Ceutics quiz 1

what is a drug defined as?

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

what is medicine when compared to a drug?

a safe, approved product made from one or more drugs to treat or cure an illness

true or false: all medicines are drugs, but not all drugs are medicines.

true

what is an example of drugs that are not medicines

drugs like meth, heroine, etc.

what is pharmaceutics described as

the pharmacy discipline concerned with the scientific and technological aspects if the design and manufacture of dosage forms

what are the 5 stages of how pharmaceutics transform drugs into medicine

1. physical pharmaceutics

2. biopharmaceutics

3. dosage form design

4. pharmaceutical microbiology

5. pharmaceutical manufacturing

what are the three forms of manufacturing

individualized compounding, small scale tests, and industrial manufacturing for commercial purposes

what is pharmaceutical formulation

designing and producing a drug in a specific form such as tablets, capsules, or injectables

what is extemporaneous compounding

creating a customized medication for an individual patient by combining, mixing, or altering ingrediants

why is pharmaceutical microbiology important

important for sterile products such as injections and ophthalmic preparations to ensure medicines remain free from harmful microorganisms

what is preformulation and what step of the dose designing process is it?

it is the first step and is the systemic study of the physical and chemical properties of a drug before formulation begins

what question does preformulation answer

"what type of dosage form is suitable for this drug?"

what does properties does preformulation study

physical, chemical, and mechanical

why are dosage forms needed

accuracy, protection, pt compliance, appropriate physical form, controlled release, drug delivery

how does absorbtion influence formulation

optimize design, dissolution rate, enhances bioavailability, and improve outcomes

why may dosage forms change

according to patient needs

what are some examples of changes in dosage form to fit patient needs

liquids for children/infants, ODT meds for dyphagia patients, inhalers, controlled release

what is a clinical trial

a research study with human volunteers that tests whether a medical intervention is safe and effective

a local clinical trial of 20-100 healthy volunteers is considered

a phase 1 clinical trial

large scale clinical trials of 100-300 patients with the target disease

a phase 2 clinical trial

clinical trials over a population of several thounsand participants

a phase 3 clinical trial

what information does the package insert provide

it summarizes important information learned through drug development

what does FDA stand for

U.S. Food and Drug Administration

under what act does the FDA require all new drugs to be approved

the Federal Food, Drug, and Cosmetic Act

what are three ways pharmaceutics plays a role in new drug development

1. identifying drug candidates

2. formulating for lab and animal testing

3. supporting clinical trials`

what did the need for drug standard lead to the invention of

pharmacopeias or formularies

what are pharmacopeias/formularies

organized sets of monographs of standards used by those involved in the production of drugs and pharmaceutical products

who are the USP and what do they provide

the United States Pharmacopeia sets public standards for medicines, food ingredients, and dietary supplements

USP Chapter 795 focuses on

non-sterile compounding

USP Chapter 797 focuses on

sterile compounding

who is NF and what do they provide

the National Formulary focuses on providing standards for excipients, botanicals, and other ingredients used in drug formulation

what is an API

active pharmaceutical ingredient

what are excipients

inactive substances that do not have any therapeutic effect

what are properties of ideal excipients

pharmacologically inert, minimal toxicity, cost-effective, stable and reproducible, does not interfere with API

what is a flavoring agent and its purpose

they are added to liquids intended for oral administration that may mask the disagreeable taste of a drug enhancing patient compliance

where are flavoring agents derived from

natural and artificial sources

what is the main naturally occurring sweetener in used in pharmaceutical preparations

sucrose

what are some examples of artificial sweetening agents

aspartame, saccharin, and cyclamate

what are the only FDA approved artificial sweeteners

acesulfame potassium, aspartame, sucralose, saccharin

most coloring agents used in pharmaceutical preparations are

synthetic lake pigments or dyes

what percent of dyes used in FDA-regulated products are synthesized from aniline

90%

what are some characteristics of aniline

pure colorants, water soluble

what is primary packaging

the container closure system containing the drug product

what is secondary packaging

contains the primary pack with associated components and information leaflets

what is tertiary packaging

contains multiple secondary packs during the facilitation of handling and transport

what are a few examples of primary packaging

blister packs, glass bottles/vials, sachet, glass ampules, dropper bottles, syringes

what is the purpose of having packaging

the protect from the environment, maintain integrity, and presentation

what is a single unit pack

a primary package that contains a single individual unit

what is a multi unit pack

a pack that contains multiple individual units

what are some advantages to single unit packs

protects the dose, stability, preservative free, fewer errors

what are drug packaging interactions

mass transport of compounds between the packaging material and the drug

what are the two types of drug-packing interactions

leaching and soprtion

what is leaching

when chemical components migrate out of the packaging material into the drug product

what is sorption

when the components initially present in the drug product move into the packaging material

what is the purpose of light resistant containers

to reduce light transmission sufficiently

compare and contrast amber glass vs. light resistant opaque plastic

amber glass filters uv and visible light and is commonly used for liquids, injectables, and some solids while opaque plastic blocks light transmission and is ideal for tablets, capsules, powders, and some liquids

what is the purpose of a well-closed container

to protect contents from contamination and loss under normal handling, shipment, and storage for products that do not require complete protection from air or moisture

what is the purpose of tight containers

they impervious to air or any other gas under normal handling, shipment, and storage for products highly sensitive to air and moisture

what are some examples of closures

screw caps, child-resistant caps, rubber stopper, flip-top caps

what is child-resistant packaging

hard to open for children, but easy for adults. it is designed to help prevent accidental poisoning

what is an easy open cap

caps that are easier to open for seniors or those who have impaired vision or reduced hand strength

what are the three physical states of matter

solid, liquid, and gas

what determines the physical state of a molecule

the forces that hold the molecules together

what are the two types of forces that hold molecules together

intramolecular forces and intermolecular forces

what are intramolecular forces

the chemical bonds between the atoms within a molecule

what are intermolecular forces

bonds between different molecules

how to identify fully charged ions

denoted by + or -

how to identify partially charged ions

denoted by the delta (S) + or (S)-

what is electronegativity

a chemical property of an atom that describes its ability to attract shared electrons in a chemical bond

what is the general rule for electronegativity

EN increases across the row and up the column

what is the most electronegative atom

Fluorine

EN

covalent non polar

0.5< EN< 2

covalent polar

EN two atoms>2

ionic

in ionic bonds formation

electrons are completely transferred, producing fully positive and fully negative ions so oppositely charged ions can interact to form ionic bonds

what are non polar covalent bonds

electrons are shared equally between atoms because there is no electron transfer or ion formation

what are polar covalent bonds

unequal sharing of electrons creating polarity

how do dipoles form

electrons are not fully transferred, but shared unequally resulting in a partial positive charge on the less electronegative atom and a partial negative charge on the more electronegative atom creating a dipole

what is dipole-dipole interaction

when two molecules with dipoles interact because the opposite charges attract

describe O-H bond formation

because there is no electron transfer or ion formation equal sharing of electron density, but electron density is pulled more towards oxygen because it has a higher electronegativity

what is the strongest dipole-dipole interaction

hydrogen bond

what is a hydrogen bond

when a dipole-dipole interaction specifically involves a hydrogen atom bonded to a highly electronegative atom

how does hydrogen bonding relate to solubility

more polar/H bonding groups--> higher solubility

what other atom is known to form dipoles with hydrogen like oxygen

nitrogen

what is ion-dipole interactions

electrostatic attractive forces between a charged ion and polar molecule's dipole

name an example of ion-dipole interactions

sodium chloride and water. water attaches to both Na and Cl forming ion dipole interactions

physical states of a molecule are determined by

intermolecular interactions

the stronger the intermolecular forces

the greater the likelihood that the substance will exist in the solid state and the solubility decreases

in the solid state the intermolecular bonds are

present

in the liquid state the intermolecular bonds

are broken in some areas

in the gas state the intermolecular bonds are

not present

what is the ratio of Intermolecular forces:Melting Point

as IF increases, MP increases

intermolecular forces influence

how molecules are arranged in the solid state, determining whether they form crystalline or amporphous structures

what are crystalline solids

orderly arrangement of the components in the solid state with optimal attraction

physical characteristics of crystalline structures

typically fine, ranging from fine dust to a slightly granular texture and has sharp edges

what are amorphous solids

molecules arranged in a random manner like the liquid state but are still solids

physical characteristics of amorphous solids

lacking in hardness and sharp edges found in crystalline structures, softer and smoother

what are polymorphs

when a substance exists in more than one crystalline form

among the multiple crystalline forms, ______ will be most stable and the rest are called ______________

one, metastable

do different polymorphs have different physiochemical properties

yes