakdown by liver enzymes and interactions with other medications.

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Extended Therapy

The patch allows for continuous drug release over an extended period, eliminating the need for frequent dosing.

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Rapid Termination

Patches can be easily removed, allowing for immediate termination of drug delivery.

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Patch Application Guidelines

Patches should be applied to clean, dry skin, free of hair and lotions to ensure proper absorption and minimize irritation.

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Patch Disposal

After removing the patch, fold it in half with the adhesive side together to prevent accidental exposure to the medication.

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Sublingual Administration

A drug delivery route where medication is placed under the tongue and absorbed directly into the bloodstream, bypassing the digestive system.

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Modified Release Drug Products

A type of dosage form where the drug is released gradually over time, allowing for fewer doses per day.

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Transdermal Delivery Systems

Drug delivery systems (like patches) that allow for the slow and sustained absorption of medication through the skin.

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Delayed-release Drugs

A type of modified release drug that releases a portion of the drug at a time other than immediately after administration. This allows for a more targeted and controlled release of the drug.

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Rectal Administration

A route of administration that bypasses the liver, allowing for a higher concentration of the drug to reach the bloodstream. However, it can lead to unpredictable absorption.

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Repeat Action Drugs

A type of modified release drug that contains two doses of medication, one for immediate release and one for delayed release.

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Pharmacokinetic Process

The process where a drug is absorbed into the bloodstream and distributed throughout the body. It is influenced by factors like route of administration and physicochemical properties of the drug.

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Targeted-release Drug

A type of modified release drug specifically designed to release the drug at or near the physiologic site of action, allowing for better efficacy and reduced side effects

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Orally Disintegrating Tablets (ODT)

A type of modified release drug that disintegrates rapidly in the mouth, allowing for easier administration, especially for patients who have difficulty swallowing.

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Extended-release Drugs

A type of modified release drug that allows for at least a twofold reduction in dosing frequency, leading to improved patient adherence and potentially fewer side effects.

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Study Notes

Introduction to Biopharmaceutics and Drug Dosage Forms/Databases

  • Gretchen M. Ray, PharmD, PhC, BCACP, CDCES, Associate Professor, UNM College of Pharmacy
  • Date: January 17, 2025

Objectives

  • Define biopharmaceutics
  • Explain the relationship between pharmaceutical equivalence, bioequivalence, and therapeutic equivalence in relation to generic drugs
  • Identify pertinent counseling points and prescribing considerations for various outpatient dosage forms (e.g., capsules, tablets, oral solutions)
  • Locate sections in a drug reference (Lexidrug™ example) describing available dosage forms, administration considerations, and ADME characteristics for a drug
  • Determine if a dosage form can be safely cut or crushed

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 drug properties, dosage form, and route of administration; effects on absorption rate and extent
  • Includes drug release/dissolution, absorption, distribution, elimination (excretion and metabolism), and pharmacologic/clinical effects

Biopharmaceutics (cont.)

  • Design of the drug dosage form
  • Stability of the drug product
  • Manufacture of the drug product
  • Release of the drug from the drug product
  • Rate of dissolution of the drug at the absorption site
  • Delivery of drug to the site of action
  • Various dosage forms significantly affect factors above and influence therapeutic decisions in prescribing

Generic Drug Approval

  • Generic and brand name drugs are not always identical
  • Once a new drug application (NDA) is FDA approved, a patent is granted
  • When the patent expires, other companies can market generic drug versions
  • Generic drug versions need to be equivalent in safety and efficacy to the brand-name drug to receive FDA approval
  • Generic drugs must contain the same active pharmaceutical ingredient, same dosage form, and same route of administration as the brand name

Generic Drug Approval (cont.)

  • ANDA approval requires therapeutic equivalence to the brand drug, proven safety and efficacy
  • Pharmaceutical equivalence to the brand drug, identical dosage form with the same amount of the chemically active pharmaceutical ingredient
  • Can contain different inactive ingredients (excipients) (like color or preservatives)
  • Bioequivalent to the brand name drug (equal rate and extent of active drug reaching the site of action)

Routes of Administration and Associated Drug Dosage Forms

  • Oral route: most frequent, but slow drug response, potential for irregular absorption. Includes tablets, capsules, suspensions, solutions, elixirs and syrups, for example
  • Rectal route: useful for vomiting or unconscious patients, can bypass the liver but absorption is irregular and difficult to predict
  • Parenteral route (via injection): rapid absorption, predictable drug levels, but difficult to reverse overdose and requires sterility considerations. Divided into: subcutaneous, intramuscular, intravenous, and intradermal
  • Epicutaneous route (skin application): for local action with minimal systemic absorption. Includes lotions, creams, and ointments; transdermal patches allow for slow, sustained systemic absorption
  • Ocular, otic, and nasal routes: for local action.

Oral Route/Oral Dosage Forms (cont.)

  • Most oral drug products are considered immediate release
  • Modified-release forms alter timing and/or rate of release to improve patient adherence or for desired therapeutic effect
  • Modify drug absorption in the GI tract to avoid adverse effects

Modified-Release Drug Products

  • Extended-release (controlled/sustained/long-acting)
  • Delayed-release

Modified-Release Drug Products (cont.)

  • Enteric-coated tablets
  • Repeat-Action
  • Targeted-release
  • Orally disintegrating tablets (ODTs)

Modified Release Drugs (Advantages and Disadvantages)

  • Advantages:

    • Sustained therapeutic blood levels
    • Improved patient adherence
    • Improved tolerability

  • Disadvantages:

    • Dose-dumping
    • Less flexibility in dose adjustments
    • More difficult to administer high doses

Clinical Considerations for Oral Modified Release Dosage Forms

  • Do not switch back to immediate-release (IR) without considering existing blood concentration from the extended-release (ER) drug
  • Counsel patients that modified-release tablets and capsules should not be crushed or chewed
  • Some non-erodible plastic matrix shells and osmotic tablets may remain in the stool
  • Empty shells/ghosts from osmotic tablets may be seen in the stool

Modified Release Via Transdermal Drug Delivery Systems (Drug Patches)

  • Allow for drug passage from skin surface into systemic circulation

  • Advantages: avoid first-pass metabolism, extended therapy, rapid termination

  • Disadvantages: only potent drugs, risk of contact dermatitis, lag time, and effects can continue after removal, can affect oral forms.

Clinical Considerations When Prescribing Drug Patches

  • Varying absorption depending on application site.
  • Apply to clean, dry skin (free of hair and/or moisture).
  • Avoid lotions at application sites
  • Ensure patient removal of old patch before application of new one
  • Fold and discard after removal
  • Drug remains in reservoir longer than stated use.

Practice with Drug Databases (Lexi-Comp)

  • Open database
  • Search for medications (Amoxicillin, promethazine, pantoprazole)
  • Retrieval of drug preparations, dosage forms, administration methods, pharmacology, pharmacokinetics, pharmacodynamics, and ADME characteristics

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Description

This quiz covers the fundamentals of biopharmaceutics and the various dosage forms of drugs. Participants will explore concepts including pharmaceutical equivalence, bioequivalence, and therapeutic equivalence, with a focus on outpatient dosage forms such as capsules and tablets. Additionally, the quiz will assess the understanding of drug databases and reference materials.

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