Dosage Form Design and Calculations Exam 1

What is pharmaceutics?

art, science, and technology of dosage form design and manufacture

Dosage form converts a drug into __________________.

medicine

What is the formal definition of APIs?

a chemical substance used in the treatment, cure, prevention, or diagnosis of disease to enhance the physical or mental well-being

What does API stand for?

Active Pharmaceutical Ingredient

What are dosage forms?

Means by which drug molecules are delivered to sites of action within the body by means of transportation

Why are dosage forms needed?

Ensures accurate dose, protection, optimal drug action, insertion, etc.

What are examples of oral dosage forms?

tablets, capsules, syrups, powders

What are examples of sublingual dosage forms?

tablets, lozenges, films

What are examples of parenteral dosage forms?

solutions, suspensions

What are examples of transdermal dosage forms?

creams, patches, lotions

What are physicochemical properties of a drug?

stability, ionization, water/lipid solubility, hydrolysis, oxidation, racemization

What are biological properties of a drug?

absorption, transport, biotransformation

What is a drug's dosage form?

physical forms of the drug such as capsules, tablets, solutions, etc

What is a form's formulation?

combination of different ingredients

Pharmaceutics is a ______________ subject.

diverse

Why is pharmaceutics taught?

-familiarize with drug delivery systems and dosage forms, creating foundational knowledge in pharmaceutics

-solve health related problems by using knowledge of pharmaceutics

-apply the fundamental principles of drug delivery and dosage forms that allow for a thorough comprehension of the drugs which will be dispensed on a daily basis

Patients do not take drugs, they take ________________.

dosage forms

Protection of drugs such as coated tablets and sealed ampoules ensure there is no damage to the drug when:

exposed to light

What is the fastest route of action?

IV

What is meant by dosage form route?

how the medication is taken

ie: oral, topical, transdermal, vaginal, ocular

What is meant by dosage form?

solid, liquid, semi-solid, and gas

What is meant by dosage release rate?

fast action, conventional, sustained, pulsatile

Intra-respiratory dosage forms include:

aerosols, inhalants

Vagninal dosage forms include:

solutions, ointments, suppositories, aerosol foams, inserts

Intraocular/aural dosage forms include:

solutions, sprays, ointments

Oral dosage forms include:

tablets, capsules, powders, elixirs, syrups, suspensions

Sublingual dosage forms include:

tablets, troches, lozenges

Transdermal dosage forms include:

creams, ointments, powders, lotions, plasters, aerosols, patches

Rectal dosage forms include:

solutions, ointments, suppositories

Intended treatment with use of a drug depends on the:

dosage form

DDS stands for:

drug delivery system

Why are drugs expensive?

-takes about 10-15 years to develop one new medicine

-average cost is $800 million to $1 billion

-One drug from 5000-10000 compounds from research pipeline

Who is responsible for drug approval?

FDA

How long does the Pre-clinical research and development stage take?

3-6 years

Pre-clinical research and development stage assess:

safety and biological activity

What is the 1st stage of the drug approval process?

pre-clinical research and development

Investigational New Drug (IND)

a request from clinical study sponsor to obtain authorization from the FDA to administer an investigational drug or biological product to humans

How long does it take for the FDA to respond to the IND?

30 days

How many phases are there in clinical research and development?

3 phases

Clinical research and development takes about:

6-7 years

Clinical research and development begins with testing

healthy volunteers and moves into larger groups of patients

The main purpose of phase I in clinical research and development is assessing:

safety

The main purpose of phase II in clinical research and development is assessing

effectiveness

Phase II tests on:

several hundred patients with conditio for which drug is intended

Phase I tests on:

healthy volunteers

Phase III tests on:

several hundred to several thousand patients in controlled and uncontrolled clinical trials

The main purpose of phase III is:

gathering information on safety AND efficacy

How is phase III performed?

tests different dosages and strengths

What is a New Drug Application (NDA)?

gains permission to market the drug product in the US

The FDA must respond to the NDA within:

180 days of receipt of an application

When the FDA must respond to the NDA within 180 days of receipt, it is known as a/an:

review clock

Phase IV studies

-post marketing studies

-reveal additional information regarding side effects, serious and unexpected adverse effects, and/or drug interactions

What population is tested during pre-clinical testing?

laboratory and animal

What is an Abbreviated New Drug Application (ANDA)?

contains data that, when submitted to the FDA's Center for Drug Evaluation and Research, provides the review and ultimate approval of a generic drug product.

Why are generic drug applications called "abbreviated"?

they are generally not required to preclinical (animal) and clinical (human) data to establish safety and efficacy

Bioequivalent means:

performs in the same manner as the innovator drug

Supplemental New Drug Application (sNDA)

application submitted for an already approved NDA for any changes in packaging, labeling, dosages, ingredients, or new indications

Drug Master File (DMF)

a submission to the FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs

Black Box Warning

appears on a prescription drug label and is designed to call attention to serious or life-threatening risks

An outpatient medication is issued by:

a prescriber

An outpatient medication order contains:

-specific medication and dosage

-prepared and dispensed by a pharmacist

-for a specific patient

Superscription

RX symbol

Inscription

mediciation prescribed

Signa

directions to the patient

Subscription

dispensing instructions to the pharmacist

-ie: quantity, brand etc

What are the components of a valid prescription in CT?

-name and address of patient

-date the RX was issued

-name, dosage form, strength, quantity of medication

-directions for use

-refill information

-name and address of prescriber

-"wet" signature on all written RXs

-any required cautionary statements

"Wet" signatures are not required on:

electronic prescriptions

An inpatient medication order is issued by a:

prescriber

An inpatient medication order must be:

-dispensed to a healthcare provider (nursing unit, etc)

-to be administered to the patient by a nurse or other designated healthcare personnel in an inpatient setting

An inpatient medication order has ___________________ of what information must be included.

no legal requirements

What are the typical components of an inpatient medication order?

-patient name and location (unit, room, bed #)

-medical record number

-date and time of order

-generic name of medication

-dosage and dosage form to be dispensed

-route of administration

-frequency of administration

-other special instructions, as needed

Many pharmaceutical abbreviations are derived from:

Latin

Pharmaceutical abbreviations are to be used with:

extreme caution

What are examples of error prone abbreviations?

QD

QOD

HS

QID

AS

AD

AU

OU

OS

OD

TSP

SC

SQ

When translating the Signa into patient instructions for the label, always include:

-verb

-quantity

-dosage form

-route

-frequency

-modifier(s)

What is the formal definition of medication errors?

any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer

Medication errors are the most common in which step of patient care?

ordering/prescribing

_________________ and _________________ are added at every level to catch an error before it reaches the patient.

barriers and safeguards

Institute for Safe Medication Practices (ISMP)

gold standard for medication safety information, devoted to preventing medication errors

What are ways to reduce calculation errors?

-never use a trailing zero

-always use a leading zero

-leave space between numbers and its' units

-use whole numbers when possible

Hygroscopic

ability to absorb moisture from air

Excipients (Adjuvants)

solubilize, suspend, thicken, dilute, emulsify, preserve, color, and flavor medicinal agents into effective and appealing dosage forms

The drug and excipients must be ________________ with one another to produce a drug product that is stable and effective.

compatible

Drug substances are rarely administered alone; rather they are given as part of a _____________ in combination with one for more non-medicinal agents.

formulation

Why should solid dosage forms such as tablets and capsules be prepared with fillers or diluents?

so that the dosage unit is large enough to pick up with fingertips

Preformulation

the physicochemical (and some biological) characterization of an active pharmaceutical ingredient

Why is preformualtion important?

-minimizes problems in the larger stages of development

-reduces drug costs

-decreases product's time to market

A dosage is form is a:

drug formulation

Formulation

a specific combination of drug(s) and excipients

Dosage forms facilitate the administration of a drug by:

the appropriate route of administration

API+adjuvants=

formulation

The dispersed phase is the _____________ amount.

smaller

The dispersion medium is the _________ amount.

larger

Excipients can act as:

-viscosity-increasing agent

-lubricating agent

-diluting agent

-emulsifying agent

-coloring, flavoring, or preserving agents

Excipients such as antioxidants are added to:

prevent deterioration of product by oxidation

Excipients such as diluent (filler) are added to:

inert filler to create desired bulk or consistency of formulation

Excipients such as binder are added to:

cause adhesion to powder particles in tablets

Excipients such as lubricant are added to:

reduce friction during compression

Excipients such as disintegrant are added to:

promote disruption of the mass into small particles

Excipients such as humectant are added to:

prevent loss of moisture