S01 Drugs and Dosage Forms 1 Learning Objectives

Learning Objective 1: Define drug, small molecule, biologic, prodrug, and pharmaceutics

What is a drug according to the Food, Drug, and Cosmetic Act of 1938?

A substance intended for use in the diagnosis, mitigation, treatment, cure, or prevention of disease in humans or other animals.

Learning Objective 1: Define drug, small molecule, biologic, prodrug, and pharmaceutics

What is an Active Pharmaceutical Ingredient (API)?

The drug substance itself.

Learning Objective 1: Define drug, small molecule, biologic, prodrug, and pharmaceutics

What is a small molecule drug?

A low molecular weight compound manufactured via chemical synthesis.

Learning Objective 1: Define drug, small molecule, biologic, prodrug, and pharmaceutics

What molecular weight threshold defines a small molecule drug?

Less than 900 Daltons.

Learning Objective 1: Define drug, small molecule, biologic, prodrug, and pharmaceutics

What are two examples of small molecule drugs?

Acetaminophen and ibuprofen.

Learning Objective 1: Define drug, small molecule, biologic, prodrug, and pharmaceutics

What is a biologic?

large molecule made in bacteria, plant, or animal cells using recombinant DNA technology.

Learning Objective 1: Define drug, small molecule, biologic, prodrug, and pharmaceutics

What is an example of a biologic?

Adalimumab (Humira).

Learning Objective 1: Define drug, small molecule, biologic, prodrug, and pharmaceutics

What is a prodrug?

An inactive compound that becomes active in the body through enzymatic or biochemical transformation.

Learning Objective 1: Define drug, small molecule, biologic, prodrug, and pharmaceutics

What converts the prodrug sulfasalazine into its active components?

Bacteria in the colon.

Learning Objective 1: Define drug, small molecule, biologic, prodrug, and pharmaceutics

What is the primary active metabolite generated from sulfasalazine in the colon?

5-aminosalicylic acid (mesalamine).

Learning Objective 1: Define drug, small molecule, biologic, prodrug, and pharmaceutics

What is the less active metabolite formed from sulfasalazine?

Sulfapyridine

Learning Objective 1: Define drug, small molecule, biologic, prodrug, and pharmaceutics

What is pharmaceutics?

science of designing dosage forms and drug delivery systems

Learning Objective 2: List the goals of dosage forms and their composition

What is a dosage form?

final physical form of a drug that can be used by the consumer without further manufacturing.

Learning Objective 2: List the goals of dosage forms and their composition

What are four physical examples of dosage forms?

Lozenges, capsules, tablets, and liquids.

Learning Objective 2: List the goals of dosage forms and their composition

Why are dosage forms needed regarding dosing?

to administer an accurate dose safely and conveniently.

Learning Objective 2: List the goals of dosage forms and their composition

Why are dosage forms needed regarding specific patient populations?

to ensure patient compliance in individuals who may have difficulty swallowing solid dosage forms, such as pediatric or geriatric patients.

Learning Objective 2: List the goals of dosage forms and their composition

How do dosage forms assist with organoleptic drug properties?

They conceal unpleasant odor or taste.

Learning Objective 2: List the goals of dosage forms and their composition

How do dosage forms protect drugs from external degradation?

They protect against chemical decomposition from atmospheric oxygen and humidity.

Learning Objective 2: List the goals of dosage forms and their compositionHow do dosage forms protect drugs from internal degradation?

They protect against chemical decomposition from gastric acid.

Learning Objective 2: List the goals of dosage forms and their composition

What drug release function do dosage forms provide?

They control the release of drugs into the body.

Learning Objective 2: List the goals of dosage forms and their composition

What two main groups of ingredients make up a finished dosage form?

Active ingredients and inactive ingredients (excipients).

Learning Objective 2: List the goals of dosage forms and their composition

What is the purpose of an active ingredient in a dosage form?

responsible for pharmacological effects.

Learning Objective 2: List the goals of dosage forms and their composition

What are inactive ingredients (excipients)?

Ingredients that have a well-defined, non-therapeutic function added for a specific purpose in a drug product.

Learning Objective 2: List the goals of dosage forms and their composition

Are excipients always completely inert in patients?

No, excipients are not always inert and may cause adverse events.

Learning Objective 2: List the goals of dosage forms and their composition

What adverse event can be caused by the tablet filler lactose in sensitive patients?

Lactose intolerance symptoms.

Learning Objective 2: List the goals of dosage forms and their compositionWhat are twelve examples of excipients used in dosage forms?

Flavors, colorants, solvents, suspending agents, sweeteners, antimicrobial preservatives, fillers, thickeners, disintegrants, and emulsifiers.

Learning Objective 2: List the goals of dosage forms and their composition

Why were pediatric patients historically dosed using simple fractions of adult doses?

There was insufficient understanding of their capacity to detoxify and eliminate drugs.

Learning Objective 2: List the goals of dosage forms and their composition

Why do infants and newborns have impaired drug inactivation and elimination?

They have immature hepatic and renal function.

Learning Objective 3: Compare and contrast between compounding and manufacturing

What is pharmaceutical compounding?

The preparation, mixing, assembling, altering, packaging, and labeling of a dosage form by a licensed pharmacist.

Learning Objective 3: Compare and contrast between compounding and manufacturing

What is drug manufacturing?

The large-scale production of dosage forms by pharmaceutical companies using standardized processes and quality control measures.

Learning Objective 3: Compare and contrast between compounding and manufacturing

How does batch scale differ between compounding and manufacturing?

Compounding is small-scale per patient, whereas manufacturing is large-scale mass production.

Learning Objective 3: Compare and contrast between compounding and manufacturing

Who regulates compounding versus manufacturing?

Compounding is regulated at the state level, while manufacturing is regulated federally by the FDA

Learning Objective 3: Compare and contrast between compounding and manufacturing

Is compounding patient-specific?

Yes, compounding is patient-specific, whereas manufacturing is not.

Learning Objective 3: Compare and contrast between compounding and manufacturing

What is an example product of compounding versus manufacturing?

Customized creams are an example of compounding, while commercial tablets are an example of manufacturing.

Learning Objective 3: Compare and contrast between compounding and manufacturing

What was the primary focus of pharmacy prior to the 20th century?

Compounding.

Learning Objective 3: Compare and contrast between compounding and manufacturing

What caused the decline of compounding in the 1950s and 1960s?

The growth of commercial drug manufacturing.

Learning Objective 3: Compare and contrast between compounding and manufacturing

How did the rise of commercial manufacturing shift the pharmacist's primary role?

It transitioned pharmacists from compounding to dispensing

Learning Objective 4: Describe the reasons for renewed interest in pharmaceutical compounding in recent years

How does compounding support personalized therapy?

It allows customization of treatments for individual patient needs when commercial "one size fits all" products are unsuitable.

Learning Objective 4: Describe the reasons for renewed interest in pharmaceutical compounding in recent years

How does compounding address discontinued or unavailable medications?

It fills the gap when manufacturers discontinue drugs that are not widely used or are less profitable

Learning Objective 4: Describe the reasons for renewed interest in pharmaceutical compounding in recent years

How has supply availability impacted the renewal of compounding?

Improved access to tools, packaging, labels, and ingredients makes safe and effective compounding easier.

Learning Objective 4: Describe the reasons for renewed interest in pharmaceutical compounding in recent years

Where can pharmacists find standardized guidance for compounding procedures?

In textbooks, scientific journals, and official sources like the U.S. Pharmacopeia (USP)