sci & calc

drug

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

small molecules

low molecular weight (<900 Daltons) compounds that are manufactured via chemical synthesis

biologics

(biopharmaceuticals, macromolecules) large molecules that are made in bacteria, plant, or animal cells using recombinant DNA technology

prodrug

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

pharmaceutics

science of designing dosage forms and drug delivery systems- turning an active ingredient into a usable medicine

dosage form

final physical form of the drug which may be used by the consumer without any further manufacturing

active ingredient

drug substance(s) that is responsible for pharmacological effectsi

inactive ingredients

have well-defined, non-therapeutic function in a drug product

inactive ingredients (excipients)

intended to be inert, but not always inert & may have risks and cause adverse events

excipients

flavors, colorants, solvents, suspending agents, and sweeteners are all examples of __

compounding

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

manufacturing

large-scale production of dosage forms by pharmaceutical companies using standardizeed processes and strict quality control measures

pediatric considerations

children are not born with fully functional organ and enzyme systems

compounding

small scale (per patient), regulated at state-level, patient-specific

manufacturing

large scale (mass production), regulated at FDA/federal level, not patient-specific

accurate dose that is convenient, ensure patient compliance, conceal unpleasant odor/taste, protect drug from decomposition, control release of drugs

What are some reasons to create dosage forms?

active and inactive (excipient) ingredients

a finished dosage form contains what 2 groups of ingredients?

dispensing

up until the 20th century, pharmacy was all compounding. growth of commercial drug manufacturing (1950s & 1960s) caused transition in pharmacists’ role from compounding into ___?

personalized therapy, discontinued/unavailable meds, improved access to supplies, more information available

what are 4 reasons a pharmacist might choose to compound a drug today?

personalized therapy

commercial drug products often follow a “one size fits all” approach, but compounding allows for customized treatments to meet individual patient needs

discontinued or unavailable medications

drugs that aren’t widely used or are less profitable, may be discontinued by manufacturers; compounding helps fill this gap

improved access to supplies

it’s now easier to get the tools, packaging, labels, and ingredients needed to compound medications safely and effectively

more information available

there’s now a lot of guidance on how to compound medications properly- available in textbooks, scientific journals, and official sources like the U.S. Pharmacopeia (USP)

a pharmacologically inactive compound that is metabolized into an active drug in the body

What is a prodrug?

False

Inactive ingredients (excipients) are always inert. (T/F)

Manufacturing is the large-scale production of FDA-approved drug products

How does manufacturing differ from compounding?

Widespread availability of compounding information, equipment, and materials

Which of the following is contributing to the increased ability to perform pharmaceutical compounding?

The United States Pharmacopeia (USP) The National Formulary (NF)

What does USP-NF stand for ?

1820; 1888

First USP was published in ___. First NF was published in ___.

they were merged into a single book

In the 1970s, what occurred regarding USP and NF? First combined was published 1980.

1938

The FD & C (Federal Food, Drug, and Cosmetic Act) recognized the USP/NF as the official compendia of drug standards in what year?

annually

How often is the USP published?

formulas, monographs, reference books

The USP-NF contains ___, _____, and ____ that describe standards that manufacturers and pharmacist should maintain when they prepare drug products.

Drug Formulation; formula

The recipe for preparation of a drug product is called _?

name and quantities of ingredients (active & excipients), mixing sequence & processing steps/procedure

What does a formula include?

pre-clinical testing

What type of testing is performed in animals?

clinical trials

What type of testing is performed in humans?

Investigational New Drug application; for first human test

What does IND stand for and what is it filed for?

New Drug Application

What does NDA stand for?

Phase I clinical trials

• administer drug to small # healthy volunteers (20-100/trial)

• learn how to administer drug safely

• monitor side effects

  • obtain initial dosing information

Phase II clinical trials

• several hundred people WITH disease participate

• determine patients’ responses to the drug (proof of concept studies)

  • determine whether/not there is useful therapeutic response that would warrant phase III trials

Phase III trials

• large # participants WITH disease (several hundreds-thousands) dispersed across many study sites (multicenter clinical trial) to confirm effectiveness in larger studies

Phase IV

Post-approval studies (post marketing surveillance) is known as what phase?

IND (investigational new drug application filed for first human test); NDA (new drug application)

Early discovery and pre-clinical development (animals)→pre-clinical testing (animals)→file ___, clinical trials/development (humans) (phase I, II, III)→file a ___→commercialization and post marketing surveillance (phase IV)

503A (Practice of Pharmacy Compounding)

The Food and Drug Administration Modernization Act (FDAMA) of 1997 added what section to the Federal Food, Drug, and Cosmetic Act?

• FDA approval of drugs under new drug applications (NDAs) or abbreviated new drug applications (ANDAs)

• labeling drugs with adequate directions for use

• current good manufacturing practices (cGMP) requirements

Section 503A states that compounded drugs by pharmacist are exempt from what 3 key provisions of the Federal Food, Drug, and Cosmetic Act?

• identified individual pt based on valid prescription order

• performed by licensed pharmacist

• compliance w/ USP (united states pharmacopoeia) chapters on pharm compounding

• licensed pharmacist doesn’t compound regularly or in inordinate amts; can’t be copies of commercially available products

What 4 conditions must be satisfied for drug products compounded by licensed pharmacist to be exempt?

brand drug product

• innovator’s product

• exclusive patent-nobody but innovator can make/sell during certain time

• have proprietary name; trademark officially registed by company

for drug companies to copy an innovator’s product when the patent expires (generic drug product)

What did the Hatch-Waxman Act of 1984 allow?

generic drug product

• chemically identical to original branded drug

• use non-proprietary names; generally recognized/common name for drug

  • standardized nomenclature established by: USAN, WHO